GB 2639-1990
Replaced
YY/T 1293.2-2022
Active
Industry standards-Medicine
YY/T 1293.2-2022 Contacting wound dressing—Part 2:Polyurethane foam dressing
YY/T 1293.2-2022 Contacting wound dressing—Part 2:Polyurethane foam dressing
Basic Information
Standard Code:
YY/T 1293.2-2022
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical hygiene products
ICS Name:
Medical materials
Publish Date:
2022-10-17
Implement Date:
2023-10-01
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
本文件规定了聚氨酯泡沫敷料的要求和试验方法。
本文件适用于无菌供应的液体吸收层为聚氨酯泡沫的敷料。
本文件不适用于含银等抑菌剂、含有活性成分或能释放活性物质/能量的物质、人/动物源性材料、组织工程材料、可降解材料等的聚氨酯泡沫敷料和负压引流用聚氨酯泡沫敷料(海绵)。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、山东新华安得医疗用品有限公司、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、振德医疗用品股份有限公司、明尼苏达矿业制造(上海)国际贸易有限公司
Drafting Persons:
林则晨、师广波、张军、肖友松、陈甜、陈巧芳、亓晓庆、冯幼强、聂君、褚祥宇
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/T 0471.1-2004 Test methods for primary wound dressing—Part 1:Aspects of absorbency
YY/T 0471.2-2004 Test methods for primary wound dressings—Part 2:Moisture vapour transmission rate of permeable film dressings
YY/T 0471.3-2004 Test methods for primary wound dressings—Part 3:Waterproofness
YY/T 0471.5-2017 Test methods for primary wound dressings—Part 5:Bacterial barrier properties
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