Active implantable medical devices -- Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems

Available format(s)

Hardcopy , PDF

Language(s)

Spanish, Castilian, English

Published date

07-21-2010

Publisher

Asociacion Espanola de Normalizacion

Committee	CTN 209/SC 62
DocumentType	Standard
Pages	50
PublisherName	Asociacion Espanola de Normalizacion
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	TEST METHOD STANDARD - 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
EN 1593:1999/A1:2003	NON-DESTRUCTIVE TESTING - LEAK TESTING - BUBBLE EMISSION TECHNIQUES
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
EN 13185:2001/A1:2003	NON-DESTRUCTIVE TESTING - LEAK TESTING - TRACER GAS METHOD
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
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
ISO 14971:2007	Medical devices Application of risk management to medical devices
EN 45502-2-1:2003	Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
EN 60118-6:1999	Hearing aids - Part 6: Characteristics of electrical input circuits for hearing aids
EN ISO 10993-1:2009/AC:2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS (ISO 10993-1:2009/COR 1:2010)
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