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SN EN ISO 10993-16 : 2010

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES

Superseded date

03-09-2018

Published date

12-01-2013

1 Scope
2 Normative reference
3 Definitions
4 Principles for design of toxicokinetic studies
5 Guidance on test methods
    5.1 General considerations
    5.2 Guidance on specific types of tests
Annexes
A Circumstances in which toxicokinetic studies shall
    be considered

Specifies the designing and performance of toxcicokinetic studies relevant to medical devices. Covers considerations for including toxicokinetic studies in the biological evaluating of medical devices.

DevelopmentNote
Supersedes SN 119800. (06/2006)
DocumentType
Standard
PublisherName
Swiss Standards
Status
Superseded
SupersededBy
Supersedes

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