11.080.01 消毒和灭菌综合 标准查询与下载
共找到 873 条与 消毒和灭菌综合 相关的标准，共 59 页
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose; Technical Corrigendum 1
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2009-02
- 实施
1.1 This International Standard provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes. This International Standard applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required of a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism. 1.2 This International Standard does not consider indicators for use in those processes that rely on physical removal of microorganisms, e.g. filtration. 1.3 This International Standard is not intended to apply to indicators for use in combination processes, for example, washer disinfectors or CIP (cleaning in place) and SIP (sterilization in place).
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
- ICS
- 11.080.01
- CCS
- C50
- 发布
- 2009-01-31
- 实施
- 2009-01-31
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008)
- ICS
- 11.080.01
- CCS
- 发布
- 2009-01-15
- 实施
- 2009-01-15
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (First Edition)
- ICS
- 11.080.01
- CCS
- 发布
- 2009-01-01
- 实施
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2009-01-01
- 实施
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (Second Edition)
- ICS
- 11.080.01
- CCS
- 发布
- 2009-01-01
- 实施
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (First Edition)
- ICS
- 11.080.01
- CCS
- 发布
- 2009-01-01
- 实施
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 inThis 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.
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO/TS 17665-2:2009)
- ICS
- 11.080.01
- CCS
- 发布
- 2009-01-01
- 实施
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2009-01
- 实施
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 formedical devices.1.1.2This International Standard applies to sterilization processes in which microorganisms are inactivatedby physical and/or chemical means.1.1.3This International Standard is intended to be applied by process developers, manufacturers ofsterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible forsterilizing medical devices.1.1.4This International Standard specifies the elements of a Quality Management System which arenecessary to assure the appropriate characterization of the sterilizing agent, development, validation androutine monitoring and control of a sterilization process.
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 (ISO 14937:2009)
- ICS
- 11.080.01
- CCS
- 发布
- 2009
- 实施
Sterilization of medical devices. Requirements for medical devices to be designated "sterile". Part 1. Requirements for terminally sterilized medical devices
- ICS
- 11.080.01
- CCS
- 发布
- 2009
- 实施
- 2011-01-01
Aseptic processing of health care products. Part 6. Isolator systems
- ICS
- 11.080.01
- CCS
- 发布
- 2009
- 实施
- 2010-09-01
Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
- ICS
- 11.080.01
- CCS
- 发布
- 20081230
- 实施
- 20081230
Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
- ICS
- 11.080.01
- CCS
- 发布
- 20081230
- 实施
- 20081230
1.1 포함사항1.1.1 이 표준은 개발(의료용 기기 습열 멸균 처리의 확증과 순서제어
Sterilization of health care products-Moist heat-Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2008-12-30
- 实施
- 2008-12-30
Sterilization of health care products－Requirements for validation and routine control－Radiation sterilization
- ICS
- 11.080.01
- CCS
- 发布
- 2008-12-30
- 实施
Sterilization of health care products－Requirements for validation androutine control－Industrial moist heat sterilization
- ICS
- 11.080.01
- CCS
- 发布
- 2008-12-30
- 实施
1.1 이 표준은 방사선을 이용한 의료기기 멸균 공정의 작업명세서 작성, 검정 및 일상적
Sterilization of health care products－Radiation－Part 1：Requirements for development, validation and routine control of a sterilization process for medical devices
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2008-12-30
- 实施
- 2008-12-30
이 표준은 KS P ISO 11137 제1부 및 제2부의 선량 계측 관련 요구사항에 대한
Sterilization of health care products－Radiation－Part 3：Guidance on dosimetric aspects
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2008-12-30
- 实施
- 2008-12-30
1.1 This International Standard provides guidance for the selection, use and interpretation of results of chemical indicators used in process definition, validation and routine monitoring and overall control of sterilization processes. This International Standard applies to indicators that show exposure to sterilization processes by means of physical and/or chemical change of substances, and which are used to monitor one or more of the variables required of a sterilization process. These chemical indicators are not dependent for their action on the presence or absence of a living organism. 1.2 This International Standard does not consider indicators for use in those processes that rely on physical removal of microorganisms, e.g. filtration. 1.3 This International Standard is not intended to apply to indicators for use in combination processes, for example, washer disinfectors or CIP (cleaning in place) and SIP (sterilization in place).
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (ISO 15882:2008); English version of DIN EN ISO 15882:2008-12
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2008-12
- 实施
