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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by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
28-09-2021
12-01-2013
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Withdrawn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 |
| UNE-EN ISO 10993-1:2010 | Identical |
| SN EN ISO 10993-1 : 2010 CORR 2010 | Identical |
| BS EN ISO 10993-1 : 2009-10 | Identical |
| NS EN ISO 10993-1 : 2009 COR 2010 | Identical |
| UNI EN ISO 10993-1 : 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 |
| ONORM EN ISO 10993-1 : 2011 | Identical |
| DIN EN ISO 10993-1:2010-04 | Identical |
| NF EN ISO 11979-5 : 2006 | OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY |
| NF EN ISO 11135-1 : 2007 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| NF EN ISO 10993-11 : 2009 | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY |
| NF ISO 22803 : 2005 | DENTISTRY - MEMBRANE MATERIALS FOR GUIDED TISSUE REGENERATION IN ORAL AND MAXILLOFACIAL SURGERY - CONTENTS OF A TECHNICAL FILE |
| NF EN ISO 7405 : 2009 AMD 1 2013 | DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY |
| NF EN ISO 9333 : 2006 | DENTISTRY - BRAZING MATERIALS |
| XP CEN/TS 15277 : 2007 XP | NON-ACTIVE SURGICAL IMPLANTS - INJECTABLE IMPLANTS |
| ISO 10993-3:2014 | Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| ISO 10993-16:2017 | Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables |
| ISO/TS 10993-20:2006 | Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 10993-18:2005 | Biological evaluation of medical devices Part 18: Chemical characterization of materials |
| ISO/TS 10993-19:2006 | Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
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