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NBN - EN ISO 10993-18 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005) Organization: NBN
Date: 2009-07-17
Description: The chemical characterization information generated can be used for a range of important applications, for example, as part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971), as a measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17), for judging equivalence of a proposed material to a clinically established material, for judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former, or for screening of potential new materials for suitability in a medical device for a proposed clinical application.
NBN - EN ISO 10993-18 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005) Organization: NBN
Date: 2009-07-17
Description: The chemical characterization information generated can be used for a range of important applications, for example, as part of an assessment of the overall biological safety of a medical device (ISO 10993-1 and 14971), as a measurement of the level of a leachable substance in a medical device in order to allow the assessment of compliance with the allowable limit derived for that substance from health based risk assessment (ISO 10993-17), for judging equivalence of a proposed material to a clinically established material, for judging equivalence of a final device to a prototype device to check the relevance of data on the latter to be used to support the assessment of the former, or for screening of potential new materials for suitability in a medical device for a proposed clinical application.
NBN - EN ISO 10993-12 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012) Organization: NBN
Date: 2012-08-31
Description: ISO 10993-12:2012 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993.
NBN - EN ISO 10993-12 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012) Organization: NBN
Date: 2012-08-31
Description: ISO 10993-12:2012 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993.
DIN EN ISO 10993-12 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012) Organization: DIN
Date: 2012-10-01
Description: This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993.
SNV - SN EN ISO 10993-8 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS (ISO 10993-8:2000) Organization: SNV
Date: 2000-11-01
SN - NS-EN ISO 10993-8:2000 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS (ISO 10993-8:2000) Organization: SN
Date: 2000-12-14
TSE - TS EN ISO 10993-8 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES- PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS (ISO 10993-8:2000) Organization: TSE
Date: 2000-11-21
AENOR UNE-EN ISO 10993-8 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS. (ISO 10993-8:2000) Organization: AENOR
Date: 2001-06-21
NBN - EN ISO 10993-8 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS (ISO 10993-8:2000) Organization: NBN
Date: 2000-11-22
DIN EN ISO 10993-8 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS (ISO 10993-8:2000); GERMAN VERSION EN ISO 10993-8:2000 Organization: DIN
Date: 2001-02-01
DIN EN ISO 10993-8 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 8: SELECTION AND QUALIFICATION OF REFERENCE MATERIALS FOR BIOLOGICAL TESTS (ISO 10993-8:2000); ENGLISH VERSION OF DIN EN ISO 10993-8 Organization: DIN
Date: 2001-02-01
SN - NS-EN ISO 10993-18:2005 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005) Organization: SN
Date: 2005-11-01
AENOR - UNE-EN ISO 10993-18 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005) Organization: AENOR
Date: 2009-09-09
SN - NS-EN ISO 10993-18:2009 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005) Organization: SN
Date: 2009-07-01
DIN EN ISO 10993-18 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS (ISO 10993-18:2005) Organization: DIN
Date: 2009-08-01
SN - NS-EN ISO 10993-12:2004 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2002) Organization: SN
Date: 2005-02-10
SN - NS-EN ISO 10993-12:1996 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:1996) Organization: SN
Date: 1996-11-06
SN - NS-EN ISO 10993-12:2007 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2007) Organization: SN
Date: 2008-03-01
SN - NS-EN ISO 10993-12:2009 - BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2007) Organization: SN
Date: 2009-07-01

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