DSF/prEN ISO 18113-1
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)
| Organization: | DS |
| Status: | inactive |
| Page Count: | 41 |
| ICS Code (In vitro diagnostic test systems): | 11.100.10 |
scope:
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 general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
Part 2 specifies the requirements for labels and instructions for use supplied with IVD reagents, calibrators and control materials for professional use.
Part 3 specifies the requirements for instructions for use supplied with IVD instruments for professional use.
Part 4 specifies the requirements for labels and instructions for use supplied with IVD reagents, calibrators and control materials for self-testing.
Part 5 specifies the requirements for instructions for use supplied with IVD instruments for self-testing.
This International Standard does not address language requirements, since that is the domain of national laws and regulations.
This International Standard does not apply to:
a) IVD medical devices for performance evaluation (e.g., for investigational use only);
b) instrument marking;
c) material safety data sheets.
Document History
