BS ISO 14117:2012:2013 Edition
$215.11
Active implantable medical devices. Electromagnetic compatibility. EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices
| Published By | Publication Date | Number of Pages |
| BSI | 2013 | 108 |
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 3 | CVP_Secretariat_Loca |
| 6 | Foreword |
| 7 | Introduction |
| 10 | 1 Scope 2 Normative references 3 Terms and definitions, symbols and abbreviations |
| 12 | 4 Test requirements for the frequency band 0 Hz ≤ ƒ ≤ 3 000 MHz 4.1 General |
| 13 | 4.2 Induced lead current |
| 14 | SameLvl |
| 20 | 4.3 Protection from persisting malfunction attributable to ambient electromagnetic fields |
| 30 | 4.4 Temporary response to continuous wave sources |
| 33 | 4.5 Protection from sensing EMI as cardiac signals |
| 35 | n |
| 43 | 4.6 Protection from static magnetic fields of flux density up to 1 mT |
| 44 | 4.7 Protection from static magnetic fields of flux density up to 50 mT |
| 45 | 4.8 Protection from AC magnetic field exposure in the range of 1 kHz to 140 kHz |
| 46 | 4.9 Test requirements for the frequency range of 450 MHz ≤ ƒ ≤ 3 000 MHz |
| 49 | PrevLvl |
| 50 | 5 Testing above frequency of 3 000 MHz 6 Protection of devices from EM fields encountered in a therapeutic environment 6.1 Protection of the device from damage caused by high-frequency surgical exposure |
| 51 | 6.2 Protection of the device from damage caused by external defibrillators |
| 55 | 7 Additional accompanying documentation 7.1 Disclosure of permanently programmable sensitivity settings 7.2 Descriptions of reversion modes 7.3 Known potential hazardous behaviour |
| 56 | Annex A (informative) Rationale |
| 67 | Annex B (informative) Rationale for test frequency ranges |
| 72 | Annex C (informative) Code for describing modes of implantable generators |
| 74 | Annex D (normative) Interface circuits |
| 79 | Annex E (informative) Selection of capacitor Cx |
| 80 | Annex F (normative) Calibration of the injection network (Figure D.5) |
| 82 | Annex G (normative) Torso simulator |
| 85 | Annex H (normative) Dipole antennas Dipole antennas |
| 87 | Annex I (normative) Pacemaker/ICD programming settings Pacemaker/ICD programming settings |
| 89 | Annex J (normative) Simulated cardiac signal Simulated cardiac signal |
| 90 | Annex K (normative) Calculation of net power into dipole antenna Calculation of net power into dipole antenna |
| 94 | Annex L (informative) Loop area calculations Loop area calculations |
| 99 | Annex M (informative) Correlation between levels of test voltages used in this International Standard and strengths of radiated fields Correlation between levels of test voltages used in this International Standard and strengths of radiated fields |
| 105 | Bibliography Bibliography |
Related products
-
BS EN 50527-2-1:2016 – TC:2020 Edition
Tracked Changes. Procedure for the assessment of the exposure to electromagnetic fields of workers bearing…
-
BS EN 50527-2-1:2016:2017 Edition
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable…
