I.S. EN ISO 23908:2013
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 (ISO 23908:2011)
Hardcopy , PDF
English
01-01-2013
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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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.
| DocumentType |
Standard
|
| Pages |
25
|
| PublisherName |
National Standards Authority of Ireland
|
| 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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