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Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015)
Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure (ISO 13402:1995)
Surgical instruments - Materials - Part 1: Metals (ISO 7153-1:2016)
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (IEC 60601-2-2:2017) (english version)
High frequency surgical equipment - Operation and maintenance (IEC/TR 61289:2011) (english version)
Ophthalmic optics - Spectacle frames and sunglasses electronic catalogue and identification - Part 3: Technical information (ISO 10685-3:2012)
Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014)
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)
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