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eLibrary > BS EN ISO 23908:2025 - TC Tracked Changes. Sharps injury protection. Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration. Requirements >

BS EN ISO 23908:2025 - TC Tracked Changes. Sharps injury protection. Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration. Requirements, 2025

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BS EN ISO 23908:2025 - TC Tracked Changes. Sharps injury protection. Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration. Requirements, 2025

A-30464912.pdf [Go to Page]
undefined
European foreword
Endorsement notice
Annex ZA (informative) Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
Table ZA.1 — Correspondence between this European standard and Annex I of Regulation (EU) 2017/745 [OJ L 117]
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Requirements [Go to Page]
5.1 General
5.2 Activation of the sharps injury protection mechanism [Go to Page]
5.2.1 Active SIPM
5.2.2 Passive SIPM
5.3 Security of safe mode protection
6 Test methods [Go to Page]
6.1 General
6.2 Test procedure and results analysis methodology
6.3 Testing activation of a sharps injury protection mechanism [Go to Page]
6.3.1 Principle
6.3.2 Apparatus
6.3.3 Procedure
6.4 Challenging the SIPM in safe mode [Go to Page]
6.4.1 General
6.4.2 Overriding or unlocking test
6.4.3 Resistance of the SIPM in safe mode to free fall
6.5 Testing access to the sharp in safe mode
7 Information supplied with the device [Go to Page]
7.1 General
7.2 Marking/labelling
7.3 Instructions for use
Annex A (normative) Methods for testing access to the sharp in safe mode
Annex B (informative) Example of apparatus for performing the free fall test
Bibliography [Go to Page]

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BS EN ISO 23908:2025 - TC Tracked Changes. Sharps injury protection. Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration. Requirements, 2025

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