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11/30243761 DC : 0

Current
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
Available format(s)

Hardcopy , PDF

Language(s)

English

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
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
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
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
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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