Standard Svensk standard · SS-EN ISO 18113-2:2011

Medicintekniska produkter för in vitro-diagnostik - Information som ska tillhandahållas av tillverkaren (märkning) - Del 2: In vitro-diagnostiska reagens för professionell användning (ISO 18113-2:2009)

Status: Gällande

Omfattning
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for professional use.

This part of ISO 18113 also applies to information supplied by the manufacturer with calibrators and control materials intended for use with IVD medical devices for professional use.

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

This part of ISO 18113 applies to the labels for outer and immediate containers and to the instructions for use.

This part of ISO 18113 does not apply to
a) IVD instruments or equipment,
b) IVD reagents for self-testing.

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 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

Artikelnummer: STD-82201

Utgåva: 2

Fastställd: 2011-11-21

Antal sidor: 28

Ersätter: SS-EN ISO 18113-2:2009