Standard Swedish standard · SS-EN ISO 18113-3:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)

Status: Withdrawn

· Replaced by: SS-EN ISO 18113-3:2024
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Standard Swedish standard · SS-EN ISO 18113-3:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
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Scope
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD instruments for professional use. This part of ISO 18113 also applies to apparatus and equipment intended to be used with IVD instruments for professional use. 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 self-testing.

Subjects

In vitro diagnostic test systems (11.100.10)


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Standard Swedish standard · SS-EN ISO 18113-3:2011

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3: In vitro diagnostic instruments for professional use (ISO 18113-3:2009)
Subscribe on standards - Read more Dölj
Price: 875 SEK
standard ikon pdf

PDF

Price: 875 SEK
standard ikon

Paper

Price: 1 400 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-82202

Edition: 2

Approved: 11/21/2011

No of pages: 24

Replaces: SS-EN ISO 18113-3:2009

Replaced by: SS-EN ISO 18113-3:2024