DS/EN ISO 17511
In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials
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| Organization: | DS |
| Publication Date: | 26 September 2003 |
| Status: | active |
| Page Count: | 31 |
| ICS Code (Laboratory medicine in general): | 11.100.01 |
| ICS Code (Medical microbiology): | 07.100.10 |
scope:
This standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices.
Document History
June 7, 2021
In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)
This document specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for...
DS/EN ISO 17511
September 26, 2003
In vitro diagnostic medical devices – Measurement of quantities in biological samples – Metrological traceability of values assigned to calibrators and control materials
This standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement. The calibrators...
In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO/DIS 17511:2019)
This international standard specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human...
In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO/FDIS 17511:2019)
This international standard specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human...
References
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