EN ISO 10993-8 : 2000
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS
23-07-2013
12-01-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Use of certified reference materials or reference
materials
5 Characteristics of reference materials
6 Use of reference materials as experimental controls
Bibliography
Annex ZA (normative) Normative references to international
publications with their relevant European
publications
Gives requirements on the use of reference materials or certified reference materials used to determine the biological response of a material. It gives the selection and qualification of reference materials for biological tests and the characteristics of reference materials for the use of reference manuals as experimental controls.
| Committee |
TC 206
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| NEN EN ISO 10993-8 : 2000 | Identical |
| UNI EN ISO 10993-8 : 2002 | Identical |
| NBN EN ISO 10993-8 : 2000 | Identical |
| I.S. EN ISO 10993-8:2000 | Identical |
| ISO 10993-8:2000 | Identical |
| NF EN ISO 10993-8 : 2001 | Identical |
| UNE-EN ISO 10993-8:2001 | Identical |
| NS EN ISO 10993-8 : 1ED 2000 | Identical |
| DIN EN ISO 10993-8:2001-02 | Identical |
| SN EN ISO 10993-8 : 2000 | Identical |
| BS EN ISO 10993-8:2001 | Identical |
| ISO Guide 33:2015 | Reference materials — Good practice in using reference materials |
| ISO Guide 35:2017 | Reference materials — Guidance for characterization and assessment of homogeneity and stability |
| ISO 10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization |
| ISO 10993-12:2012 | Biological evaluation of medical devices Part 12: Sample preparation and reference materials |
| ISO Guide 30:2015 | Reference materials — Selected terms and definitions |
| EN ISO 10993-12:2012 | Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2012) |
| ISO Guide 31:2015 | Reference materials — Contents of certificates, labels and accompanying documentation |
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