美利体育登录入口官网

端到端微生物质量和无菌保证

End-to-end microbiological quality and sterility assurance

医疗装置的消毒.贴有"已消毒"标签的产品要求

Sterilization of medical devices - Requirements for products labeled "STERILE"

最终灭菌医疗器械包装 第1部分：材料、无菌屏障系统和包装系统的要求

Packaging for terminally sterilized medical devices— Part 1: Requirements for materials, sterile barrier systems and packaging systems

医疗器械的灭菌 医疗器械被指定为“无菌”的要求 无菌加工医疗器械的要求

Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices

最终灭菌医疗器械包装纸袋要求和试验方法

Packaging for terminally sterilized medical devices - Paper bags. Requirements and test methods

最终灭菌医疗器械包装 低温灭菌用粘合剂涂层纸 要求和试验方法

Packaging for terminally sterilized medical devices - Adhesive coated paper for low temperature sterilization processes. Requirements and test methods

终端无菌医学美利体育官网首页网址的包装. 组成、密封和装配过程的确认要求

Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes

保健品的无菌加工 一般要求

Aseptic processing of health care products. General requirements

最终灭菌医疗器械的包装 第1部分：材料、无菌屏障系统和包装系统的要求（已采用 ISO 11607-1:2019，第二版，2019-02）

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (Adopted ISO 11607-1:2019, second edition, 2019-02)

最终灭菌医疗器械的包装.第3部分:生产纸袋(EN 868-4标准指定)和生产盒和卷筒(EN 868-5标准指定)用纸.试验方法和要求.英文版本DIN EN 868-3-2009-09

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; English version of DI

灭菌医疗器械包装 第4部分：纸袋 要求和测试方法 德文版本 EN 868-4:2025

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2025

终末灭菌医疗器械的包装 第7部分：用于低温灭菌工艺的粘合剂涂层纸 要求和试验方法 德语版本 EN 868-7:2025

Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-7:2025

最终灭菌医疗器械的包装 第1部分：材料、无菌屏障系统和包装系统的要求

Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems

最终灭菌医疗器械的包装 第1部分：材料、无菌屏障系统和包装系统的要求

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); German version EN ISO 11607-1:2020/A11:2022

最终灭菌医疗器械的包装 第 1 部分：材料、无菌屏障系统和包装系统的要求 修正案 1：风险管理的应用 (ISO 11607-1:2019/Amd 1:2023)

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)

小容量药物 终端灭菌生产 与制剂区域相关的文件和记录编制指南

Small-volume drugs. Production with terminal sterilization. Guidelines for compiling documentation and records related to the manufacturing area.

医疗保健产品的灭菌 具有终端灭菌的医疗器械包装

Sterilization of health care products. Packaging for terminally sterilized medical devices.

最终灭菌医疗器械的包装第1部分:材料、无菌屏障系统和包装系统的要求修改1

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1

灭菌医疗器械包装 第4部分：纸袋 要求和试验方法

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

经伽林灭菌处理的医疗器械包装 第7部分 用于低温灭菌过程的涂胶纸 要求和试验方法

Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods

最终灭菌医疗器械的包装 第1部分：材料、无菌屏障系统和包装系统的要求 修正案 A11

Packaging for terminally sterilized medical devices - Part 1: requirements for materials, sterile barrier systems and packaging systems - Amendment A11

终端灭菌医疗器械的包装 第4部分：纸袋 要求和试验方法

Packaging for terminally sterilized medical devices - Part 4 : paper bags - Requirements and test methods

终端灭菌医疗器械的包装 第7部分：用于低温灭菌工艺的粘合涂层纸 要求和试验方法

Packaging for terminally sterilized medical devices - Part 7 : adhesive coated paper for low temperature sterilization processes - Requirements and test methods

终末灭菌医疗器械包装 第1部分：材料、无菌屏障系统和包装系统的要求 修订 A11

Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems - Amendment A11

关于基于风险的方法的各个方面的指南 以确保最终灭菌的一次性医疗保健产品的无菌性 这些产品无法承受加工以达到最大10-6的无菌保证水平

Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6

终末灭菌医疗器械的包装 第4部分：纸袋 要求和试验方法

Packaging for terminally sterilized medical devices — Part 4: Paper bags — Requirements and test methods

最终灭菌医疗器械的包装 第9部分：聚烯烃未涂层非织造材料 要求和试验方法

Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods

医疗保健产品无菌加工 第1部分：通用要求

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)

用于最终灭菌卫生产品的包装材料 第4部分：纸袋 要求和试验方法

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

最终灭菌医疗器械包装 第7部分：低温灭菌过程用涂胶纸要求和试验方法

Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods

用于最终灭菌卫生产品的包装材料 第7部分：用于低温灭菌工艺的粘合剂涂层纸 要求和试验方法

Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods

终末灭菌医疗器械包装 第4部分：纸袋 要求和试验方法

Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

终端灭菌医疗器械包装 第7部分：低温灭菌工艺用粘性纸 要求和试验方法

Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods