Your cart is currently empty!
“ISO 20916:2019 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice” has been added to your cart. View cart
ISO 18113:2022
ISO 18113:2022 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 4: In vitro diagnostic reagents for self-testing
CDN $115.00
Description
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for professional use.
Edition
2
Published Date
2022-10-06
Status
PUBLISHED
Pages
11
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 information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for professional use.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 18113:2022 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use
CDN $115.00 Add to cart -
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 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 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
