ISO 18113-3:2022

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 3: In vitro diagnostic instruments for professional use

Publication date: Oct 6, 2022

General information

Current stage: 60.60 Effective date: Oct 6, 2022

Originator: ISO

Owner: ISO/TC 212

Type: International Standard

ICS: 11.100.10

Languages: English French

Buying

Status: Published

PDF - EC$183.61

Paper - EC$183.61

PDF and Paper - EC$367.22

Language

Language in which you want to receive the document.

Scope

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.

Life cycle

PREVIOUSLY

Revises
ISO 18113-3:2009

NOW

PUBLISHED
ISO 18113-3:2022
60.60 Standard published
Oct 6, 2022

Preview

Only informative sections of projects are publicly available. To view the full content, you will need to members of the committee. If you are a member, please log in to your account by clicking on the "Log in" button.