In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
Abstract
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.
DIN EN ISO 18113-1:2013-01 (E)
In vitro diagnostic medical devices – Information supplied by the manufacturer
(labelling) – Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………….. 6
2 Normative references …………………………………………………………………………………………………….. 6
3 Terms and definitions …………………………………………………………………………………………………….. 7
4 General requirements for information supplied by the manufacturer ……………………………… 22
4.1 General ………………………………………………………………………………………………………………………… 22
4.2 Language …………………………………………………………………………………………………………………….. 23
4.3 Symbols and identification colours ………………………………………………………………………………. 23
4.4 Values and nomenclature ……………………………………………………………………………………………… 23
4.5 Microbiological state …………………………………………………………………………………………………….. 23
4.6 Instructions for use ………………………………………………………………………………………………………. 23
4.7 Changes to the IVD medical device ……………………………………………………………………………….. 24
4.8 Disclosure of residual risks ………………………………………………………………………………………….. 24
4.9 Identification of components ………………………………………………………………………………………… 25
4.10 Assistance …………………………………………………………………………………………………………………… 25
Annex A (informative) Performance characteristics of IVD medical devices ………………………………….. 26
Bibliography ………………………………………………………………………………………………………………………………… 50
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of the EU Directive 98/79/EC on “in vitro Diagnostic Medical Devices” …….. 55