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BS EN ISO 10993-8:2001

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 Selection and qualification of reference materials for biological tests
Available format(s)

Hardcopy , PDF

Withdrawn date

31-10-2007

Language(s)

English

Published date

15-08-2001

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

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
CH/194
DevelopmentNote
Supersedes 99/561061 DC. (06/2005)
DocumentType
Standard
Pages
16
PublisherName
British Standards Institution
Status
Withdrawn
Supersedes

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

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