GB 2639-1990
Replaced
YY/T 1872-2022
Active
Industry standards-Medicine
YY/T 1872-2022 Sponge for negative pressure wound therapy
YY/T 1872-2022 Sponge for negative pressure wound therapy
Basic Information
Standard Code:
YY/T 1872-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical hygiene products
ICS Name:
Medical materials
Publish Date:
2022-08-17
Implement Date:
2023-09-01
Publisher:
国家药品监督管理局
Technical Committee:
山东省医疗器械和药品包装检验研究院
Pages:
12 pages
Scope
本文件规定了主要由聚氨酯或聚乙烯醇制成作为负压创面治疗中引流端海绵的基本要求。不包括负压创面治疗的其他配套器械和附件的要求。
本文件适用于聚氨酯负压引流海绵和聚乙烯醇负压引流海绵。
本文件不适用于含有任何药物及可吸收性成分的聚氨酯负压引流海绵和聚乙烯醇负压引流海绵。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、施乐辉医用产品国际贸易(上海)有限公司、浙江隆泰医疗科技股份有限公司、威海世创医疗科技有限公司、3M中国有限公司、巴斯特医药科技(常州)有限公司、北京英佳麦迪克医用材料有限公司
Drafting Persons:
薄晓文、王秀秀、肖友松、陈巧芳、杜兰平、王芸、杨保新、田翔、栾同青、朱福余
Referenced Standards
GB/T 6344-2008 Flexible cellular polymeric materials—Determination of tensile strength and elongation at break
GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
中华人民共和国药典(2020年版 四部)
GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods
GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods
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
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1:Requirements for materials,sterile barrier systems and packaging systems
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/T 0615.1-2007 Requirements for medical devices to be designated "STERILE"—Part 1:Requirements for terminally sterilized medical devices
Related Standards
GB 2641-1990
Abolished
GB 2641-1990 Tube vial for antibiotic use
GB/T 2640-1990
Replaced
GB/T 2640-1990 Injection vials for antibiotics
GB 2637-1995
Replaced
GB 2637-1995 Ampoule
GB/T 12414-1995
Replaced
GB/T 12414-1995 Pharmaceutical glass tube
GB 15980-1995
Abolished