GB/T 42063-2022Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling (English PDF)
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Issued by
State Administration for Market Regulation, China National Standardization Administration
Level / Type
National · Recommended
Issue date
October 14, 2022
Implementation date
November 1, 2023
Scope
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) is available as an English-translated PDF.
GB/T 42063-2022 is the Chinese standard "Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling".
Its scope clause reads: This document specifies the requirements and test methods for evaluating the performance parameters of sharps injury protection devices.
This document applies to single-use hypodermic needles with active or passive sharps injury protection devices, introducer needles for interventional catheters, Blood sample collection needle.
Sharps injury protection devices can be integrated with the product or combined with the product prior to use for sharps injury protection Function. This document does not address requirements for the storage and handling of sharps injury protection devices prior to their intended use, nor does it address requirements for the medical device itself. Require.
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Document preview — GB/T 42063-2022
National Standard of the People's Republic of China
- ICS
- 11.040.20
- Classification
- C 31
Issued by: State Administration for Market Regulation, China National Standardization Administration
Contents
- Preface
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Requirements
- 4.1 General Requirements
- 4.2 Activation of sharps injury protection devices
- 4.3 Security of Safe Mode Protection
- 5 Test method
- 5.1 General requirements
- 5.2 Sharps injury protection device activation test
- 5.3 Challenge testing of the device safety model
- 5.4 Sharps contact test in safe mode
- 5.5 Simulated clinical use test
- 5.6 Test report
- 6 Information provided by the manufacturer
- 6.1 General requirements
- 6.2 Identification/labeling
- 6.3 Instruction Manual
- Appendix A (Informative) Simulation User Study Guide
- Appendix B (Informative) Test Methods for Sharps Exposure in Safe Mode
1 Scope
This document specifies the requirements and test methods for evaluating the performance parameters of sharps injury protection devices.
This document applies to single-use hypodermic needles with active or passive sharps injury protection devices, introducer needles for interventional catheters,
Blood sample collection needle. Sharps injury protection devices can be integrated with the product or combined with the product prior to use for sharps injury protection
Function.
This document does not address requirements for the storage and handling of sharps injury protection devices prior to their intended use, nor does it address requirements for the medical device itself.
Require.
2 Normative references
The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.
GB/T 2828 (all parts) Count sampling inspection procedure [ISO 2859 (all parts)]
Note. GB/T 2828.1 Counting Sampling Inspection Procedure Part 1.Lot-by-Lot Inspection Sampling Plan Retrieved by Acceptance Quality Limit (AQL) (GB/T 2828.1-
2012, ISO 2859-1.1999, IDT);
GB/T 2828.2 Counting Sampling Inspection Procedures Part 2.Isolated Lot Inspection Sampling Plans Retrieved by Limiting Quality (LQ) (GB/T 2828.2-
2008, ISO 2859-2.1985, NEQ);
GB/T 2828.3 Counting Sampling Inspection Procedure Part 3.Skipping Batch Sampling Procedure (GB/T 2828.3-2008, ISO 2859-3.2005, IDT);
GB/T 2828.4 Counting Sampling Inspection Procedures Part 4.Assessment Procedures for Claimed Quality Levels (GB/T 2828.4-2008, ISO 2859-4.
2002,MOD);
GB/T 2828.5 Counting sampling inspection procedures - Part 5.Lot-by-lot sequential sampling inspection system retrieved by acceptance quality limit (AQL) (GB/T 2828.5-2011, ISO 2859-5.2005, IDT);
GB/T 2828.10 Counting Sampling Inspection Procedure Part 10.GB/T 2828 Counting Sampling Inspection Series Standard Guide (GB/T 2828.10-
2010, ISO 2859-10.2006, MOD).
GB/T 3359 Statistical processing and interpretation of data Determination of statistical tolerance intervals (GB/T 3359-2009, ISO 16269-6.
2005, IDT)
GB/T 6378.1 Metrological sampling inspection procedure Part 1.Retrieved by acceptance quality limit (AQL) for single quality characteristics and single quality characteristics
One-time sampling plan for batch-by-batch inspection of AQL (GB/T 6378.1-2008, ISO 3951-1.2005, IDT)
GB/T 6378.4 Metrology Sampling Inspection Procedures Part 4.Evaluation Procedures for the Claimed Quality Level of the Mean
YY/T 0316-2016 Application of Medical Device Risk Management to Medical Devices (ISO 14971.2007 Corrected Edition, IDT)
ISO 3951-2 Metrological sampling inspection procedures Part 2.General specification for single sampling plans retrieved by acceptance quality limit (AQL) actors]
GB 15811 | GB/T 18457 | GB/T 19335 | GB/T 14233.2 | […]
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 24 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 2828.1Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
- GB/T 2828.2Sampling procedures for inspection by attributes -- Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
- GB/T 2828.3Sampling procedures for inspection by attributes -- Part 3: Skip-lot sampling procedures
- GB/T 2828.3-2008Sampling procedures for inspection by attributes -- Part 3: Skip-lot sampling procedures
- GB/T 2828.4Sampling procedures for inspection by attributes -- Part 4: Procedures for assessment of declared quality levels
- GB/T 2828.4-2008Sampling procedures for inspection by attributes -- Part 4: Procedures for assessment of declared quality levels
GB/T 2828 · ISO 2859 · ISO 16269 · ISO 3951 · ISO 14971.2007
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Related Standards
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 2828.10-2010 — 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
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GB/T 42063-2022
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