DSF/FprEN ISO 18113-1
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/FDIS 18113-1:2009)
inactive
| Organization: | DS |
| Status: | inactive |
| Page Count: | 64 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
scope:
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.
Document History
December 9, 2011
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.
January 15, 2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
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...
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions, and general requirements (ISO/FDIS 18113-1:2022)
This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This document does not...
Clinical laboratory testing and in vitro diagnostic medical systems - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/DIS 18113-1:2006)
This International Standard specifies requirements for information supplied by the manufacturer of IVD
medical devices. It consists of five parts as follows:
Part 1 defines concepts, establishes...
DSF/FprEN ISO 18113-1
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO/FDIS 18113-1:2009)
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...
In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions, and general requirements (ISO/DIS 18113-1:2021)
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