BS EN ISO 10993-1 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS

Available format(s)

Hardcopy , PDF

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles applying to biological evaluation
  of medical devices
5 Categorization of medical devices
6 Biocompatibility evaluation process
7 Interpretation of biological evaluation data and
  overall biological safety assessment
Annex A (informative) - Endpoints to be addressed
        in a biological risk assessment
Annex B (informative) - Guidance on the conduct of
        biological evaluation within a risk management
        process
Annex C (informative) - Suggested procedure for
        literature review
Annex ZA (informative) - Relationship between this
         European Standard and the essential requirements
         of Directive 93/42/EEC [OJ L 169] aimed to be covered
Annex ZB (informative) - Relationship between this
         European Standard and the essential requirements
         of Directive 90/385/EEC [OJ L 189] aimed to be covered
Bibliography

BS EN ISO 10993-1.

Committee	CH/194
DocumentType	Draft
Pages	53
PublisherName	British Standards Institution
Status	NA

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO/TR 10993-22:2017	Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
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 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO/TR 10993-33:2015	Biological evaluation of medical devices Part 33: Guidance on tests to evaluate genotoxicity Supplement to ISO 10993-3
ISO 10993-2:2006	Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 7405:2008	Dentistry Evaluation of biocompatibility of medical devices used in dentistry
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 9004:2009	Managing for the sustained success of an organization A quality management approach
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 9001:2015	Quality management systems — Requirements
ISO 10993-9:2009	Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
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