In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
Abstract
ISO 18113-5:2009 specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments for self-testing.
ISO 18113-5:2009 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.
ISO 18113-5:2009 can also be applied to accessories.
DIN EN ISO 18113-5:2013-01 (E)
In vitro diagnostic medical devices – Information supplied by the manufacturer
(labelling ) – Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
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 ……………………………………………………………………………….. 7
7 Content of the instructions for use …………………………………………………………………………………. 7
7.1 Manufacturer ………………………………………………………………………………………………………………….. 7
7.2 Identification of the IVD instrument ………………………………………………………………………………… 7
7.3 Intended use ………………………………………………………………………………………………………………….. 8
7.4 Storage and handling ……………………………………………………………………………………………………… 8
7.5 Warnings and precautions ……………………………………………………………………………………………… 8
7.6 Instrument installation ……………………………………………………………………………………………………. 8
7.7 Principles of measurement …………………………………………………………………………………………….. 9
7.8 Performance of the IVD instrument …………………………………………………………………………………. 9
7.9 Limitations of use …………………………………………………………………………………………………………… 9
7.10 Preparation prior to operation ………………………………………………………………………………………… 9
7.11 Operating procedure ………………………………………………………………………………………………………. 9
7.12 Control procedure ………………………………………………………………………………………………………… 10
7.13 Reading of examination results …………………………………………………………………………………….. 10
7.14 Special functions ………………………………………………………………………………………………………….. 10
7.15 Shut-down procedure …………………………………………………………………………………………………… 10
7.16 Disposal information …………………………………………………………………………………………………….. 10
7.17 Maintenance …………………………………………………………………………………………………………………. 11
7.18 Troubleshooting …………………………………………………………………………………………………………… 11
7.19 Follow-up action …………………………………………………………………………………………………………… 11
Bibliography ………………………………………………………………………………………………………………………………… 12
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” …….. 13