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.
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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 |
| Standards | Relationship |
| UNI EN ISO 10993-16 : 2010 | Identical |
| BS EN ISO 10993-16:2010 | Identical |
| ISO 10993-16:2017 | Identical |
| EN ISO 10993-16:2017 | Identical |
| NBN EN ISO 10993-16 : 2010 | Identical |
| DIN EN ISO 10993-16:2016-04 (Draft) | Identical |
| SN EN ISO 10993-16 : 2010 | Identical |
| UNE-EN ISO 10993-16:2010 | Identical |
| 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 |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.