ISO 18113:2022
ISO 18113:2022 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use
CDN $124.00
Description
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.
This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for self-testing.
Edition
2
Published Date
2022-10-06
Status
PUBLISHED
Pages
10
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) instruments intended for professional use.
This document also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
This document can also be applicable to accessories.
This document does not apply to:
a) instructions for instrument servicing or repair;
b) IVD reagents, including calibrators and control materials for use in control of the reagent;
c) IVD instruments for self-testing.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 20916:2019 In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice
CDN $418.00 Add to cart -
ISO 18113:2022 In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions, and general requirements
CDN $379.00 Add to cart -
ISO 21474:2022 In vitro diagnostic medical devices – Multiplex molecular testing for nucleic acids – Part 2: Validation and verification
CDN $186.00 Add to cart -
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
CDN $251.00 Add to cart
