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
This part of ISO 13408 specifies requirements and provides guidance on alternative approaches to process simulations for the qualification of the aseptic processing of medical devices and combination products that cannot be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied. This part of ISO 13408 describes how risk assessment can be used during the development of an aseptic process to design a process simulation study for medical devices and combination products in those cases where a straightforward substitution of media for product during aseptic processing is not feasible or would not simulate the actual aseptic process.
Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
- ICS
- 11.080.01
- CCS
- C30
- 发布
- 2012-08
- 实施
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2012)
- ICS
- 11.080.01
- CCS
- 发布
- 2012-07-27
- 实施
- 2012-07-27
This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specifiedrequirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose toachieve a sterility assurance level, SAL, of 10–6.This part of ISO 11137 also specifies methods of sterilizationdose audit used to demonstrate the continued effectiveness of the sterilization dose.
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- ICS
- 11.080.01
- CCS
- 发布
- 2012-03-01
- 实施
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2012-03-01
- 实施
이 표준은 의료기기용 멸균제의 특징과 멸균 공정의 개발, 밸리데이션 및 정기 모니터링에 대
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
- C47
- 发布
- 2012-01-02
- 实施
- 2012-01-02
이 표준은 멸균 공정을 개발, 밸리데이션 및 일상 감시하기 위해 사용할 생물학적 지시제의
Sterilization of health care products－Biological indicators－Guidance for the selection, use and interpretation of results
- ICS
- 11.080.01
- CCS
- C05
- 发布
- 2012-01-02
- 实施
- 2012-01-02
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2012
- 实施
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- ICS
- 11.080.01
- CCS
- C50
- 发布
- 2012
- 实施
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- ICS
- 11.080.01
- CCS
- C50
- 发布
- 2012
- 实施
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- ICS
- 11.080.01
- CCS
- C50
- 发布
- 2012
- 实施
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- ICS
- 11.080.01
- CCS
- C50
- 发布
- 2012
- 实施
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- ICS
- 11.080.01
- CCS
- C50
- 发布
- 2012
- 实施
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2012
- 实施
Sterilization of medical devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices
- ICS
- 11.080.01
- CCS
- 发布
- 2012
- 实施
- 2013-06-01
Sterilization of health care products. General criteria 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
- 2012
- 实施
- 2013-06-01
Sterilization of health care products. Biological indicators. Part 2. Biological indicators for ethylene oxide sterilization
- ICS
- 11.080.01
- CCS
- 发布
- 2012
- 实施
- 2015-01-01
Sterilization of health care products. Biological indicators. Part 3. Biological indicators for moist heat sterilization
- ICS
- 11.080.01
- CCS
- 发布
- 2012
- 实施
- 2015-01-01
Sterilization of health care products. Biological indicators. Part 1. Technical requirements
- ICS
- 11.080.01
- CCS
- 发布
- 2012
- 实施
- 2015-01-01
Sterilization of health care products. Chemical indicators. Guidance for selection, use and interpretation of results
- ICS
- 11.080.01
- CCS
- 发布
- 2012
- 实施
- 2013-06-01
YY/T 0567的本部分规定了通过无菌加工来生产无菌医疗保健产品的设备的产品接触表面进行在线灭菌（SIP）的通用要求，并提供鉴定、确认、运行和控制方面的指南。 本部分适用于灭菌剂被送入设备的内部表面从而与产品接触的过程。 本部分不适用于设备被拆卸后送至灭菌器的过程。 本部分并不取代或替代国家法规要求，特别是属于国家或地区管辖权限内的要求，如生产管理规范（GMPs）和/或药典要求等。 本部分没有规定海绵状脑病的病原体灭活过程开发、确认和常规控制的具体要求，如羊瘙痒病、疯牛病和克雅病。
Aseptic processing of health care products.Part 5:Sterilization in place
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2011-12-31
- 实施
- 2013-06-01
