Standard Svensk standard · SS-EN ISO 18113-1:2011

Medicintekniska produkter för in vitro-diagnostik - Information som ska tillhandahållas av tillverkaren (märkning) - Del 1: Termer, definitioner och allmänna krav (ISO 18113-1:2009)

Status: Gällande

Omfattning
This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.

This part of ISO 18113 does not address language requirements, since that is the domain of national laws and regulations.

This part of ISO 18113 does not apply to
a) IVD devices for performance evaluation (e.g., for investigational use only),
b) instrument marking,
c) material safety data sheets.

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 1: Terms, definitions and general requirements (ISO 18113-1:2009)

Artikelnummer: STD-82200

Utgåva: 2

Fastställd: 2011-11-21

Antal sidor: 68

Ersätter: SS-EN ISO 18113-1:2009