ONORM EN ISO 10993-5 : 2009
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 5: TESTS FOR IN VITRO CYTOTOXICITY
01-12-2013
1 Scope
2 Normative references
3 Terms and definitions
4 Sample preparation
5 Cell lines
6 Culture medium
7 Preparation of cell stock culture
8 Test procedures
9 Test report
10 Assessment of results
Specifies test procedures to assess the in vitro cytotoxicity of medical devices. Describes the incubation of cultured cells either directly or through diffusion in contact with a device and / or with extracts of a device.
| Committee |
TC 179
|
| DevelopmentNote |
New child AMD 11 2025 is now added
|
| DocumentType |
Standard
|
| ProductNote |
New child AMD 11 2025 is now added
|
| PublisherName |
Osterreichisches Normungsinstitut/Austrian Standards
|
| Status |
Current
|
| Standards | Relationship |
| DIN EN ISO 10993-5:2009-10 | Identical |
| EN ISO 10993-5:2009 | Identical |
| NBN EN ISO 10993-5 : 2009 | Identical |
| BS EN ISO 10993-5:2009 | Identical |
| NEN EN ISO 10993-5 : 2009 | Identical |
| NF EN ISO 10993-5 : 2010 | Identical |
| NS EN ISO 10993-5 : 2009 | Identical |
| I.S. EN ISO 10993-5:2009 | Identical |
| ISO 10993-5:2009 | Identical |
| UNE-EN ISO 10993-5:2009 | Identical |
| ONORM EN 455-3 : 2015 | MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| 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) |
| ONORM EN 14683 : 2014 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| 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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