JPS62164469A - Treatment after high pressure steam sterilization of liquid treatment apparatus - Google Patents

Treatment after high pressure steam sterilization of liquid treatment apparatus

Info

Publication number
JPS62164469A
JPS62164469A JP61006218A JP621886A JPS62164469A JP S62164469 A JPS62164469 A JP S62164469A JP 61006218 A JP61006218 A JP 61006218A JP 621886 A JP621886 A JP 621886A JP S62164469 A JPS62164469 A JP S62164469A
Authority
JP
Japan
Prior art keywords
pressure steam
pressure
buffer bag
steam sterilization
body fluid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
JP61006218A
Other languages
Japanese (ja)
Other versions
JPH0446590B2 (en
Inventor
脇田 稔夫
東 秀敬
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SB Kawasumi Laboratories Inc
Original Assignee
Kawasumi Laboratories Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kawasumi Laboratories Inc filed Critical Kawasumi Laboratories Inc
Priority to JP61006218A priority Critical patent/JPS62164469A/en
Publication of JPS62164469A publication Critical patent/JPS62164469A/en
Publication of JPH0446590B2 publication Critical patent/JPH0446590B2/ja
Granted legal-status Critical Current

Links

Abstract

(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。
(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

【発明の詳細な説明】 (産業上の利用分野) 本発明は、体液処理装置を高圧蒸気滅菌した後に、圧逃
げ用の緩衝袋を無菌的に切り離す方法に関するものであ
る。
DETAILED DESCRIPTION OF THE INVENTION (Industrial Application Field) The present invention relates to a method for aseptically separating a pressure relief buffer bag after high-pressure steam sterilization of a body fluid treatment device.

(従来技術及びその問題点) 人工腎臓、血漿分離処理装置、人工肺、人工肝臓等の体
液処理装置は、ケーシングの中に多数の中空糸膜を収納
し、その中空糸膜の両端部をウレタン等の固定部材で固
定するとともに、ケーシングの上下部に体液出入口を設
けた構造となっている。
(Prior art and its problems) Body fluid processing devices such as artificial kidneys, plasma separation processing devices, artificial lungs, and artificial livers house a large number of hollow fiber membranes in a casing, and both ends of the hollow fiber membranes are covered with urethane. It is fixed with a fixing member such as, and has a structure in which body fluid entrances and exits are provided at the upper and lower parts of the casing.

従来、このような体液処理装置を滅菌するにあたっては
、前記ケーシング内に生体に無害な生理食塩水、蒸留水
等を充填し、体液出入口。
Conventionally, when sterilizing such a body fluid treatment device, the casing is filled with physiological saline, distilled water, etc. that are harmless to living organisms, and the body fluid treatment device is closed to the body fluid inlet/outlet.

透析液出入口等の開口部を密栓した後、高圧蒸気滅菌す
る方法が一般的である。
A common method is to seal the opening, such as the dialysate inlet/outlet, and then sterilize it with high-pressure steam.

このような方法では、滅菌時、充填液か熱膨張し、ケー
シング等を破損するため、これを逃すための緩衝部材が
必要となる。
In such a method, during sterilization, the filling liquid thermally expands and damages the casing, etc., so a buffer member is required to release this.

この緩衝部材として、従来では前記開口部をゴム栓等で
密封し、内部圧力を吸収する方法(特公昭55−363
40号)や、rjij記!3)]1口の密封キャップに
緩衝袋を接続して膨張した論体をこの緩衝袋に移行させ
る方法(特開昭54−103297号)等が知られてい
る。
Conventionally, as this buffer member, a method of sealing the opening with a rubber plug or the like to absorb the internal pressure (Japanese Patent Publication No. 55-363
No. 40) and rjij! 3)] A method is known in which a buffer bag is connected to one sealing cap and the expanded liquid is transferred to the buffer bag (Japanese Patent Application Laid-open No. 103297/1983).

しかし、前者のゴム栓を密封する方法では、装置を密閉
系で滅菌するため、装舒内の空気が抜は出す、そのまま
残留するという問題がある。また、後者の緩衝袋を接続
する方法は、この袋内に装詮内の空気が抜は出るという
利点はあるが、滅菌後に緩衝袋を取りはずした際、密封
キャップ側にあいた緩衝製接続用の小孔を無菌的に閉塞
しなければならないという問題がある。
However, in the former method of sealing the rubber stopper, since the device is sterilized in a closed system, there is a problem that the air inside the device may escape or remain as it is. The latter method of connecting a buffer bag has the advantage that the air inside the package can be released into the bag, but when the buffer bag is removed after sterilization, the hole in the sealing cap side for the buffer connection There is a problem in that the ostium must be closed aseptically.

本発明は、特に後者の緩衝袋を接続する方法の問題点を
解決するために検討の結果提案されたものである。
The present invention was proposed as a result of studies, particularly in order to solve the latter problem of the method of connecting buffer bags.

(問題点を解決するための手段) 本発明は、体液処理袋はの内部に充填液を充填するとと
もに、該装置の口部を密封し、その密封口部に圧力緩衝
袋を接続した状態で高圧蒸気滅菌を行ない、前記充填液
の熱膨張を前記圧力緩衝袋で吸収する方法において、前
記体液処理装置の口部構成部材をポリカーボネート樹脂
と密着しない熱可塑性エラストマ樹脂材とするとともに
、前記圧力緩衝袋と前記口部密封部材を接続し、この状
態で高圧蒸気滅菌を行なった後、口部密封部材を溶着に
より切断するようにしたものである。
(Means for Solving the Problems) The present invention includes filling a body fluid processing bag with a filling liquid, sealing the opening of the device, and connecting a pressure buffer bag to the sealed opening. In the method of performing high-pressure steam sterilization and absorbing thermal expansion of the filling liquid with the pressure buffer bag, the mouth component of the body fluid treatment device is made of a thermoplastic elastomer resin material that does not come into close contact with polycarbonate resin, and the pressure buffer bag absorbs thermal expansion of the filling liquid. After the bag and the mouth sealing member are connected and high-pressure steam sterilization is performed in this state, the mouth sealing member is cut by welding.

一般にポリカーボネートに接続される熱可塑性エラスト
マーとして、ポリ塩化ビニル系エラストマー、スチレン
系エラストマー、ポリエステル系エラストマー、ポリウ
レタン系エラストマー、ポリオレフィン系エラストマー
等が考えられる。
Generally, examples of thermoplastic elastomers to be connected to polycarbonate include polyvinyl chloride elastomers, styrene elastomers, polyester elastomers, polyurethane elastomers, polyolefin elastomers, and the like.

しかし、ポリカーボネートとポリ塩化ビニル系エラスト
マー及びポリウレタン系エラストマーは高圧蒸気滅菌す
ると密着し、使用時に取りはずせなくなる。
However, when polycarbonate, polyvinyl chloride elastomer, and polyurethane elastomer are sterilized by high-pressure steam, they stick together and cannot be removed during use.

これに対し、スチレン系エラストマー、ポリエステル系
エラストマー、ポリオレフィン系エラストマーはポリカ
ーボネートに接続し、高圧蒸気滅菌を施しても密着する
ことはない。このため、本発明では、体液処理装置の口
部構成部材をポリカーボネートとした場合、その口部の
密封部材をスチレン系エラストマー、ポリエステル系エ
ラストマー、オレフィン系エラストマーとするものであ
る。
On the other hand, styrene-based elastomers, polyester-based elastomers, and polyolefin-based elastomers are connected to polycarbonate and do not adhere tightly even when subjected to high-pressure steam sterilization. Therefore, in the present invention, when the mouth component of the body fluid treatment device is made of polycarbonate, the sealing member of the mouth is made of styrene elastomer, polyester elastomer, or olefin elastomer.

また、コスト面、成形面から考えると、スチレン系エラ
ストマーかオレフィンエラストマーが良い。
In addition, from the viewpoint of cost and molding, styrene elastomer or olefin elastomer is preferable.

具体的には、スチレン系エラストマーとして、スチレン
−ブタジェン−スチレン共重合体Vd nYI 、  
スチレン−エチレン−ブチレン−スチレン共重合体樹脂
等であり、オレフィン系エラストマートシて、エチレン
ブロビレンゴムトPPのグラフト及びブレンド樹脂等で
ある。
Specifically, as the styrenic elastomer, styrene-butadiene-styrene copolymer Vd nYI,
These include styrene-ethylene-butylene-styrene copolymer resins, olefin elastomers, and graft and blend resins of ethylene brobylene rubber PP.

また、圧力緩衝袋と口部密封部材とを接続した場合、高
圧蒸気滅菌後、接続部に充填液が入り込む。接続部を溶
着して切断する方法として、熱シールや高周波ウェルダ
ー、超音波ウェルダーなどがあるが、使用する樹脂及び
接続部に充填液があることを考え合せテストしたところ
、超音波ウェルダーの方式が最も有効な方法であること
がわかった。
Moreover, when the pressure buffer bag and the mouth sealing member are connected, the filling liquid enters the connection part after high-pressure steam sterilization. Heat sealing, high-frequency welding, and ultrasonic welding are methods for welding and cutting connections, but when we tested the resin used and the presence of a filling liquid in the connections, we found that the ultrasonic welding method was the best. It turned out to be the most effective method.

本発明における体液処理装置とは、人工腎臓、血漿分離
処理装置、人工肺、人工肝臓等であり、これら装置の口
部とは、たとえば血液の出入口部、透析液出入口部等、
その装置の内部に通じる流体出入口部である。また、本
発明における圧力緩衝袋とは、バッグ状、風船状、チュ
ーブ状その他液体を収納できる形状のものであり、その
材質はポリ塩化ビニル、ポリプロピレン、天然ゴム、合
成ゴム等毒性がなく、高圧蒸気滅菌に耐えられるもので
あれば任意である。
The body fluid processing device in the present invention includes an artificial kidney, a plasma separation processing device, an artificial lung, an artificial liver, etc., and the mouth portion of these devices includes, for example, a blood inlet/outlet portion, a dialysate inlet/outlet portion, etc.
It is a fluid inlet/outlet portion leading to the interior of the device. In addition, the pressure buffer bag according to the present invention is a bag-like, balloon-like, tube-like, or other shape capable of storing a liquid, and is made of non-toxic materials such as polyvinyl chloride, polypropylene, natural rubber, synthetic rubber, etc. Any material can be used as long as it can withstand steam sterilization.

(実施例) 第1図は、本発明を中空糸型人工腎臓の高圧蒸気滅菌に
適用した場合の実施例を示したもので、ケーシング1内
にはたとえばセルロース系の中空糸膜が多数収納されて
おり(図示せず)、そのケーシング1の上部には血液入
口部2、下部には血液出口部3がそれぞれ固定リング4
.5により取付けられている。
(Example) Fig. 1 shows an example in which the present invention is applied to high-pressure steam sterilization of a hollow fiber artificial kidney. (not shown), the upper part of the casing 1 has a blood inlet part 2, the lower part has a blood outlet part 3, and a fixing ring 4.
.. It is attached by 5.

なお、ケーシング1の上側には透析液入口部6、下側に
は透析液出口部7が形成されている。
Note that a dialysate inlet portion 6 is formed on the upper side of the casing 1, and a dialysate outlet portion 7 is formed on the lower side.

本実施例では、前記ケーシング1、血液出入口部2.3
及び固定リング4,5は、ポリカーボネート材で作られ
ている。
In this embodiment, the casing 1, blood inlet/outlet portion 2.3
and the fixing rings 4, 5 are made of polycarbonate material.

こうした人工腎臓は、組立後、内部に生理食塩液等の充
填液が注入されるとともに、前記血液出入口部2,3及
び透析液出入口部6,7が密封栓8,9及び10.11
で密封される。この密封栓8〜工1は、高圧蒸気滅菌後
、ポリカーボネートとブロッキングを生じない熱可塑性
エラストマー樹脂のスチレン系エラストマで作られてい
る。
After assembly, such an artificial kidney is filled with a filling liquid such as physiological saline, and the blood inlet/outlet portions 2, 3 and the dialysate inlet/outlet portions 6, 7 are connected to the sealing plugs 8, 9 and 10.11.
sealed. The sealing plugs 8 to 1 are made of styrene-based elastomer, which is a thermoplastic elastomer resin that does not block with polycarbonate after high-pressure steam sterilization.

一方、図中12で示すものは、ポリ塩化ビニル製の圧力
緩衝袋であり、この圧力緩衝袋12にはポリ塩化ビニル
製の連通チューブ13が連結され、その連通チューブ1
3は、前記密封栓のいずれか1つ、たとえば血液出口部
3の密封栓9、に接続される。
On the other hand, 12 in the figure is a pressure buffer bag made of polyvinyl chloride, and a communication tube 13 made of polyvinyl chloride is connected to this pressure buffer bag 12.
3 is connected to any one of the sealing plugs, for example the sealing plug 9 of the blood outlet section 3.

本実施例では、第2図に示すごとく、密封栓9にチュー
ブ差込口9aを形成し、その差込口9aに連通チューブ
13の先端部を挿入し固定する。これらの固定方法は、
滅菌時に抜けない方式であれば良く、また連通チューブ
13の材質は高圧蒸気滅菌に耐えれば良い。
In this embodiment, as shown in FIG. 2, a tube insertion port 9a is formed in the sealing plug 9, and the distal end of the communication tube 13 is inserted and fixed into the insertion port 9a. These fixing methods are
Any method is sufficient as long as it does not come off during sterilization, and the material of the communication tube 13 only needs to withstand high-pressure steam sterilization.

この連通チューブ13は、密封栓9を血液出口部3に被
冠した後、接続してもよいが、あらかじめ連通チューブ
13に密封栓9を接続しておいてもよい。
The communication tube 13 may be connected after the sealing stopper 9 is placed on the blood outlet portion 3, but the sealing stopper 9 may be connected to the communication tube 13 in advance.

なお、前記圧力緩衝袋12には、あらかじめ、生理食塩
水等の充填液が所定量封入されており、緩衝袋12内の
空気が人工腎臓の内部に移行しないようにしている。
Note that the pressure buffer bag 12 is filled with a predetermined amount of a filling liquid such as physiological saline in advance to prevent air within the buffer bag 12 from moving into the interior of the artificial kidney.

本発明では、密封栓9に圧力緩衝袋12を接続した状態
で、日本薬局方による高圧蒸気滅菌(たとえば121℃
、20分間)を行なう。その際、人工腎臓の内部の充填
液が熱膨張すると、血液出口部3から連通チューブ13
を通って圧力緩衝袋12に移行する。
In the present invention, with the pressure buffer bag 12 connected to the sealing stopper 9, high-pressure steam sterilization according to the Japanese Pharmacopoeia (for example, 121° C.
, 20 minutes). At that time, if the filling liquid inside the artificial kidney expands thermally, it will cause the blood to flow from the blood outlet section 3 to the communication tube 13.
The pressure buffer bag 12 is transferred through the pressure buffer bag 12.

こうした滅菌処理を終えた後、常温まで放冷する。次い
で、たとえば第2図の点線で示したカット位置14を超
音波ウェルダによりシール力、トシ、圧力緩衝袋を切り
離すものである。
After completing this sterilization process, it is left to cool to room temperature. Next, the sealing force, the toe, and the pressure buffer bag are separated by using an ultrasonic welder at a cut position 14 indicated by a dotted line in FIG. 2, for example.

以上説明した実施例では、ケーシング1及び血液出入口
2,3をポリカーボネート材にしているが、いずれか一
方、たとえば血液出入口2.3をポリカーボネート樹脂
とし、密封栓8.9を高圧蒸気滅菌においてポリカーボ
ネート樹脂と密着しない熱可塑性エラストマーとするこ
とができ、その場合のケーシング1及び密封栓10.1
1の材質は任意である。
In the embodiment described above, the casing 1 and the blood inlet/outlet ports 2, 3 are made of polycarbonate material, but one of them, for example, the blood inlet/outlet port 2.3 is made of polycarbonate resin, and the sealing plug 8.9 is made of polycarbonate resin in high-pressure steam sterilization. The casing 1 and the sealing plug 10.1 may be made of a thermoplastic elastomer that does not adhere closely to the casing 1 and the sealing plug 10.1.
The material of 1 is arbitrary.

実験例1 ポリカーボネート樹脂で成形したブラットボート(血液
出入口)を用い、製品化し、高圧蒸気滅菌(121℃、
20分間)下での密封栓としての機能を調べた。その結
果を下表に示す。
Experimental Example 1 Using a blood boat (blood inlet/outlet) molded from polycarbonate resin, it was commercialized and sterilized using high-pressure steam (121℃,
The function as a sealing stopper was investigated under conditions (20 minutes). The results are shown in the table below.

第    1    表 実験例2 下表の条件で高圧蒸気滅菌後のスチレン系エラストマー
樹脂(スチレン−エチレン−ブチレン−スチレン共重合
体)のシール性テストを行なった。
Table 1 Experimental Example 2 A sealing property test of styrene elastomer resin (styrene-ethylene-butylene-styrene copolymer) after high-pressure steam sterilization was conducted under the conditions shown in the table below.

第    2    表 上表のごとく、シール部には充填液が入っていることか
ら、熱シールでは一定にシールできず、高周波ウェルダ
ーでは出力を上げても十分に溶着することはできなかっ
た。
As shown in the upper table of Table 2, since the seal part contains a filling liquid, it was not possible to achieve a constant seal using heat sealing, and sufficient welding could not be achieved using a high frequency welder even if the output was increased.

(効果) 以上説明したように、本発明によれば、体液処理装置に
充填液を充填し、密封口部に圧力緩衝袋を接続した状態
で高圧蒸気滅菌を行なう方法において、滅菌の際、密封
部材が口部に密着せず、使用時の取りはずしか容易とな
るとともに、滅菌後の圧力緩衝袋の切り離しが無菌的に
完全に封止されることになる。
(Effects) As explained above, according to the present invention, in a method of performing high-pressure steam sterilization with a body fluid treatment device filled with a filling liquid and a pressure buffer bag connected to the sealed opening, the sealed opening is sealed during sterilization. The member does not come into close contact with the mouth, and can only be easily removed during use, and the pressure buffer bag can be completely sealed aseptically when removed after sterilization.

【図面の簡単な説明】[Brief explanation of drawings]

第1図は本発明の詳細な説明するための概略図、第2図
は第1図のA部拡大図である。 図中1はケーシング、2は血液入口部、3は血液出口部
、6は透析液入口部、7は透析液出口部、8,9,10
.11は密封栓、12は圧力緩衝袋、13は連通チュー
ブである。 特許出願人 川澄化学工業株式会社 代理人 弁理士 西  野  茂  美第  1  図
FIG. 1 is a schematic diagram for explaining the present invention in detail, and FIG. 2 is an enlarged view of section A in FIG. 1. In the figure, 1 is the casing, 2 is the blood inlet, 3 is the blood outlet, 6 is the dialysate inlet, 7 is the dialysate outlet, 8, 9, 10
.. 11 is a sealing plug, 12 is a pressure buffer bag, and 13 is a communication tube. Patent applicant Kawasumi Chemical Industry Co., Ltd. Agent Patent attorney Shigeru Nishino Figure 1

Claims (1)

【特許請求の範囲】[Claims] 体液処理装置の内部に充填液を充填するとともに、該装
置の口部を密封し、その密封口部に圧力緩衝袋を接続し
た状態で高圧蒸気滅菌を行ない、前記充填液の熱膨張を
前記圧力緩衝袋で吸収する方法において、前記体液処理
装置の口部構成部材をポリカーボネート樹脂と密着しな
い熱可塑性エラストマ樹脂材とするとともに、前記圧力
緩衝袋と口部密封部材を接続し、この状態で高圧蒸気滅
菌を行なった後、前記圧力緩衝袋と口部密封部材の接続
部を溶着し切断することを特徴とする体液処理装置の高
圧蒸気滅菌後の処理方法。
While filling the inside of the body fluid treatment device with the filling liquid, the mouth of the device is sealed, and high-pressure steam sterilization is performed with a pressure buffer bag connected to the sealed opening, and the thermal expansion of the filling liquid is absorbed by the pressure. In the method of absorption using a buffer bag, the mouth component of the body fluid treatment device is made of a thermoplastic elastomer resin material that does not adhere to polycarbonate resin, the pressure buffer bag and the mouth sealing member are connected, and in this state high pressure steam is applied. A method for processing a body fluid processing device after high-pressure steam sterilization, characterized in that after sterilization, the connection between the pressure buffer bag and the mouth sealing member is welded and cut.
JP61006218A 1986-01-17 1986-01-17 Treatment after high pressure steam sterilization of liquid treatment apparatus Granted JPS62164469A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP61006218A JPS62164469A (en) 1986-01-17 1986-01-17 Treatment after high pressure steam sterilization of liquid treatment apparatus

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP61006218A JPS62164469A (en) 1986-01-17 1986-01-17 Treatment after high pressure steam sterilization of liquid treatment apparatus

Publications (2)

Publication Number Publication Date
JPS62164469A true JPS62164469A (en) 1987-07-21
JPH0446590B2 JPH0446590B2 (en) 1992-07-30

Family

ID=11632377

Family Applications (1)

Application Number Title Priority Date Filing Date
JP61006218A Granted JPS62164469A (en) 1986-01-17 1986-01-17 Treatment after high pressure steam sterilization of liquid treatment apparatus

Country Status (1)

Country Link
JP (1) JPS62164469A (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH03207366A (en) * 1989-11-04 1991-09-10 Fresenius Ag Method and apparatus for disinfecting medical unit
WO2015099015A1 (en) * 2013-12-27 2015-07-02 旭化成メディカル株式会社 Membrane module device, package body, liquid processing system, steam sterilization method, and system configuration method
EP3443994A1 (en) * 2017-08-17 2019-02-20 Gambro Lundia AB Method of sterilizing water-filled devices

Citations (1)

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Publication number Priority date Publication date Assignee Title
JPS54103297A (en) * 1978-01-31 1979-08-14 Teijin Ltd Method of thermally sterilizing artificial kidney

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS54103297A (en) * 1978-01-31 1979-08-14 Teijin Ltd Method of thermally sterilizing artificial kidney

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH03207366A (en) * 1989-11-04 1991-09-10 Fresenius Ag Method and apparatus for disinfecting medical unit
JPH0567304B2 (en) * 1989-11-04 1993-09-24 Fresenius Ag
WO2015099015A1 (en) * 2013-12-27 2015-07-02 旭化成メディカル株式会社 Membrane module device, package body, liquid processing system, steam sterilization method, and system configuration method
JPWO2015099015A1 (en) * 2013-12-27 2017-03-23 旭化成メディカル株式会社 Membrane module device, package, liquid processing system, steam sterilization method and system configuration method
US10384166B2 (en) 2013-12-27 2019-08-20 Asahi Kasei Medical Co., Ltd. Membrane module apparatus, packaging body, liquid treatment system, steam sterilization method and system constructing method
EP3443994A1 (en) * 2017-08-17 2019-02-20 Gambro Lundia AB Method of sterilizing water-filled devices
WO2019034714A1 (en) * 2017-08-17 2019-02-21 Gambro Lundia Ab Method of sterilizing water-filled devices
CN110997034A (en) * 2017-08-17 2020-04-10 甘布罗伦迪亚股份公司 Method for sterilizing water filling device
US11833258B2 (en) 2017-08-17 2023-12-05 Gambro Lundia Ab Method for sterilizing water-filled devices

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