I.S. EN ISO 10993-11:2018
Current
The latest, up-to-date edition.
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)
Hardcopy , PDF
English
04-10-2018
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.
Dates of withdrawal of national standards are available from NSAI.
Important note : Users cannot be edited or removed once added to your Multi user PDF.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 |
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 |
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