11.080.01 消毒和灭菌综合 标准查询与下载

ANSI/AAMI/ISO 20857:2010 保健用品的消毒.干热法:医疗器械工业灭菌过程的制定,生效和程序控制的要求

Specifies requirements for the development, validation and routine control of an industrial dry heat sterilization process for medical devices. Dry heat sterilization processes covered by this standard include but are not limited to forced air cycles and convection cycles. Although this standard primarily addresses dry heat sterilization, it also covers depyrogenation processes. The standard excludes processes that utilize infrared or microwaves as the heating.

Sterilization of health care products - Dry heat: Requirements for the development, validation and routine control of an industrial sterilization process for medical devices

ANSI/AAMI ST79-2010 卫生保健设施中蒸汽灭菌和无菌保证综合指南

Comprehensive guide to steam sterilization and sterility assurance in health care facilities

KS P ISO 11140-5:2009 卫生保健品的灭菌.化学指示剂.第5部分:布维.狄克形式(Bowie.and.Dick.type)除气试验的2级指示剂

이 표준에서는 사전 진공 고압 멸균 주기의 사전 진공 단계 중 공기 제거 효과를 평가하는

Sterilization of health care products-Chemical indicators-Part 5:Class 2 indicators for Bowie and Dick-type air removal tests

KS P ISO 11138-5:2009 保健产品灭菌.生物指示物.第5部分:低温蒸汽和甲醛灭菌过程用生物指示物

이 표준에서는 저온증기와 포름알데히드를 멸균제로 사용하는 멸균법을 평가하기 위한 시험 미생

Sterilization of health care products－Biological indicators－Part 5：Biological indicators for low-temperature steam and formaldehyde sterilization processes

KS P ISO 11140-3:2009 卫生保健品的灭菌.化学指示剂.第3部分:布维.狄克(Bowie.and.Dick.type)蒸汽穿透试验用2级指示剂体系

이 표준은 포장형 의료용품(예로써, 기구 및 기공물질)의 멸균을 위한 증기침투시험에 사용되

Sterilization of health care products-Chemical indicators-Part 3:Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

KS P ISO 11140-4:2009 卫生保健品的灭菌.化学指示剂.第4部分:蒸汽穿透检测布维.狄(Bowie.and.Dick)形式试验的2级指示剂

이 표준에서는 포장된 의료용품(기기 등과 기공 부하)에 대한 증기 멸균기의 보위 및 딕형

Sterilization of health care products-Chemical indicators-Part 4:Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

ISO/CD 11140-4 保健品灭菌“化学指标”第4部分：替代 Bowie 和 Dick 型试验的 2 类指标用于检测蒸汽渗透

Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

ISO/DIS 17665 保健品灭菌“湿热”医疗器械灭菌过程开发、验证和常规控制要求

Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO/FDIS 13408-1 《保健品无菌加工》第1部分：通用要求

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

ISO/CD 11140-3 保健品灭菌《化学指示剂》第3部分：用于Bowie和Dick型蒸汽渗透试验的2类指示剂系统

Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test

ISO/DIS 11137-1 保健品灭菌“辐射”第1部分：医疗器械灭菌过程的开发、验证和常规控制要求

Sterilization of health care products — Radiation — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

ISO/CD 11140-5 保健品灭菌《化学指标》第5部分：Bowie和Dick型除气试验二级指标

Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests

ISO/DIS 11135 医疗保健产品灭菌-环氧乙烷-医疗器械灭菌过程开发、验证和常规控制要求

Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

DS/EN ISO 14937:2009 医疗保健产品灭菌 灭菌剂表征和医疗器械灭菌过程的开发、验证和常规控制的一般要求

1.1.1 This International Standard specifies general requirements for the characterization of a sterilizingagent and for the development, validation and routine monitoring and control of a sterilization process for medical devices.NOTE Although the scope of this International Standard is limited to medical devices, the requirements specified herein can also be applied to sterilization processes for other health care products.1.1.2 This International Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.1.1.3 This International Standard is intended to be applied by process developers, manufacture

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

DS/EN ISO 14161:2009 保健品灭菌 生物指标 选择、使用和结果解释指南

This International Standard provides guidance for the selection, use and interpretation of results fromapplication of biological indicators when used in the development, validation and routine monitoring ofsterilization processes. This International Standard applies to biological indicators for which International Standards exist.NOTE 1 See, for example, the ISO 11138 series.NOTE 2 The general information provided in this International Standard can have useful application for processes and biological indicators not currently addressed by existing International Standards, e.g., new and developing sterilization processes.This International Standard does not c

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results

NF S98-100:2009 医疗保健产品灭菌.生物指示物.选择、使用和检验结果解释指南

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results.

CAN/CSA-Z17665-2-2009 保健品灭菌 湿热 第2部分：ISO 17665-1 应用指南

Preface This is the first edition of CAN/CSA-Z17665-2, Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Technical Specification 17665-2 (first edition, 2009-01-15). Scope This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO 17665-1. NOTE 1 The structure of the main body of this ISO Technical Specification (Clauses 1 to 12) corresponds to the structure of ISO 17665-1, so that the guidance given under a particular clause or subclause of this part of ISO 17665 applies to the requirements given in the corresponding clause or subclause of ISO 17665-1. For example, guidance for subclause 5.2 of ISO 17665-1:2006 is given in 5.2. This guidance is provided in addition to the guidance given in ISO 17665-1:2006, Annex A. See also Annexe E. NOTE 2 Special considerations specific to sterilization processes performed in health care facilities are given in Annex D.

Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1

ISO 14937:2009 保健产品灭菌.医疗器械用消毒剂的特性和消毒方法的研发,验证及常规控制的一般要求

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

LST EN ISO 11140-1:2009 保健品灭菌化学指标第1部分：一般要求（ISO 11140-1:2005）

Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2005)

LST EN ISO 11140-3:2009 保健品灭菌 化学指示剂 第3部分：用于 Bowie 和 Dick 型蒸汽渗透试验的 2 类指示剂系统（ISO 11140-3:2007，包括 Cor 1:2007）

Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test (ISO 11140-3:2007, including Cor 1:2007)