YY/T 0567.6-2022 Active Industry standards-Medicine

YY/T 0567.6-2022 Aseptic processing of health care products—Part 6:Isolator systems

Publish Date: 2022-08-17 Implement Date: 2024-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0567.6-2022

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2022-08-17

Implement Date: 2024-03-01

Publisher: 国家药品监督管理局

Technical Committee: 全国消毒技术与设备标准化技术委员会(SAC/TC 200)

Pages: 28 pages

Scope

本文件规定了用于医疗保健产品无菌加工的隔离器系统的要求，包括规范、选择、鉴定、生物去污、确认、操作和控制方面，并提供相关指南。
本文件适用于用于医疗保健产品无菌加工的隔离器系统。
本文件未规定限制进入屏障系统（RABS）的要求。
本文件未规定无菌检查隔离器的要求，但是本文件内的部分原则和信息也可适用于相关应用。
本文件不适用于生物安全防护。

Development Information

Drafting Units:

广东省医疗器械质量监督检验所、浙江泰林生物技术股份有限公司、山东新华医疗器械股份有限公司、强生(苏州)医疗器材有限公司

Drafting Persons:

朱鹏志、寿敏杭、李晓明、刘雪美、廖惠儿、何灼华、夏晓久、赵振波、赵嘉、丁洪勇

Word Count: 52 Thousand words Pages: 28 pages

Replace the following standards

YY/T 0567.6-2011 Aseptic processing of health care products—Part 6:Isolator systems

Referenced Standards

ISO 11139:2018 ISO 13408-1:2008 ISO 13408-4 ISO 13408-7 ISO 14644-1:2015 ISO 14644-7 ISO 18362 ISO/IEC/IEEE 90003

Adopt standards

ISO 13408-6:2021

Related Standards

GB 18278-2000 Replaced

GB 18278-2000 Sterilization of health care products—Requirements for validation and routine control—Industrial moist heat sterilization

Publish Date: 2000-12-13

GB 18281.1-2000 Replaced

GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General

Publish Date: 2000-12-13

GB 18281.2-2000 Replaced

GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization

Publish Date: 2000-12-13

GB 18281.3-2000 Replaced

GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization

Publish Date: 2000-12-13

GB 18282.1-2000 Replaced

GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements

Publish Date: 2000-12-13

YY/T 0567.2-2005 Replaced

YY/T 0567.2-2005 Aseptic processing of health care products—Part 2:filtration

Publish Date: 2005-04-05