GB 8662-1988
Replaced
YY/T 0720-2023
Active
Industry standards-Medicine
YY/T 0720-2023 Single-use maternity kits—General requirements
YY/T 0720-2023 Single-use maternity kits—General requirements
Basic Information
Standard Code:
YY/T 0720-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Other specialized equipment
ICS Name:
Surgical instruments and materials
Publish Date:
2023-01-13
Implement Date:
2024-01-15
Publisher:
国家药品监督管理局
Technical Committee:
全国计划生育器械标准化技术委员会(SAC/TC 169)
Pages:
16 pages
Scope
本文件规定了用于产科的一次性使用产包(以下简称产包)的通用要求、产包配置及技术要求、制造商提供的信息以及包装。
本文件适用于剖腹产用手术包及自然分娩用手术包。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、上海市医疗器械检验研究院、振德医疗用品股份有限公司、河南亚都实业有限公司、江苏省医疗器械检验所、北京市医疗器械审评检查中心
Drafting Persons:
艾冲冲、姚天平、鲁建国、张正男、郑涤新、张秀丽、姚秀军、钱心依、郜艳博、段书霞、陈泱、方萍、刘雪婷、杜珩
Replace the following standards
Referenced Standards
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
YY 0852-2011 Sterile surgical films for single use
YY/T 0854.2-2011 Performance requirements for pure cotton nonwoven surgical compresses—Part 2:Finished compress
YY/T 1470-2016 Disposable cut of the umbilical cord
GB 7543-1996 Rubber surgical gloves
GB 7543-2006 Single-use sterile rubber surgical gloves
GB/T 7543-2020 Single-use sterile rubber surgical gloves
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
YY/T 0313-1998 Package,lable,transport and storage for medical polymer products
YY/T 0313-2014 Medical polymer products—Requirement for package and information supplied by manufacturer
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
YY 0469-2004 Technical requirements for surgical mask
YY 0469-2011 Surgical mask
YY 0469-2023 Surgical mask
YY/T 0506.1-2005 Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment—Part 1: General requirements for manufacturers, processors and products
YY/T 0506.1-2023 Surgical drapes,gowns and clean air suits for medical use—Part 1:General requirements
YY 0594-2006 General requirements for surgical gauze dressings
Related Standards
GB 2766-1995
Replaced
GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced