ISO 14708-3:2017
Current
Current
The latest, up-to-date edition.
Implants for surgery — Active implantable medical devices — Part 3: Implantable neurostimulators
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
French, English
Published date
12-04-2017
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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.
| Committee |
ISO/TC 150/SC 6
|
| DevelopmentNote |
Supersedes ISO/DIS 14708-3. (04/2017)
|
| DocumentType |
Standard
|
| Pages |
57
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ANSI/AAMI/ISO 14708-3:2017 | Identical |
| NF EN ISO 14708-3:2022 | Identical |
| PN-EN ISO 14708-3:2023-01 | Identical |
| ÖVE/ÖNORM EN ISO 14708-3:2023 01 15 | Identical |
| DS/EN ISO 14708-3:2022 | Identical |
| NF EN ISO 14708-3 : 2017 PR | Identical |
| DS/ISO 14708-3:2017 | Identical |
| UNI EN ISO 14708-3:2022 | Identical |
| VDE 0750-20-3:2022-12 | Identical |
| DIN EN ISO 14708-3:2022-12 | Identical |
| SN EN ISO 14708-3:2022 | Identical |
| BIS IS/ISO 14708-3 : 2008 | Identical |
| NEN ISO 14708-3 : 2008 | Identical |
| DS ISO 14708-3 : 2008 | Identical |
| BS EN ISO 14708-3:2022 | Identical |
| UNE-EN ISO 14708-3:2023 | Identical |
| ANSI/AAMI CI86:2017 | COCHLEAR IMPLANT SYSTEMS: REQUIREMENTS FOR SAFETY, FUNCTIONAL VERIFICATION, LABELING AND RELIABILITY REPORTING |
| UNE-EN 61000-4-39:2017 | Electromagnetic Compatibility (EMC) - Part 4-39: Testing and measurement techniques - Radiated fields in close proximity - Immunity test |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| 15/30321267 DC : DRAFT FEB 2015 | BS EN 50527-1 - PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL |
| ANSI/AAMI/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 |
| EN 50527-1:2016 | Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices - Part 1: General |
| BS EN 61000-4-39:2017 | Electromagnetic compatibilty (EMC) Testing and measurement techniques. Radiated fields in close proximity. Immunity test |
| ASTM F 3020 : 2016 | Performance Standard for Hand-Worn Metal Detectors Used in Safety and Security |
| PREN 50527-1 : DRAFT 2015 | PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL |
| 14/30310418 DC : 0 | BS EN 61000-4-39 ED. 1.0 - ELECTROMAGNETIC COMPATIBILTY (EMC) - PART 4-39: TESTING AND MEASUREMENT TECHNIQUES - RADIATED FIELDS IN CLOSE PROXIMITY IMMUNITY TEST |
| BS EN 50527-1:2016 | Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices General |
| ASTM F 2401 : 2016 : REDLINE | Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices |
| I.S. EN 60601-1-2:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| I.S. EN 61000-4-39:2017 | ELECTROMAGNETIC COMPATIBILITY (EMC) - PART 4-39: TESTING AND MEASUREMENT TECHNIQUES - RADIATED FIELDS IN CLOSE PROXIMITY - IMMUNITY TEST |
| TR 102 756 : 1.1.1 | ELECTROMAGNETIC COMPATIBILITY AND RADIO SPECTRUM MATTERS (ERM); SYSTEM REFERENCE DOCUMENT FOR REVISED SPECTRUM REQUIREMENTS FOR RFID EQUIPMENT AND INDUCTIVE LOOP SYSTEMS OPERATING IN THE FREQUENCY RANGE OF 9 KHZ TO 148,5 KHZ |
| I.S. EN 50527-1:2016 | PROCEDURE FOR THE ASSESSMENT OF THE EXPOSURE TO ELECTROMAGNETIC FIELDS OF WORKERS BEARING ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL |
| IEC 61000-4-39:2017 | Electromagnetic compatibility (EMC) - Part 4-39: Testing and measurement techniques - Radiated fields in close proximity - Immunity test |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests |
| 12/30159217 DC : 0 | BS EN 60601-1-2 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| BS EN 60601-1-2:2015 | Medical electrical equipment General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests |
| ASTM F 3278 : 2017 | Standard Performance Specification for Hand-Held Metal Detectors Used in Safety and Security |
| EN 61000-4-39:2017 | Electromagnetic Compatibility (EMC) - Part 4-39: Testing and measurement techniques - Radiated fields in close proximity - Immunity test |
| CSA C22.2 No. 60601.1.2 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS |
| 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 |
| ISO 14117:2012 | Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices |
| 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 |
| EN 50527-2-1:2016 | 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 |
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