Standard Svensk standard · SS-EN ISO 18113-5:2011

Medicintekniska produkter för in vitro-diagnostik - Information som ska tillhandahållas av tillverkaren (märkning) - Del 5: In vitro-diagnostiska instrument för självtestning (ISO 18113-5:2009)

Status: Gällande

Omfattning
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for self-testing.

This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for self-testing.

This part of ISO 18113 can also be applied to accessories.

This part of ISO 18113 does not apply to
a) instructions for instrument servicing or repair,
b) IVD reagents, including calibrators and control materials for use in control of the reagent,
c) IVD instruments for professional use.

Ämnesområden

(11.100.10)


Produktinformation

Språk: Engelska

Framtagen av: Laboratoriemedicin, SIS/TK 331

Internationell titel: In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)

Artikelnummer: STD-82204

Utgåva: 2

Fastställd: 2011-11-21

Antal sidor: 24

Ersätter: SS-EN ISO 18113-5:2009