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端到端微生物质量和无菌保证

End-to-end microbiological quality and sterility assurance

美国国家卫生护理设施蒸汽灭菌和无菌保证综合指南

Comprehensive Guidelines for Steam Sterilization and Sterility Assurance in Health Care Facilities

医疗器械处理—医疗机构中的质量管理体系

Processing of health care products—Quality management systems for processing in health care facilities

无菌处理医疗产品 第1部分：通用要求

Aseptic processing of health care products — Part 1: General requirements

保健品无菌加工 第3部分：冻干

Aseptic processing of health care products — Part 3: Lyophilization

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

医疗器械灭菌 指定为“无菌”的医疗器械的要求 无菌处理医疗器械的要求

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

保健品无菌加工通用要求

Aseptic processing of health care products - General requirements

保健品的无菌加工 隔离系统

Aseptic processing of health care products. Isolator systems

基于细胞的健康护理产品的制造. 加工过程中的微生物风险控制

Manufacture of cell-based health care products. Control of microbial risks during processing

医疗保健产品无菌加工 第1部分：一般要求

Aseptic processing of health care products – Part 1: General requirements

医疗器械的灭菌 被指定为“无菌”的医疗器械的要求 第2部分：无菌加工医疗器械的要求

Sterilization of Medical Devices - Requirements for Medical Devices to be Designated "STERILE" - Part 2: Requirements for Aseptically Processed Medical Devices

医用器械的灭菌 标记为“无菌”的医用器械的要求 第2部分：无菌加工医用器械的要求 德文版EN 556-2:2024

Sterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2024

医疗保健产品无菌加工 第1部分：通用要求（ISO 13408-1:2023）

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

医疗保健产品无菌加工 第1部分：通用要求（ISO 13408-1:2023）

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

基于细胞的保健产品的制造 加工过程中微生物风险的控制（ISO 18362:2016）

Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018

保健品的无菌加工. 第1部分: 一般要求. 修改件1

Aseptic processing of health care products - Part 1: General requirements; Amendment 1

保健品无菌加工 第1部分：一般要求

Aseptic processing of health care products — Part 1: General requirements

医疗器械灭菌 贴有"无菌"标签医疗器械的要求 第2部分：要求适用于无菌处理的医疗器械

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

医疗保健产品无菌处理 第1部分：通用要求（ISO 13408-1:2023）

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

医疗器械灭菌 标记为“无菌”的医疗器械的要求 第2部分：无菌处理医疗器械的要求

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2 : requirements for aseptically processed medical devices

医疗保健产品无菌加工 第1部分：一般要求

Aseptic processing of health care products - Part 1 : general requirements

医疗器械灭菌- 标记为“无菌”的医疗器械的要求- 第2部分：无菌处理医疗器械的要求

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2 : requirements for aseptically processed medical devices

医疗保健产品无菌加工 第1部分：一般要求

Aseptic processing of health care products - Part 1 : general requirements

医疗器械灭菌 液体医疗器械的无菌处理 要求

Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

医疗器械的灭菌 标记为“无菌”的医疗器械的要求 第2部分：无菌加工医疗器械的要求

Sterilization of medical devices — Requirements for medical devices to be designated ''STERILE" — Part 2: requirements for aseptically processed medical devices

医用产品的无菌加工 第1部分：通用要求（ISO 13408-1:2023 等同）

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023, IDT)

医疗器械灭菌 指定为“无菌”医疗器械的要求 第2部分：无菌处理医疗器械的要求

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

医疗器械的灭菌 被指定为“无菌”的医疗器械的要求 第2部分：无菌处理医疗器械的要求

Sterilization of medical devices - Requirements for medical devices to be designated \"STERILE\" - Part 2: Requirements for aseptically processed medical devices

保健产品无菌加工 第1部分：一般要求（ISO 13408-1:2023）

Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

保健品的无菌加工 第6部分：隔离系统（ISO 13408-6:2005）

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005)

医疗器械的灭菌 标有“STERILE”字样医疗器械的要求 第2部分：无菌条件下制备的医疗器械的要求

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

医疗保健产品无菌加工 第1部分：一般要求

Aseptic processing of health care products - Part 1: General requirements