
发布时间:2024-05-27 17:49:26 - 更新时间:2024年06月29日 15:22
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Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 1: General Requirements and Test Methods
Packaging materials and systems for medical devices which are to be sterilized — Part 1: General requirements and test methods
Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 4: Paper Bags - Requirements and Test Methods
Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 2: Sterilization Wrap - Requirements and Test Methods
Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 9 : matériaux non tissés à base de polyoléfines, non enduits - Exigences et méthodes d'essai
SN/T 3062的本部分规定了进口医疗器械灭菌包装材料和预成型菌屏障系统要求和检测方法。 本部分适用于对进口医疗器械灭菌包装材料和预成型菌屏障系统的检验。 本部分不包括菌屏障系统的有关药物/设备组合和各阶段生产控制质量保证体系的要求
Pachaking materials for terminally sterilized medical devices for import.Part 4:Requirements for materials and sterile barrier systems of importing medical device sterilization packaging
Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 10 : matériaux non tissés à base de polyoléfines enduits d'adhésif - Exigences et méthodes d'essai
Packaging Materials and Systems for Medical Devices Which are to Be Sterilized - Part 8: Re-Usable Sterilization Containers for Steam Sterilizers Conforming to EN 285 - Requirements and Test Methods
Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 9: Uncoated Nonwoven Materials of Polyolefines for Use in the Manufacture of Heat Sealable Pouches, Reels and Lids - Requirements and Test Methods
Packaging materials and systems for medical devices to be sterilized Part 5: Heat- and self-sealable transparent bags and tubes made of paper and plastic composite film — requirements and test methods
Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 10: Adhesive Coated Nonwoven Materials of Polyolefines for Use in the Manufacture of Heat Sealable Pouches, Reels and Lids - Requirements and Test Methods
Tracked Changes. Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods
Packaging Materials and Systems for Medical Devices Which are to Be Sterilized - Part 7: Adhesive Coated Paper for the Manufacture of Heat Sealable Packs for Medical Use for Sterilization by Ethylene Oxide or Irradiation - Requirements and Test Methods
本标准提供了用于确定医疗器械菌屏障系统中材料(或包装材料)的生物相容性试验的指南。 本标准不涉及包装材料的所有安全问题
Guide for biological evaluation of packaging materials for medical devices
1.1 本标准规定了用于最终灭菌医疗器械包装(或是在工厂中生产,或是在医疗保健机构中生产)的一次性使用材料和可再次使用的容器的要求(见第6章)。 1.2 本标准概述了最终灭菌医疗器械制造者对包装过程开发和确认的主要要求(见第7章)。成型和密封被认为是最关键的过程,但其他过程操作也能
Packaging for terminally sterilized medical devices
Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 1: General Requirements and Test Methods
Packaging materials and systems for medical devices which are to be sterilized — Part 1: General requirements and test methods
Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 4: Paper Bags - Requirements and Test Methods
Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 2: Sterilization Wrap - Requirements and Test Methods
Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 9 : matériaux non tissés à base de polyoléfines, non enduits - Exigences et méthodes d'essai
SN/T 3062的本部分规定了进口医疗器械灭菌包装材料和预成型菌屏障系统要求和检测方法。 本部分适用于对进口医疗器械灭菌包装材料和预成型菌屏障系统的检验。 本部分不包括菌屏障系统的有关药物/设备组合和各阶段生产控制质量保证体系的要求
Pachaking materials for terminally sterilized medical devices for import.Part 4:Requirements for materials and sterile barrier systems of importing medical device sterilization packaging
Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 10 : matériaux non tissés à base de polyoléfines enduits d'adhésif - Exigences et méthodes d'essai
Packaging Materials and Systems for Medical Devices Which are to Be Sterilized - Part 8: Re-Usable Sterilization Containers for Steam Sterilizers Conforming to EN 285 - Requirements and Test Methods
Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 9: Uncoated Nonwoven Materials of Polyolefines for Use in the Manufacture of Heat Sealable Pouches, Reels and Lids - Requirements and Test Methods
Packaging materials and systems for medical devices to be sterilized Part 5: Heat- and self-sealable transparent bags and tubes made of paper and plastic composite film — requirements and test methods
Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 10: Adhesive Coated Nonwoven Materials of Polyolefines for Use in the Manufacture of Heat Sealable Pouches, Reels and Lids - Requirements and Test Methods
Tracked Changes. Packaging for terminally sterilized medical devices. Sealable pouches and reels of porous materials and plastic film construction. Requirements and test methods
Packaging Materials and Systems for Medical Devices Which are to Be Sterilized - Part 7: Adhesive Coated Paper for the Manufacture of Heat Sealable Packs for Medical Use for Sterilization by Ethylene Oxide or Irradiation - Requirements and Test Methods
本标准提供了用于确定医疗器械菌屏障系统中材料(或包装材料)的生物相容性试验的指南。 本标准不涉及包装材料的所有安全问题
Guide for biological evaluation of packaging materials for medical devices
1.1 本标准规定了用于最终灭菌医疗器械包装(或是在工厂中生产,或是在医疗保健机构中生产)的一次性使用材料和可再次使用的容器的要求(见第6章)。 1.2 本标准概述了最终灭菌医疗器械制造者对包装过程开发和确认的主要要求(见第7章)。成型和密封被认为是最关键的过程,但其他过程操作也能
Packaging for terminally sterilized medical devices








