ANSI/AAMI/ISO 14708-3:2017
Current
The latest, up-to-date edition.
IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 3: IMPLANTABLE NEUROSTIMULATORS
Hardcopy , PDF
English
02-03-2017
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Glossary of equivalent standards
Background of AAMI adoption of ISO
14708-3:2017
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 clause
of this document
Annex BB (informative) - Rationale
Annex CC (informative) - Injection network
example and board layout guidance
Bibliography
Pertains to active implantable medical devices intended for electrical stimulation of the central or peripheral nervous system.
| Committee |
ISO/TC 150
|
| DevelopmentNote |
Supersedes AAMI NS14 and AAMI NS15. (09/2009)
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-658-0
|
| Pages |
64
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 14708-3:2017 | Identical |
| IEC TR 61000-2-7:1998 | Electromagnetic compatibility (EMC) - Part 2: Environment - Section 7: Low frequency magnetic fields in various environments |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC TR 61000-2-3:1992 | Electromagnetic compatibility (EMC) - Part 2: Environment - Section 3: Description of the environment - Radiated and non-network-frequency-related conducted phenomena |
| IEC TR 61000-2-5:2017 | Electromagnetic compatibility (EMC) - Part 2-5: Environment - Description and classification of electromagnetic environments |
| ISO 14117:2012 | Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices |
| PREN 50527-2-1 : DRAFT 2015 | PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-1: SPECIFIC ASSESSMENT FOR WORKERS WITH CARDIAC PACEMAKERS |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO/TR 14283:2004 | Implants for surgery Fundamental principles |
| 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 |
| IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
| ISO/TS 10974:2012 | Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| IEC 62226-2-1:2004 | Exposure to electric or magnetic fields in the low and intermediate frequency range - Methods for calculating the current density and internal electric field induced in the human body - Part 2-1: Exposure to magnetic fields - 2D models |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
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