Back

EVS-EN ISO 18113-1:2010

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements

General information
Withdrawn from 02.11.2011
Base Documents
ISO 18113-1:2009; EN ISO 18113-1:2009
Directives or regulations
None
Standard history
Status
Date
Type
Name
This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations. This part of ISO 18113 does not apply to a) IVD devices for performance evaluation (e.g., for investigational use only), b) instrument marking, c) material safety data sheets.
*
*
*
PDF
21.60 € incl tax
Paper
21.60 € incl tax
Price: 2.40 € incl tax
Standard monitoring
Customers who bought this item also bought
Main

EVS-EN ISO 18113-3:2010

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use
Withdrawn from 02.11.2011
Main

EVS-EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices
Newest version Valid from 01.09.2002