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 3: Preparations for analytical CTC staining” has been added to your cart. View cart
ISO 23640:2011
ISO 23640:2011 In vitro diagnostic medical devices – Evaluation of stability of in vitro diagnostic reagents
CDN $115.00
Description
ISO 23640:2011 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device.
ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:
- the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained;
- the establishment of stability of the IVD reagent in use after the first opening of the primary container;
- the monitoring of stability of IVD reagents already placed on the market;
- the verification of stability specifications after modifications of the IVD reagent that might affect stability.
Edition
1
Published Date
2011-11-29
Status
PUBLISHED
Pages
7
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 23640:2011 is applicable to the stability evaluation of in vitro diagnostic medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent kits, hereinafter called IVD reagents. ISO 23640:2011 can also be applied to specimen collection devices that contain substances used to preserve samples or to initiate reactions for further processing of the sample in the collection device.
ISO 23640:2011 specifies general requirements for stability evaluation and gives specific requirements for real time and accelerated stability evaluation when generating data in:
- the establishment of IVD reagent shelf life, including transport conditions suitable to ensure that product specifications are maintained;
- the establishment of stability of the IVD reagent in use after the first opening of the primary container;
- the monitoring of stability of IVD reagents already placed on the market;
- the verification of stability specifications after modifications of the IVD reagent that might affect stability.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 21474:2022 In vitro diagnostic medical devices – Multiplex molecular testing for nucleic acids – Part 2: Validation and verification
CDN $173.00 Add to cart -
ISO 17511:2020 In vitro diagnostic medical devices – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
CDN $351.00 Add to cart -
ISO 16256:2021 Clinical laboratory testing and in vitro diagnostic test systems – Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against yeast fungi involved in infectious diseases
CDN $173.00 Add to cart -
ISO 20166:2021 Molecular in vitro diagnostic examinations – Specifications for preexamination processes for formalin-fixed and paraffin-embedded (FFPE) tissue – Part 4: In situ detection techniques
CDN $233.00 Add to cart
