JPS61244372A - Sterilization of body fluid treating apparatus - Google Patents

Sterilization of body fluid treating apparatus

Info

Publication number
JPS61244372A
JPS61244372A JP60086555A JP8655585A JPS61244372A JP S61244372 A JPS61244372 A JP S61244372A JP 60086555 A JP60086555 A JP 60086555A JP 8655585 A JP8655585 A JP 8655585A JP S61244372 A JPS61244372 A JP S61244372A
Authority
JP
Japan
Prior art keywords
body fluid
casing
fluid treatment
vaporization
sterilization
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
JP60086555A
Other languages
Japanese (ja)
Other versions
JPH0446589B2 (en
Inventor
耕二 宗
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 JP60086555A priority Critical patent/JPS61244372A/en
Publication of JPS61244372A publication Critical patent/JPS61244372A/en
Publication of JPH0446589B2 publication Critical patent/JPH0446589B2/ja
Granted legal-status Critical Current

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  • Apparatus For Disinfection Or Sterilisation (AREA)
  • External Artificial Organs (AREA)

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、人工腎臓、血漿分離処理装置その他の体液処
理装置の滅菌方法に関するものである。
DETAILED DESCRIPTION OF THE INVENTION (Field of Industrial Application) The present invention relates to a method for sterilizing artificial kidneys, plasma separation processing devices, and other body fluid processing devices.

(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
定し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 has a structure that is fixed with fixing members such as.

従来、このような体液処理装置を滅菌するにあたっては
、乾燥状態の中空糸膜をケーシング内に組み込み1体液
出入口やケーシングの透析液等の出入口を開放した状態
で直接高圧蒸気滅菌を行っていた。しかし、水は蒸発熱
が高いので水蒸気により膜が急激な熱をうけ、吸湿し、
滅菌後の乾燥過程における糸の収縮及び支持部材の陥没
、クラック等が生成し、膜機能が著しく低下するととも
に、体液処理装置自体が破損することもあった。
Conventionally, when sterilizing such a body fluid treatment device, a dry hollow fiber membrane was installed in a casing, and direct high-pressure steam sterilization was performed with the body fluid inlet/outlet and the dialysate inlet/outlet of the casing open. However, since water has a high heat of vaporization, the membrane receives rapid heat from the water vapor and absorbs moisture.
In the drying process after sterilization, shrinkage of the threads, depression of the support member, cracks, etc. occur, resulting in a significant decrease in membrane function and even damage to the body fluid treatment device itself.

このため、たとえば特開昭53−84394号や同53
−84395号で提案されているごとく、中空糸膜を収
納した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、開口部を密栓した後、高圧蒸気滅菌する方
法も知られている。この方法によると、膜機能低下の面
ではある程度解決されたが、滅菌時、充填液の膨張によ
る破損が問題となるため、これを逃すための緩衝部材(
11張性の栓、液入りバッグ等)が必要となり、製造工
程の能率が低下し、コストアップの原因となっていた。
For this reason, for example, JP-A-53-84394 and JP-A-53-84394
As proposed in No. 84395, it is also known to fill a casing containing a hollow fiber membrane with physiological saline, distilled water, etc. that is harmless to living organisms, seal the opening, and then sterilize it with high-pressure steam. There is. Although this method has solved the problem of membrane function deterioration to some extent, damage due to expansion of the filling liquid during sterilization is a problem, so a buffer member (
(11-tonic stopper, liquid-filled bag, etc.), which reduces the efficiency of the manufacturing process and increases costs.

本発明は、このような従来技術の問題点を解決するため
に提案されたものである。
The present invention was proposed to solve the problems of the prior art.

(問題点を解決するための手段) 本発明はケーシング内に中空糸膜や吸着剤等の体液処理
部材が収容された装置を滅菌するにあたり、前記体液処
理部材を低蒸発熱の有機物質と水の混合物によりウェッ
ト化した状態で高温加熱処理するものであり、さらには
ケーシング内部を減圧状態に維持して高温加熱処理する
ものである。
(Means for Solving the Problems) When sterilizing an apparatus in which a body fluid treatment member such as a hollow fiber membrane or an adsorbent is housed in a casing, the present invention provides a method for sterilizing the body fluid treatment member using an organic substance with a low heat of vaporization and water. The casing is wetted with a mixture thereof and subjected to high-temperature heat treatment, and furthermore, the inside of the casing is maintained in a reduced pressure state and high-temperature heat treatment is performed.

本発明における体液処理装置とは、具体的には人工腎臓
、血漿分離処理装置、人工肺、人工肝臓等である。また
ケーシング内に収容される体液処理部材とは中空糸膜や
吸着剤等であり、中空糸膜としては、セルロース系、ポ
リビニルアルコール系、ポリエステル系等が使用され、
その素材の限定はない。
Specifically, the body fluid processing device in the present invention includes an artificial kidney, a plasma separation processing device, an artificial lung, an artificial liver, and the like. In addition, the body fluid treatment member accommodated in the casing is a hollow fiber membrane, an adsorbent, etc., and the hollow fiber membrane is made of cellulose, polyvinyl alcohol, polyester, etc.
There are no restrictions on the material.

中空糸膜の場合、その束はケーシング内に収容され、両
端部がウレタン樹脂等の支持部材によって固定されてい
る。また一方の端部には体液導入口が設けられ、他方の
端部には体液導出口が設けられるとともに、前記ケーシ
ングには、たとえば透析液の出入口や排液の出口等が設
けられている。
In the case of hollow fiber membranes, the bundle is housed in a casing, and both ends are fixed by supporting members such as urethane resin. Further, a body fluid inlet is provided at one end, a body fluid outlet is provided at the other end, and the casing is provided with, for example, a dialysate inlet/outlet, a drainage outlet, and the like.

本発明における蒸発熱の低い有機物質としては、エチル
アルコール、イソプロピルアルコールの外、n−プロピ
ル、n−ブチル、n−ペンチル、n−ヘキシル、n−ヘ
プチル、n−オクチル、イソブチル、5ec−ブチル、
tert−ブチル、インペンチル、活性アミル、ter
t−ペンチル、シクコベンタノール、シクロヘキサノー
ル、アリルアルコール、クロチルアルコール、メチルビ
ニルカルビノール、ニチレングリコール、プロピレング
リコール、1.3−プロパンジオール、グリセリン等が
あり、膜を劣化させず人体に無害の殺菌性を有するもの
であればよい。
Examples of organic substances with low heat of vaporization in the present invention include ethyl alcohol, isopropyl alcohol, n-propyl, n-butyl, n-pentyl, n-hexyl, n-heptyl, n-octyl, isobutyl, 5ec-butyl,
tert-butyl, impentyl, activated amyl, tert
These include t-pentyl, cyclobentanol, cyclohexanol, allyl alcohol, crotyl alcohol, methyl vinyl carbinol, nitylene glycol, propylene glycol, 1,3-propanediol, glycerin, etc., and are harmless to the human body without degrading the membrane. Any material may be used as long as it has bactericidal properties.

また、有機物質の濃度はその種類により異なるがエチル
アルコール又はイソプロピルアルコールの場合70 v
 / v%〜95 v / v%とするのが好ましい、
その理由は、95 v / v%のアルコール分のみで
は充分に滅菌できず、70v/V%以下では蒸発熱が水
の影響により大きくなるため膜が劣化しやすい、したが
って、膜機能低下がなく滅菌が充分可能な70 v /
 v%〜95v/v%の範囲が好ましい。
In addition, the concentration of organic substances varies depending on the type, but in the case of ethyl alcohol or isopropyl alcohol, it is 70 v.
/v% to 95 v/v%,
The reason for this is that alcohol content of 95 v/v% alone cannot sterilize sufficiently, and if the alcohol content is less than 70 v/v%, the heat of evaporation increases due to the influence of water, which tends to cause the membrane to deteriorate. 70v/
A range of v% to 95v/v% is preferred.

前記低蒸発熱有機物の水溶液で体液処理部材をウェット
化するためには、通常、その水溶液を体液導入口から中
空糸膜等の体液処理部材内に注入する。その注入量は体
液処理部材を湿潤させる程度の量、たとえば5〜100
m1とする。その注入方法は、中空糸膜の外側すなわち
ケーシング内に注入してもよく、ハウジング、中空糸、
ウレタン(膜の固定部)全体にゆきわたる方法であれば
良い。
In order to wet the body fluid treatment member with the aqueous solution of the low heat of vaporization organic substance, the aqueous solution is usually injected into the body fluid treatment member such as a hollow fiber membrane through the body fluid inlet. The injection amount is an amount that wets the body fluid treatment member, for example, 5 to 100
Let it be m1. The injection method may be injection into the outside of the hollow fiber membrane, that is, into the casing;
Any method that covers the entire urethane (membrane fixing part) is fine.

また本発明では、ケーシング内部に存在する空気及び体
液処理部材内に存在する空気を体液導入口とケーシング
開口部から真空吸引し、内部をたとえば30 i+mH
g以下の減圧状態に維持しておく、これにより、高圧蒸
気滅菌時の空気の熱膨張を防いでいる。
Further, in the present invention, the air existing inside the casing and the air existing inside the body fluid treatment member are vacuum-suctioned from the body fluid inlet and the casing opening, and the inside is heated to a temperature of, for example, 30 i+mH.
This prevents thermal expansion of the air during high-pressure steam sterilization.

なお、前記体液導入口やケーシングの開口部はシリコー
ンゴム等の弾性ボールを組み込んだ栓で封止されており
、前記水溶液の注入や、真空吸引は、この栓にシリンジ
の針を刺し込んで行なうとよい。
Note that the body fluid inlet and the opening of the casing are sealed with a plug incorporating an elastic ball such as silicone rubber, and injection of the aqueous solution and vacuum suction are performed by inserting a syringe needle into the plug. Good.

本発明において高圧蒸気滅菌をするに当っては、低蒸発
熱有機物水溶液が注入され、内部が減圧された体液処理
装置を、通気部を有する包装容器(たとえばポリプロピ
レン製)に封入し、通常100〜130℃の高圧蒸気中
で5〜30分間加熱処理をする。その後、室温にもどし
、袋ごしに栓を開けて体液処理装置内部を常圧にもどし
た後、体液処理装置の内部と中空糸膜に残存している有
機物水溶液を真空乾燥して除去させるものである。
In performing high-pressure steam sterilization in the present invention, a body fluid treatment device in which a low heat of vaporization organic substance aqueous solution is injected and whose interior is depressurized is enclosed in a packaging container (for example, made of polypropylene) having a ventilation section. Heat treatment is performed in high pressure steam at 130°C for 5 to 30 minutes. After that, the temperature is returned to room temperature, and the inside of the body fluid treatment device is returned to normal pressure by opening the stopper through the bag, and then the organic aqueous solution remaining inside the body fluid treatment device and the hollow fiber membrane is removed by vacuum drying. It is.

(実施例1) 第1図に示すごとく、中空糸型人工腎臓(セルロース系
中空糸ll5I)の血液導入口l、血液導出口2、透析
液人口3、透析液出口4をそれぞれ第2図に示すような
シリコーンゴム製ポール5を組み込んだ栓6で密封した
。′その後、血液導入口lからシリンジにより70%、
80%、90%のエチルアルコール水溶液を中空糸膜内
部へ注入し、その中空糸膜を湿潤状態にした。
(Example 1) As shown in Figure 1, the blood inlet 1, blood outlet 2, dialysate port 3, and dialysate outlet 4 of the hollow fiber artificial kidney (cellulose-based hollow fiber 115I) are shown in Figure 2. It was sealed with a stopper 6 incorporating a silicone rubber pole 5 as shown. 'Then, use a syringe from the blood inlet l to 70%,
80% and 90% aqueous ethyl alcohol solutions were injected into the hollow fiber membrane to make the hollow fiber membrane wet.

なお、エチルアルコールは蒸発熱が200cal/g 
 (水は540 cal/g )である。
Furthermore, the heat of vaporization of ethyl alcohol is 200 cal/g.
(Water is 540 cal/g).

次に、血液導入口lと透析液入口3に真空ポンプと接続
した針7.7を穿入し、中空糸膜とケーシング側の両方
から真空吸引することにより1人工腎臓の内部を30 
iueHg程度の減圧状態に維持した。その後、前記人
工腎臓を、下記第1表〜第3表の条件の高圧蒸気中で加
熱処理した。それぞれのエチルアルコール濃度における
生存菌を測定し、生存曲線を作成しD値(Decima
l  peduction  value )を求めた
。これを第3図〜第5図に示す。
Next, a needle 7.7 connected to a vacuum pump is inserted into the blood inlet 1 and the dialysate inlet 3, and vacuum suction is applied from both the hollow fiber membrane and the casing side, so that the inside of the artificial kidney 1 is removed for 30 minutes.
The vacuum state was maintained at approximately 1.5 mph. Thereafter, the artificial kidney was heat-treated in high-pressure steam under the conditions shown in Tables 1 to 3 below. The viable bacteria at each ethyl alcohol concentration was measured, a survival curve was created, and the D value (Decima
l peduction value ) was calculated. This is shown in FIGS. 3 to 5.

なお、第3図は第1表、第4図は第2表、第5図は第3
表に対応するものである。
Furthermore, Figure 3 is based on Table 1, Figure 4 is based on Table 2, and Figure 5 is based on Table 3.
It corresponds to the table.

同実施例に示すごとく、エチルアルコール水溶液でウェ
ット化した状態で高温加熱滅菌をすれば、低温域でも充
分な滅菌効果が得られることがわかる。また本実施例で
は、エチルアルコール濃度が70%になると、やや膜の
性能低下がみられたが、実用には支障はなく、膜性能も
満足のいくレベルに維持できた。さらにケーシングにも
クラック等の発生はみられなかった。
As shown in the same example, it can be seen that sufficient sterilization effect can be obtained even in a low temperature range by performing high temperature heat sterilization in a wet state with an ethyl alcohol aqueous solution. Further, in this example, when the ethyl alcohol concentration reached 70%, a slight decrease in membrane performance was observed, but this did not pose a problem in practical use, and the membrane performance was maintained at a satisfactory level. Furthermore, no cracks or the like were observed in the casing.

(実施例2) 上記人工腎臓の各部1,2,3.4を開放状態にし、中
空糸膜が外気と通じる状態にしておいて、この人工腎臓
を通気性のある背貼付包装袋に封入し、高圧蒸気滅菌釜
に入れ、約110℃の85%アルコール水溶液の高圧蒸
気で30分間滅菌処理を行なった。この場合、アルコー
ル水溶液の高圧蒸気は背貼りの部分から人工腎臓内部に
侵入し、ハウジング内部、中空糸膜を完全にウェット化
することになる。その結果。
(Example 2) Each part 1, 2, 3.4 of the artificial kidney was left open so that the hollow fiber membrane could communicate with the outside air, and the artificial kidney was sealed in a breathable back-attached packaging bag. The sample was placed in a high-pressure steam sterilization pot and sterilized with high-pressure steam of an 85% alcohol aqueous solution at about 110° C. for 30 minutes. In this case, the high-pressure vapor of the alcohol aqueous solution enters the inside of the artificial kidney from the backing part and completely wets the inside of the housing and the hollow fiber membrane. the result.

満足できる滅菌効果が得られ、また各口部が開放状態に
あることから、内部空気の熱膨張による膜性能の低下、
ケーシングの破損もみられなかった。また、透析効率も
実施例1と同様に、はとんど低下はみられなかった。
Satisfactory sterilization effects are obtained, and since each opening is open, there is no reduction in membrane performance due to thermal expansion of internal air.
No damage to the casing was observed. Further, as in Example 1, no decrease in dialysis efficiency was observed.

(効果) 以上の実施例にみちれるように、本発明によれば1体液
処理装置を高温加熱滅菌するに際し、支持部材に固定さ
れた中空糸膜等の性能を低下させることなく、従来の高
圧蒸気滅菌より短時間で、しかも低温にて滅菌すること
ができ、効率的な滅菌処理が可能となる。また、従来の
ごとく、ケーシングの口部等に内部充填液の圧逃げ用の
緩衝部材を設ける必要がなくなるため、製造工程の省力
化、コストダウンが可能となる等のすぐれた効果が得ら
れることになる。
(Effects) As can be seen in the above embodiments, according to the present invention, when sterilizing a body fluid treatment device at high temperature, it is possible to sterilize a body fluid treatment device using conventional high pressure without deteriorating the performance of the hollow fiber membrane fixed to the support member. It can be sterilized in a shorter time than steam sterilization and at a lower temperature, allowing for efficient sterilization. In addition, unlike in the past, it is no longer necessary to provide a buffer member at the mouth of the casing to relieve the pressure of the internally filled liquid, resulting in excellent effects such as labor saving and cost reduction in the manufacturing process. become.

第  l  専 (噂J 処理温度:110℃    真空度:30mHg   
加水条件:9o%EtOH:115℃        
            20■lレコ目加水条件70
%EtO)1,20鰭1その他は第1表と同じ備考=9
0%EtOHに同じ 第  3  表 開目加水条件8096EtOH、20fi1その他は第
1表と同じ
Part I (Rumor J) Processing temperature: 110℃ Vacuum degree: 30mHg
Water addition conditions: 9o% EtOH: 115°C
20■l water addition condition 70
%EtO) 1,20 Fin 1 Others are the same as Table 1 Notes = 9
Same as 0% EtOH Table 3 Open water addition conditions 8096EtOH, 20fi1 Others are the same as Table 1

【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体液処理装置の
概略図、第2図は本発明における口部の密封栓の構造を
示す断面図、第3図〜第5図は本発明の実施例における
菌生存曲線である。 図中、lは血液導入口、2は血液導出口、3は透析液入
口、4は透析液出口、5は弾性ボール、6は栓である。
Fig. 1 is a schematic diagram of a body fluid treatment device for explaining the present invention in detail, Fig. 2 is a sectional view showing the structure of the mouth sealing plug of the present invention, and Figs. It is a bacterial survival curve in an example. In the figure, 1 is a blood inlet, 2 is a blood outlet, 3 is a dialysate inlet, 4 is a dialysate outlet, 5 is an elastic ball, and 6 is a stopper.

Claims (5)

【特許請求の範囲】[Claims] (1)体液処理部材がケーシング内に収容された装置を
滅菌するにあたり、前記体液処理部材を低蒸発熱の有機
物質と水の混合物によりウエット化した状態で高温加熱
処理することを特徴とする体液処理装置の滅菌方法。
(1) When sterilizing a device in which a body fluid treatment member is housed in a casing, the body fluid treatment member is wetted with a mixture of an organic substance with a low heat of vaporization and water and subjected to high temperature heat treatment. Sterilization method for processing equipment.
(2)体液処理部材がケーシング内に収容された装置を
滅菌するにあたり、前記体液処理部材を低蒸発熱の有機
物質と水の混合物によりウエット化し、かつケーシング
内部を減圧状態に維持して高温加熱処理することを特徴
とする体液処理装置の滅菌方法。
(2) When sterilizing a device in which a body fluid treatment member is housed in a casing, the body fluid treatment member is wetted with a mixture of an organic substance with a low heat of vaporization and water, and the inside of the casing is maintained at a reduced pressure state and heated at high temperature. 1. A method for sterilizing a body fluid treatment device.
(3)低蒸発熱の有機物質がエチルアルコールであるこ
とを特徴とする前記第1項または第2項記載の発明。
(3) The invention according to item 1 or 2 above, wherein the organic substance having a low heat of vaporization is ethyl alcohol.
(4)低蒸発熱の有機物質がイソプロピルアルコールで
あることを特徴とする前記第1項または第2項記載の発
明。
(4) The invention according to item 1 or 2 above, wherein the organic substance having a low heat of vaporization is isopropyl alcohol.
(5)低蒸発熱の有機物質の濃度が70v/v%〜95
v/v%であることを特徴とする前記第1項または第2
項記載の発明。
(5) The concentration of organic substances with low heat of vaporization is 70v/v% to 95%
The first term or the second term is characterized in that it is v/v%.
The invention described in Section 1.
JP60086555A 1985-04-24 1985-04-24 Sterilization of body fluid treating apparatus Granted JPS61244372A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP60086555A JPS61244372A (en) 1985-04-24 1985-04-24 Sterilization of body fluid treating apparatus

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP60086555A JPS61244372A (en) 1985-04-24 1985-04-24 Sterilization of body fluid treating apparatus

Publications (2)

Publication Number Publication Date
JPS61244372A true JPS61244372A (en) 1986-10-30
JPH0446589B2 JPH0446589B2 (en) 1992-07-30

Family

ID=13890251

Family Applications (1)

Application Number Title Priority Date Filing Date
JP60086555A Granted JPS61244372A (en) 1985-04-24 1985-04-24 Sterilization of body fluid treating apparatus

Country Status (1)

Country Link
JP (1) JPS61244372A (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5647984A (en) * 1995-06-07 1997-07-15 Cobe Laboratories, Inc. Extracorporeal fluid treatment systems selectively operable in a treatment mode or a disinfecting mode
JPH10235167A (en) * 1997-02-24 1998-09-08 Asahi Chem Ind Co Ltd Removing method for alcohol from porous membrane
US5948247A (en) * 1994-09-23 1999-09-07 Gambro Ab Disinfection arrangement for dialysis machines

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS56104672A (en) * 1980-01-23 1981-08-20 Nikkiso Co Ltd Method of sterilizing blood purifier
JPS5749465A (en) * 1980-09-10 1982-03-23 Terumo Corp Artificial internal organ for thermal sterization
JPS57206452A (en) * 1981-06-11 1982-12-17 Kuraray Co Pasturization of body liquid treating apparatus

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS56104672A (en) * 1980-01-23 1981-08-20 Nikkiso Co Ltd Method of sterilizing blood purifier
JPS5749465A (en) * 1980-09-10 1982-03-23 Terumo Corp Artificial internal organ for thermal sterization
JPS57206452A (en) * 1981-06-11 1982-12-17 Kuraray Co Pasturization of body liquid treating apparatus

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5948247A (en) * 1994-09-23 1999-09-07 Gambro Ab Disinfection arrangement for dialysis machines
US5647984A (en) * 1995-06-07 1997-07-15 Cobe Laboratories, Inc. Extracorporeal fluid treatment systems selectively operable in a treatment mode or a disinfecting mode
US5733457A (en) * 1995-06-07 1998-03-31 Cobe Labortories, Inc. Technique for disinfecting extracorporeal fluid treatment systems
JPH10235167A (en) * 1997-02-24 1998-09-08 Asahi Chem Ind Co Ltd Removing method for alcohol from porous membrane

Also Published As

Publication number Publication date
JPH0446589B2 (en) 1992-07-30

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LAPS Cancellation because of no payment of annual fees