GB/T 16886.11-1997
Replaced
GB/Z 42217-2022
Active
National standards
GB/Z 42217-2022 Medical device—Validation of software for medical device quality system
GB/Z 42217-2022 Medical device—Validation of software for medical device quality system
Basic Information
Standard Code:
GB/Z 42217-2022
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Integrated medical equipment
Publish Date:
2022-12-30
Implement Date:
2024-01-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
全国医疗器械质量管理和通用要求标准化技术委员会(SAC/TC 221)
Pages:
77 pages
Scope
本文件适用于医疗器械设计、测试、组件接收、制造、标记、包装、流通以及投诉处置中所使用的任何软件，或GB/T 42061中所描述的医疗器械质量体系的任何其他方面的自动化软件。
本文件适用于：
——用于质量管理体系的软件；
——用于生产和服务提供的软件；
——用于监视和测量要求的软件。
不适用于：
——用作医疗器械组件、部件或附件的软件，或
——医疗器械独立软件。
Development Information
Drafting Units:
北京国医械华光认证有限公司、中国食品药品检定研究院、东软医疗系统股份有限公司、山东威高集团医用高分子制品股份有限公司、上海微创医疗器械(集团)有限公司、深圳迈瑞生物医疗电子股份有限公司、北京万东医疗科技股份有限公司、上海联影医疗科技股份有限公司、航卫通用电气医疗系统有限公司
Drafting Persons:
常佳、王美英、郑佳、陈芳、刘丽娜、李勇、王红漫、徐强、黄鑫、韩强、李朝晖、张建锋、刘荣敏、艾莹莹
Referenced Standards
GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes
GB/T 19000-2000 Quality management systems—Fundamentals and vocabulary
GB/T 19000-2008 Quality management systems—Fundamentals and vocabulary
GB/T 19000-2016 Quality management systems—Fundamentals and vocabulary
GB/T 19000.2-1998 Quality management and quality assurance standards—Part 2:Generic guidelines for the application of GB/T 19001、GB/T 19002 and GB/T 19003
GB/T 19000.3-2001 Quality management and quality assurance standards—Part 3:Guidelines for the application of GB/T 19001-1994 to the development, supply, installation and maintenance of computer software
GB/T 19000.4-1995 Quality management and quality assurance standards—Part 4:Cuide to dependability programme management
Adopt standards
ISO/TR 80002-2:2017
Related Standards
GB/T 16886.3-1997
Replaced
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.6-1997
Replaced
GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation
GB/T 16886.1-2001
Replaced
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.13-2001
Replaced
GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices
GB/T 16886.7-2001
Replaced