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Standard Swedish standard · SS-EN ISO 10993-16:2017

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)

Status: Valid

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Standard Swedish standard · SS-EN ISO 10993-16:2017

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
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Scope
ISO 10993-16:2017 provides principles on designing and performing toxicokinetic studies relevant to medical devices. 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 10993-16:2017

Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
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: 1 013 SEK
standard ikon pdf

PDF

Price: 1 013 SEK
standard ikon

Paper

Price: 1 620,80 SEK
standard ikon pdf + standard ikon

PDF + paper

Show more Show less

Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-8030059

Edition: 4

Approved: 12/13/2017

No of pages: 23

Replaces: SS-EN ISO 10993-16:2010