NBN EN ISO 10993-16 : 2010
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES
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.
| DocumentType |
Standard
|
| PublisherName |
Belgian Standards
|
| Status |
Current
|
| Standards | Relationship |
| I.S. EN ISO 10993-16:2010 | Identical |
| DIN EN ISO 10993-16:2016-04 (Draft) | Identical |
| ISO 10993-16:2017 | Identical |
| EN ISO 10993-16:2017 | Identical |
| SN EN ISO 10993-16 : 2010 | Identical |
| UNI EN ISO 10993-16 : 2010 | Identical |
| UNE-EN ISO 10993-16:2010 | Identical |
| BS 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 |
| NS EN ISO 10993-16 : 2017 | Identical |
| I.S. EN ISO 10993-16:2017 | Identical |
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