JPH0550946B2 - - Google Patents

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Publication number
JPH0550946B2
JPH0550946B2 JP61046036A JP4603686A JPH0550946B2 JP H0550946 B2 JPH0550946 B2 JP H0550946B2 JP 61046036 A JP61046036 A JP 61046036A JP 4603686 A JP4603686 A JP 4603686A JP H0550946 B2 JPH0550946 B2 JP H0550946B2
Authority
JP
Japan
Prior art keywords
hollow fiber
processing device
blood processing
radiation
oxygen
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.)
Expired - Lifetime
Application number
JP61046036A
Other languages
Japanese (ja)
Other versions
JPS62204754A (en
Inventor
Toshiaki Masuda
Yonezo Ono
Hitoshi Oomya
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.)
Nisso KK
Original Assignee
Nisso KK
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 Nisso KK filed Critical Nisso KK
Priority to JP61046036A priority Critical patent/JPS62204754A/en
Publication of JPS62204754A publication Critical patent/JPS62204754A/en
Publication of JPH0550946B2 publication Critical patent/JPH0550946B2/ja
Granted legal-status Critical Current

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  • External Artificial Organs (AREA)

Description

【発明の詳細な説明】[Detailed description of the invention] 【産業上の利用分野】[Industrial application field]

本発明は中空糸型血液処理器の放射線滅菌方法
に関する。さらに詳しくは放射線の照射による中
空糸型血液処理器の強度低下や機能低下が殆どな
く、また放射線滅菌をした中空糸型血液処理器が
保存中に経時的に強度低下や機能低下を殆ど生じ
ることのない中空糸型血液処理器の放射線滅菌方
法に関する。
The present invention relates to a radiation sterilization method for a hollow fiber blood processing device. More specifically, there is almost no decrease in strength or function of the hollow fiber type blood processing device due to radiation irradiation, and there is almost no decrease in strength or function of the hollow fiber type blood processing device that has been sterilized by radiation over time during storage. This invention relates to a radiation sterilization method for a hollow fiber type blood processing device.

【従来の技術】[Conventional technology]

医療用具の滅菌方法として、最近特に使い捨て
の医療器具の分野で、放射線特にガンマ線による
滅菌が普及しつつあるが、使い捨ての医療用具は
その構成材料の殆どがプラスチツクであるため、
放射線の照射によりプラスチツクが劣化(強度低
下や着色)して医療用具が不良品となつたり、臭
気を発生したりすることがあり問題であつた。ま
た、放射線滅菌後に医療用具を構成するプラスチ
ツクが経時的に劣化して医療用具が不良品となる
ことがあり問題であつた。そこで、このようなプ
ラスチツクの放射線による劣化に対しては、従来
耐放射線医療材料の開発と並行して放射線照射に
よる医療用具の劣化抑制方法について色々研究が
行われてきた。 その代表的なものとして、中空糸型血液処理器
などに水や生理食塩水を充填して放射線を照射す
る、いわゆる湿式の放射線滅菌方法がある(特公
昭55−23620号公報)。これは大気雰囲気などで放
射線を照射する、いわゆる乾式の放射線滅菌では
劣化を許容範囲に抑制できない場合の滅菌方法
で、主として人工腎臓透析器等の血液処理器に利
用されてきた。 また、プラスチツクの経時的な劣化は酸素の存
在下で進行することが知られているが、このよう
な酸素の存在による経時的な劣化を抑制する方法
として、半透膜を使用した浸透装置内を窒素ガス
や炭酸ガス等の不活性ガス雰囲気とした後ガンマ
線を照射する方法(特開昭59−192373号公報)等
がある。
Sterilization using radiation, particularly gamma rays, has recently become popular as a method for sterilizing medical devices, especially in the field of disposable medical devices.However, since most of the constituent materials of disposable medical devices are plastic,
Exposure to radiation has caused problems as the plastic deteriorates (reduces strength and becomes discolored), resulting in defective medical devices and the generation of odors. Further, after radiation sterilization, the plastics constituting the medical devices deteriorate over time, resulting in the medical devices becoming defective, which has been a problem. Therefore, in order to prevent the deterioration of plastics caused by radiation, various studies have been conducted on methods of suppressing the deterioration of medical equipment due to radiation irradiation, in parallel with the development of radiation-resistant medical materials. A typical example is a so-called wet radiation sterilization method in which a hollow fiber blood processing device is filled with water or saline and irradiated with radiation (Japanese Patent Publication No. 23620/1983). This is a sterilization method used when so-called dry radiation sterilization, in which radiation is irradiated in the atmosphere, cannot suppress deterioration within an acceptable range, and has been primarily used for blood processing devices such as artificial kidney dialysis machines. It is also known that the deterioration of plastics over time progresses in the presence of oxygen, but as a method to suppress such deterioration over time due to the presence of oxygen, a semi-permeable membrane is used in the osmosis device. There is a method in which gamma rays are irradiated after creating an inert gas atmosphere such as nitrogen gas or carbon dioxide gas (Japanese Patent Application Laid-open No. 192373/1983).

【発明が解決しようとする問題点】[Problems to be solved by the invention]

しかしながら、特公昭55−23620号公報の方法
は水や生理食塩水を充填しているために、 滅菌線量(被滅菌物に付着した細菌を全て殺
菌するために必要な照射線量)が非常に大きく
なり滅菌コスト的に不利である。 水や生理食塩水を充填しなければならないの
で面倒である。 水や生理食塩水が充填されているので、寒冷
地において、冬季に水や生理食塩水が凍結し
て、医療用具を破損する恐れがある。 等の問題があつた。 また、特開昭59−192373号公報の方法は、放射
線滅菌後僅かずつであるが、浸透装置の外壁から
外部の酸素が浸透装置内に侵入し、徐々に半透膜
の劣化が進行していく問題があつた。
However, since the method disclosed in Japanese Patent Publication No. 55-23620 uses water or physiological saline, the sterilization dose (the dose of irradiation required to sterilize all bacteria attached to the object to be sterilized) is extremely large. This is disadvantageous in terms of sterilization costs. It is troublesome because it has to be filled with water or saline. Since the device is filled with water or saline, there is a risk that the water or saline may freeze during the winter in cold regions and damage the medical equipment. There were other problems. Furthermore, in the method of JP-A No. 59-192373, after radiation sterilization, external oxygen enters into the infiltration device through the outer wall of the infiltration device, and the deterioration of the semipermeable membrane gradually progresses. I had some problems.

【問題点を解決するための手段】[Means to solve the problem]

本願発明者等は前記問題点に鑑み鋭意研究を行
つた結果、予めガス不透過性材料製容器に脱酸素
剤と共に中空糸型血液処理器を密封した状態で放
射線を照射しても、脱酸素剤の活性が失われず、
中空糸型血液処理器の強度低下や機能低下および
毒性の発生等の問題が起こらないことを確認し、
本発明に到達した。 すなわち、本発明は中空糸型血液処理器を脱酸
素剤と共にガス不透過性材料製容器に密封し放射
線を照射することを特徴とする中空糸型血液処理
器の放射線滅菌方法である。 また、本発明は前記中空糸型血液処理器の放射
線滅菌方法において、放射線がガンマ線である中
空糸型血液処理器の放射線滅菌方法である。 更に、本発明は前記中空糸型血液処理器の放射
線滅菌方法において、脱酸素剤が活性酸化鉄を主
成分とする脱酸素剤である中空糸型血液処理器の
放射線滅菌方法である。 更にまた、本発明は前記中空糸型血液処理器の
放射線滅菌方法において、ガス不透過性材料製容
器が、ポリエステル/アルミニウム/ポリエチレ
ンのラミネートシートから形成された袋体である
中空糸型血液処理器の放射線滅菌方法である。 また、本発明は前記中空糸型血液処理器の放射
線滅菌方法において、中空糸型血液処理器が再生
セルロースの中空糸膜を用いた血液処理器である
中空糸型血液処理器の放射線滅菌方法である。
The inventors of the present application conducted intensive research in view of the above problems, and found that even if a hollow fiber blood processing device is sealed in advance with an oxygen scavenger in a container made of a gas-impermeable material and irradiated with radiation, oxygen The activity of the agent is not lost,
We confirmed that problems such as a decrease in strength, a decrease in functionality, and the occurrence of toxicity of the hollow fiber blood processing device did not occur.
We have arrived at the present invention. That is, the present invention is a radiation sterilization method for a hollow fiber type blood processing device, characterized in that the hollow fiber type blood processing device is sealed together with an oxygen scavenger in a container made of a gas-impermeable material and irradiated with radiation. The present invention also provides a radiation sterilization method for a hollow fiber blood processing device, in which the radiation is gamma rays. Furthermore, the present invention provides a radiation sterilization method for a hollow fiber blood processing device, wherein the oxygen scavenger is an oxygen scavenger whose main component is activated iron oxide. Furthermore, the present invention provides the radiation sterilization method for a hollow fiber blood processing device, wherein the container made of a gas-impermeable material is a bag formed from a polyester/aluminum/polyethylene laminate sheet. This is a radiation sterilization method. The present invention also provides a radiation sterilization method for a hollow fiber type blood processing device, wherein the hollow fiber type blood processing device is a blood processing device using a hollow fiber membrane of regenerated cellulose. be.

【作用】[Effect]

本発明の滅菌方法によれば、ガス不透過性容器
に中空糸型血液処理器と共に脱酸素剤が密封され
ているので、容器内は内部の酸素が脱酸素剤によ
つて吸収され、滅菌時には無酸素状態になつてい
る。そして、ガス不透過性材料製の容器壁を透過
して外部から侵入する僅かな量の酸素や、中空糸
型血液処理器を構成する中空糸膜の微細孔から
徐々に放出される酸素も即座に脱酸素剤に吸収さ
れてしまうので、少量の脱酸素剤で十分に長期に
亘つて容器内を無酸素状態に維持することができ
る。 従つて、酸素の存在に原因する経時的な中空糸
型血液処理器の強度低下や着色、機能低下等を十
分に長期に亘つて抑制することができる。
According to the sterilization method of the present invention, since the oxygen absorber is sealed together with the hollow fiber blood processing device in a gas-impermeable container, the oxygen inside the container is absorbed by the oxygen absorber, and during sterilization, the oxygen absorber absorbs the oxygen inside the container. He is in an oxygen-free state. In addition, a small amount of oxygen that enters from the outside through the container wall made of gas-impermeable material, and oxygen that is gradually released from the micropores of the hollow fiber membrane that makes up the hollow fiber blood processing device, is immediately removed. Therefore, a small amount of oxygen absorber can maintain the inside of the container in an oxygen-free state for a sufficiently long period of time. Therefore, it is possible to suppress a decrease in strength, discoloration, and a decrease in function of the hollow fiber blood processing device over time due to the presence of oxygen for a sufficiently long period of time.

【実施例】【Example】

次に、本発明の実施例について説明する。 まず、被滅菌物である中空糸型血液処理器を脱
酸素剤と共に、ガス不透過性材料製容器に収容し
密封する。そして、この中空糸型血液処理器を密
封した容器を少なくとも12時間放置して容器内を
無酸素状態にした後に放射線、好ましくはコバル
ト60から放射されるガンマ線を決められた量、す
なわち滅菌に必要な量(滅菌線量という)照射す
れば滅菌は完了し、かつ中空糸型血液処理器の経
時的な劣化を防ぐことができる。 ここで、中空糸型血液処理器を脱酸素剤と共に
容器に密封しているのは、無酸素状態で放射線照
射するとともに放射線照射後の中空糸型血液処理
器の環境を無酸素状態に維持するためであり、容
器をガス不透過性材料で形成しているのは、でき
るだけ容器外部からの酸素の侵入を抑制し、脱酸
素剤の活性をできるだけ長期間維持させるためで
ある。 本発明で使用される中空糸型血液処理器の中空
糸材料としては、酢酸セルロースけん化セルロー
ス、銅アンモニア法セルロースなどの再生セルロ
ース、ポリ塩化ビニル、ポリメチルメタクリレー
ト、ポリアクリロニトリル、ポリプロピレン、ポ
リ塩化ビニリデンなどのビニル重合体、ポリスル
ホン、ポリカーボネート、酢酸セルロース、ポリ
エステル、ポリウレタン、ポリアミド、ポリビニ
ルアルコール、エチレン/酢酸ビニル共重合体な
どが挙げられる。特に、従来大気雰囲気中におい
ては、乾式の放射線滅菌に適さないとされてきた
再生セルロースの中空糸からなる血液処理器の放
射線滅菌に最適である。 また、脱酸素剤については、脱酸素剤が中空糸
型血液処理器と共に容器内に密封されているわけ
であるから、それ自身の無毒性が要求されること
はいうまでもなく、酸素の吸収時他のガス成分が
発生したり、放射線照射によりガス成分を発生し
たり、脱酸素剤の活性を失つたりしないものが好
ましい。例えば、活性金属を主成分とし触媒によ
りその反応速度がコントロールされるものが好ま
しい。活性金属としては鉄、亜鉛、銅、錫などが
挙げられ、特に活性酸化鉄を主成分とするものが
最適である。 次に、ガス不透過性材料製の容器としては、保
有上およびコスト的に有利な袋体が好ましい。ガ
ス不透過性材料としては、ポリ塩化ビニリデン、
ポリビニルアルコール、ポリアミド、ポリエステ
ル等のの未延伸または延伸フイルムまたはシー
ト、あるいはこれらの樹脂をコーチングしたフイ
ルムまたはシート、またはこれらのフイルムをラ
ミネートしたフイルムまたはシート、あるいはポ
リエステル/アルミニウム/ポリエチレンのラミ
ネートフイルムまたはシート、アルミニウム箔、
アルミニウム蒸着膜等の金属箔、金属蒸着膜、あ
るいはそのラミネート製品などが挙げられる。特
に、外層がポリエステル、中間層がアルミニウム
箔またはアルミニウム蒸着膜、内層がポリエチレ
ンのラミネートシートからなる袋体が好適であ
る。 実施例 1 内径200μm、膜厚80μmの銅アンモニア再生セ
ルロースの中空糸膜を膜面積0.9m2で成形したダ
イアライザーをポリエチレンテレフタレートフイ
ルム/アルミニウム箔/ポリエチレンフイルムの
ラミネートシート(厚さ76μm)のポリエチレン
フイルム側を内側にして成形した袋内に収納し、
更に袋内にエージレス(三菱ガス化学社製脱酸化
剤の商品名)を収納して密封した。この袋体を24
時間放置後、2.5Mradのガンマ線照射をした。ガ
ンマ線照射後のダイアライザーの尿素クリアラン
ス、ビタミンB12クリアランスおよび限外濾過率
を第1表に示す。 比較例 1 実施例1の袋内にエージレスを収納しないでダ
イアライザーのみを収納して密封した袋体を、実
施例1と同様にガンマ線照射した。ガンマ線照射
後のダイアライザーの尿素クリアランス、ビタミ
ンB12クリアランスおよび限外濾過率を第1表に
示す。 比較例 2 実施例1のダイアライザーのガンマ線照射前の
尿素クリアランス、ビタミンB12クリアランスお
よび限外濾過率を第1表に示す。
Next, examples of the present invention will be described. First, a hollow fiber blood processing device to be sterilized is placed together with an oxygen absorber in a container made of a gas-impermeable material and sealed. After the container containing the hollow fiber blood processing device is left in an oxygen-free state for at least 12 hours, radiation, preferably gamma rays emitted from cobalt-60, is applied to a predetermined amount, that is, necessary for sterilization. Sterilization is completed by irradiating a certain amount (referred to as sterilization dose), and deterioration of the hollow fiber blood processing device over time can be prevented. Here, the reason why the hollow fiber blood processing device is sealed in a container together with an oxygen scavenger is to irradiate radiation in an oxygen-free state and maintain the environment of the hollow fiber blood processing device in an oxygen-free state after radiation irradiation. The reason why the container is made of a gas-impermeable material is to suppress the intrusion of oxygen from outside the container as much as possible and maintain the activity of the oxygen scavenger for as long as possible. Hollow fiber materials for the hollow fiber blood treatment device used in the present invention include regenerated cellulose such as cellulose acetate, saponified cellulose, cuprammonium cellulose, polyvinyl chloride, polymethyl methacrylate, polyacrylonitrile, polypropylene, polyvinylidene chloride, etc. vinyl polymer, polysulfone, polycarbonate, cellulose acetate, polyester, polyurethane, polyamide, polyvinyl alcohol, ethylene/vinyl acetate copolymer, and the like. In particular, it is most suitable for radiation sterilization of blood processing devices made of hollow fibers of regenerated cellulose, which have conventionally been considered unsuitable for dry radiation sterilization in an air atmosphere. In addition, since the oxygen absorber is sealed in a container together with the hollow fiber blood processing device, it goes without saying that it must be non-toxic and must be able to absorb oxygen. It is preferable to use one that does not generate other gas components when exposed to radiation, does not generate gas components when exposed to radiation, and does not lose its activity as an oxygen scavenger. For example, it is preferable to use an active metal as a main component whose reaction rate is controlled by a catalyst. Examples of active metals include iron, zinc, copper, tin, etc., and those containing active iron oxide as a main component are particularly suitable. Next, as a container made of a gas-impermeable material, a bag is preferable because it is advantageous in terms of storage and cost. Gas impermeable materials include polyvinylidene chloride,
Unstretched or stretched films or sheets of polyvinyl alcohol, polyamide, polyester, etc., films or sheets coated with these resins, films or sheets laminated with these films, or laminate films or sheets of polyester/aluminum/polyethylene. , aluminum foil,
Examples include metal foils such as aluminum vapor deposited films, metal vapor deposited films, and laminate products thereof. Particularly suitable is a bag whose outer layer is made of polyester, whose middle layer is made of aluminum foil or an aluminum vapor-deposited film, and whose inner layer is made of a laminate sheet of polyethylene. Example 1 A dialyzer made of a cuprammonium regenerated cellulose hollow fiber membrane with an inner diameter of 200 μm and a membrane thickness of 80 μm and a membrane area of 0.9 m 2 was placed on the polyethylene film side of a laminate sheet of polyethylene terephthalate film/aluminum foil/polyethylene film (thickness 76 μm). It is stored in a bag formed with the inside of the
Furthermore, Ageless (trade name of a deoxidizing agent manufactured by Mitsubishi Gas Chemical Co., Ltd.) was placed in the bag and sealed. This bag body is 24
After leaving it for a while, it was irradiated with 2.5 Mrad gamma rays. Table 1 shows the urea clearance, vitamin B 12 clearance and ultrafiltration rate of the dialyzer after gamma irradiation. Comparative Example 1 The bag of Example 1, in which only the dialyzer was housed without Ageless and sealed, was irradiated with gamma rays in the same manner as in Example 1. Table 1 shows the urea clearance, vitamin B 12 clearance and ultrafiltration rate of the dialyzer after gamma irradiation. Comparative Example 2 Table 1 shows the urea clearance, vitamin B 12 clearance, and ultrafiltration rate of the dialyzer of Example 1 before gamma irradiation.

【表】【table】

【表】 試験項目はいずれも日本人工臓器学会のダイア
ライザー性能評価基準に基づき測定した。尿素ク
リアランスおよびビタミンB12クリアランスはい
ずれも血液流量200ml/分での測定値であり、単
位はml/分である。限外濾過率の単位は、 ml/mmHg・hrである。 第1表から明らかなように、袋体に脱酸素剤を
収納した実施例1と脱酸素剤を収納していない比
較例1とでは、尿素クリアランスでは両者は殆ど
差はなかつた。しかし、ビタミンB12クリアラン
スおよび限外濾過率は袋体に脱酸素剤を収納した
実施例1はガンマ線照射前の比較例2の数値と殆
ど差がないのに対して、脱酸素剤を収納していな
い比較例1の数値は著しく低下しており、ダイア
ライザーの性能低下が起こつていることを示して
いる。
[Table] All test items were measured based on the dialyzer performance evaluation standards of the Japanese Society for Artificial Organs. Both urea clearance and vitamin B 12 clearance are measured at a blood flow rate of 200 ml/min and are in ml/min. The unit of ultrafiltration rate is ml/mmHg·hr. As is clear from Table 1, there was almost no difference in urea clearance between Example 1, in which an oxygen absorber was housed in the bag, and Comparative Example 1, in which no oxygen absorber was housed. However, the vitamin B 12 clearance and ultrafiltration rate of Example 1 in which the oxygen absorber was stored in the bag were almost the same as those in Comparative Example 2 before gamma irradiation, whereas The numerical value of Comparative Example 1, which was not tested, was significantly lower, indicating that the performance of the dialyzer was decreasing.

【発明の効果】【Effect of the invention】

本発明方法によつて中空糸型血液処理器の放射
線滅菌をすれば、酸素の存在に基因する経時的な
中空糸型血液処理器の性能の劣化を十分に長期に
亘つて許容範囲内に抑制することができる。 また、従来大気中における乾式の放射線滅菌が
適しないとされてきた再生セルロースの中空糸膜
を用いた血液処理器の放射線滅菌が、水や生理食
塩水を血液処理器内に充填しなくても行うことが
でき、滅菌操作が簡単になつた。
By radiation sterilizing a hollow fiber blood processing device using the method of the present invention, deterioration of the performance of the hollow fiber blood processing device over time due to the presence of oxygen can be suppressed to within an acceptable range for a sufficiently long period of time. can do. In addition, radiation sterilization of blood processing equipment using regenerated cellulose hollow fiber membranes, which has traditionally been considered unsuitable for dry radiation sterilization in the atmosphere, can now be performed without filling the blood processing equipment with water or physiological saline. The sterilization operation has become easier.

Claims (1)

【特許請求の範囲】 1 中空糸型血液処理器を脱酸素剤と共にガス不
透過性材料製容器に密封し放射線を照射すること
を特徴とする中空糸型血液処理器の放射線滅菌方
法。 2 前記放射線がガンマ線である特許請求の範囲
第1項記載の中空糸型血液処理器の放射線滅菌方
法。 3 前記脱酸素剤が活性酸化鉄を主成分とする脱
酸素剤である特許請求の範囲第1項または第2項
記載の中空糸型血液処理器の放射線滅菌方法。 4 前記ガス不透過性材料製容器が、ポリエステ
ル/アルミニウム/ポリエチレンのラミネートシ
ートから形成された袋体である特許請求の範囲第
1項ないし第3項のいずれかに記載の中空糸型血
液処理器の放射線滅菌方法。 5 前記中空糸型血液処理器が再生セルロースの
中空糸膜を用いた血液処理器である特許請求の範
囲第1項ないし第4項のいずれかに記載の中空糸
型血液処理器の放射線滅菌方法。
[Scope of Claims] 1. A radiation sterilization method for a hollow fiber blood processing device, which comprises sealing the hollow fiber blood processing device together with an oxygen scavenger in a container made of a gas-impermeable material and irradiating the device with radiation. 2. The radiation sterilization method for a hollow fiber blood processing device according to claim 1, wherein the radiation is a gamma ray. 3. The radiation sterilization method for a hollow fiber blood processing device according to claim 1 or 2, wherein the oxygen absorber is an oxygen absorber containing activated iron oxide as a main component. 4. The hollow fiber blood processing device according to any one of claims 1 to 3, wherein the container made of gas-impermeable material is a bag formed from a polyester/aluminum/polyethylene laminate sheet. radiation sterilization method. 5. A radiation sterilization method for a hollow fiber blood processing device according to any one of claims 1 to 4, wherein the hollow fiber blood processing device is a blood processing device using a hollow fiber membrane made of regenerated cellulose. .
JP61046036A 1986-03-03 1986-03-03 Radiation sterilization of medical instrument Granted JPS62204754A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP61046036A JPS62204754A (en) 1986-03-03 1986-03-03 Radiation sterilization of medical instrument

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP61046036A JPS62204754A (en) 1986-03-03 1986-03-03 Radiation sterilization of medical instrument

Publications (2)

Publication Number Publication Date
JPS62204754A JPS62204754A (en) 1987-09-09
JPH0550946B2 true JPH0550946B2 (en) 1993-07-30

Family

ID=12735812

Family Applications (1)

Application Number Title Priority Date Filing Date
JP61046036A Granted JPS62204754A (en) 1986-03-03 1986-03-03 Radiation sterilization of medical instrument

Country Status (1)

Country Link
JP (1) JPS62204754A (en)

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