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      • IEC 60601-2-19:2020 RLV

      Codes & Standards - Purchase

      IEC 60601-2-19:2020 RLV

      Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
      SKU: iec_067566_108824 Published by IEC Publication Year 2020 3.0 Edition 81 pages

      Product Details

      • Overview
      IEC 60601-2-19:2020 RLV contains both the official IEC International Standard and its Redline version. The Redline version is available in English only and provides you with a quick and easy way to compare all the changes between the official IEC Standard and its previous edition.

      IEC 60601-2-19:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT INCUBATORS, as defined in 201.3.209, also referred to as ME EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard. IEC 60601-2-19:2020 specifies safety requirements for INFANT INCUBATORS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.
      IEC 60601-2-19:2020 does not apply to:
      - INFANT TRANSPORT INCUBATORS; for information, see IEC 60601-2-20;
      - INFANT RADIANT WARMERS; for information, see IEC 60601-2-21;
      - devices supplying heat via BLANKETS, PADS or MATTRESSES in medical use; for information, see IEC 60601-2-35;
      - INFANT PHOTOTHERAPY EQUIPMENT; for information see IEC 60601-2-50.
      SKIN TEMPERATURE SENSORS which are applied to operate a BABY CONTROLLED INCUBATOR including the displayed value are not considered to be a CLINICAL THERMOMETER in the sense of the particular standard ISO 80601-2-56. IEC 60601-2-19:2020 cancels and replaces the second edition published in 2009 and Amendment 1:2016. This edition constitutes a technical revision. IEC 60601-2-19:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.

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      GST REG No R119441681
      QST REG No R1006017360

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      Select the subscription format that is right for you. Table with 13 rows and 3 columns, identifies features available and not available for the two different subscription formats - CSA Advantage TM and CSA OnDemand TM
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