Specifies particular requirements for active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system in order to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | ANSI\/AAMI\/ISO 14708-3:2017; Implants for surgery \u2014 Active implantable medical devices \u2014 Part 3: Implantable neurostimulators <\/td>\n<\/tr>\n | ||||||
| 2<\/td>\n | Objectives and uses of AAMI standards andrecommended practices <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Standard 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 | ||||||
| 8<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Background of AAMI adoption of ISO 14708-3:2017 <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 3 Terms and definitions 4 Symbols and abbreviated terms 5 General requirements for active implantable medical devices <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 6 Requirements for particular active implantable medical devices 7 General arrangement of the packaging 8 General markings for active implantable medical devices 9 Markings on the sales packaging 10 Construction of the sales packaging 11 Markings on the sterile pack 12 Construction of the non-reusable pack 13 Markings on the active implantable medical device 14 Protection from unintentional biological effects being caused by the active implantable medical device <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 15 Protection from harm to the patient or user caused by external physical features of the active implantable medical device 16 Protection from harm to the patient caused by electricity 17 Protection from harm to the patient caused by heat Table 101 \u2014 CEM43 dose thresholds for various tissues <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 18 Protection from ionizing radiation released or emitted from the active implantable medical device 19 Protection from unintended effects caused by the active implantable medical device 20 Protection of the active implantable medical device from damage caused by external defibrillators 21 Protection of the active implantable medical device from changes caused by electrical fields applied directly to the patient 22 Protection of the active implantable medical device from changes caused by miscellaneous medical treatments <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | Table 102 \u2014 Acceptance criteria for test requirements of ISO\/TS 10974 23 Protection of the active implantable medical device from mechanical forces <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 24 Protection of the active implantable medical device from damage caused by electrostatic discharge 25 Protection of the active implantable medical device from damage caused by atmospheric pressure changes 26 Protection of the active implantable medical device from damage caused by temperature changes 27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | Table 103 \u2014 Minimum risk management and test report contents <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | Figure 101 \u2014 Injection network diagram for the range of frequencies from 16,6 Hz to 80 MHz <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | Table 104 \u2014 Frequency steps for the voltage injection test <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | Table 105 \u2014 Peak-peak injected test levels VPP Figure 102 \u2014 Amplitude modulated test signal for voltage injection test <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | Table 106 \u2014 Minimum magnetic field test levels H Table 107 \u2014 Frequency steps for the radiated magnetic test Figure 103 \u2014 Amplitude modulated test signal for radiated magnetic test <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | Figure 104 \u2014 IPG and lead layout <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | Table 108 \u2014 Proximity test method requirements <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | Table 109 \u2014 Test frequencies, modulations, and net RF power 28 Accompanying documentation <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | Annex AA (normative) Relationship between the fundamental principles in ISO\/TR 14283 [1] and the clauses of this document <\/td>\n<\/tr>\n | ||||||
| 40<\/td>\n | Annex BB (informative) Rationale BB.1 General BB.2 Notes on specific clauses and subclauses <\/td>\n<\/tr>\n | ||||||
| 41<\/td>\n | Table BB.1 \u2014 Evaluating CEM43 formula at different temperatures <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | Figure BB.1 \u2014 CEM43 versus temperature for constant time Figure BB.2 \u2014 Two examples of the same CEM43 result with different exposure times <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | Figure BB.3 \u2014 Example showing a time and temperature profile <\/td>\n<\/tr>\n | ||||||
| 47<\/td>\n | Figure BB.4 \u2014 Magnetic field environment test reference level Table BB.2 \u2014 Magnetic field test reference levels <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | Figure BB.5 \u2014 Injected voltage test levels (VPP) 16,6 Hz to 80 MHz Table BB.3 \u2014 Peak-peak injected test levels VPP <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | Annex CC (informative) Injection network example and board layout guidance CC.1 General CC.2 Tissue equivalent circuit board example <\/td>\n<\/tr>\n | ||||||
| 51<\/td>\n | Figure CC.1 \u2014 Tissue equivalent interface board example <\/td>\n<\/tr>\n | ||||||
| 52<\/td>\n | Table CC.1 \u2014 Tissue interface circuit switch configuration examples <\/td>\n<\/tr>\n | ||||||
| 54<\/td>\n | CC.3 DUT contactor board examples <\/td>\n<\/tr>\n | ||||||
| 55<\/td>\n | Figure CC.2 \u2014 DUT contactor board examples <\/td>\n<\/tr>\n | ||||||
| 56<\/td>\n | Figure CC.3 \u2014 Simplified lead model (distributed parameters) <\/td>\n<\/tr>\n | ||||||
| 57<\/td>\n | Figure CC.4 \u2014 Simplified lead models (lumped parameters) <\/td>\n<\/tr>\n | ||||||
| 58<\/td>\n | CC.4 Board layout guidance <\/td>\n<\/tr>\n | ||||||
| 62<\/td>\n | CC.5 Example board layout floorplan Figure CC.5 \u2014 Example board layout floorplan <\/td>\n<\/tr>\n | ||||||
| 63<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI\/ISO 14708-3:2017 – Implants for surgery-Active implantable medical devices-Part 3: Implantable neurostimulators<\/b><\/p>\n |