FR3080473A1 - METHOD AND TOOL FOR MANUFACTURING AND / OR DESIGNING A DEVICE - Google Patents

Abstract

The present invention relates to a method and a tool for manufacturing / designing a device that must comply with at least a quality threshold Sq. From a collection of digital documents (D1, ... DN), we cut each document into data of constraints (dC11 ... dCnm), we identify links between the data of constraints, we introduce data of constraints (dco11, ...) corresponding to a selected constraint data, we introduce applicability data (dadc11, ... dadcnm) and we automatically select constraint data according to applicability data and operational constraints to constitute temporary constraints (C11, C21 ... Cnk) to be applied to the manufacture and then a rough draft of the device is produced from a technical specification and, from the edition, it is determined according to the state of manufacturing follow-up, quality data S1 that is compared with the quality threshold Sq to modify the blank, and / or modify the specifications.

Description

MANUFACTURING AND / OR DESIGN METHOD AND TOOL

OF A DEVICE.

The present invention relates to a process for manufacturing and / or designing a device, in particular a medical device and / or at least one of its constituents, which must comply with at least one determined manufacturing quality threshold.

It also relates to a tool implementing such a method.

The invention finds a particularly important although not exclusive application in the manufacturing and / or design field in which the manufacture and / or the use of the products obtained present a risk for goods or persons, in particular the operators of the manufacturer or end users of the device, as well as in areas where a high level of quality is required.

By way of example, the invention is particularly of great use in the fields of design and manufacture of equipment for medical use.

When making a new device, for example radiology, device design errors (concerning electromagnetic, electrical or other insulation, calibration of gauges and / or actuators, ...) or prototype design are sources of risk.

They can endanger the personnel and / or the equipment including the prototype itself, in particular during the tests, or even the practitioners or even the patients thereafter, for example by electrocution, irradiation, or overdose.

In general, the more late it takes to take into account bad designs, the more it implies difficulties in modifying the entire system, sometimes technically very complex, or even the impossibility of doing so in particular without significant financial consequences.

In addition, the placing on the market of these devices is conditioned by a rigorous analysis of all the sources of risk and their effects on patients or users.

It is therefore necessary to identify the risks and the constraints and to set up the stages of the manufacturing process making it possible to avoid these errors.

Processes of design / manufacture of a product are already known in which a preliminary draft relating to the product is elaborated, certain elements of which defining it are arranged in a hierarchical manner and are stored in a relational database.

These elements make it possible, from a performance value desired a priori, to build a service proposal document for the production of the product and then to produce it according to these constraints.

However, such methods have drawbacks.

They associate a theoretical performance value of the device manufactured with text elements but do not allow an a posteriori verification and / or technical identification of the real level of quality and / or the respect by the product obtained of assimilable regulatory and / or normative constraints. compliance with a series of steps or with technical characteristics with a view to a technical result allowing the desired security. They generate indeed only documents containing remarks elaborated ab initio and a priori without integrating thereafter the concrete stages going until obtaining the products.

In other words, these processes are static and do not allow dynamic determination and / or monitoring of manufacturing and / or design to reach the level of error reduction and / or quality envisaged as and when of realization / design.

They do not present flexibility and adaptability from one project to another or in case of amendment of said project. No re-use of even partial results is possible.

No measurement and / or analysis of the consequences and / or impacts, in particular risk analyzes, is possible.

The hierarchy which these processes deal with are structural hierarchies of the product to be obtained from the most generic (for example apartment building) to the most specific (for example window insulation) but no hierarchy, in particular of relevance, severity of consequences, priority of measures to be taken are not considered in their development / manufacturing process.

The present invention aims to provide a method and a tool that meet the requirements of practice better than those previously known, in particular in that it will allow the manufacture and / or design of a product integrating the management and measurement of quality data throughout the manufacturing and / or design process up to an acceptable threshold, modifiable and adaptable in real time, without the need for specific knowledge, in particular of the regulatory, normative or security environment of the field, while authorizing the generation of standard documentation or easily usable in particular by third parties including administrative authorities and containing in a hierarchy prescriptions and / or impact data directly associated with the product concerned, and therefore the technical effect of the latter on the environment and / or the user of said product.

With the invention, errors and / or omissions of application of constraints such as for example a standard are reduced, even harmful; which will facilitate on the one hand its safe use (for a patient for example), and on the other hand the manufacturing, called exhaustive, of the product that is to say without forgetting technical elements structurally concerning it

in a while record. As example 1'invention will allow for a user wish design and or make a device medical such as through example a

electrocardiograph, and having no experience in applying regulatory standards in the field, to carry out his study in five days / man against several weeks man / days with the methods of the prior art.

This saving in design time thus saves the time associated with the presentation of documentation suitable for use by certification bodies or marketing authorization allows, on the one hand, to devote during a project more time to reduce errors (in order to obtain technical results for an optimized product) and on the other hand accelerates the implementation

available goods products this mistletoe East particularly advantageous in the field of medical material • For this purpose 1'invention offers especially a

process for manufacturing and / or designing a device and / or at least one of its constituents which must comply with at least one defined manufacturing quality threshold, characterized in this way, from a collection of normative documents previously identified and hierarchically organized according to a series of data called hierarchy data, at least one impact data is generated forming a first set, the documents being in digital form, and the following steps having been carried out:

(step a) cutting each document from the collection of documents into constraint data and introducing these constraint data automatically by first calculation means in a first Bi database, (step b) identifying existing links, or not between said constraint data, said links being established as a function of the hierarchy data and automatic introduction, by second calculation means into a second database B ₂ , of so-called operational constraint data each corresponding to a selected constraint datum, weighted or not according to the existence of a link associated with said constraint, (step c) introduction into third means of calculating data called applicability data of at least a portion of said previously established normative documents, (step d) automatic selection of constraint data based on applicability and constraint data es operational contained in the base B ₂ , to constitute a list of so-called provisional constraints data to be applied to the manufacturing, (step e) association in a table with each so-called provisional constraint of the list of at least one impact datum which is specific to it, then called operational impact data, the set of operational impact data forming at least one second set called set of operational impact data,

- and (step f) edition of less a part (P ±) of the dataset impacts operational, process in which (step g) we make a draft of device from a specification technical Spec (step h) on determines to go of said

part of the second set of operational impact data, and as a function of the monitoring state of the production of the blank, a data of quality S ± which is compared to the determined quality of production threshold,

If the quality data is lower than the determined quality threshold, the draft of the device is modified, then step (h) is repeated until the quality threshold is reached or exceeded and / or its specifications are modified .

More particularly here is understood by:

- Quality data, a data representative of the ability of a set of intrinsic characteristics of a device to meet requirements. Thereafter any indication of quality will be directly or associated with quantitative data, for example boolean or percentage, constituting the quality data.

- Normative documents, a document containing a structured set of prescriptions, constraints, measures or tests relating to the manufacture and / or design of a product, and in particular documents presented as standards by at least one standardization body, public or private as for example the International Organization for Standardization, the French agency for standardization, the International Electrotechnical Commission or the World Wide Web Consortium.

- Impact data, a quantifiable or textual data, simple or organized (listing, table, or any heterogeneous association or not of data) whose failure to take into account has harmful or detrimental consequences for the outcome of a manufacture and / or design of a product in particular with regard to its performance and / or the risks it represents.

-Applicability data, a Boolean datum representing, for a constraint contained in a normative document or for the document itself, if for a particular technical field and / or for an intrinsic characteristic of a device, said constraint must be applied or not.

- Table, any associative collection of data, whether or not contained in a database, and which can be represented, for example, in the form of a table.

-State of monitoring the production of the blank, the progress of a manufacturing project and / or design of said blank and can be represented by quantifiable data, for example corresponding to a number of previous modification steps of the draft and / or its technical specifications.

In advantageous embodiments, use is also made of one and / or the other of the following provisions:

- the operational impact data include at least risk data linked to an operational constraint and / or test data to be carried out and / or quality indicator data which will therefore directly impact on the technical characteristics of the product obtained in particular as to its subsequent manipulation by a user;

- for at least part of the elements of the list L of temporary constraints, it is determined whether said constraint is respected or not by the device and for each quality data S ± according to the state of monitoring of manufacture, said data is formed of quality S ± by weighted summation of the number of elements respecting the corresponding provisional constraint;

hierarchy data is automatically generated from the numbering of the chapters and / or paragraphs of each normative document in the collection of documents;

each normative document of the collection of documents is divided into constraint data corresponding to a chapter or a paragraph or a sentence, constraint data which can for example be printed, such a division allowing physical access to this data easier for users ;

the identified links are assigned a value taken from the set of data (add, replace, modify) and / or a corresponding code;

the state of each data item is recorded in a non-volatile memory in at least one step from a) to

h);

- data are generated in real time;

- the database is hosted on a server accessible by entering a code via a telecommunication means.

The invention also relates to a tool implementing the method as described above.

It also relates to a tool for manufacturing and / or designing a device and / or at least one of its constituents which must comply with at least one threshold S _q of determined manufacturing quality, characterized in that it comprises:

a collection of digital normative documents determined and hierarchically organized according to a series of data called hierarchy data, means for generating at least one impact data forming a first set, means arranged for cutting out each document from the collection of documents in constraint data, first means of automatic introduction of this constraint data into a first database, said introduction means comprising first calculation means, means for identifying links existing or not between said data constraints, the first means of calculation being arranged to establish said links as a function of the hierarchy data, second means of automatic introduction comprising second means of calculation in a second database E> 2, first means of selecting data and so-called operational constraint data, each corresponding to a selected constraint datum, weighted or not depending on the existence of a link associated with said constraint, third means of introduction into third means of calculating data, said applicability data, of at least a portion of said documents previously established standards, second means for automatically selecting the constraint data according to the applicability data and operational constraints contained in the second database E> 2, arranged to constitute a list of so-called provisional constraint data to be applied to manufacturing, means of association in a table with each so-called provisional constraint of the list L at least one impact data which is specific thereto, then called operational impact data, all of the operational impact data forming at least a second set says set of operational impact data,

- means for editing at least part (P ±) of the set of operational impact data,

- at least partial means of manufacturing and / or designing the device, and, from a draft of the device from a technical specification S _peC r, means for determining from said part of the second set of data d operational impacts, and as a function of the monitoring state of the production of the blank, of a quality data S ±, fourth calculation means being arranged to compare said data of quality S ± with the quality threshold of determined manufacturing S _q and if the quality data Si is less than the determined quality threshold S _q , the manufacturing / design means modify the outline of the device and the means for determining a quality data S ± determine the data of quality Si + i as a function of the modified state of monitoring of the production of the blank and the fourth calculation means compare the data Si + i to S _q , by iteration, until the threshold is reached or exceeded S _q by Si + i and / or its specifications are modified.

The invention will be better understood on reading the following description of embodiments given below by way of nonlimiting examples. The description refers to the accompanying drawings in which:

Figure 1 schematically shows the flow of a method according to an embodiment of one invention.

FIG. 2 is a step diagram of a method according to an embodiment of the invention.

Figure 3 shows schematically a tool according to an embodiment implementing a method according to the invention.

FIG. 1 schematically shows the progress of a process leading to manufacturing (symbolized by a toothed wheel in the figure) and / or the design of a device 1 (symbolized by a three-dimensional part in the figure) and / or at least one of its constituents.

It may, for example and without limitation, be the manufacture of a medical device, or the cutting of a metal part or the manufacture of a carton box forming machine, or the design of a motor vehicle having to meet specifications.

Depending on the specifications of the device to be obtained, those skilled in the art will be able to adapt the mechanical or conceptual steps to be carried out by applying the steps of the method according to the invention.

In other words, it is understood that wanting to describe in more detail the other mechanical manufacturing and / or design steps would be too limiting, the manufacturing / design process according to the invention being applicable to numerous embodiments.

Subsequently, except where this will be expressly stated, the terms manufacturing and design (manufacturer and designer and user) will be used in an equivalent manner as both the device and the device.

The device or at least one of its components having to respect at least a quality threshold 2 (S _q ), at least said threshold S _q of manufacturing quality is determined (for example by the manufacturer or the end customer (snowman 3 on the figure)), in particular in view of the technical field and / or use of the device 1.

The quality threshold S _q is a digital datum which represents a set of performances expected from the various constituents of the device 1 with respect to technical criteria such as for example the risks of use.

The quality threshold S _q is a whole or real number, or a percentage, or any data comparable to another of the same kind.

The manufacturing quality threshold S _q is determined on the basis of commercial, technical, legal and / or regulatory constraints.

To ensure a certain level of quality, the device 1 must in fact meet these determined constraints.

They are for example contained (see upper part of FIG. 1) in the form of textual data in a collection 4 of normative documents 5 (Di ... D _n ) in digital form or adapted to be digitizable and identified before manufacture.

Their identification is done for example automatically by means 6 of reading and / or calculations (MCI) referenced 6 ′ and / or manually, by the manufacturer / designer and / or the user 3.

The normative documents 5 are for example taken from the published standards relating to the processes which indicate the procedures to be observed in particular quality, development, tests, validation, and the technical standards which indicate precisely the elements of design and the risks to be considered, such as for example electrical standards and / or biocompatibility risks.

For example, the collection 4 of documents 5 may include at least one general standard and at least one specific standard, whether or not mandatory.

Advantageously, the normative documents 5 (Di ... D _n ) of the collection 4 include subdivisions 7.

Subdivisions 7 can be through example of the sections, parts, chapters, paragraphs, under paragraphs, sentences or parties of sentences of document. Collection 4 of documents 5 (Di ... D _N ) East

hierarchically organized.

Each document (Di ... D _n ) thus comprises a data item 8 of hierarchy d _H i, d _H 2, -d _H N respectively associated with said document Di, D2, ... Di (link 9 in dashed line, where i GH and d _H i is the hierarchy data associated with Di).

The hierarchy data d _H i, d _H 2, -d _H N is for example digital and can be numeric or literal, or can be in the form of codes.

For example, there is an order relationship, even a total order in the collection of documents (For all i GH, D _{i +} i> Di, or ">" means document of higher hierarchy).

For example, the order relation corresponds to the comparison of digital data assigned to the documents according to the following criteria taken alone or in combination, namely the generic or particular characters of the said documents, their date of publication, their version number, of digital data assigned to documents according to the issuer of the standard, for example a document containing legal obligations will have data, called hierarchy data, associated with a value greater than that of a normative document which will have even associated hierarchy data of greater value than that of a customer specification document. The particular standards then have, for example, data corresponding to a hierarchy higher than that of the general standard.

In one embodiment, at least one subdivision 7 (Sn, Si2 S21, ...) of a normative document (Di ... D _n ) also includes associated hierarchy data (link with mixed line 10), namely d _H iSi, d _H iS2 „..

In the embodiment more particularly described here, each subdivision thus includes such data of hierarchy (d _H iSi, d _H iS2, „.) Which is for example equal in value to the value of the data of hierarchy 8 of the document D ± which contains said subdivision 7 or for example a specific hierarchy data item of _H iSj specific to the subdivision.

The hierarchy datum 8 is then associated with a complex datum therefore comprising, for example, a vector of subdata 11 of hierarchy (d _H iSi,

d _H iS ₂ , J corresponding every subdivision of document and / or at the value the given 8 document hierarchy himself. In d other words, for all 1 G H, for all j G H

d _H i corresponds to the hierarchy value of the document Di and d _H iSj corresponds to the hierarchy data of the j-th subdivision of the document D ±.

All of the hierarchy data (of the document or of the subdivisions 7 of the documents) is recorded in the same non-volatile memory 12 in which the normative documents of the collection 4 are also recorded.

In the method described here further, one generates (arrow 13) then for the device to manufacture at least one data item 15 (dijk) called impact or set 14 of said data items Ii, I2 ... IN ·

The impact data 15 (dijk) and the data sets 14 Ii, 12-I _N containing them are for example at least partially contained in the normative documents of collection 4 and are then identified therein and / or in their subdivision 7.

By way of example, one of said impact data 15 is extracted manually or automatically by the calculation means 6 ′ or from the memory 12 from said subdivisions.

For all pENetj GH, I _p corresponds to the set 14 of impact data of the normative document D _p , di _P j is the impact data 15 extracted from the j-th subdivision of said document.

The impact data therefore represents any data associated with the consequences and / or the risks of non-compliance with the corresponding constraints.

In one embodiment, the impact data comprises at least risk data linked to each other and / or test data to be carried out and / or quality indicator data.

They are for example risk data relating to the device in its design, and / or its manufacture and / or its use and / or include tests to be taken into account for its realization.

For example, for a constraint such as "Ensuring visibility by the user of a status indicator", an impact data item can be qualified:

- of “risk to be taken into account”, for example “Risk of use concerning an error in the state of the switches” and may be affected by the event frequency of “0.1”; and / or "design requirement", for example "the indicator must be bright"; and or

- “test to take into account”, for example “carry out a visibility test”; and / or "specification precision", for example "producing the indicators according to standard EN EN 60204-1".

The impact data is for example in quantifiable digital form and / or text.

The set 14 of the impact data 15 itself forms a first set 16 (Ei).

The set Ei is arranged to be recorded in a non-volatile manner on a digital medium, such as for example a database B ± (reference 17).

In one embodiment, a generic database 18 (lmp) is also used which comprises a previously formed association between the subdivisions of normative documents and the set (s) of impact (s) and / or data. (s) din ... di _n k associated impact (s).

During a new design / manufacturing project, after the identification of the normative documents applicable to the project, the first calculation means 6 ′ detect the presence of a normative document 5 in the collection 4 and consequently populate the base 17 of data (B ±) from the lmp database (arrow 19).

We then cut out (step a) of FIG. 2, into subdivisions 7 the normative documents 5 of the collection 4 of documents.

The subdivisions 7 correspond and / or include (mixed line arrow 20 in Figure 1) each at least one datum 21 known as of constraint d _c ij (for all (i, j) G dcij corresponds to the jth constraint datum of document D ±).

A constraint datum 21 is a textual datum comprising a description of an action to be carried out for the manufacture, possibly subject to conditions, for example “take into account other constraints or information”, “add an element”, “check a criterion ".

The division into subdivisions into constraint data 21 can be manual or automatic.

More precisely with reference to FIG. 2, and after cutting up, we introduce (always step a) for each document 5 of the collection 4, the data 21 of corresponding constraints, for example here again automatically, by the first means 6 ′ of calculation in a first Eh database.

The first calculation means 6 ′ are for example a personal computer with a MCI microprocessor known per se, and include a non-volatile memory hosting the first Efi database.

If the subdivisions include an associated numbering, for example if the documents in the collection of normative documents have been drafted in accordance with the requirements of the ISO / IEC Directives Part 2, seventh edition dated May 2016 (subsequently ISO / IEC Directives) , the data 8 of hierarchy d _H i between documents is determined, and the data 11 of hierarchy (d _H iSk) automatically from said numbering of the subdivisions, for example in chapters and / or in paragraphs, of each normative document of the collection of documents.

The numbering and / or the corresponding code also makes it possible to determine link information between two subdivisions 7 and / or between two data items 21 of constraints contained in said subdivisions 7.

In the same way, said numbering and / or the corresponding code also makes it possible to determine a value associated with the link information and corresponding to an action to be carried out by the link.

Thus, from and as a function of the hierarchy data 8, 11, each subdivision 7 having its own hierarchy data 11 associated with said subdivision 7, data 22 is then identified (step b), called link data between the different subdivisions 7 of the normative documents 5 and / or between the data 21 of constraints contained in said subdivisions (for all (a, b, c, d) GH ⁴ , L _abc d corresponds to the data item 22 of link between the b-th subdivision of ath document 5 and the d-th subdivision 7 of the c-th document 5, that is to say the data item 22 of link between the data items 21 of constraints d _Cab and d _Cc d ·

More precisely, the data 22 of links are digital data representing a link between two constraints and include on the one hand a reference (link information) to two data 21 of constraints or subdivisions 7 linked by said link and on the other hand a data 24 of action (value of the link) to be carried out with respect to said two data 21 of constraints.

Said link data 22 is established in digital form, manually or automatically, for example by second calculation means 23 (microprocessor MC2) and they are introduced into a link database B _l i (arrow 22 ').

For example, if the two normative documents are written in accordance with the ISO / IEC Directives, the numbering of the subdivisions 7 or of the grammatical entity containing it (title, chapter, section, paragraph ...) makes it possible to detect the existence of the link and automatically assign action data to it.

Note that between two data 21 constraints of two different documents 5 there may be a data link 22 or not.

The link action data can be text and / or a corresponding code, for example, the action data is taken from all the data

"Add" and / or "+ "(Eg Lih ₂ ); "Se substitutes "and / or " "(For example L1213) ; or "Modify" and / or " ~ " (for example L _xyza ). Data 8 of hierarchy allow through

comparisons to determine for two data 21 of constraints for which a datum 22 of link exists, which is the datum 21 of constraint which undergoes the action of link 22 and on the basis of which datum 21 of constraint.

The lowest hierarchy sub-data 11 corresponds to the data of constraint which is modified by the action of the link and the highest corresponds to the data of constraint constituting the modifying element of the first.

For example, for two data 21 with constraints dci j:

If the data d _C n is less than that of the data d _C i2 this implies that the link data Lm2 includes an action data "+" (25)

If the data d _C i2 is greater than that of the data d _C i3 this implies that the link data L1213 includes an action data “-” (26)

If the datum d _cxy is equal to that of the datum d _cza this implies that the link _datum L _xyza includes an action datum "~" (27).

We then generate (step b) a data item of constraint resulting from the link 22 or as a function of it, called data item 28 of operational stress d _coxy , and which comprises the data item of constraint (or subdivision 7) as modified by the action datum of the link 22 (d _C o _P k <means the constraint datum corresponding to the k-th constraint of subdivision 7 of the p-th document).

In summary, the constraint data 21 are therefore weighted or not according to the existence of a link 22 associated with said constraint.

The weighting can be binary, for example a coefficient 1 when the link exists and / or a value 0 otherwise. It may also include a weighting comprising more than two elements.

Finally, the operational constraint data are automatically introduced by the second computing means 23 (MC2) into a second database 29 of B2 data (arrow 29 ').

In one embodiment, the second calculation means 23 and the second base 29 (B2) are similar or identical respectively to the first calculation means 6 ′ and to the first database Bi.

So :

for the data item 25 of link Lm2, having the value “+” meaning “is added”, place (mixed line arrow 30) in the database 29, the data items 21 of constraints respectively dcu and dci2 become d _co ii and d _co i2 · for the data item 2 6 of link L1213, having the value "-" meaning "substitute" one places (arrow dashed line 31) only dci3 become d _co i3 · for the data item 27 of link L _xyza , having the value "~" Meaning "modify" we place (arrow dotted line 32) d _CO nmr a modified stress data between d _cxy and d _cza .

Then, for at least a portion of said normative documents (Di, D2 ... D _N ), we identify and introduce (step c) manually and / or automatically data 33 called applicability data (dai, .. . da _n ) (for all i GH, da ± corresponds to the data of applicability of the i-th document) in third means of calculations MC3.

The applicability data 33 represent the applicability or otherwise of a document 5 and / or of a subdivision 7 of said document 5 to the design / manufacture of the device 1.

They can be a Boolean data or a numerical code, for example a value "True" means "applies".

They can also be associated with a collection of specific applicability data corresponding to a subdivision 7.

In the case of subdivisions 7, each of them itself includes a data item 33 'of specific applicability associated dadcij (for all (i, j) GH ² , dadcij corresponds to the jth data of applicability of the 1st document) . Note that this applicability data of a subdivision 7 can by default be equal or equivalent to that of the normative document which contains it, or not.

The applicability data 33 (or 33 ′) can be determined for example by the manufacturer 3 (arrow 34) or can for example be determined automatically as a function of field of application data, for example from specifications 35 of the device 1 (arrow 36).

For example, the user 3 of the method directly introduces or points to specification data 35 (S _pec ) ·

For example, by analyzing the content of the specification data in a manner known per se, the first MCI calculation means 6 ′ determine at least one domain of use data corresponding to said specification data.

A database Bd _a (reference 74 in FIG. 3), for example recorded in memory 12, having been previously formed, and comprising an association between data of field of use (reference 76 symbolized by D _C Tij in FIG. 3) and data of applicability of a document, the first means 6 'of MCI calculations, recover according to the specific area of use data determined by the first means 6' of calculation, at least one data of applicability of a corresponding document.

For example, for a specification data item comprising “medical instrumentation domain”, the first calculation means 6 ′ (MCI) retrieve from the database Bda a list of documents whose applicability data have a value of “True” constituting the data 33 d specific applicability of the device manufacturing project 1.

Each document 5 thus thus includes at least one datum of applicability da ± of said document 5.

The method then comprises a step c in which the third calculation means 37 (MC3) recover and enter into a memory (not shown), manually or automatically said data 33 (and / or 33 ′ when they exist) of applicability ( arrow 40).

We then automatically select (step d) data 21 of constraints (d _C n, ... d _Cn m) according to data 33 'of specific applicability (dadcii, dadcnm) and data 28 of operational constraints (d _C oii, ···) contained in the database 29 of B2, to constitute a list 38 (L) of data 39 of so-called provisional constraints (Cn, C12 ... Cnk) to be applied to the manufacturing (For all (i, j) GH ² , Cij corresponds to the data d _CO ij) ·

By way of example, the third calculation means 37 MC3 verify the existence of operational data d _co ii in the base B ₂ (arrow 41).

If it is present, they look in their memory for the data 33 'of corresponding specific applicability dadcii · If its value is "true", they then introduce into the list L 38 the data 28 of operational constraint d _co ii as provisional data 39 Cu (arrow 42).

The list L 38 thus includes all of the data 28 of so-called provisional operational constraints (Cn, C12 ... C _n k) for example of a general normative document 5, modified as a function of the links 22 identified by the hierarchy data higher, for example specific standards. A list has thus been determined as a function of the applicability or not of each data item of operational constraint to form said set L of so-called provisional constraint data.

We then associate (step e in FIG. 2) in a table 43 (T) with each provisional constraint (Ou, C12 ... C _n k) of the list L 38 at least one datum 15 of impact which is specific to it (arrow 44).

Table 43 is a data organization by association arranged to be recordable on a digital medium such as for example a table T of a database, a table for example of spreadsheet software.

In one embodiment, the impact data 15 to be associated with each data item 39 of provisional stress is selected, for example manually, from the first set 16 (Ei).

In another embodiment, each data item 39 of provisional stress being previously associated with at least one data item 15 of impact of the first set 16 (Ei), and this prior association having been recorded digitally in a non-volatile manner, the components are automatically selected. impact data specific to each provisional constraint data.

For example, the indices of the provisional stress data 39 correspond to those of the impact data 15.

An i-th document 5 corresponds on the one hand to the set of j-th subdivisions (C ± j) and on the other hand to the set 14 of impact data Ι ±.

So to each C ± j corresponds the set I ± of impact data comprising the set of j-th data di _O ij.

Means 45 of association calculation can thus associate the impact data (arrow 46) and provisional stresses (arrow 47) in the table 43 (T) (arrow 44).

The impact data 15 thus associated are then called operational impact data 48 (dioll, dio! 2—) ·

More precisely the whole of the data 48 impacts operational (Dion, · diol2 ..) form at minus one second set 49 (E ₂ ) said together of the

operational impact data (arrow 50).

At least one part 51 (Pi) of the data set 48 of operational impacts data of the second set E2 is then edited (step f, FIG. 2) (arrow 52).

The edition can be in any form allowing the visualization by a user 3 of the data 48 of operational impacts, for example a printing on paper support by a printer known per se to those skilled in the art and / or a display on a means display connected to calculation means such as a computer screen.

The operational impacts of the second set E2 are shaped according to standards or models to obtain editable documents di _n l4, d ^ Is, d _i3 i2, di4li.

If a blank for the device has not yet been produced, a blank for the device is manufactured (step g, FIG. 2) from the technical specifications S _pec and from the materials and / or constituents 53 of said blank (arrows 54 and 55 ).

Here, of course, the manufacturing steps themselves are not detailed, which will depend on the product which one wishes to manufacture.

If it is a machine tool cutter, obtained by machining according to a determined process, or a automatic box forming machine from corrugated cardboard blanks at 60 strokes per minute, the person skilled in the art will adapt the manufacturing process according to the invention with specified specifications.

One then determines (under step hi of h, FIG. 2) by fourth calculation means 56 (MC4) a state data item for monitoring the production of the blank (arrow 57).

The tracking status data is for example a digital data, for example an integer, for example initialized to 0 for the design and / or the manufacture of the first blank and incremented with each modification of the design and / or the manufacture of 'a different draft.

It is then determined (in step h2 of h, FIG. 2) from said part (Pi) of the second set 49 (E2) of operational impact data, and according to the state of monitoring of the manufacture of the draft, data 58 of quality S ± (arrows 59 and 60).

Thus, with each iteration (i G H) of design and / or manufacture, data 58 of quality Si is associated.

The data 58 of quality S ± is a data of the same nature as the data 2 of threshold S _q of quality.

As an example, quality data can be a percentage, for example calculated to represent the number of operational impact data considered to be taken into account and / or resolved by the draft relative to the number of operational impact data. of the list E2, and / or of provisional constraint data considered as taken into account and / or resolved by the draft relative to the number of provisional constraint data of the list L, and / or for example of standards whose all the provisional constraint data and / or impact data have been taken into account and / or resolved by the device, in relation to the number of documents in the collection of normative documents.

In one embodiment (step 1, FIG. 2), the determination of the quality data includes an associated weighting and / or a calculation algorithm.

As an example of an algorithm, in the fourth calculation means 56 are associated with each provisional constraint data item in the list L, a multiplying coefficient (not shown) corresponding to the importance of respecting the impact data item for the determination of the quality data S ±.

In an embodiment for at least part of the elements of the list L of provisional constraints, said quality data S ± is formed (step i, FIG. 2) by weighted summation of the number of elements respecting the corresponding provisional constraint.

In another embodiment, imperative application constraints such as that contained in a mandatory standard are identified (step i, FIG. 2) in the set of provisional constraints of the list L and / or the Table T. arrow 61), and the calculation algorithm is arranged to return data of quality S ± for example zero or negative if at least one of said data is not satisfied.

We compare (test 62) (Tqual) iteratively to each manufacturing follow-up state, by the fourth 56 calculation means, identical or equivalent to the other calculation means, the quality data at the determined manufacturing quality threshold S _q and it is determined whether the quality data item Si is less than the determined quality threshold S _q .

Depending on the result of the comparison of the quality data S ± and the quality data S _q :

If the quality data S ± is greater than the quality threshold data S _q (arrow 63), then the device has reached the desired quality threshold (step j, FIG. 2).

Otherwise, the blank of the device is modified (step k, FIG. 2) (arrow 64), then one or more of the steps of step h are repeated by incrementing the data for monitoring the state of manufacture, determination of the part (P ±) of the second set E2, comparison of the quality data Si + i at the determined quality threshold S _q and this until the threshold S _{q is} reached or exceeded.

In one embodiment, the specifications of the device are modified (step k) and the process steps are reiterated accordingly (arrow 65).

In one embodiment, the state of at least one data item at at least one step of the process is recorded (step 1) in a non-volatile memory, for example fourth calculation means 56, for example all the data at each step.

As of course, the various electronic elements including memories, calculation means or any other are connected together (arrows) by means known per se to those skilled in the art such as in particular database, modem connection, internet or any other.

We will now describe an example of the use of a manufacturing and / or design tool according to embodiments of the invention, more particularly with reference to FIG. 3.

In the following, we will endeavor to use the same reference numbers to designate elements identical or similar to those already described, but this is not compulsory.

The manufacturer 66 wishes to start a project for the development of a device 1, for example a medical instrument, for example for the acquisition of biological data, for example an electrocardiograph.

The device comprises an architecture comprising for example electrical systems supplying and / or interconnecting different means (power electronics, control electronics), an information processing system, man-machine interface means, with the operator of measurement and / or with the patient.

The architecture and the various systems are described in a functional and / or technical manner in a document 35 of specifications S _pec ·

The manufacturer uses, for example, subcontractors for the design and / or manufacturing part of the device 1.

The manufacturer wishes to ensure for its customers a final level of quality of the device and / or at least one of its constituents.

The manufacturer then uses a tool 67 according to an embodiment of the invention.

The manufacturer sets for example a threshold 2 (S _q ) of overall quality for the device 1 and thresholds 68, 68 ', 68''(S _q i, S _q 2 ... S _qN ) of secondary qualities for each constituent of device 1, the design and / or manufacture of which has been entrusted at least partially to a subcontractor.

The manufacturer then forms threshold data 68 (S _q i) of complex quality formed for example of 100% compliance with the mandatory normative constraints and at least 85% of the non-mandatory normative constraints for one of the constituents.

It introduces this quality threshold 68 (S _q i) determined in first calculation means 6 ′ into the memory of a computer via a web application platform with secure access by password (arrow 70).

The manufacturer and / or a third party then identifies, on the basis of their experience, documents 71, 72, 73 containing requirements for the design and / or production of the device and / or its constituents.

By way of example, for the design of a medical device 1 subject to certification and / or operating or marketing authorization, the documents are normative and can be process standards such as the IEC 62366 standards ( reference 71) and 62366-1 (reference 72) relating to the suitability for use and / or the standard NE EN ISO 14971: 2013 relating to risk analysis (reference 73).

Technical standards can be, for example, IEC 60417-5011 (2002-10) and / or IEC 604175010 (2002-10).

In one embodiment of the invention, the tool 67 comprises a database 74 in which are associated with each standard a collection 75 of data 76 of domain of use (D _C th <· · DcTnk) associated with areas of applicability of the corresponding standard.

The user introduces into the first calculation means, via an interface 77, values, for example main characteristics of the development project, for example of design and / or manufacture of the device 1, constituting usage data, allowing by comparison and / or interpretation with the data 76 of constraints (arrow 78) to form by said means 6 'of calculations a request to recover a set of corresponding standards (arrow 79).

The first calculation means 6 ′ analyze the specifications and automatically detect, in a manner known per se, for example by semantic analysis techniques, usage data of the type “electrocardiographic device for acquiring medical data” and recover a collection of standards 71, 72, 73 with their corresponding applicability data.

The database 74 is recorded and / or hosted by the first calculation means 6 ′.

The interface is an application hosted by a server and operating according to the technology known per se to those skilled in the art under the name software as a service ("Software as a Service" in English).

For example, the databases are hosted on a server accessible by entering a code via a telecommunication means.

On a server 80 connected to one of the means 81 of communication on a network, for example internal or internet, the data are updated by the first means 6 'of calculations and accessible by other means 69, 82 of calculations, called client workstations, connected to said network.

The use of the connected server 80 makes it possible in particular to capitalize and / or pool the operations of dividing standards into subdivisions comprising constraints or directly into constraint data and / or the prior identification of impact data and / or their association to the breakdowns of standards.

The data can thus be updated and / or modified in the first database and passed on and / or available in real time or almost real time, for example within less than a minute, for example less than ten seconds for example a second, for at least one client station.

The normative documents having been identified and / or selected, the means 71, 72, 73 of calculations form a collection of digital normative documents.

The documents in the collection being documents from standards, they are hierarchically organized.

Standard 71 is a general standard and has the same hierarchical level, equal to that of general standard 73 and lower than that of specific standard 72 of the first order (standard number ending with "-1"), itself lower that of specific second-order documents, and so on, when there are any.

The first calculation means 6 ′ detect, thus from the number of the standard, the degree of hierarchy, and attribute a hierarchy datum of a value corresponding to each document.

The means 6 arranged to split each document (Di, ... D _N ) from the collection of documents into constraint data (d _C n, ... d _Cn m) are executed automatically or at the request of the user and manually selected in each normative document and / or by request in a database 83 of data B _doc in which is associated with each standard (Di, ... D _n ) a previously established collection 84, ... 84 'of data 85 , ... 85 '; 86 ... 86 'of corresponding constraints.

The database B _doc , digital, is reusable for each applicability of the standard to a project.

The tool also includes the first automatic input means comprising the first MCI means for calculating these stress data recovered in the first database B _d (directly from the calculation means (arrow 87) or indirectly by the base data B _doc (arrow 88).

By default, each constraint data is assigned a hierarchy data of the same value as that of the document that contains it.

By way of example, the tables below include examples of records of B _d of FIG. 1 in three columns, the first of which includes the data 8 of hierarchy D _h i of the document and in brackets the data 11 of hierarchy d _H iSj of the corresponding constraint data, the second an identifier or primary key (name of the constraint data), and the third the content of the 5 constraint data respectively for the IEC standard

60601-1 (TABLE 1) and one of its specific standards

IEC 60601-2-25 (TABLE 2)

Dhi (dmSi) dcn If a push button with bistable positions is used: - it must be marked with the symbol IEC 60417-5010 (2002-10) (see Table D.l, symbol 14); and - the status must be indicated by an indicator light placed nearby or by any other unambiguous means. Dh2 (dicSi) dc21 If a push button in the on position by maintained action is used: - it must be marked with the IEC symbol 60417-5011 (2002-10) (see Table D.l, symbol 15); or - the status must be indicated by an indicator light placed nearby; or - the status must be indicated by any other unambiguous means. dh3 (dmSi) DC31 A PROTECTIVE EARTH CONDUCTOR must be identified along its entire length with green-yellow insulation. Dh4 (dmSi) DC41 a) AN APPLIED PART which is specified in the ACCOMPANYING DOCUMENTS as suitable for direct cardiac application must be an APPLIED PART OF TYPE CF. b) AN APPLIED PART which includes a PATIENT CONNECTION intended to supply electrical energy or an electrophysiological signal to or from the PATIENT must be an APPLIED PART OF TYPE BF or an APPLIED PART OF TYPE CF.

c) AN APPLIED PART which is not covered by a) or b) must be an APPLIED PART OF TYPE B, an APPLIED PART OF TYPE BF or an APPLIED PART OF TYPE CF. Dh5 (dnsSi) DC51 When applicable, the MANUFACTURER must deal with the RISKS associated with the accuracy of controls and instruments within the RISK MANAGEMENT PROCESS.

TABLE 1

Dh4 (Dn4S2) DC42 The APPLIED PART must be an applied TYPE CF

TABLE 2

The manufacturer also determines the data sets 89, 89 'of impacts Τι, I2 ... forming the first set Ei.

The impact data can be arranged and / or formatted to be transmitted to a third party, for example a laboratory, administrative authority, and / or subcontractor, and retrieved from the base 18 of

data lmp in which is associated every given of constraint 90 and / or standard 91, a collection 92 of data 93 impacts.

The user introduces into the first means 6 ′ for calculating, via the interface, values, for example an impact type for example “Risk” and / or an addressee of an impact report, for example “certifying body” , retrieves a list of risk events associated with damage intensity if the event occurs and its probability of occurrence.

The tool also includes the means 94 for identifying the links contained in the first calculation means.

The link data are then identified by calculation or by a specific database, for example in a table 95 (Ti) of the first database Bi (arrow 96).

As an example, the table below includes an example recording of E> 2 in three columns, the first of which includes a reference to a constraint datum object of the link, the second includes the action datum contained in the link, and the third corresponds to a reference to a target constraint datum of the link (TABLE 3).

d _c 42 replaces d _c 41

TABLE 3

The hierarchy data d _H 4S2 being greater than the data d _H 4Si, the associated content of the constraint data d _C 4i is replaced by the content of the constraint data dc42.

A link data L4241 containing "Replaces" is automatically created and the operational constraint data then formed by modification by said link.

Thus "a) AN APPLIED PART which is specified in the ACCOMPANYING DOCUMENTS as suitable for direct cardiac application must be an APPLIED PART OF TYPE CF. b) AN APPLIED PART which includes a PATIENT CONNECTION intended to supply electrical energy or an electrophysiological signal to or from the PATIENT must be an APPLIED PART OF TYPE BF or an APPLIED PART OF TYPE CF. c) AN APPLIED PART which is not covered by a) or b) must be an APPLIED PART OF TYPE B, an APPLIED PART OF TYPE BF or an APPLIED PART OF TYPE CF. "Is replaced by" The APPLIED PART must be an applied part of TYPE CF ".

Operational constraints data (d _C oii, ···) are then automatically selected by the first calculation means 6 ′ and the manufacturer displays on a display means, for example from the client station 69, the list of constraints data. and can manually modify their applicability status and / or the associated applicability data.

The user introduces, via the interface, information elements allowing the calculation means to automatically determine the applicability of each constraint data item for the device considered.

This information could for example have already been entered at the time of the automatic determination of the collection of applicable normative document.

By way of example, the table below includes an example of registration of an applicability database and / or of all the applicability data introduced by the manufacturer, in three columns, the first of which comprises data d hierarchy, the second a reference to a constraint datum, the third includes the applicability datum for the development project of the device considered (TABLE 4).

d _H iSi dcn dadcii = applicable d _H 2Si dc21 dadc2i = not applicable dnsSi DC31 dadc3i = not applicable If d ^ DC41 dadc4i = applicable dnsSi DC51 dadcsi = applicable If d ^ DC42 dadc42 = applicable

TABLE 4

The tool includes the second means of automatic selection of the constraint data (dcii, ... dcnm) according to the applicability data (dadcii / · - dadcnm) and the operational constraints (dcoii / · ···) contained in B ₂ , arranged to constitute the list L of provisional stress data (Ch, Ci2 ... Cnk) to be applied to manufacturing.

By way of example, the table below includes an example of recording a list L, in two columns, the first of which includes provisional constraint data and the second includes the provisional constraint data in textual form (TABLE 5).

ch If a push button with bistable positions is used: - it must be marked with the symbol IEC 60417-5010 (2002-10) (see Table D.l, symbol 14); and - the status must be indicated by a nearby indicator light or by any other unambiguous means. cgi The APPLIED PART must be a applied part

TYPE CF C ₅₁ When applicable, the MANUFACTURER must deal with the RISKS associated with the accuracy of controls and instruments within the RISK MANAGEMENT PROCESS.

TABLE 5

We associate in table T with each provisional constraint (Cn, C12 ... C _n k) of list L at least one impact datum (Ii, Ii) which is specific to it (operational impact datum).

By way of example, the table below comprises a record of table T, in two columns 10, the first of which comprises the provisional stress data and the second of which includes the collection of impacts in textual form of operational impact data ( TABLE 6).

Cn Ii (dion): If a push button with bistable positions is used it must be marked with the symbol IEC 60417-5010 (2002-10) (see Table D.1, symbol 14 I2 (dio2i): If a push button with bistable positions is used, the status must be indicated by an indicator light placed nearby or by any other unambiguous means. c ₆₁ Ig (diogi): The applied part must be TYPE CF c ₅₁ I4 (dio4i): The MANUFACTURER must deal within the RISK MANAGEMENT PROCESS the RISKS associated with the precision of the controls and instruments. I ₅ (dio ₅₁ ): Dangerous phenomenon: Control devices Predictable sequence of events: poor precision of controls and instruments

TABLE 6

The tool includes all of the operational impact data forming at least the second set E2 of operational impact data.

As an example, the table below includes a record of a set E2, in two columns, the first of which includes a reference to operational impact data and the second of which includes in text form the value of the impact data operational (TABLE 7).

dion If a push button with bistable positions is used it must be marked with the symbol IEC 60417-5010 (2002-10) (see Table D.l, symbol 14 dio2i If a push button with bistable positions is used, the status must be indicated by an indicator light placed nearby or by other unambiguous means. diogi The applied part must be TYPE CF dio4i The MANUFACTURER must deal within the RISK MANAGEMENT PROCESS the RISKS associated with the precision of the controls and instruments. dio ₅ i Dangerous phenomenon: Control devices Predictable sequence of events: poor precision of controls and instruments

TABLE 7

The tool includes the means for editing the part (P ±) of the set of operational impact data E2.

The data, in particular the set of operational impact data, are available for display on a display means, as soon as they are generated by calculation means.

They are arranged to be printable on a printing device such as for example a printer known per se to those skilled in the art.

In one embodiment, the tool includes a collection and / or a report template database.

Depending on the data entered concerning the type of recipient, the calculation means generate a report according to the model in a manner adapted to the requirements of said recipient.

The tool comprises means 98 for manufacturing and / or at least partial design of the device.

For example, the manufacturing means comprise an assembly line, for example by automated robot.

In one embodiment, the manufacturing means comprise means 99 for measuring quality.

The quality measurement means are for example means for measuring a physical quantity. This physical quantity can be associated with data for verifying compliance with constraint data, for example provisional or operational.

By way of example, the measurement means may comprise an image sensor means, connected to calculation means and arranged to determine the distance between a switch and an associated indicator light.

Thus, the measurement means can determine whether the presence of the marking and its symbol recommended in the constraint data, for the push buttons, is respected or not.

The tool then includes technical specification S _pec from which a first draft of the device is made.

The tool comprises means for determining from the part (P ±) of the second set E ₂ of operational impact data, and as a function of the monitoring state of the production of the blank, a data of quality S ±.

The tool includes data on the number of iterations of the draft modifications.

The means of calculating the tool determine the quality data.

In one embodiment, the determination comprises an automatic qualification of at least one operational impact datum by the measurement means.

For example in FIG. 3, the measurement means 99 do not detect, at the first iteration, a compulsory marking.

The quality data generated is therefore, for example, of Si = 90% of the constraints observed.

The tool comprises the fourth calculation means (MC4) arranged to compare said quality data Si with the determined manufacturing quality threshold S _q i. The quality data Si is less than the determined quality threshold S _q i, the manufacturing / design means then modify the blank of the device by adding the missing marking by the manufacturing means 98.

The means for determining a quality datum determine the quality datum of the second iteration (1 = 2) S2 of the modified blank.

Depending on the modified state (i = 2) of the monitoring of the production of the blank and the fourth calculation means compare the data S2 to S _q i, by iteration.

S2 then being equal to 100%, the quality data reaches the threshold S _q i without the need to modify the specifications.

The quality threshold being exceeded, we then built, after modification, the electrocardioqraphic device which corresponds to the last modified draft and the manufacturer can for example present the reports edited by the publishing means to third parties for example certifier or authority administrative in the expected form and adapted to said third parties.

In one embodiment, the data are recorded as they are generated and a version of these saved at each step.

This made it possible to carry out only the modification of the device and recalculates the quality data after iteration without repeating the other steps.

Data is also generated in real time.

For example, in the case where a new device project would be implemented, or if the third party organization refused, for example, its authorization, it is possible with the tool to recover the manufacturing process in any state without having to start again the work undertaken.

For example, the applicable standards being the same, the breakdown does not have to be carried out with each project but only with each change of version of standards.

The electrocardiographic device is then manufactured with the tool on the basis of the data modified for at least one manufacturing step.

To facilitate understanding, a summary table of the main references used in the drawings 15 and / or any associated symbol is shown below:

Purpose of the reference Numbers from reference Reference symbol Device 1 Quality threshold 2; 68 ... 68 ' Sqz Sq] _... Sqn Snowman (Manufacturer or designer or end customer) 3; 66 Collection of documents 4 Normative documents 5; 71-73; 91 Di ... D _n Reading medium 6 First means of calculation 6 ' MCI Document subdivision 7 Yes ... S _pk Document hierarchy data 8 dm · dnN

Subdivision hierarchy sub-data 11 dHiSi ... dHkS _p Memory 12 Impact data set 14, 89, 89 ' Impact data 15 diii ... dijk First set of impact data 16 Ei Impact database 17 Bi Generic impact database 18 lmp Constraint data 21, 90 dcn ... d _C pk First constraint database Bi Link data 22 Lllll ... Lijkm Second means of calculation 23 mc ₂ Action data 24 Symbols: NULL Links database B _Li Constraint data operational 28 d-al. . . d-CopK Second operational constraint database 29 b ₂ Document applicability data 33 dai ... da _n Applicability data constraint specific 33 ' dadcii ... dadcnk Specification 35 Spec Third calculation means 37 mc ₃ Data list of 38 The

temporary constraints Constraints data provisional 39 Cn ... Cj _k Stress table provisional 43 T Calculation means Association 45 Impact data operational 48 d-ioll *** d.ionk Second set of operational impact data 49 e ₂ Parts of the second set of operational impact data 51 pi Fourth means of calculation 56 mc ₄ Quality data 58 Yes Tool according to an embodiment of the invention 67 Domain of use database 74 BDA Domain data of use 76 DcTll --- DcTnk Application interface 77 Server 80 Means of communication 81 Cut standards database 83 Bdoc Means of identification of link 94 Database table 95 Ti

specific links

As is obvious and as also follows from the above, the present invention is not limited to the embodiments more particularly described. On the contrary, it embraces all the variants thereof and in particular those where the first, second, third, or fourth means of calculation or the first and second databases and / or any other database 10 mentioned and / or the list L and / or the table T are completely or partially combined or split up and saved or hosted on different devices.

Claims (10)

1. A method of manufacturing and / or designing a device and / or at least one of its constituents which must comply with at least one threshold S _q of determined manufacturing quality, characterized in that, from a collection of normative documents previously identified and hierarchically organized according to a series of data called hierarchy data (d _H i ... d _H N) <at least one impact data (din ... dijk) is generated forming a first set Ei, the documents being in digital form, and the following steps having been carried out: (step a) cutting each document (Di, ... D _n ) from the collection of documents into constraint data (d _C n, d _C i 2 -, d _C 2i, d _C 22- d _Cn m) and introduction of these data automatically constrained by first means MCI of calculation in a first database Bi, (step b) identification of links Lun, Limjk existing, or no between said constraint data (d _C n, ... d _Cn m), said links being established as a function of hierarchy data (d _H i ..., d _H N) and automatic introduction, by second means MC2 of calculation in a second database B2, data called operational constraints (d _C oii, ...) each corresponding to a selected constraint data (dci2, ··· dcnm), weighted or not according to the existence of 'a link (Lnn ... L _nm jk) associated with said constraint, (step c) introduction into third means MC3 of calculating data called applicability data (dadcii, - dadcnm) of at least a portion of said documents standards (Di, D2 ... D _N ) previously established, (step d) automatic data selection of constraints (d _C n, ... d _cn m) according to the applicability data (dadcii, - dadcnm) and operational constraints (d _C oii, ···) contained in B2, to constitute a list L of data of so-called provisional constraints (Cn, C21 ... C _n k) to be applied to manufacturing, (step e) association in a table T with each so-called provisional constraints (Cn, C21 ... C _n k) of the list L at least one impact datum (din ... dijk) which is specific to it, then called operational impact datum, all the operational impact datum (di _O n, di _on k ···) forming at least one second set E2 says set of operational impact data, - and (step f) edition of less a part (P ±) of the dataset impacts operational E2, process in which (step g) we make a draft of device from a specification technical Spec (step h) on determines to go of said part (P ±) of the second set E2 of operational impact data, and as a function of the monitoring state of the production of the blank, a quality data S ± which is compared to the manufacturing quality threshold determined S _q , - If the quality data S ± is less than the determined quality threshold S _q , the blank of the device is modified, then step (h) is repeated until 1'atteinte or exceeding the threshold S _q and / or we changes its specifications. 2. Method according to the tion 1, characterized in that the data impacts operational (di _O n, di _on k ···) include at least risk data linked to an operational constraint and / or test data to be carried out and / or quality indicator data. 3. Method according to any one of the preceding claims, characterized in that for at least part of the elements of the list L of temporary constraints it is determined whether said constraint is respected or not by the device and for each quality data S ± as a function of the manufacturing follow-up state, said quality data S ± is formed by weighted summation of the number of elements respecting the corresponding provisional constraint. 4. Method according to any one of the preceding claims, characterized in that the hierarchy data (d _H i ..., d _H N) are automatically generated from the numbering of the chapters and / or of the paragraphs of each normative document from the collection of documents. 5. Method according to any one of the preceding claims, characterized in that each normative document from the collection of documents is divided into constraint data corresponding to a chapter or a paragraph or a sentence. 6. Method according to any one of the preceding claims, characterized in that the identified links (Mon, -, Lij _k i) are assigned a value taken from the set of data (adds; replaces; modifies) and / or a corresponding code. 7. Method according to any one of the preceding claims, characterized in that the state of each datum in at least one step from a) to h) is recorded in a non-volatile memory. 8. Method according to any one of the preceding claims, characterized in that the data is generated in real time. 9. Method according to any one of the preceding claims, characterized in that the database is hosted on a server accessible by entering a code via a telecommunication means. 10. Tool for manufacturing and / or designing a device and / or at least one of its constituents which must comply with at least one threshold S _q of determined manufacturing quality, characterized in that it comprises: a collection of digital normative documents determined and hierarchically organized according to a series of data called hierarchy data (d _H i ..., d _H N) r means for generating at least one impact datum (di _O n, di _on k ···) forming a first set El, means arranged to split each document (Di, ... D _n ) from the collection of documents into constraint data (d _C n, ... d _Cn m) , first means of automatic introduction of these constraint data into a first Bi database, said introduction means comprising first means MCI of calculation, means of identifying links (Lnu, ... Limki) existing , or not between said constraint data (d _C n, ... d _Cn m), the first calculation means being arranged to establish said links as a function of the hierarchy data (d _H i ..., d _H N) , second means of automatic introduction comprising second means MC ₂ of calculation in a second e database B ₂ , first means for selecting data and so-called operational constraint data (dcoii / · ···) each corresponding to a selected constraint datum (d _C n, ... d _Cn m), weighted or not according to the existence of a link (Mon ... L _nm ki) associated with said constraint, of the third means introductory in of the third means MC3 data calculation say applicability data (Dadcii. ... da _d cnm) of less a portion of said documents normative (Di, D ₂ ... D _n ) beforehand established second means for automatic selection of the constraint data (d _c ii, ... d _cn m) according to the applicability data (dadcii, dadcnm) and the operational constraints (d _C oii, ···) contained in E > 2, arranged to constitute a list L of data of so-called provisional constraints (Cn, C21 ... Cnk) to be applied to manufacturing, means of association in a table T with each so-called provisional constraint (Cn, C21 .. . C _n k) from the list L at least one impact datum (dadcii, dadcnm) which is specific thereto, then called operational impact datum, the set of operational impact datums (di _O n, di _O 2i ···) forming at least a second set E2 said set of operational impact data, means for editing at least part (P ±) of the set of operational impact data E2, - means of manufacturing and / or at least partial design of the device, - And, from a draft of the device from a technical specification S _pe c <means for determining from said part (P ±) of the second set E2 of operational impact data, and according to the state of monitoring the production of the blank, of a quality data S ±, fourth calculation means being arranged to compare said quality data S ± with the determined manufacturing quality threshold S _q and if the data of quality S ± is less than the determined quality threshold S _q , the manufacturing / design means modify the blank of the device and the means for determining a quality data S ± determine the quality data Si + i as a function of the modified state of the monitoring 5 of the manufacturing of the blank and the fourth calculation means compare the data Si + i to S _q , by iteration, until the threshold S _{q is} reached or exceeded by Si + i and / or modify its specifications.