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Standard Swedish standard · SS-EN 591

Instructions for use for in vitro diagnostic instruments for professional use

Status: Withdrawn

· Replaced by: SS-EN ISO 18113-3:2009
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Standard Swedish standard · SS-EN 591

Instructions for use for in vitro diagnostic instruments for professional use
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Scope
This standard specifies the requirements for the contents of instructions for use for in vitro diagnostic instruments including apparatus, equipment, calibrators and control materials for professional use, hereafter called IVD instruments.
NOTE 1 Instructions for use are essential to enable the safe and proper operation of IVD instruments.
NOTE 2 This standard can also be applied to accessories.
This standard is not applicable to field repair instructions.

Subjects

In vitro diagnostic test systems (11.100.10)

Buy this standard

Standard Swedish standard · SS-EN 591

Instructions for use for in vitro diagnostic instruments for professional use
Subscribe on standards with our subscription service. When you use our service you can be assured the latest editions and easy access. Read more about SIS Subscriptions
Subscribe on standards - Read more Dölj
Price: 735 SEK
standard ikon pdf

PDF

Price: 735 SEK
standard ikon

Paper

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Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-30441

Edition: 2

Approved: 6/29/2001

No of pages: 12

Replaces: SS-EN 591

Replaced by: SS-EN ISO 18113-3:2009