Your cart is currently empty!
“ISO 7552:2024 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for circulating tumour cells (CTCs) in venous whole blood – Part 2: Isolated DNA” has been added to your cart. View cart
ISO 15194:2009
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
CDN $173.00
Description
ISO 15194:2009 specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.
ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15194:2009 does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.
Edition
2
Published Date
2009-04-28
Status
PUBLISHED
Pages
16
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
ISO 15194:2009 specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.
ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.
ISO 15194:2009 does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 29701:2010 Nanotechnologies – Endotoxin test on nanomaterial samples for in vitro systems – Limulus amebocyte lysate (LAL) test
CDN $233.00 Add to cart -
ISO 21474:2020 In vitro diagnostic medical devices – Multiplex molecular testing for nucleic acids – Part 1: Terminology and general requirements for nucleic acid quality evaluation
CDN $233.00 Add to cart -
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 Add to cart -
ISO 18113:2022 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 2: In vitro diagnostic reagents for professional use
CDN $115.00 Add to cart
