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    IEC 60601-1-9:2007+AMD1:2013+AMD2:2020

    Medical electrical equipment – Part 1-9: General requirements for basic safety and essential performance – Collateral Standard: Requirements for environmentally conscious design

    International Electrotechnical Committee

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    IEC 60601-1-11:2015+AMD1:2020

    Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

    International Electrotechnical Committee

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    IEC 62366-1:2015+AMD1:2020

    Medical devices – Part 1: Application of usability engineering to medical devices

    International Electrotechnical Committee

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    ISO 15378 : 2017

    PRIMARY PACKAGING MATERIALS FOR MEDICINAL PRODUCTS - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF ISO 9001:2015, WITH REFERENCE TO GOOD MANUFACTURING PRACTICE (GMP)

    International Organization for Standardization

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    IEC 60601-2-31:2020

    Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

    International Electrotechnical Committee

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    IEC 80601-2-78:2019

    Medical electrical equipment – Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

    International Electrotechnical Committee

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    IEC 80601-2-77:2019

    Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

    International Electrotechnical Committee

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    ISO 16142-2 : 2017

    MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS

    International Organization for Standardization

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    IEC 80601-2-60:2019

    Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment

    International Electrotechnical Committee

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    IEC 80601-2-26:2019

    Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalograph

    International Electrotechnical Committee

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