GB/T 4506-1984
Abolished
GB/T 42063-2022
Active
National standards
GB/T 42063-2022 Sharps injury protection—Requirements and test methods—Sharps protection features for single-use hypodermic needles,introducers for catheters and needles used for blood sampling
GB/T 42063-2022 Sharps injury protection—Requirements and test methods—Sharps protection features for single-use hypodermic needles,introducers for catheters and needles used for blood sampling
Basic Information
Standard Code:
GB/T 42063-2022
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2022-10-12
Implement Date:
2023-11-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
全国医用注射器(针)标准化技术委员会(SAC/TC 95)
Pages:
14 pages
Scope
本文件规定了锐器伤害保护装置性能参数评价的要求和试验方法。本文件适用于带有主动或者被动锐器伤害保护装置的一次性使用皮下注射针、介入导管的导引针、血样采集针。锐器伤害保护装置可与所述产品集成，或在使用前与所述产品组合，以实现锐器伤害保护功能。本文件未给出锐器伤害保护装置预期使用前的储存和处理的要求，也未给出对医疗器械自身的要求。
Development Information
Drafting Units:
上海市医疗器械检验研究院、浙江康德莱医疗器械股份有限公司、山东威高集团医用高分子制品股份有限公司、河南驼人医疗器械集团有限公司、碧迪医疗器械(上海)有限公司、贝朗医疗(上海)国际贸易有限公司
Drafting Persons:
陆离原、花松鹤、王丹、张谦、刘幸林、张菁、苏立琴、叶茂
Referenced Standards
YY/T 0316-2016 Medical devices—Application of risk management to medical devices
ISO 3951-2
ISO 3951-3
ISO 3951-5
GB/T 2828.1-2003 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection
GB/T 2828.1-2012 Sampling procedures for inspection by attributes—Part 1:Sampling schemes indexed by acceptance quality limit(AQL) for lot-by-lot inspection
GB/T 2828.2-2008 Sampling procedures for inspection by attributes—Part 2:Sampling plans indexed by limiting quality(LQ)for isolated lot inspection
GB/T 2828.3-2008 Sampling procedures for inspection by attributes—Part 3:Skip-lot sampling procedures
GB/T 2828.4-2008 Sampling procedures for inspection by attributes—Part 4:Procedures for assessment of declared quality levels
GB/T 2828.5-2011 Sampling procedures for inspection by attributes—Part 5:System of sequential sampling plans indexed by acceptance quality limit(AQL)for lot-by-lot inspection
GB/T 2828.10-2010 Sampling procedures for inspection by attributes—Part 10:Introduction to the GB/T 2828 series of standards for sampling for inspection by attributes
GB/T 2828.11-2008 Sampling procedures for inspection by attributes—Part 11:Procedures for assessment of declared quality levels for small population
GB/T 3359-1982 Statistical interpretation of data—Determination of a statistical tolerance interval
GB/T 3359-2009 Statistical interpretation of data—Determination of statistical tolerance intervals
GB/T 6378.1-2008 Sampling procedures for inspection by variables—Part 1:Specification for single sampling plans indexed by acceptance quality limit(AQL)for lot-by-lot inspection for a single quality characteristic and a single AQL
GB/T 6378.4-2008 Sampling procedures for inspection by variables—Part 4:Procedures for assessment of declared quality levels for mean
GB/T 6378.4-2018 Sampling procedures for inspection by variables—Part 4:Procedures for assessment of declared quality levels for mean
Adopt standards
ISO 23908:2011
Related Standards
GB/T 11751-1989
Abolished
GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension
GB/T 12256-1990
Abolished
GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing
GB/T 13074-1991
Replaced
GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration
GB 14232-1993
Abolished
GB 14232-1993 Bags for human blood and blood components
GB/T 14233.2-1993
Replaced