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Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
本标准按照GB/T1.1-2009给出的规则起草。 本标准依据《医疗器械生产质量管理规范》相关要求制定。 本标准由中国医疗器械行业协会医用高分子制品分会提出
Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
YY/T 0615的本部分规定了标示“菌”的菌加工医疗器械的要求。 注：医疗器械只有当使用了一个确认过的灭菌过程，才可以标示“菌”。YY/T 0567规定了菌加工的确认和常规控制
Requirements for medical devices to be dwsignated“SIERILE”.Part 2:Requirements for aseptically processed medical devices
YY/T 0615的本部分规定了标示“ 菌”最终灭菌医疗器械的要求。YY/T 0615第2部分规定了标示“ 菌”的菌加工医疗器械的要求。 注：医疗器械只有当使用了一个确认过的灭菌过程，才可以标示“ 菌”.GB 18278、GB 18279、GB 18280、GB/T 19974、ISO
Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices
ISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
Aseptic processing of health care products. Alternative processes for medical devices and combination products
Sterilization of medical devices-information to be provided by the manufacturer for the processing of resterilizable medical devices
本标准规定了医疗器械制造商应提供的关于可重复灭菌医疗器械与预期由处理者灭菌医疗器械的再处理信息。 本标准规定了制造商提供的处理信息的要求，以确保医疗器械的被安全处理，并持续满足其性能要求。 本标准规定了以下所有或某些处理过程的要求： -使用后的现场准备； -准备，清洗，消毒； -干燥
Sterilization of medical devices.Information to be provided by the manufacturer for the processing of resterilizable medical devices
本标准定义了在灭菌技术领域内使用的术语。 本标准没有对灭菌过程的确认和常规控制提出要求，只是为理解、使用和制定灭菌技术领域内的标准提供基础参考
Sterilization of health care products.Vocabulary
Packaging for terminally sterilized medical devices
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
本标准按照GB/T1.1-2009给出的规则起草。 本标准依据《医疗器械生产质量管理规范》相关要求制定。 本标准由中国医疗器械行业协会医用高分子制品分会提出
Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
YY/T 0615的本部分规定了标示“菌”的菌加工医疗器械的要求。 注：医疗器械只有当使用了一个确认过的灭菌过程，才可以标示“菌”。YY/T 0567规定了菌加工的确认和常规控制
Requirements for medical devices to be dwsignated“SIERILE”.Part 2:Requirements for aseptically processed medical devices
YY/T 0615的本部分规定了标示“ 菌”最终灭菌医疗器械的要求。YY/T 0615第2部分规定了标示“ 菌”的菌加工医疗器械的要求。 注：医疗器械只有当使用了一个确认过的灭菌过程，才可以标示“ 菌”.GB 18278、GB 18279、GB 18280、GB/T 19974、ISO
Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices
ISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.
Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
Aseptic processing of health care products. Alternative processes for medical devices and combination products
Sterilization of medical devices-information to be provided by the manufacturer for the processing of resterilizable medical devices
本标准规定了医疗器械制造商应提供的关于可重复灭菌医疗器械与预期由处理者灭菌医疗器械的再处理信息。 本标准规定了制造商提供的处理信息的要求，以确保医疗器械的被安全处理，并持续满足其性能要求。 本标准规定了以下所有或某些处理过程的要求： -使用后的现场准备； -准备，清洗，消毒； -干燥
Sterilization of medical devices.Information to be provided by the manufacturer for the processing of resterilizable medical devices
本标准定义了在灭菌技术领域内使用的术语。 本标准没有对灭菌过程的确认和常规控制提出要求，只是为理解、使用和制定灭菌技术领域内的标准提供基础参考
Sterilization of health care products.Vocabulary
Packaging for terminally sterilized medical devices
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