ONORM EN ISO 10993-11 : 2009
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
12-01-2013
Committees responsible
National foreword
Foreword
Introduction
Method
1 Scope
2 Normative references
3 Definitions
4 Test sample requirements and recommendations
5 Method for extraction from medical devices
6 Selection of test procedures for systemic toxicity
7 Selection of test procedures for pyrogenicity
8 Assessment of results
9 Test report
Annex
A (informative) Addresses
ZA (normative) Normative references to international
publications with their relevant European
publications
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 179
|
| DocumentType |
Standard
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Current
|
| Standards | Relationship |
| UNI EN ISO 10993-11 : 2009 | Identical |
| ISO 10993-11:2017 | Identical |
| NF EN ISO 10993-11 : 2009 | Identical |
| UNE-EN ISO 10993-11:2009 | Identical |
| SN EN ISO 10993-11 : 2009 | Identical |
| I.S. EN ISO 10993-11:2009 | Identical |
| BS EN ISO 10993-11:2009 | Identical |
| NS EN ISO 10993-11 : 2009 | Identical |
| EN ISO 10993-11:2009 | Identical |
| DIN EN ISO 10993-11:2015-12 (Draft) | Identical |
| NEN EN ISO 10993-11 : 2009 | Identical |
| NBN EN ISO 10993-11 : 2009 | Identical |
| DIN EN ISO 10993-11:2009-08 | Identical |
| OVE/ONORM EN 60601-1 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005 + COR.:2006 + COR.:2007 + A1:2012) |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
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