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
1 Scope
This document gives requirements and test methods for evaluating the performance parameters of sharps protection features,
whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps protection features may be integral to these products or combined with them prior to use to achieve the sharps injury protection.
This document does not give requirements for the storage and handling of the sharps injury protection feature before its intended use, or for the medical device itself.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 2828 (All parts) Sampling procedures for inspection by attributes [ISO 2859 (all parts)]
Notes:
GB/T 2828.1 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, ISO 2859-1:1999, IDT);
GB/T 2828.2 Sampling procedures for inspection by attributes - Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection (GB/T 2828.2-2008, ISO 2859-2:1985, NEQ);
GB/T 2828.3 Sampling procedures for inspection by attributes - Part 3: Skip-lot sampling procedures (GB/T 2828.3-2008, ISO 2859-3:2005, IDT);
GB/T 2828.4 Sampling procedures for inspection by attributes - Part 4: Procedures for assessment of declared quality levels (GB/T 2828.4-2008, ISO 2859-4:2002, MOD);
GB/T 2828.5 Sampling procedures for inspection by attributes - Part 5: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (GB/T 2828.5-2011, ISO 2859-5:2005, IDT);
GB/T 2828.10 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 2828.10-2010, ISO 2859-10:2006, MOD).
GB/T 3359 Statistical interpretation of data - Determination of a statistical tolerance interval (GB/T 3359-2009, ISO 16269-6:2005, IDT)
GB/T 6378.1 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 6378.1-2008, ISO 3951-1:2005, IDT)
GB/T 6378.4 Sampling procedures for inspection by variables - Part 4: Procedures for assessment of declared quality levels for mean
YY/T 0316-2016 Medical devices - Application of risk management to medical devices (ISO 14971:2007 modified edition, IDT)
ISO 3951-2 Sampling procedures for inspection by variables - Part 2：General specification for single sampling plans indexed by acceptance quality limit (AQL) for lot-by-lot inspection of independent quality characteristics
ISO 3951-3 Sampling procedures for inspection by variables - Part 3：Double sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
ISO 3951-5 Sampling procedures for inspection by variables - Part 5：Sequential sampling plans indexed by acceptance quality limit (AQL) for inspection by variables (known standard deviation)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
activation
deployment of the sharps protection feature
3.2
active safety feature
sharps injury protection feature that requires an additional step by the user to activate after performing the intended function of the device
3.3
accidental sharps injury
unintentional penetration into human tissue by the sharp after the intended use
3.4
passive safety feature
sharps protection feature that does not require an additional step by the user to activate
3.5
safe mode
state of the device after activation of the safety feature
3.6
sharp
part of the device that can penetrate human tissue
3.7
sharps injury protection feature
feature that prevents accidental sharps injury
4 Requirements
4.1 General requirements
4.1.1 Where this document do not specify forces for activation of the safety feature, the appropriate force shall be determined by using a risk-based approach in accordance with YY/T 0316-2016, supported by simulated user studies that mimic actual clinical use by using patient substitutes (e.g. instructional models) rather than actual patients. The study design should be based on statistical considerations and should have clear acceptance criteria. Guidance on conducting simulated user studies is outlined in Annex A.
4.1.2 Once in safe mode, the safety feature(s) of the device shall provide protection against sharps injury until safe disposal of the sharp.
4.1.3 It shall be apparent to the user as to when the device is in safe mode.
Activated information in safe mode shall be communicated to the user in a clear and unmistakable manner by either visual, tactile and/or audible means. If the manufacturer determines that the user environment requires a permanent indication of safe mode, then a visual indication shall be included.
4.1.4 Activation of the sharps injury protection feature shall permit the user's hand(s) to maintain a certain distance or effective physical isolation from the tip of the needle.
Safety features may be operated either actively or passively. If active operation is required, one-handed operation is recommended.
4.1.5 Safety features shall meet the following requirements:
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 General requirements
4.2 Activation of sharps injury protection feature
4.3 Security of safe mode protection
5 Test methods
5.1 General
5.2 Testing activation of a sharps injury protection feature
5.3 Challenging the device in safe mode
5.4 Testing access to the sharp in safe mode
5.5 Testing simulated clinical use
5.6 Test report
6 Information supplied by the manufacturer
6.1 General
6.2 Marking/labelling
6.3 Instructions for use
Annex A (Informative) Guidance on simulated user studies
A.1 General
A.2 Study design
A.3 Report forms
A.4 Failed tests
Annex B (Informative) Method for testing access to the sharp in safe mode
Bibliography
