I.S. EN 45502-2-3:2010
Current
The latest, up-to-date edition.
ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 2-3: PARTICULAR REQUIREMENTS FOR COCHLEAR AND AUDITORY BRAINSTEM IMPLANT SYSTEMS
Hardcopy , PDF
English
01-01-2010
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Introduction
1 Scope
2 Normative references
3 Definitions
4 Symbols and abbreviations (optional)
5 General requirements for non-implantable parts
6 Inspection and measurement
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 device
20 Protection of the device from damage caused by external
defibrillators
21 Protection of the device from changes caused by high
power 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-ionising radiation
28 Accompanying documentation
Annex AA (informative) - Notes on EN 45502-2-3
Annex BB (informative) - Notes on theoretical modelling to
demonstrate compliance to Clause 27
Annex CC (informative) - Notes on EMI measurements to demonstrate
compliance to Clause 27
Bibliography
Describes requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES that are intended to treat hearing impairment via electrical stimulation of the auditory pathways.
| DocumentType |
Standard
|
| Pages |
47
|
| PublisherName |
National Standards Authority of Ireland
|
| 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 |
| 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 |
| 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 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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