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DIN EN ISO 14630

Non-active surgical implants - General requirements (ISO 14630:2012)

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Organization: DIN
Publication Date: 1 March 2013
Status: active
Page Count: 23
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40

Document History

DIN EN ISO 14630
October 1, 2022
Non-active surgical implants - General requirements (ISO/DIS 14630:2022); German and English version prEN ISO 14630:2022
A description is not available for this item.
DIN EN ISO 14630
March 1, 2013
Non-active surgical implants - General requirements (ISO 14630:2012)
A description is not available for this item.
DIN EN ISO 14630
August 1, 2009
Non-active surgical implants - General requirements (ISO 14630:2008)
A description is not available for this item.
DIN EN ISO 14630/A1
February 1, 2009
Non-active surgical implants - General requirements (ISO 14630:2008); English version prEN ISO 14630:2008, Amendment 1
A description is not available for this item.
DIN EN ISO 14630
April 1, 2008
Non-active surgical implants - General requirements (ISO 14630:2008)
A description is not available for this item.
DIN EN ISO 14630
August 1, 2005
Non-active surgical implants - General requirements (ISO 14630:2005)
A description is not available for this item.
DIN EN ISO 14630
December 1, 1997
Non-active surgical implants - General requirements (ISO 14630:1997)
A description is not available for this item.
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References

This document references:
F2052 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
October 1, 2021
This test method covers the measurement of the magnetically induced displacement force produced by static magnetic field gradients (spatial field gradient) on medical devices and the comparison of...
This document references:
ASTM F2119 - Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
Published by ASTM on September 1, 2007
This test method characterizes the distortion and signal loss artifacts produced in a magnetic resonance (MR) image by a passive implant (implant that functions without the supply of electrical or...
This document references:
ASTM F2182 - Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging
Published by ASTM on September 15, 2019
This test method covers measurement of radio frequency (RF)-induced heating on or near a passive medical implant within a phantom during magnetic resonance imaging (MRI). The test method does not...
This document references:
ASTM F2213 - Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
Published by ASTM on September 1, 2017
This test method covers the measurement of the magnetically induced torque produced by the static magnetic field in the magnetic resonance environment on medical devices and the comparison of that...
This document references:
ASTM F2503 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Published by ASTM on February 1, 2020
This international standard applies to the practice of marking of items that might be used in the magnetic resonance (MR) environment. The purpose of this practice is to mark items that might be...
This document is referenced by:
DIN EN ISO 15798 - Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013 + Amd.1:2017) (includes Amendment :2017)
Published by DIN on February 1, 2018
This International Standard is applicable to ophthalmic viscosurgical devices (OVDs), a class of nonactive surgical implants with viscous and/or viscoelastic properties, intended for use during...
This document is referenced by:
DIN EN ISO 21536 - Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2007 + Amd.1:2014) (includes Amendment :2014)
Published by DIN on July 1, 2014
This International Standard provides specific requirements for knee joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance,...
This document is referenced by:
DIN EN ISO 16672 - Ophthalmische Implantate - Okulare Endotamponaden (ISO 16672:2015); Deutsche Fassung EN ISO 16672:2015
Published by DIN on December 1, 2015
Diese Internationale Norm gilt für okulare Endotamponaden (OE), einer Klasse nicht-solider Implantate, die in der Ophthalmologie zur Glättung und zum Anlegen einer abgelösten Netzhaut an die Aderhaut...
This document is referenced by:
DIN EN ISO 5840-2 - Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2015); German version EN ISO 5840-2:2015
Published by DIN on May 1, 2016
Dieser Teil von ISO 5840 ist auf Herzklappenersatz anwendbar, der für die Implantation im menschlichen Herzen vorgesehen ist, für die in der Regel ein kardiopulmonaler Bypass und direkte Sichtbarkeit...
This document is referenced by:
DIN EN ISO 16671 - Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015 + Amd 1:2017) (includes Amendment :2017)
Published by DIN on March 1, 2018
This International Standard defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product...
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