11.080.30 消毒封装 标准查询与下载
共找到 211 条与 消毒封装 相关的标准，共 15 页
本标准规定了无菌医疗器械初包装及初包装材料微粒污染检验的方法。 本标准适用于无菌医疗器械初包装及初包装材料的微粒污染检查。
Sterile Medical Device Package - Part 1： Test Methods for Particulate Matter
- ICS
- 11.080.30
- CCS
- Q849
- 发布
- 2018-03-01
- 实施
- 2018-06-04
This part of ISO 11607 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO/DIS 11607-2:2017); German and English version prEN ISO 11607-2:2017
- ICS
- 11.080.30
- CCS
- 发布
- 2017-11-00
- 实施
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming@ sealing and assembly processes
- ICS
- 11.080.30
- CCS
- 发布
- 2017-07-01
- 实施
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials@ sterile barrier systems and packaging systems
- ICS
- 11.080.30
- CCS
- 发布
- 2017-07-01
- 实施
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2017
- ICS
- 11.080.30
- CCS
- C08
- 发布
- 2017-05
- 实施
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2017
- ICS
- 11.080.30
- CCS
- C08
- 发布
- 2017-05
- 实施
Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods; German version EN 868
- ICS
- 11.080.30
- CCS
- C08
- 发布
- 2017-05
- 实施
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-6:2017
- ICS
- 11.080.30
- CCS
- C08
- 发布
- 2017-05
- 实施
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-7:2017
- ICS
- 11.080.30
- CCS
- C08
- 发布
- 2017-05
- 实施
This European Standard specifies test methods and values for paper, used in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard. The materials specified in this part of EN 868 are intended for single use only.
Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2017-02
- 实施
This European Standard specifies test methods and values for paper bags manufactured from paper specified in EN 868-3, used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard. The materials specified in this part of EN 868 are intended for single use only.
Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2017-02
- 实施
This European Standard specifies test methods and values for paper used in the manufacture of preformed sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard. Paper specified in this European Standard is intended for use in part or complete manufacture of pouches and form and fill packs and lidding material for trays. NOTE 1 The paper specified in this part of the EN 868 series is suitable for the manufacture of sterile barrier systems to be used in ethylene oxide, irradiation or low temperature steam formaldehyde sterilization processes and to produce coated paper according to EN 868-7. NOTE 2 Paper according to EN 868-3 can also be used for these sterilization processes. The materials specified in this part of EN 868 are intended for single use only.
Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2017-02
- 实施
This European Standard specifies test methods and values for materials for sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard. While materials specified in 4.2.2.1 to 4.2.2.3 of this part of EN 868 are intended for single use, the materials specified in 4.2.2.4 are intended for reuse.
Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2017-02
- 实施
This European Standard specifies test methods and values for sealable adhesive coated paper manufactured from paper complying with EN 868-6, used as sterile barrier systems and/or packaging systems that are intended to maintain sterility of terminally sterilized medical devices to the point of use. The materials specified in this part are intended to be used for ethylene oxide or irradiation sterilization. Other than the general requirements as specified in EN ISO 11607-1 and EN ISO 11607-2 this part of EN 868 specifies materials, test methods and values that are specific to the products covered by this European Standard. The materials specified in this part of EN 868 are intended for single use only.
Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
- ICS
- 11.080.30
- CCS
- C30
- 发布
- 2017-02
- 实施
第一章 总 则 第二章 机构与人员 第三章 厂房与设施 第四章 设 备 第五章 文件管理 第六章 设计和开发 第七章 采 购 第八章 生产管理 第九章 质量控制 第十章 销售和售后服务 第十一章 不合格品控制 第十二章 监测、分析和改进
Good Manufacturing Practice for Primary Packaging of Sterile Medical Devices
- ICS
- 11.080.30
- CCS
- Q849
- 发布
- 2016-12-22
- 实施
- 2018-03-09
Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized
- ICS
- 11.080.30
- CCS
- C05
- 发布
- 2016-12
- 实施
La présente partie de l’ISO 11607 spécifie les exigences et les méthodes d'essai pour les matériaux, les systèmes de barrière stérile préformés, les systèmes de barrière stérile et les systèmes d'emballage destinés à maintenir l'état de stérilité des dispositifs médicaux stérilisés au stade terminal jusqu'au point d'utilisation. La présente partie de l’ISO 11607 s'applique à l'industrie, aux installations de santé et à tout lieu où les dispositifs médicaux se trouvent dans des systèmes de barrière stérile et stérilisés. La présente partie de l’ISO 11607 ne couvre pas toutes les exigences relatives aux systèmes de barrière stérile et systèmes d'emballage pour les dispositifs médicaux fabriqués de manière aseptique. Dans ce cas, des exigences supplémentaires sont nécessaires pour garantir les combinaisons médicaments/dispositifs. La présente partie de l’ISO 11607 ne décrit pas de système d'assurance qualité pour le contrôle de toutes les étapes de fabrication.
Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, IDT)
- ICS
- 11.080.30
- CCS
- 发布
- 2016-07-01
- 实施
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1:2014); German version EN ISO 11607-1:2009 + A1:2014
- ICS
- 11.080.30
- CCS
- C08
- 发布
- 2014-11-01
- 实施
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006 + Amd 1:2014); German version EN ISO 11607-2:2006 + A1:2014
- ICS
- 11.080.30
- CCS
- C47
- 发布
- 2014-11-01
- 实施
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
- ICS
- 11.080.30
- CCS
- 发布
- 2014-07-07
- 实施
