GB 12259-1990
Abolished
YY/T 2004.1-2026
Pending
Industry standards-Medicine
YY/T 2004.1-2026 Traditional Chinese medical device—Dermal needle—Part 1:Tapping type
YY/T 2004.1-2026 Traditional Chinese medical device—Dermal needle—Part 1:Tapping type
Basic Information
Standard Code:
YY/T 2004.1-2026
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Other specialized equipment
ICS Name:
Treatment equipment
Publish Date:
2026-03-09
Implement Date:
2027-03-01
Publisher:
国家药品监督管理局
Technical Committee:
中医器械标准化技术归口单位(SMD/TU 008)
Pages:
20 pages
Scope
本文件规定了叩刺式皮肤针(以下简称“皮肤针”)的规格、结构和分类,材料,性能要求,包装和标签。
本文件适用于叩刺式皮肤针。
Development Information
Drafting Units:
苏州医疗用品厂有限公司、天津市医疗器械质量监督检验中心、河南省药品医疗器械检验院(河南省疫苗批签中心)、上海中医药大学附属曙光医院、天津中医药大学、天津中医药大学第一附属医院
Drafting Persons:
徐爱民、张历、孟凡敏、孟涛、徐晓婷、邓杰、李立宾、杨毅、郭扬
Referenced Standards
GB/T 4340.1-1999 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2009 Metallic materials—Vickers hardness test—Part 1:Test method
GB/T 4340.1-2024 Metallic materials—Vickers hardness test—Part 1:Test method
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 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals
GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals
YY/T 0149-2006 Medical instruments of stainless steel—Test methods of corrosion resistance
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 0802.1-2024 Processing of medical devive—Information to be provided by the medical device manufacturer—Part 1:Critical and semi-critical medical devices
Adopt standards
ISO 23958‑
1:2022
Related Standards
GB 12261-1990
Abolished
GB 12261-1990 Artificial heart-lung machine—Bubble oxygenator
GB 12262-1990
Abolished
GB 12262-1990 Artificial heart-lung machine—Heat exchanger
GB 2024-1994
Replaced
GB 2024-1994 Acupuncture needles
GB 10035-1994
Replaced
GB 10035-1994 The air-bag type sequential external counter-pulsation device
GB 16174.1-1996
Replaced