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
이 표준은 무균 처리에 사용되는 아이솔레이터 시스템에 대한 요구사항을 규정하고, 헬스케어
Aseptic processing of health care products－Part 6：Isolator systems
- ICS
- 11.080.01
- CCS
- C50
- 发布
- 2010-12-30
- 实施
- 2010-12-30
이 표준은 무균 처리로써 동결 건조의 제어 및 타당성 확인에 대한 장비, 프로세스, 프로그
Aseptic processing of health care products－Parts 3：Lyophilization
- ICS
- 11.080.01
- CCS
- C50
- 发布
- 2010-12-30
- 实施
- 2010-12-30
이 표준은 헬스케어 제품의 무균 처리의 부분으로 멸균 여과에 대한 요구사항을 규정한다. 이
Aseptic processing of health care products-Part 2:Filtration
- ICS
- 11.080.01
- CCS
- C50
- 发布
- 2010-12-30
- 实施
- 2010-12-30
Aseptic processing of health care products－Parts 3：Lyophilization
- ICS
- 11.080.01
- CCS
- 发布
- 2010-12-30
- 实施
이 표준은 무균 처리된 헬스케어 제품용 제조 프로세스의 개발, 타당성 확인 및 일상 관리에
Aseptic processing of health care products-Part 1:General requirements
- ICS
- 11.080.01
- CCS
- C50
- 发布
- 2010-12-30
- 实施
- 2010-12-30
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； -检査，维护和试验； -包装； -灭菌； -贮存。 如果提供上述过程的使用说明，医疗器械制造商应考虑提供相关的程序培训、说明和处理装置有用的说明。某些处理程序可能是通用的、常见的，和公认标准需要使用设备和易耗品的，这种情况下，使用说明书应包括所有的要求。不需要随机附带使用说明书时，可以通过方法进行信息交流，如单独提供用户手册，符号或挂图等。 本标准不适用于病人铺单或手术衣类的纺织物。 注：对于只需要消毒的医疗器械所应提供的处理信息，本标准的原则也可以釆用。
Sterilization of medical devices.Information to be provided by the manufacturer for the processing of resterilizable medical devices
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2010-12-27
- 实施
- 2012-06-01
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
- ICS
- 11.080.01
- CCS
- C30
- 发布
- 2010-08
- 实施
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
- ICS
- 11.080.01
- CCS
- 发布
- 2010-03-31
- 实施
- 2010-03-31
1.1.1 This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a sterilization process for medical devices. 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, manufacturers of sterilization equipment, manufacturers of medical devices to be sterilized, and organizations responsible for sterilizing medical devices. 1.1.4 This International Standard specifies the elements of a Quality Management System which are necessary to assure the appropriate characterization of the sterilizing agent, development, validation and routine 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
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2010-03-31
- 实施
- 2010-03-31
This Standard specifies general requirements for the characterization of a sterilizing agent, 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.This Standard applies to sterilization processes in which microorganisms are inactivated by physical and/or chemical means.
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); German version EN ISO 14937:2009
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2010-03
- 实施
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
- 2010-02-26
- 实施
- 2010-02-26
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
- C04
- 发布
- 2010-02-25
- 实施
Sterilization of health care products -- Ethylene oxide -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2010-02-25
- 实施
Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2010-02-25
- 实施
Sterilization of health care products -- Radiation -- Part 3: Guidance on dosimetric aspects
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2010-02-25
- 实施
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
- 2010-02-25
- 实施
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results (ISO 14161:2009)
- ICS
- 11.080.01
- CCS
- 发布
- 2010-02-17
- 实施
- 2010-02-17
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. 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 consider those processes that rely solely on physical removal of microorganisms, e.g., filtration. This International Standard is not intended to apply to combination processes using, for example, washer disinfectors or flushing and steaming of pipelines. This International Standard is not intended to apply to liquid sterilization processes.
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
- ICS
- 11.080.01
- CCS
- C05
- 发布
- 2010-01-31
- 实施
- 2010-01-31
Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results
- ICS
- 11.080.01
- CCS
- 发布
- 2010-01-31
- 实施
- 2010-01-31
1.1 This part of ISO 11737 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.1.2 This part of ISO 11737 is not applicable to:a) sterility testing for routine release of product that has been subjected to a sterilization process;b) performing a test for sterility (see 3.12);NOTE 1 The performance of a) or b) is not a requirement of ISO 11135-1, ISO 11137-1, ISO 14160, ISO 14937 or ISO
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ICS
- 11.080.01
- CCS
- 发布
- 2010-01-15
- 实施
- 2010-01-15
