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Standard Swedish standard · SS-EN ISO 10993-16:2009

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)

Status: Withdrawn

· Replaced by: SS-EN ISO 10993-16:2010
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Standard Swedish standard · SS-EN ISO 10993-16:2009

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
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Scope
This part of ISO 10993 gives principles on how toxicokinetic studies relevant to medical devices should be designed and performed. Annex A describes the considerations for inclusion of toxicokinetic studies in the biological evaluation of medical devices.

Subjects

Biological evaluation of medical devices (11.100.20)

Buy this standard

Standard Swedish standard · SS-EN ISO 10993-16:2009

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
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: 875 SEK
standard ikon pdf

PDF

Price: 875 SEK
standard ikon

Paper

Show more Show less

Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-69662

Edition: 2

Approved: 5/8/2009

No of pages: 24

Replaces: SS-EN ISO 10993-16

Replaced by: SS-EN ISO 10993-16:2010