In vitro diagnostic instruments for self-testingIn vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

12-06-2024

Publisher

British Standards Institution

Committee	CH/212
DocumentType	Standard
Pages	24
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN ISO 18113-5:2011

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.

View more information

€227.28

Excluding VAT

Product format

I agree to the DRM document license rules apply against the PDF selection made.

Please confirm that you agree to the document license rules for this document.

I agree to the document license rules .

Please confirm that you agree to the document license rules for this document.

Access your standards online with a subscription

Features

Simple online access to standards, technical information and regulations.
Critical updates of standards and customisable alerts and notifications.
Multi-user online standards collection: secure, flexible and cost effective.

Get in touch with us

BS EN ISO 18113-5:2024

In vitro diagnostic instruments for self-testingIn vitro diagnostic medical devices. Information supplied by the manufacturer (labelling)

General Product Information

Scope

Category

Subcategory