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I.S. EN ISO 10993-16:2017

Current
Current

The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES (ISO 10993-16:2010)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
European foreword
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
Bibliography
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

Gives principles on designing and performing toxicokinetic studies relevant to medical devices.

DocumentType
Standard
Pages
34
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

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

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