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Technical rule [CURRENT]

ISO/TR 12417-2

Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 2: Local regulatory information
Edition 2022-07

Pre-standard

ISO/TS 17137

Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants
Edition 2021-09

Technical rule [CURRENT]

ISO/TR 17327-2

Non-active surgical implants - Implant coating - Part 2: Reference standards related to coatings
Edition 2021-04

Standards [CURRENT]

OENORM EN 301489-31 V 1.1.1

Electromagnetic compatibility and Radio spectrum Matters (ERM) - ElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P)
Edition 2005-11-01

Standards [CURRENT]

OENORM EN 302195-1 V 1.1.1

Electromagnetic compatibility and Radio spectrum Matters (ERM) - Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories - Part 1: Technical characteristics and test methods
Edition 2004-05-01

Standards [CURRENT]

OENORM EN 302195-2 V 1.1.1

Electromagnetic compatibility and Radio spectrum Matters (ERM) - Radio equipment in the frequency range 9 kHz to 315 kHz for Ultra Low Power Active Medical Implants (ULP-AMI) and accessories - Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
Edition 2004-05-01

ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; - Part 27: Specific conditions for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P) operating in the 402 MHz to 405 MHz bands; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (ETSI EN 301 489-27 V2.2.1 (2019-04)) (english version)
Edition 2019-06-01

ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; - Part 31: Specific conditions for equipment in the 9 kHz to 315 kHz band for Ultra Low Power Active Medical Implants (ULP-AMI) and related peripheral devices (ULP-AMI-P); Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (ETSI EN 301 489-31 V2.2.1 (2019-04)) (english version)
Edition 2019-06-01

ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; - Part 35: Specific requirements for Low Power Active Medical Implants (LP-AMI) operating in the 2483,5 MHz to 2500 MHz bands; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (ETSI EN 301 489-35 V2.2.1 (2019-04)) (english version)
Edition 2019-06-01

Standards [CURRENT]

OEVE/OENORM EN 301559 V2.1.1

Short Range Devices (SRD); Low Power Active Medical Implants (LP-AMI) and associated Peripherals (LP-AMI-P) operating in the frequency range 2483,5 MHz to 2500 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU
Edition 2016-12-01

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