AAMI ISO 10993-17 : 2002

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

Describes a method for determining allowable limits for leachable substances from medical devices and describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.