Standard Swedish standard · SS-EN ISO 18113-2:2009

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)

Status: Withdrawn

· Replaced by: SS-EN ISO 18113-2:2011
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Standard Swedish standard · SS-EN ISO 18113-2:2009

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
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Scope
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.

Subjects

In vitro diagnostic test systems (11.100.10)


Buy this standard

Standard Swedish standard · SS-EN ISO 18113-2:2009

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use (ISO 18113-2:2009)
Subscribe on standards - Read more Dölj
Price: 1 013 SEK
standard ikon pdf

PDF

Price: 1 013 SEK
standard ikon

Paper

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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-72147

Edition: 1

Approved: 12/28/2009

No of pages: 28

Replaces: SS-EN 375

Replaced by: SS-EN ISO 18113-2:2011