DIN EN ISO 10993-8:2001-02
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
03-01-2006
English
01-12-2013
1 Scope
2 Normative references
3 Terms and definitions
3.1 Certified reference material
3.2 Reference material
3.3 Homogeneous
3.4 Reference method
3.5 Stability of property values
4 Use of certified reference materials or reference
materials
5 Characteristics of reference materials
5.1 One or more property values
5.2 Long-term availability of the reference material
5.3 Certification of reference materials for
biological safety testing
6 Use of reference materials as experimental controls
6.1 Material screening versus biocompatibility of
medical devices
6.2 Misuse of CRMs
Bibliography
Annex ZA (normative) Normative references to international
publications with their relevant European
publications
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