ГОСТ Р ИСО 14630—2011
Библиография
[1]ISO.TR 14263:2004 Implants for surgery — Fundamental principles
[2]ISO/IEC Guide 51:1999 Safety aspects — Guidelines for their inclusion in standards
[3]MEDOEV 2.12-1 rev 5 (April 2007) Medical Devices: Guidance document. Guidelines on a medical devices
vigilance system
Level 1standards
[4]ISO 16061 Instrumentation for use in association with non-active surgical implants — General requirements
Level 2 standards
[5]ISO 14602 Non-active surgical implants — Implants for osteosynthesis — Particular requirements
[6]ISO 21534 Non-active surgical implants — Joint replacement implants — Particular requirements
(7JISO 5840 Cardiovascular implants — Cardiac valve prostheses
(8) EN 12006-2 Non-active surgical implants — Particular requirements for cardiac and vascular implants — Part 2:
Vascular prostheses including cardiac valve conduits
19] EN 12006-3 Non-active surgical implants — Particular requirements for cardiac and vascular implants — Part 3:
Endovascular devices
Level 3 standards
(101ISO 7197 Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components
(11JISO 14607 Non-active surgical implants — Mammary implants — Particular requirements
(12J ISO 21535 Non-active surgical implants — Joint replacement implants — Specific requirements for hip-joint
replacement implants
(13J ISO 21536 Non-active surgical implants — Joint replacement implants — Specific requirements for knee-joint
replacement implants
Additional standards relevant in this context
(14]ISO 1000 SI units and recommendations for the use of their multiples and of certain other units
(15]ISO 7000 Graphical symbols for use on equipment — Index and synopsis
(16]ISO 12891-1 Retrieval and analysis of surgical implants — Part 1: Retrieval and handling
(17]ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes
(18] IS0 16429 Implants forsurgery — Measurements of open-circuit potential to assess corrosion behaviour ofmetallic
implantable materials and medical devices over extended time periods
(19]IEC 60068-2-27 Environmental testing — Part 2-27: Tests — Test Ea and guidance: Shock
(20]IEC 60068-2-32 Environmental testing — Part 2-32: Tests — Test Ed: Free fall
(21] IEC 60068-2-47 Environmental testing — Part 2-47: Test— Mounting of specimens for vibration, impact and similar
dynamic tests
(22] IEC 60601-2-33 Medical electrical equipment — Part 2-33: Particular requirements for the safety of magnetic
resonance equipment for medical diagnosis
(23]ASTM F 2052-02 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical
Devices in the Magnetic Resonance Environment
(24]ASTM F 2119-01 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
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