16/30335531 DC : 0

Superseded

BS EN ISO 10993-16 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES

Available format(s)

Hardcopy , PDF

Superseded date

01-31-2018

Language(s)

English

Publisher

British Standards Institution

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principles for design of toxicokinetic studies
5 Guidance on test methods
Annex A (normative) - Circumstances in which
         toxicokinetic studies shall be considered
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 10993-16.

Committee	CH/194
DocumentType	Draft
Pages	22
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN ISO 10993-16:2010

ISO/TR 10993-22:2017	Biological evaluation of medical devices — Part 22: Guidance on nanomaterials
ISO 10993-2:2006	Biological evaluation of medical devices — Part 2: Animal welfare requirements
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 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14971:2007	Medical devices Application of risk management to medical devices