I.S. EN ISO 10993-16:2017
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)
Hardcopy , PDF
English
01-01-2017
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.
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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
|
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