RU2003136811A - Способ изготовления стерилизованного и тарированного медицинского устройства на основе биосенсора (варианты) - Google Patents
Способ изготовления стерилизованного и тарированного медицинского устройства на основе биосенсора (варианты) Download PDFInfo
- Publication number
- RU2003136811A RU2003136811A RU2003136811/15A RU2003136811A RU2003136811A RU 2003136811 A RU2003136811 A RU 2003136811A RU 2003136811/15 A RU2003136811/15 A RU 2003136811/15A RU 2003136811 A RU2003136811 A RU 2003136811A RU 2003136811 A RU2003136811 A RU 2003136811A
- Authority
- RU
- Russia
- Prior art keywords
- biosensor
- medical device
- sterilization
- sterilized
- medical devices
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/08—Radiation
- A61L2/081—Gamma radiation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/001—Enzyme electrodes
- C12Q1/004—Enzyme electrodes mediator-assisted
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T436/00—Chemistry: analytical and immunological testing
- Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
Claims (19)
1. Способ изготовления стерилизованного и тарированного медицинского устройства на основе биосенсора, заключающийся в том, что стерилизуют, по меньшей мере, одно медицинское устройство на основе биосенсора, которое содержит реагент биосенсора, для создания по меньшей мере, одного стерилизованного медицинского устройства на основе биосенсора, и после этого тарируют реагент биосенсора, по меньшей мере, одного стерилизованного медицинского устройства на основе биосенсора.
2. Способ по п.1, в котором на стадии стерилизации используют способ стерилизации облучением.
3. Способ по п.2, в котором на стадии стерилизации используют способ стерилизации гамма-излучением.
4. Способ по п.3, в котором на стадии стерилизации используют дозу гамма-излучения в пределах от 10 до 30 кГр.
5. Способ по п.1, в котором стадия стерилизации включает в себя стерилизацию медицинского устройства на основе биосенсора с реагентом биосенсора, который содержит специфический фермент для анализируемого вещества и медиатор.
6. Способ по п.5, в котором специфический фермент для анализируемого вещества содержит ПХХ, а медиатор содержит феррицианид.
7. Способ по п.1, в котором стадия стерилизации включает в себя стерилизацию медицинского устройства на основе биосенсора, содержащего реагент биосенсора, который включает в себя специфический фермент для анализируемого вещества и медиатор, и пристроенный ланцет.
8. Способ по п.7, в котором специфический фермент для анализируемого вещества содержит ПХХ, а медиатор содержит феррицианид.
9. Способ по п.1, дополнительно содержащий до стадии стерилизации стадию упаковывания, по меньшей мере, одного медицинского устройства на основе биосенсора.
10. Способ по п.1, в котором медицинское устройство на основе биосенсора содержит реагент, чья аналитическая способность значительно изменяется под воздействием облучения.
11. Способ по п.1, в котором на стадии стерилизации стерилизуют множество медицинских устройств на основе биосенсора для создания множества стерилизованных медицинских устройств на основе биосенсора и используют образец из множества стерилизованных медицинских устройств на основе биосенсора.
12. Способ изготовления стерилизованного и тарированного медицинского устройства на основе биосенсора, заключающийся в том, что выполняют сборку множества медицинских устройств на основе биосенсора, которые содержат реагент биосенсора, упаковывают медицинские устройства на основе биосенсора, тем самым создавая упакованные медицинские устройства на основе биосенсора, стерилизуют упакованные медицинские устройства на основе биосенсора с использованием способа стерилизации облучением, тем самым создавая множество стерилизованных, упакованных медицинских устройств на основе биосенсора, и после этого тарируют реагент биосенсора стерилизованных, упакованных медицинских устройств на основе биосенсора.
13. Способ по п.12, в котором на стадии стерилизации используют дозу гамма-излучения в пределах от 10 до 30 кГр.
14. Способ по п.12, в котором стадия стерилизации включает в себя стерилизацию медицинского устройства на основе биосенсора с реагентом биосенсора, который содержит специфический фермент для анализируемого вещества и медиатор.
15. Способ по п.14, в котором специфический фермент для анализируемого вещества содержит ПХХ, а медиатор содержит феррицианид.
16. Способ по п.12, в котором на стадии тарирования используют образец из стерилизованных, упакованных медицинских устройств на основе биосенсора.
17. Способ по п.12, в котором множество медицинских устройств на основе биосенсора представляет собой множество медицинских устройств с объединенными в одно целое биосенсором и ланцетом.
18. Способ по п.17, в котором медицинское устройство с объединенными в одно целое биосенсором и ланцетом представляет собой электрохимическое медицинское устройство на основе биосенсора.
19. Способ по п.17, в котором медицинское устройство с объединенными в одно целое биосенсором и ланцетом представляет собой фотометрическое медицинское устройство на основе биосенсора.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/324,933 | 2002-12-20 | ||
US10/324,933 US20040120848A1 (en) | 2002-12-20 | 2002-12-20 | Method for manufacturing a sterilized and calibrated biosensor-based medical device |
Publications (2)
Publication Number | Publication Date |
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RU2003136811A true RU2003136811A (ru) | 2005-05-20 |
RU2357759C2 RU2357759C2 (ru) | 2009-06-10 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
RU2003136811/15A RU2357759C2 (ru) | 2002-12-20 | 2003-12-19 | Способ изготовления стерилизованного и тарированного медицинского устройства на основе биосенсора (варианты) |
Country Status (16)
Country | Link |
---|---|
US (1) | US20040120848A1 (ru) |
EP (1) | EP1430831B1 (ru) |
JP (1) | JP2004219409A (ru) |
KR (1) | KR20040055647A (ru) |
CN (1) | CN100354009C (ru) |
AU (1) | AU2003270938A1 (ru) |
CA (1) | CA2453741A1 (ru) |
ES (1) | ES2528623T3 (ru) |
HK (1) | HK1064905A1 (ru) |
IL (1) | IL159389A (ru) |
MX (1) | MXPA03011949A (ru) |
NO (1) | NO20035649L (ru) |
PL (1) | PL364155A1 (ru) |
RU (1) | RU2357759C2 (ru) |
SG (1) | SG121846A1 (ru) |
TW (1) | TWI332394B (ru) |
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Cited By (2)
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CN110996794A (zh) * | 2017-08-18 | 2020-04-10 | 雅培糖尿病护理公司 | 与医疗装置的个体化校准和/或制造相关的系统、装置以及方法 |
CN110996794B (zh) * | 2017-08-18 | 2023-09-08 | 雅培糖尿病护理公司 | 用于校准医疗装置的方法及计算机系统 |
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CN1511590A (zh) | 2004-07-14 |
NO20035649D0 (no) | 2003-12-17 |
EP1430831B1 (en) | 2014-12-03 |
RU2357759C2 (ru) | 2009-06-10 |
AU2003270938A1 (en) | 2004-07-08 |
JP2004219409A (ja) | 2004-08-05 |
IL159389A0 (en) | 2004-06-01 |
US20040120848A1 (en) | 2004-06-24 |
ES2528623T3 (es) | 2015-02-11 |
CA2453741A1 (en) | 2004-06-20 |
NO20035649L (no) | 2004-06-21 |
TW200418429A (en) | 2004-10-01 |
EP1430831A1 (en) | 2004-06-23 |
TWI332394B (en) | 2010-11-01 |
IL159389A (en) | 2012-06-28 |
CN100354009C (zh) | 2007-12-12 |
KR20040055647A (ko) | 2004-06-26 |
PL364155A1 (en) | 2004-06-28 |
HK1064905A1 (en) | 2005-02-08 |
SG121846A1 (en) | 2006-05-26 |
MXPA03011949A (es) | 2005-04-11 |
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