Standard Swedish standard · SS-EN 556-2:2004

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

Status: Withdrawn

· Replaced by: SS-EN 556-2:2015
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Standard Swedish standard · SS-EN 556-2:2004

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
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Scope
This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.
NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in prEN 13824 (in preparation).

Subjects

Sterilization and disinfection in general (11.080.01)


Buy this standard

Standard Swedish standard · SS-EN 556-2:2004

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
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: Svenska institutet för standarder

International title:

Article no: STD-37374

Edition: 1

Approved: 9/24/2004

No of pages: 10

Replaced by: SS-EN 556-2:2015