SN EN ISO 10993-16 : 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
03-09-2018
12-01-2013
1 Scope
2 Normative reference
3 Definitions
4 Principles for design of toxicokinetic studies
5 Guidance on test methods
5.1 General considerations
5.2 Guidance on specific types of tests
Annexes
A Circumstances in which toxicokinetic studies shall
be considered
Specifies the designing and performance of toxcicokinetic studies relevant to medical devices. Covers considerations for including toxicokinetic studies in the biological evaluating of medical devices.
| DevelopmentNote |
Supersedes SN 119800. (06/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Swiss Standards
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBN EN ISO 10993-16 : 2010 | Identical |
| I.S. EN ISO 10993-16:2010 | Identical |
| DIN EN ISO 10993-16:2016-04 (Draft) | Identical |
| BS EN ISO 10993-16:2010 | Identical |
| ISO 10993-16:2017 | Identical |
| UNI EN ISO 10993-16 : 2010 | Identical |
| UNE-EN ISO 10993-16:2010 | Identical |
| NF EN ISO 10993-16 : 2017 | Identical |
| ONORM EN ISO 10993-16 : 2018 | Identical |
| NEN EN ISO 10993-16 : 2018 | Identical |
| BS EN ISO 10993-16:2017 | Identical |
| EN ISO 10993-16:2017 | Identical |
| NS EN ISO 10993-16 : 2017 | Identical |
| I.S. EN ISO 10993-16:2017 | Identical |
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.