Standard Swedish standard · SS-EN ISO 13408-7:2015

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)

Status: Valid

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Standard Swedish standard · SS-EN ISO 13408-7:2015

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
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Scope
This part of ISO 13408 specifies requirements and provides guidance on alternative approaches to process
simulations for the qualification of the aseptic processing of medical devices and combination products that cannot
be terminally sterilized and where the process simulation approach according to ISO 13408-1 cannot be applied.
This part of ISO 13408 describes how risk assessment can be used during the development of an aseptic
process to design a process simulation study for medical devices and combination products in those cases
where a straightforward substitution of media for product during aseptic processing is not feasible or would not
simulate the actual aseptic process.

Subjects

Sterilization and disinfection in general (11.080.01) Disinfectants and antiseptics (11.080.20) Other (11.080.99)


Buy this standard

Standard Swedish standard · SS-EN ISO 13408-7:2015

Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
Subscribe on standards - Read more Dölj
Price: 995 SEK
standard ikon pdf

PDF

Price: 995 SEK
standard ikon

Paper

Price: 1 592 SEK
standard ikon pdf + standard ikon

PDF + paper

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Product information

Language: English

Written by: SIS - Standardiseringens stöd

International title:

Article no: STD-8015359

Edition: 1

Approved: 8/9/2015

No of pages: 36