ISO 18113-5:2022

	Format	Language
std 1 63	PDF + ePub
std 2 63	Paper

Convert Swiss francs (CHF) to your currency

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.

Preview this standard in our Online Browsing Platform (OBP)

Check out our FAQs

Customer care

+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)