I.S. 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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
Hardcopy , PDF
01-02-2005
English
01-12-2000
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.
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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.
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| Standards | Relationship |
| 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 |
| NEN EN ISO 10993-8 : 2000 | Identical |
| UNI EN ISO 10993-8 : 2002 | Identical |
| NBN EN ISO 10993-8 : 2000 | Identical |
| ISO 10993-8:2000 | Identical |
| EN ISO 10993-8 : 2000 | Identical |
| NF 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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