AAMI 10993 17 2002 RA 2012
$93.55
ANSI/AAMI/ISO 10993-17:2002/(R)2012 – Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances
| Published By | Publication Date | Number of Pages |
| AAMI | 2002 | 33 |
Specifies the method to be used to determine allowable limits for leachable substances in medical devices
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ISO 10993-17:2002/(R)2012, Biological evaluation of medical devices — Part 17: Methods for the establishment of allowable |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | Copyright information |
| 5 | Contents |
| 7 | Glossary of equivalent standards |
| 9 | Committee representation |
| 10 | Background of ANSI/AAMI adoption of ISO 10993-17:2002 |
| 11 | Foreword |
| 12 | Introduction |
| 13 | 1 Scope 2 Normative reference 3 Terms and definitions |
| 15 | 4 General principles for establishing allowable limits |
| 17 | 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 |
| 18 | 5.2.3 Considerations of route of exposure 5.3 Collection and evaluation of data |
| 19 | 5.4 Set TI for noncancer endpoints 5.4.1 General 5.4.2 Determination of uncertainty factors 5.4.2.1 General 5.4.2.2 Uncertainty Factor 1 (UF1) 5.4.2.3 Uncertainty Factor 2 (UF2) |
| 20 | 5.4.2.4 Uncertainty Factor 3 (UF3) 5.4.3 Determination of the modifying factor 5.5 Set TI for cancer endpoints 5.5.1 Procedure for carcinogenic leachable substances |
| 21 | 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 5.6.3.1 General |
| 22 | 5.6.3.2 Determination of uncertainty factors 5.6.3.3 Determination of the TCL modifying factor 5.7 Risk assessment of mixtures |
| 23 | 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 |
| 24 | 6.3.2 Concomitant exposure factor (CEF) 6.3.3 Proportional exposure factor (PEF) |
| 25 | 6.4 Tolerable exposure 7 Feasibility evaluation 8 Benefit evaluation 9 Allowable limits |
| 26 | 10 Reporting requirements |
| 27 | Annex A, Some typical assumptions for biological parameters A.1 General A.2 Assumptions A.2.1 Human A.2.2 Rat A.2.3 Mouse A.2.4 Hamster |
| 28 | A.2.5 Guinea pig A.2.6 Dog A.2.7 Rabbit |
| 29 | Annex B, Risk assessment for mixtures of leachable substances |
| 30 | Annex C, Conversion of allowable limits for systemic exposure and for body surface contact to maximum dose to patient from a C.1 Introduction C.2 Calculation of the maximum dose to patient of a leachable substance from a medical device for systemic exposure C.2.1 Permanent-contact devices C.2.2 Prolonged-exposure devices |
| 31 | C.2.3 Limited-exposure devices C.3 Calculation of the maximum dose to patient of a substance leachable from medical devices from body-surface contact |
| 32 | Annex D, Risk analysis report D.1 General D.2 Contents |
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