I.S. EN ISO 10993-11:2018
Current
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Hardcopy , PDF
English
10-04-2018
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.
This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
50
|
| ProductNote |
This standard also referce to ISO 10993, ASTM F619-03, AAMI/ST72 The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-11:2017 | Identical |
| EN ISO 10993-11:2009 | Identical |
| EN ISO 10993-11:2018 | Identical |
| BS EN ISO 10993-11:2018 | Equivalent |
| DIN EN ISO 10993-11:2018-09 | Equivalent |
| UNE-EN ISO 10993-11:2018 | Equivalent |
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