ISO 18113-1:2009
In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
ISO 18113-1:2009 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) medical devices.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$118.26 NZD
|
|
| HardCopy |
$152.17 NZD
|
|
| Networkable PDF |
Price varies
|
Scope
Normative references
Terms and definitions
General requirements for information supplied by the manufac
General
Language
Symbols and identification colours
Values and nomenclature
Microbiological state
Instructions for use
Changes to the IVD medical device
4.8 Disclosure of residual risks
4.9 Identification of components
4.10 Assistance
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
-
BS EN 13532:2002
General requirements for in vitro diagnostic medical devices for self-testing
-
BS EN 13612:2002
Performance evaluation of in vitro diagnostic medical devices
-
BS EN 13641:2002
Elimination or reduction of risk of infection related to in vitro diagnostic reagents
-
BS EN 13975:2003
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
Scope
Normative references
Terms and definitions
General requirements for information supplied by the manufac
General
Language
Symbols and identification colours
Values and nomenclature
Microbiological state
Instructions for use
Changes to the IVD medical device
4.8 Disclosure of residual risks
4.9 Identification of components
4.10 Assistance