PREN ISO 23908-1 : DRAFT 2009
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
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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