GB/T 3533.1-1983
Replaced
YY/T 1473-2023
Active
Industry standards-Medicine
YY/T 1473-2023 Guide for standardization for medical devices—Inclusion of safety aspects in the development of standards
YY/T 1473-2023 Guide for standardization for medical devices—Inclusion of safety aspects in the development of standards
Basic Information
Standard Code:
YY/T 1473-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
General Principles of Standardization
Publish Date:
2023-01-13
Implement Date:
2024-01-15
Publisher:
国家药品监督管理局
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:
28 pages
Scope
本文件为标准编写者提供了在医疗器械标准中纳入与安全有关内容的要求和建议。这些要求和建议基于已建立的风险管理概念和方法。
本文件适用于医疗器械标准中涉及的人员、财产、环境或这些因素组合的安全有关内容。
本文件中，术语“产品”包括单个医疗器械或由一个或多个医疗器械(也可能与非医疗器械组合使用)组成的系统。
Development Information
Drafting Units:
中国食品药品检定研究院、北京国医械华光认证有限公司、上海市医疗器械检验研究院、山东省医疗器械和药品包装检验研究院、天津市医疗器械质量监督检验中心、深圳迈瑞生物医疗电子股份有限公司、上海微创医疗器械(集团)有限公司
Drafting Persons:
郑佳、邵玉波、王美英、何骏、侯丽、李立宾、王红漫、李勇、李朝晖、王慧芳、叶莎莎、张建锋、艾莹莹
Replace the following standards
Adopt standards
ISO/IEC 指南 63:2019
Related Standards
GB/T 12366.1-1990
Replaced
GB/T 12366.1-1990 Guideline for the work of complex standardization—Principle and method
GB/T 12366.2-1990
Replaced
GB/T 12366.2-1990 Guideline for the work of complex standardization—General requirements of complex standardization for industrial products
GB/T 12366.3-1990
Replaced
GB/T 12366.3-1990 Guideline for the work of complex standardization—General requirements of complex standardization for agriculture products
GB/T 12366.4-1991
Replaced
GB/T 12366.4-1991 Guideline for the work of complex standardization—Drafting method for program of standard-complex
GB/T 12366.5-1991
Abolished