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UNI EN ISO 23908 : 2013

Current
Current

The latest, up-to-date edition.

SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING
Published date

04-04-2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Information supplied by the manufacturer
Annex A (informative) - Guidance on simulated user studies
Annex B (informative) - Method for testing access to the
        sharp in safe mode
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements
         of EU Directive 93/42/EEC on Medical Devices
Bibliography

Provides requirements and test methods for evaluating the performance parameters of sharps injury 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.

Committee
CT 44
DocumentType
Test Method
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Current
Supersedes

Standards Relationship
EN ISO 23908:2013 Identical
ISO 23908:2011 Identical

IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
ISO 16269-6:2014 Statistical interpretation of data Part 6: Determination of statistical tolerance intervals
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements

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