Your cart is currently empty!
“ISO 16972:2020 Respiratory protective devices – Vocabulary and graphical symbols” has been added to your cart. View cart
ISO 21151:2020
ISO 21151:2020 In vitro diagnostic medical devices – Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
CDN $233.00
Description
This document specifies requirements for a protocol implemented by an international body to achieve equivalent results among two or more IVD MDs for the same measurand for cases where there are no reference measurement procedures and no fit-for-purpose certified reference materials or international conventional calibrators. In this case, the harmonisation protocol defines the highest level of metrological traceability for the stated measurand.
This document can be applied in cases when certified reference materials or international conventional calibrators exist but are not fit-for-purpose because, for example, they are not commutable with human samples.
NOTE This document addresses one case of traceability of assigned and measured values described in 5.6 in ISO 17511:2020.
Edition
1
Published Date
2020-05-25
Status
PUBLISHED
Pages
20
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
This document specifies requirements for a protocol implemented by an international body to achieve equivalent results among two or more IVD MDs for the same measurand for cases where there are no reference measurement procedures and no fit-for-purpose certified reference materials or international conventional calibrators. In this case, the harmonisation protocol defines the highest level of metrological traceability for the stated measurand.
This document can be applied in cases when certified reference materials or international conventional calibrators exist but are not fit-for-purpose because, for example, they are not commutable with human samples.
NOTE This document addresses one case of traceability of assigned and measured values described in 5.6 in ISO 17511:2020.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 23975:2025 Traditional Chinese medicine – Priority list of single herbal medicines for developing standards
CDN $390.00 Add to cart -
ISO 9687:2015 Dentistry – Graphical symbols for dental equipment
CDN $273.00 Add to cart -
ISO 20560:2024 Safety information for the content of piping systems and tanks – Part 1: Piping systems
CDN $233.00 Add to cart -
ISO 16840:2006 Wheelchair seating – Part 1: Vocabulary, reference axis convention and measures for body segments, posture and postural support surfaces
CDN $351.00 Add to cart
