Please select and order
€98.22
excl. VAT
Add to cart
Norm
ÖNORM EN ISO 18113-3
Issue date: 2024 10 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2022)
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for professional use.
This document a...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 23 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 18113-3
2024 10 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3:...
Norm
↖
ÖNORM EN ISO 18113-3
2012 12 01
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3:...
Norm
ÖNORM EN ISO 18113-3
2010 04 15
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3:...
Norm
ÖNORM EN 591
2002 03 01
Instructions for use for in vitro diagnostic instruments for professional use
Norm
ÖNORM EN 591
1995 01 01
In vitro diagnostic systems - Requirements for user manuals for in vitro diagnostic instruments for ...
Norm
Norm
Issue date :
2019 12 10
Medical devices — Application of risk management to medical devices
Norm
Issue date :
2021 07 06
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements (Corrected version 2021-07)
Norm
Issue date :
2009 12 09
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
