In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
Abstract
ISO 18113-3:2009 specifies requirements for information supplied by the manufacturer of in vitro dignostic (IVD) instruments for professional use.
ISO 18113-3:2009 also applies to apparatus and equipment intended to be used with IVD instruments for professional use.
ISO 18113-3:2009 can also be applied to accessories, where appropriate.
DIN EN ISO 18113-3:2013-01 (E)
In vitro diagnostic medical devices – Information supplied by the manufactur er
(labelling) – Part 3: In vitro diagnostic instruments for professional use (ISO 18113-
3:2009)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………….. 5
2 Normative references …………………………………………………………………………………………………….. 5
3 Terms and definitions …………………………………………………………………………………………………….. 6
4 Essential requirements …………………………………………………………………………………………………… 6
5 Labels and marking ………………………………………………………………………………………………………… 6
5.1 General ………………………………………………………………………………………………………………………….. 6
5.2 Identification of the IVD instrument ………………………………………………………………………………… 6
6 Elements of the instructions for use ……………………………………………………………………………….. 6
7 Content of the instructions for use …………………………………………………………………………………. 7
7.1 Manufacturer ………………………………………………………………………………………………………………….. 7
7.2 Identification of the IVD instrument ………………………………………………………………………………… 7
7.3 Intended use ………………………………………………………………………………………………………………….. 7
7.4 Storage and handling ……………………………………………………………………………………………………… 8
7.5 Warnings and precautions ……………………………………………………………………………………………… 8
7.6 Instrument installation ……………………………………………………………………………………………………. 8
7.7 Theory of operation ………………………………………………………………………………………………………… 9
7.8 Functions ………………………………………………………………………………………………………………………. 9
7.9 Performance of the IVD instrument …………………………………………………………………………………. 9
7.10 Limitations of use …………………………………………………………………………………………………………. 10
7.11 Preparation prior to operation ………………………………………………………………………………………. 10
7.12 Operating procedure …………………………………………………………………………………………………….. 10
7.13 Control procedure ………………………………………………………………………………………………………… 10
7.14 Calculation of examination results ………………………………………………………………………………… 10
7.15 Special functions ………………………………………………………………………………………………………….. 11
7.16 Emergency primary samples ………………………………………………………………………………………… 11
7.17 Shut-down procedure …………………………………………………………………………………………………… 11
7.18 Disposal information …………………………………………………………………………………………………….. 11
7.19 Maintenance …………………………………………………………………………………………………………………. 11
7.20 Troubleshooting …………………………………………………………………………………………………………… 12
Bibliography ………………………………………………………………………………………………………………………………… 13
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” …….. 14