{"id":198059,"date":"2024-10-19T12:36:33","date_gmt":"2024-10-19T12:36:33","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-10993-17-2002-ra-2012\/"},"modified":"2024-10-25T05:09:46","modified_gmt":"2024-10-25T05:09:46","slug":"aami-10993-17-2002-ra-2012","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-10993-17-2002-ra-2012\/","title":{"rendered":"AAMI 10993 17 2002 RA 2012"},"content":{"rendered":"
Specifies the method to be used to determine allowable limits for leachable substances in medical devices<\/p>\n
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
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1<\/td>\n | ANSI\/AAMI\/ISO 10993-17:2002\/(R)2012, Biological evaluation of medical devices — Part 17: Methods for the establishment of allowable <\/td>\n<\/tr>\n | ||||||
2<\/td>\n | Objectives and uses of AAMI standards and recommended practices <\/td>\n<\/tr>\n | ||||||
3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
4<\/td>\n | Copyright information <\/td>\n<\/tr>\n | ||||||
5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | Glossary of equivalent standards <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
10<\/td>\n | Background of ANSI\/AAMI adoption of ISO 10993-17:2002 <\/td>\n<\/tr>\n | ||||||
11<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
12<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
13<\/td>\n | 1\tScope 2\tNormative reference 3\tTerms and definitions <\/td>\n<\/tr>\n | ||||||
15<\/td>\n | 4\tGeneral principles for establishing allowable limits <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 5\tEstablishment of tolerable intake (TI) for specific leachable substances 5.1\tGeneral 5.2 Exposure considerations for TI calculation 5.2.1 Data used 5.2.2\tExposure duration considerations <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 5.2.3\tConsiderations of route of exposure 5.3\tCollection and evaluation of data <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 5.4\tSet TI for noncancer endpoints 5.4.1\tGeneral 5.4.2\tDetermination of uncertainty factors 5.4.2.1\tGeneral 5.4.2.2\tUncertainty Factor 1 (UF1) 5.4.2.3\tUncertainty Factor 2 (UF2) <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 5.4.2.4\tUncertainty Factor 3 (UF3) 5.4.3\tDetermination of the modifying factor 5.5\tSet TI for cancer endpoints 5.5.1\tProcedure for carcinogenic leachable substances <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | 5.5.2\tOptions for substances that pass the weight-of-evidence test 5.5.3\tProcedure when weight-of-evidence test fails or is equivocal 5.6\tEstablishment of tolerable contact levels (TCLs) 5.6.1\tGeneral 5.6.2\tExposure consideration for TCL calculation 5.6.3\tSet TCL for irritation endpoint 5.6.3.1\tGeneral <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | 5.6.3.2\tDetermination of uncertainty factors 5.6.3.3\tDetermination of the TCL modifying factor 5.7\tRisk assessment of mixtures <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | 6\tCalculation of tolerable exposure (TE) 6.1\tGeneral 6.2\tExposure population 6.2.1\tBody mass 6.2.2\tDevices specifically intended for use in neonates and children 6.3\tCalculation of utilization factor from intended use pattern 6.3.1\tGeneral <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | 6.3.2\tConcomitant exposure factor (CEF) 6.3.3\tProportional exposure factor (PEF) <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | 6.4\tTolerable exposure 7\tFeasibility evaluation 8\tBenefit evaluation 9\tAllowable limits <\/td>\n<\/tr>\n | ||||||
26<\/td>\n | 10\tReporting requirements <\/td>\n<\/tr>\n | ||||||
27<\/td>\n | Annex A, Some typical assumptions for biological parameters A.1\tGeneral A.2\tAssumptions A.2.1\tHuman A.2.2\tRat A.2.3\tMouse A.2.4\tHamster <\/td>\n<\/tr>\n | ||||||
28<\/td>\n | A.2.5\tGuinea pig A.2.6\tDog A.2.7\tRabbit <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | Annex B, Risk assessment for mixtures of leachable substances <\/td>\n<\/tr>\n | ||||||
30<\/td>\n | Annex C, Conversion of allowable limits for systemic exposure and for body surface contact to maximum dose to patient from a C.1\tIntroduction C.2\tCalculation of the maximum dose to patient of a leachable substance from a medical device for systemic exposure C.2.1\tPermanent-contact devices C.2.2\tProlonged-exposure devices <\/td>\n<\/tr>\n | ||||||
31<\/td>\n | C.2.3\tLimited-exposure devices C.3\tCalculation of the maximum dose to patient of a substance leachable from medical devices from body-surface contact <\/td>\n<\/tr>\n | ||||||
32<\/td>\n | Annex D, Risk analysis report D.1\tGeneral D.2\tContents <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI\/ISO 10993-17:2002\/(R)2012 – Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances<\/b><\/p>\n |