GB 2639-1990
Replaced
GB/T 47333-2026
Pending
National standards
GB/T 47333-2026 Disposable swab for the collection of clinical specimens
GB/T 47333-2026 Disposable swab for the collection of clinical specimens
Basic Information
Standard Code:
GB/T 47333-2026
Standard Type:
National standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Medical hygiene products
ICS Name:
Medical materials
Publish Date:
2026-03-31
Implement Date:
2027-04-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
全国医用防护器械标准化工作组(SAC/SWG 30)
Pages:
16 pages
Scope
本文件规定了一次性使用采样拭子(以下简称拭子)的结构组成、要求、使用说明书、标志和包装,描述了相应的试验方法。
本文件适用于临床检验样本收集、运输和储存的一次性使用采样拭子。
本文件不适用于纯棉敷布拭子、粘胶纤维敷布拭子、混纤敷布拭子、X射线可探测敷布拭子、纱布拭子等外科敷料。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、成都瑞琦医疗科技有限责任公司、福建省食品药品质量检验研究院、北京市医疗器械检验研究院(北京市医用生物防护装备检验研究中心)、华润医疗用品(河南)有限公司、河南省驼人医疗科技有限公司、杭州医国仁生物科技有限公司、中国人民解放军总医院第三医学中心
Drafting Persons:
刘斌、刘肖帅、张露文、王小梅、李翔、李莹、李承芝、段书霞、孟强、王海英、赵爱景、周小双、董传俊、黄永富、周一灵
Referenced Standards
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 14233.1-2022 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods
GB/T 14233.3-2024 Test methods for infusion,transfusion,injection equipments for medical use—Part 3:Microbiological 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
中华人民共和国药典(2025年版 四部)
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