EN ISO 10993-17:2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
03-21-2010
04-29-2009
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
5.1 General
5.2 Exposure considerations for TI calculation
5.3 Collection and evaluation of data
5.4 Set TI for noncancer endpoints
5.5 Set TI for cancer endpoints
5.6 Establishment of tolerable contact levels (TCLs)
5.7 Risk assessment of mixtures
6 Calculation of tolerable exposure (TE)
6.1 General
6.2 Exposure population
6.3 Calculation of utilization factor from intended
use pattern
6.4 Tolerable exposure
7 Feasibility evaluation
8 Benefit evaluation
9 Allowable limits
10 Reporting requirements
Annex A (informative) - Some typical assumptions for
biological parameters
Annex B (informative) - Risk assessment for mixtures
of leachable substances
Annex C (informative) - Conversion of allowable limits
for systemic exposure and for body surface
contact to maximum dose to patient from a
medical device
Annex D (informative) - Risk analysis report
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this European
Standard and the Essential Requirements of EU
Directive 90/385/EEC on Active Implantable
Medical Devices
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