UNE-EN 45502-2-3:2010
Current
Current
The latest, up-to-date edition.
Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
Amended by
Available format(s)
Hardcopy , PDF
Language(s)
Spanish, Castilian, English
Published date
21-07-2010
Publisher
€114.00
Excluding VAT
| Committee |
CTN 209/SC 62
|
| DocumentType |
Standard
|
| Pages |
50
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| EN 45502-2-3:2010 | Identical |
| AAMI PC69 : 2007 | |
| EN 60068-2-75:2014 | Environmental testing - Part 2-75: Tests - Test Eh: Hammer tests |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| MIL-STD-883 Revision K:2016 | Microcircuits |
| IEC 60068-2-27:2008 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| IEC 60118-6:1999 | Hearing aids - Part 6: Characteristics of electrical input circuits for hearing aids |
| HD 323.2.17 : 200S4 | BASIC ENVIRONMENTAL TESTING PROCEDURES - TESTS - TEST Q: SEALING |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| HD 323.2.33 : 200S1 | BASIC ENVIRONMENTAL TESTING PROCEDURES - TESTS - GUIDANCE ON CHANGE OF TEMPERATURE TESTS |
| ISO 13485:2016 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| EN 60068-2-64:2008 | Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
| EN 50061 : 88 AMD 1 95 | SAFETY OF IMPLANTABLE CARDIAC PACEMAKERS |
| IEC 60068-2-31:2008 | Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens |
| IEC 60068-2-64:2008 | Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance |
| ISO 5841-2:2014 | Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads |
| 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 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 |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| EN 60068-2-27:2009 | Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock |
| ASTM F 2052 : 2015 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| IEC 60068-2-47:2005 | Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| IEC 60068-2-17:1994 | Basic environmental testing procedures - Part 2-17: Tests - Test Q: Sealing |
| EN 45502-1:2015 | IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 1: GENERAL REQUIREMENTS FOR SAFETY, MARKING AND FOR INFORMATION TO BE PROVIDED BY THE MANUFACTURER |
| ASTM F 2213 : 2017 : REDLINE | Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment |
| IEEE C95.1-2005 | IEEE Standard for Safety Levels with Respect to Human Exposure to Radio Frequency Electromagnetic Fields, 3 kHz to 300 GHz |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| IEC 60068-2-75:2014 | Environmental testing - Part 2-75: Tests - Test Eh: Hammer tests |
| CISPR 11:2015 RLV | Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - Limits and methods of measurement |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| EN 60118-6:1999 | Hearing aids - Part 6: Characteristics of electrical input circuits for hearing aids |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
| IEC 60801-2:1991 | Electromagnetic compatibility for industrial-process measurement and control equipment - Part 2: Electrostatic discharge requirements |
| EN 60801-2 : 1993 | ELECTROMAGNETIC COMPATIBILITY FOR INDUSTRIAL-PROCESS MEASUREMENT AND CONTROL EQUIPMENT - PART 2: ELECTROSTATIC DISCHARGE REQUIREMENTS (IEC 801-2:1991) |
| EN 60068-2-31:2008 | Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens |
| EN 60068-2-47:2005 | Environmental testing - Part 2-47: Tests - Mounting of specimens for vibration, impact and similar dynamic tests |
| IEC 60068-2-56:1988 | Environmental testing - Part 2: Tests. Test Cb: Damp heat, steady state, primarily for equipment |
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