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AAMI ISO 10993-17 : 2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES
Hardcopy , PDF
08-05-2020
English
01-01-2008
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
5.1 General
5.2 Exposure considerations for TI calculation
5.2.1 Data used
5.2.2 Exposure duration considerations
5.2.3 Considerations of route of exposure
5.3 Collection and evaluation of data
5.4 Set TI for noncancer endpoints
5.4.1 General
5.4.2 Determination of uncertainty factors
5.4.3 Determination of the modifying factor
5.5 Set TI for cancer endpoints
5.5.1 Procedure for carcinogenic leachable substances
5.5.2 Options for substances that pass the
weight-of-evidence test
5.5.3 Procedure when weight-of-evidence test fails
or is equivocal
5.6 Establishment of tolerable contact levels (TCLs)
5.6.1 General
5.6.2 Exposure consideration for TCL calculation
5.6.3 Set TCL for irritation endpoint
5.7 Risk assessment of mixtures
6 Calculation of tolerable exposure (TE)
6.1 General
6.2 Exposure population
6.2.1 Body mass
6.2.2 Devices specifically intended for use in neonates
and children
6.3 Calculation of utilization factor from intended use
pattern
6.3.1 General
6.3.2 Concomitant exposure factor (CEF)
6.3.3 Proportional exposure factor (PEF)
6.4 Tolerable exposure
7 Feasibility evaluation
8 Benefit evaluation
9 Allowable limits
10 Reporting requirements
Annexes
A - Some typical assumptions for biological parameters
B - Risk assessment for mixtures of leachable substances
C - Conversion of allowable limits for systemic exposure
and for body surface contact to maximum dose
to patient from a medical device
D - Risk analysis report
Bibliography
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