ISO 14708-3:2017 is applicable to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system. The tests that are specified in this document are type tests and are to be carried out on a sample of a device to assess device behavioural responses, and are not intended to be used for the routine testing of manufactured products.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | 1 Scope 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 10<\/td>\n | 4 Symbols and abbreviated terms 5 General requirements for active implantable medical devices 6 Requirements for particular active implantable medical devices <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 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 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 <\/td>\n<\/tr>\n | ||||||
| 12<\/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 <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 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 | ||||||
| 14<\/td>\n | 23 Protection of the active implantable medical device from mechanical forces 24 Protection of the active implantable medical device from damage caused by electrostatic discharge <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 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 | ||||||
| 24<\/td>\n | 28 Accompanying documentation <\/td>\n<\/tr>\n | ||||||
| 26<\/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 | ||||||
| 38<\/td>\n | Annex BB (informative) Rationale <\/td>\n<\/tr>\n | ||||||
| 49<\/td>\n | Annex CC (informative) Injection network example and board layout guidance <\/td>\n<\/tr>\n | ||||||
| 61<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Implants for surgery. Active implantable medical devices – Implantable neurostimulators<\/b><\/p>\n |