07/30162839 DC : 0

Withdrawn

BS EN ISO 10993-9 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 9: FRAMEWORK FOR IDENTIFICATION AND QUANTIFICATION OF POTENTIAL DEGRADATION PRODUCTS

Available format(s)

Hardcopy , PDF

Withdrawn date

06-06-2007

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of degradation studies
  4.1 General
  4.2 Preliminary considerations
  4.3 Study design
  4.4 Characterization of degradation products
      from medical devices
5 Study report
Annex A (normative) Consideration of the need for
        degradation studies
Annex B (informative) Biodegradation study
        considerations
      B.1 General
      B.2 Description of medical device and/or
          material
      B.3 Assessment of potential and known degradation
          products
          B.3.1 Bulk material changes
          B.3.2 Release of substances from the surface
          B.3.3 Multicomponent device or device used
                with other components
Annex ZA (informative) Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on Medical Devices and
         90/385/EEC on Active Implantable Medical Devices
Bibliography

BS EN ISO 10993-9

Committee	CH/194
DocumentType	Draft
Pages	18
PublisherName	British Standards Institution
Status	Withdrawn

ISO/IEC 17025:2005	General requirements for the competence of testing and calibration laboratories
ISO 10993-16:2017	Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables
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 10993-12:2012	Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process