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NF EN ISO 10993-1 : 2010

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT SYSTEM PROCESS
Withdrawn date

09-28-2021

Published date

01-12-2013

Publisher

Association Francaise de Normalisation

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)
DocumentType
Standard
PublisherName
Association Francaise de Normalisation
Status
Withdrawn
SupersededBy
Supersedes

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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