11/30243761 DC : 0
Current
The latest, up-to-date edition.
BS ISO 14708-7 - IMPLANTS FOR SURGERY - ACTIVE IMPLANTABLE MEDICAL DEVICES - PART 7: PARTICULAR REQUIREMENTS FOR COCHLEAR IMPLANT SYSTEMS
Hardcopy , PDF
English
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Foreword
Introduction
1 Scope
2 Normative references
3 Definitions
4 Symbols and abbreviations (optional)
5 General requirements for non-implantable parts
6 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) - Relationship between
the fundamental principles in ISO/TR 14283
and the clauses of this standard
Annex BB (informative) - Relationship between
the clauses of this standard and the
fundamental principles listed in Annex A
Annex CC (informative) - Notes on EN 45502-2-3
Annex DD (informative) - Notes on theoretical modelling
to demonstrate compliance to Clause 27
Annex EE (informative) - Notes on EMI measurements to
demonstrate compliance to Clause 27
Bibliography
BS ISO 14708-7
| Committee |
CH/150/2
|
| DocumentType |
Draft
|
| Pages |
63
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| AAMI PC69 : 2007 | |
| 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 |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| 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 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| 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 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| 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 |
| ISO 14708-2:2012 | Implants for surgery Active implantable medical devices Part 2: Cardiac pacemakers |
| 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 |
| IEC 61000-4-2:2008 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| 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 |
| IEC 60068-2-14:2009 | Environmental testing - Part 2-14: Tests - Test N: Change of temperature |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| IEC 60068-2-56:1988 | Environmental testing - Part 2: Tests. Test Cb: Damp heat, steady state, primarily for equipment |
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