ISO 14708-3:2017
Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General requirements for active implantable medical devices
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
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
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
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
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
28 Accompanying documentation
Annex AA (normative) Relationship between the fundamental principles in ISO/TR 14283 [1] and the clauses of this document
Annex BB (informative) Rationale
Annex CC (informative) Injection network example and board layout guidance
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General requirements for active implantable medical devices
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
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
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
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
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
28 Accompanying documentation
Annex AA (normative) Relationship between the fundamental principles in ISO/TR 14283 [1] and the clauses of this document
Annex BB (informative) Rationale
Annex CC (informative) Injection network example and board layout guidance
Bibliography