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Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters (ISO 25539-3:2011)
Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the frequency range 2 483,5 MHz to 2 500 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems (english version)
Implants for surgery - Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer (english version)
Short Range Devices (SRD); Ultra Low Power Active Medical Membrane Implants (ULP-AMI-M) and Peripherals (ULP-AMI-M-P) operating in the frequency range 30 MHz to 37,5 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
Ultra Low Power Active Medical Implants (ULP-AMI) and associated Peripherals (ULP-AMI-P) operating in the frequency range 402 MHz to 405 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU (ETSI EN 301 839 V2.1.1 (2016-04))
Short Range Devices (SRD); Ultra Low Power Active Medical Implants (ULP-AMI) and accessories (ULP-AMI-P) operating in the frequency range 9 kHz to 315 kHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
ÖNORM EN 45502-1:1998-10
Действует
Active implantable medical devices - Part 1: General requirements for safety, marking and information to be provided by the manufacturer
Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, corrected version 2018-08)
Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010)
Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) (ISO 13356:2015)
Non-active surgical implants - General requirements (ISO 14630:2012)
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 1: General requirements (ISO 12417-1:2015)
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
ÖNORM EN ISO 9713:2009-09
Действует
Neurosurgical implants - Self-closing intracranial aneurysm clips (ISO 9713:2002)
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8637-2:2018)
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy (ISO 5832-3:2016)
OVE EN 50527-1:2018-01
Действует
Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices -- Part 1: General (english version)
Implants for surgery - Metallic materials - Part 2: Unalloyed titanium (ISO 5832-2:2018)
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