11.100.10: In vitro diagnostic test systems
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UNE-EN 12286:1999
IN VITRO DIAGNOSTIC MEDICAL DEVICES. MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN. PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES.
standard by UNE-EN, 03/08/1999.
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Amendments, rulings, and supplements: UNE-EN 12286/A1:2000
- MULTI-USER
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UNE-EN 12286/A1:2000
IN VITRO DIAGNOSTIC MEDICAL DEVICES. MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN. PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES.
Amendment by UNE-EN, 07/26/2000.
Languages:
- MULTI-USER
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UNE-EN 12287:2000
In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Description of reference materials.
standard by UNE-EN, 03/31/2000.
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- MULTI-USER
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UNE-EN 13532:2002
General requirements for in vitro diagnostic medical devices for self-testing.
standard by UNE-EN, 10/29/2002.
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- MULTI-USER
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UNE-EN 13612:2002
Performance evaluation of in vitro diagnostic medical devices.
standard by UNE-EN, 07/29/2002.
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Corrigenda: UNE-EN 13612/AC:2003
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UNE-EN 13612/AC:2003
Performance evaluation of in vitro diagnostic medical devices.
Corrigenda by UNE-EN, 03/21/2003.
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- MULTI-USER
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UNE-EN 13640:2002
Stability testing of in vitro diagnostic reagents.
standard by UNE-EN, 07/29/2002.
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- MULTI-USER
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UNE-EN 13975:2003
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
standard by UNE-EN, 12/12/2003.
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- MULTI-USER
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UNE-EN ISO 15193:2009
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
standard by UNE-EN ISO, 11/25/2009.
Languages:
- MULTI-USER
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UNE-EN ISO 15194:2009
In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation (ISO 15194:2009)
standard by UNE-EN ISO, 11/25/2009.
Languages:
- MULTI-USER
