Your cart is currently empty!
“ISO 20184:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part 3: Isolated DNA” 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 5: In vitro diagnostic instruments for self-testing
CDN $115.00
Description
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
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 professional use.
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 self-testing.
This document is also applicable to apparatus and equipment intended to be used with IVD instruments for self-testing.
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 professional use.
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 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 -
ISO 20184:2021 Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for frozen tissue – Part 3: Isolated DNA
CDN $173.00 Add to cart -
ISO 5649:2024 Medical laboratories – Concepts and specifications for the design, development, implementation and use of laboratory-developed tests
CDN $273.00 Add to cart
