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ANSI/AAMI/ISO 10993-17:2002/(R)2012 - Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances >
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ANSI/AAMI/ISO 10993-17:2002/(R)2012 - Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances, 2002
- ANSI/AAMI/ISO 10993-17:2002/(R)2012, Biological evaluation of medical devices -- Part 17: Methods for the establishment of allowable
- Objectives and uses of AAMI standards and recommended practices
- Title page
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Background of ANSI/AAMI adoption of ISO 10993-17:2002
- Foreword
- Introduction
- 1 Scope
- 2 Normative reference
- 3 Terms and definitions
- 4 General principles for establishing allowable limits
- 5 Establishment of tolerable intake (TI) for specific leachable substances [Go to Page]
- 6 Calculation of tolerable exposure (TE) [Go to Page]
- 7 Feasibility evaluation
- 8 Benefit evaluation
- 9 Allowable limits
- 10 Reporting requirements
- Annex A, Some typical assumptions for biological parameters [Go to Page]
- Annex B, Risk assessment for mixtures of leachable substances
- Annex C, Conversion of allowable limits for systemic exposure and for body surface contact to maximum dose to patient from a [Go to Page]
- Annex D, Risk analysis report [Go to Page]
