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    ABNT NBR ISO 11195:2021

    Gas mixers for medical use - Stand-alone gas mixers

    Brazilian Standards

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    SS-ISO 20417:2021

    Kvalitetsledning- och riskhanteringssystem samt andra tillhörande standarder för medicinteknik, SIS/TK 355

    Standardiserings-Kommissionen I Sverige

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    ISO 15225 : 2016

    MEDICAL DEVICES - QUALITY MANAGEMENT - MEDICAL DEVICE NOMENCLATURE DATA STRUCTURE

    International Organization for Standardization

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    PN-EN IEC 60601-2-22:2021-03

    Medical electrical equipment -- Part 2-22: Particular requirements for the basic safety and essential functioning of surgical, cosmetic, therapeutic and diagnostic laser devices

    Polish Committee for Standardization

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    EN 60601-1-2:2015/A1:2021

    Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

    European Committee for Standards - Electrical

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    UNI EN 13718-2:2021

    Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

    Ente Nazionale Italiano di Unificazione (UNI)

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    UNI EN 13718-1 : 2021

    Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

    Ente Nazionale Italiano di Unificazione (UNI)

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    NF EN 301489-29 : 2021

    ElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Part 29 : specific conditions for Medical Data Service Devices (MEDS) operating in the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands - Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (V2.2.1)

    Association Francaise de Normalisation

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    NF EN 301489-35:2021

    ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 35: Specific ElectroMagnetic Compatibility (EMC) standard for radio equipment and services - Part 35 : specific requirements for Low Power Active Medical Implants (LP-AMI) operating in the 2 483,5 MHz to 2 500 MHz bands - Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU (V2.2.1)

    Association Francaise de Normalisation

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    NS-EN ISO 10993-1:2020

    Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-11)

    Norwegian Standards (Norges Standardiseringsforbund)

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