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. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2014-07-31
- 实施
- 2014-07-31
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
- ICS
- 11.080.01
- CCS
- C42
- 发布
- 2014-07
- 实施
本标准规定了液路、血路无针接口微生物侵入试验的方法。
Needleless access ports for fluid lines and blood lines.Test method for microbial ingress
- ICS
- 11.080.01
- CCS
- C31
- 发布
- 2014-06-17
- 实施
- 2015-07-01
Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2014-05-01
- 实施
Sterilization of heal th 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
- 发布
- 2014-03-12
- 实施
Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2014-02-28
- 实施
- 2014-02-28
Sterilization of health care products. Radiation. Substantiation of selected sterilization dose: Method VDmaxSD
- ICS
- 11.080.01
- CCS
- C42
- 发布
- 2014-02-28
- 实施
- 2014-02-28
本标准提供了评价医疗保健产品(包括包装)的组成材料,包括高分子材料、金属、陶瓷/玻璃及其他材料对辐射灭菌加工的适宜性的程序和信息,为选择和鉴定医疗保健产品和包装的材料提供指南。
Evaluation of materials of health care product subject to radiation sterilization
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2013-10-21
- 实施
- 2014-10-01
本标准规定了带有真空阶段(预真空)的蒸汽灭菌器进行蒸汽渗透测试用的过程挑战装置及指示物系统的要求、试验方法。本标准所指的蒸汽渗透测试是基于GB 8599—2008和YY 0646—2008的规定。本标准适用过程挑战装置及指示物系统,包括多孔负载过程挑战装置及指示物系统和空腔负载过程挑战装置及指示物系统。
Specification of process challenge devices and indicator systems for steam penetration testing
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2013-10-21
- 实施
- 2014-10-01
YY/T 0567的本部分规定了关于经过无菌加工的医疗保健产品的制造过程的开发、确认和日常控制的流程、程序和执行步骤的一般要求以及指南。本部分涵盖关于整个无菌加工的总体要求和指南。其他部分则规定了关于过滤、冻干、在线清洗、在线灭菌和隔离系统的各种专用/专门流程和方法的特定要求及准则。
Aseptic processing of health care products.Part 1:General requirements
- ICS
- 11.080.01
- CCS
- C47
- 发布
- 2013-10-21
- 实施
- 2014-10-01
Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008 + Amd 1:2013); German version EN ISO 13408-1:2011 + A1:2013
- ICS
- 11.080.01
- CCS
- C10
- 发布
- 2013-08
- 实施
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010); German version EN ISO 20857:2013
- ICS
- 11.080.01
- CCS
- C05
- 发布
- 2013-08
- 实施
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
- C42
- 发布
- 2013-07-19
- 实施
- 2013-07-19
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Amendment 1
- ICS
- 11.080.01
- CCS
- C04
- 发布
- 2013-07-15
- 实施
Aseptic processing of health care products - Part 1: general requirements - Amendment 1
- ICS
- 11.080.01
- CCS
- C11
- 发布
- 2013-07-12
- 实施
- 2013-07-12
Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2005 + Amd 1:2013); German version EN ISO 13408-6:2011 + A1:2013
- ICS
- 11.080.01
- CCS
- C90
- 发布
- 2013-07
- 实施
ISO 13408-1:2008 specifies the general requirements for, and offers guidance on, processes, programmes and procedures for development, validation and routine control of the manufacturing process for aseptically-processed health care products.ISO 13408-1:2
Aseptic processing of health care products - Part 1: General requirements
- ICS
- 11.080.01
- CCS
- 发布
- 2013-06-06
- 实施
- 2013-06-06
ISO 20857:2010 specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. Although ISO 20857:2010 primarily addresses dry heat sterilization, it also specifies requirements and provi
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
- 发布
- 2013-05-31
- 实施
- 2013-05-31
Aseptic processing of health care products - Part 6: isolator systems - Amendment 1
- ICS
- 11.080.01
- CCS
- C42
- 发布
- 2013-05-17
- 实施
- 2013-05-17
Packaging system and materials for sterilization of health products Part 8: Packaging envelope and pouches type for sterilization by ionizing radiation
- ICS
- 11.080.01
- CCS
- 发布
- 2013-05-14
- 实施
