NF EN ISO 10993-1 : 2010
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM PROCESS
12-01-2013
28-09-2021
Avant-propos
Introduction
1 Domaine d'application
2 Termes et définitions
3 Principes généraux applicables à l'évaluation biologique
des dispositifs médicaux
4 Classification des dispositifs médicaux
5 Essais
6 Choix des essais d'évaluation biologique
7 Assurance de la qualité des méthodes d'essai
Annexe A (informative) Justification
Annexe B (informative) Organigramme facilitant l'approche
systématique de l'évaluation biologique des
dispositifs médicaux
Bibliographie
Specifies general principles governing the biological evaluation of medical devices, categorization of devices based on the nature and duration of their contact with the body and the selection of appropriate tests.
| DevelopmentNote |
Indice de classement: S99-501-1PR. Supersedes NF EN 30993-1 and NF ISO 10993-1. (05/2004) PR NF EN ISO 10993-1 February 2007. (02/2007) PR NF EN ISO 10993-1 March 2009. (03/2009) PR NF EN ISO 10993-1 April 2017. (05/2017)
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| DocumentType |
Standard
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| PublisherName |
Association Francaise de Normalisation
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| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBN EN ISO 10993-1 : 2009 COR 2010 | Identical |
| BS EN ISO 10993-1 : 2009-10 | Identical |
| NS EN ISO 10993-1 : 2009 COR 2010 | Identical |
| EN ISO 10993-1:2009 | Identical |
| NEN EN ISO 10993-1 : 2009 C1 2010 | Identical |
| I.S. EN ISO 10993-1:2009+AC:2010 | Identical |
| ISO 10993-1:2009 | Identical |
| DIN EN ISO 10993-1:2010-04 | Identical |
| UNE-EN ISO 10993-1:2010 | Identical |