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 10993-16:2017)
06-12-2017
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
ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.
| Committee |
CEN/TC 206
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Standards | Relationship |
| DIN EN ISO 10993-16:2018-02 | Identical |
| NBN EN ISO 10993-16 : 2010 | Identical |
| NF EN ISO 10993-16 : 2017 | Identical |
| PN EN ISO 10993-16 : 2010 | Identical |
| NS EN ISO 10993-16 : 2017 | Identical |
| BS EN ISO 10993-16:2010 | Identical |
| ISO 10993-16:2017 | Identical |
| I.S. EN ISO 10993-16:2010 | Identical |
| DIN EN ISO 10993-16:2016-04 (Draft) | Identical |
| PN-EN ISO 10993-16:2018 | Identical |
| NEN EN ISO 10993-16 : 2018 | Identical |
| I.S. EN ISO 10993-16:2017 | Identical |
| BS EN ISO 10993-16:2017 | Identical |
| UNE-EN ISO 10993-16:2018 | 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 |