Specifies requirements that are generally applicable to active implantable medical devices. The tests that are specified in this document are type tests and are to be carried out on samples of an active implantable medical device to show compliance. This document is applicable not only to active implantable medical devices that are electrically powered but also to those powered by other energy sources. This document is also applicable to some non-implantable parts and accessories of the active implantable medical devices.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | ANSI\/AAMI\/ISO 14708-1:2014, Implants for surgery \u2014 Active implantable medical devices \u2014 Part 1: General requirements for safety, marking and for information to be provided by the manufacturer <\/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 | 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 ANSI\/AAMI adoption of ISO 14708-1:2014 <\/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 <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 4 Symbols and abbreviations (optional) 5 General requirements for active implantable medical devices 5.1 General requirements for non-implantable parts 5.2 General requirements for software <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 5.3 Usability of non-implantable parts 5.3.1 Usability of non-implantable parts of an active implantable medical device connected to or equipped with an electrical power source 5.3.2 Usability of non-implantable parts of an active implantable medical device not connected to or equipped with an electrical power source 5.4 Data security and protection from harm caused by unauthorized information tampering 5.5 General requirements for risk management 5.5.1 Risk management policy 5.5.2 Risk management file 5.5.3 Risk management plan 5.5.4 Risk management process <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 5.6 Misconnection of parts of the active implantable medical device 6 Requirements for particular active implantable medical devices 7 General arrangement of the packaging 8 General markings for active implantable medical devices <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 9 Markings on the sales packaging <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 10 Construction of the sales packaging <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 11 Markings on the sterile pack <\/td>\n<\/tr>\n | ||||||
| 25<\/td>\n | 12 Construction of the non-reusable pack 13 Markings on the active implantable medical device <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 14 Protection from unintentional biological effects being caused by the active implantable medical device <\/td>\n<\/tr>\n | ||||||
| 28<\/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 17.1 Protection from harm to the patient caused by heat <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 17.2 Active implantable medical device intended to supply heat 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 <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 20 Protection of the active implantable medical device from damage caused by external defibrillators <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | Figure 1 \u2014 Damped sinus defibrillation waveform <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | Figure 2 \u2014 Defibrillation test voltage generator Figure 3 \u2014 Timing sequence used for Test 1 and Test 2 <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | Figure 4 \u2014 Test setup for truncated exponential defibrillation waveform Table 1 \u2014 Timing parameters of test signal for Test 2 Figure 5 \u2014 Biphasic defibrillation waveform for Test 2 <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 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 | ||||||
| 35<\/td>\n | 23 Protection of the active implantable medical device from mechanical forces <\/td>\n<\/tr>\n | ||||||
| 37<\/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 <\/td>\n<\/tr>\n | ||||||
| 38<\/td>\n | 27 Protection of the active implantable medical device from electromagnetic non-ionizing radiation <\/td>\n<\/tr>\n | ||||||
| 39<\/td>\n | 28 Accompanying documentation <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | Annex A: General guidance and rationale A.1 General A.2 Rationale for specific subclauses <\/td>\n<\/tr>\n | ||||||
| 48<\/td>\n | Figure A.1 \u2014 RLC implementation for generating a damped sinus defibrillation waveform <\/td>\n<\/tr>\n | ||||||
| 50<\/td>\n | Figure A.2 \u2014 Positioning and scanning the ultrasound field exposure upon the implantable part <\/td>\n<\/tr>\n | ||||||
| 53<\/td>\n | Annex B: Relationship between the fundamental principles in ISO\/TR 14283:2004 and the clauses of this part of ISO 14708 <\/td>\n<\/tr>\n | ||||||
| 64<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI\/ISO 14708-1:2014 – Implants for surgery-Active implantable medical devices-Part 1: General requirements for safety, marking and for information to be provided by the manufacturer<\/b><\/p>\n |