11.080.01 消毒和灭菌综合 标准查询与下载

EN ISO 14161:2009 医疗保健产品的消毒.生物指示剂.选择,使用和检验结果解释指南

This International Standard provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.This International Standard applies to biological indicators for which International Standards exist.

Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)

ISO 25424:2009 医疗器械的消毒.低温蒸汽和甲醛.医疗器械消毒工序的制订,认证和日常控制要求

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices

LST EN ISO 11138-2:2009 保健品灭菌-生物指示剂-第2部分：环氧乙烷灭菌过程的生物指示剂（ISO 11138-2:2006）

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO 11138-2:2006)

LST EN ISO 11138-3:2009 保健品灭菌-生物指示剂-第3部分：湿热灭菌过程的生物指示剂（ISO 11138-3:2006）

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2006)

DS/EN ISO 11140-1:2009 保健品灭菌化学指标第1部分：一般要求

1.1 This part of ISO 11140 specifies general requirements and test methods for indicators that showexposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.NOTE Biological test systems are regarded as those tests which are dependent for their interpretation on the demonstration of the viability of an organism. Test systems of this type are considered in the ISO 11138 series for biological indicators (BIs).1.2 The require

Sterilization of health care products - Chemical indicators - Part 1: General requirements

DS/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

This part of ISO 11140 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator for this purpose is a Class 2 indicator as described in ISO 11140-1.Indicators complying with this part of ISO 11140 are intended for use in combination with the standard test pack as described in EN 285. This part of ISO 11140 does not consider the performance of the standard test pack, but does specify the performance of the indicator systems.

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

DS/EN ISO 11138-2:2009 保健品灭菌 生物指示剂 第2部分：环氧乙烷灭菌过程的生物指示剂

This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135.NOTE 2 National or regional regulations could provide requirements for work place safety.

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

DS/EN ISO 11138-3:2009 保健品灭菌生物指示剂第3部分：湿热灭菌过程的生物指示剂

This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.Moist heat as the sterilizing agent is defined in this part of ISO 11138 as dry saturated steam. While air-steam mixtures may be used in moist heat sterilization processes, the methods and performance requirements of this part of ISO 11138 might not be applicable for biological indicators used in such processes.NOTE 1 Requirements for validation and control of moist heat sterilization processes a

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes

DIN ISO/TS 17665-2:2009 保健品的灭菌.湿热.第2部分:ISO 17665.1标准ISO/TS17665-2:2009)的应用指南,德文版本CEN ISO/TS17665-2:2009

Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009); German version CEN ISO/TS 17665-2:2009

DS/CEN ISO/TS 11135-2/AC:2009 保健品灭菌-环氧乙烷-第2部分：ISO 11135-1应用指南

This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation.The exclusions in ISO 11135-1 apply also to this Technical Specification.For ease of reference, the clause numbering in this Technical Specification corresponds to that inISO 11135-1:2007. Further guidance for the requirements given in ISO 11135-1 is also included in Annex C of ISO 11135-1:2007 and should be used in conjunction with this Technical Specification.This guidance document is intended for people who have a basic knowledge of the principles of EOsterilization but may need help in d

Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1

EN ISO 11138-3:2009 卫生保健产品的消毒.生物指示剂.第3部分:湿热消毒工方法的生物指示剂

This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.

Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes

EN ISO 11140-3:2009 卫生保健品灭菌.化学指示剂.第3部分:Bowie和Dick型蒸汽渗透试验用2级指示剂系统(ISO 11140-3-2007,合并勘误表

This part of ISO 11140 specifies the requirements for chemical indicators to be used in the steam penetration test for steam sterilizers for wrapped goods, e.g. instruments and porous materials. The indicator forThis purpose is a Class 2 indicator as described in ISO 11140-1.

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)

EN ISO 11140-1:2009 生保健产品的消毒.化学指示剂.第1部分:一般要求

This part of ISO 11140 specifies general requirements and test methods for indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor the attainment of one or more of the variables required for a sterilization process. They are not dependent for their action on the presence or absence of a living organism.

Sterilization of health care products - Chemical indicators - Part 1: General requirements

EN ISO 11138-2:2009 保健产品的灭菌.生物指示剂.第2部分:环氧乙烷灭菌过程的生物指示器

This part of ISO 11138 provides specific requirements for test organisms, suspensions, inoculated carriers,biological indicators and test methods intended for use in assessing the performance of sterilizers andsterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxidegas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 ℃ to 65 ℃.

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes

NF S98-105-2*NF CEN ISO/TS 17665-2:2009 卫生护理用品的消毒.湿热法.第2部分:ISO 17665-1应用指南

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

DS/CEN ISO/TS 17665-2:2009 保健品灭菌-湿热-第2部分：ISO 17665-1应用指南

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

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

CAN/CSA-Z11135-1-2009(R2014) 医疗保健产品灭菌 环氧乙烷 第1部分：医疗器械灭菌过程的开发、验证和常规控制要求

This National Standard of Canada is based on International Standard ISO 11135-1:2007. Scope This part of ISO 11135 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices. NOTE 1 Although the scope of this part of ISO 11135 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. Sterilization processes validated and controlled in accordance with the requirements of this part of ISO 11135 are not assumed to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld Jacob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

CAN/CSA-Z11135-2-2009(R2014) 保健品灭菌 环氧乙烷 第2部分：ISO 11135-1 应用指南

1 Scope This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation. The exclusions in ISO 11135-1 apply also to this Technical Specification. For ease of reference, the clause numbering in this Technical Specification corresponds to that in ISO 11135-1:2007. Further guidance for the requirements given in ISO 11135-1 is also included in Annex C of ISO 11135-1:2007 and should be used in conjunction with this Technical Specification. This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in ISO 11135-1. This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.

Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1

CAN/CSA-Z17665-1-2009(R2014) 保健品灭菌 湿热 第1部分：医疗器械灭菌过程的开发、验证和常规控制要求

This National Standard of Canada is based on International Standard ISO 17665-1:2006. Scope 1.1 Inclusions 1.1.1 This part of ISO 17665 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. NOTE Although the scope of this part of ISO 17665 is limited to medical devices, it specifies requirements and provides guidance that may be applicable to other health care products. 1.1.2 Moist heat sterilization processes covered by this part of ISO 17665 include but are not limited to: a) saturated steam venting systems; b) saturated steam active air removal systems; c) air steam mixtures; d) water spray; e) water immersion.

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

BS DD CEN ISO/TS 17665-2:2009 保健产品的消毒.潮热.ISO 17665-1应用指南

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