Standard Swedish standard · SS-EN ISO 18113-1:2024

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022, IDT)

Status: Valid

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Standard Swedish standard · SS-EN ISO 18113-1:2024

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022, IDT)
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Scope
This document defines concepts, establishes general principles, and specifies essential requirements for information supplied by the manufacturer of IVD medical devices.
This document does not address language requirements since that is the domain of national laws and regulations.
This document does not apply to:
a) IVD medical devices for performance evaluation (e.g. for investigational use only);
b) shipping documents;
c) material safety data sheets / Safety Data Sheets;
d) marketing information (consistent with applicable legal requirements).
.

Subjects

In vitro diagnostic test systems (11.100.10)


Buy this standard

Standard Swedish standard · SS-EN ISO 18113-1:2024

In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements (ISO 18113-1:2022, IDT)
Subscribe on standards - Read more Dölj
Price: 1 487 SEK
standard ikon pdf

PDF

Price: 1 487 SEK
standard ikon

Paper

Price: 2 379,20 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less

Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-82089691

Edition: 3

Approved: 9/2/2024

No of pages: 68

Replaces: SS-EN ISO 18113-1:2011