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
Price:
$ 54
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
Pages:
14 pages
Scope
This document specifies the requirements and test methods for evaluating the performance parameters of sharps injury protection devices. This document is applicable to disposable hypodermic needles, guide needles for interventional catheters, and blood sampling needles equipped with active or passive sharps injury protection devices. The sharps injury protection devices can be integrated with the aforementioned products, or combined with them before use, to achieve the function of protecting against sharps injuries. This document does not specify the requirements for the storage and handling of sharps injury protection devices before intended use, nor does it set forth requirements for the medical devices themselves.
Development Information
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