EN ISO 10993-8 : 2000

Name: EN ISO 10993-8 : 2000
Brand: CEN

Withdrawn

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS

Withdrawn date

23-07-2013

Published date

12-01-2013

Publisher

Comite Europeen de Normalisation

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Status	Withdrawn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