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PREN ISO 23908-1 : DRAFT 2009

Current

Current

The latest, up-to-date edition.

SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - PART 1: SHARPS PROTECTION FEATURES FOR SINGLE-USED HYPODERMIC NEEDLES, CATHETERS, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING

Published date

12-01-2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 Requirements
6 Test methods
7 Information supplied by the manufacturer
Annex A (informative) - Guidance on simulated user studies
Annex B (informative) - Test method to test access to the
        sharp once in safe mode
Bibliography

Gives requirements and test methods to evaluate the performance parameters for sharps injury protection features for medical devices, either active or passive in design, for the medical device containing the (sharp) hypodermic needle for single use, catheters and introducers for catheters and needles used for blood sampling.

Committee
TC 205
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Current

Standards Relationship
DIN EN ISO 23908-1:2009-11 (Draft) Identical
NEN EN ISO 23908-1 : DRAFT 2009 Identical
09/30186527 DC : 0 Identical

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