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EN 60601-1-8:2007/AC:2010 Standard

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  Keywords:

#systems #alarm #equipment #electrical #medical

This standard is superseded by:
  •   EN 60601-1-8:2007/A11:2017
  •   Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 5th of January 2022

      Description:

    Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsIEC 60601-1-8:2006

      Purpose

    This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS. This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS. It also provides guidance for the application of ALARM SYSTEMS.

      Publication

    Friday 17th of November 2017

      Correction

    This standard is a correction for "EN 60601-1-8:2007"

      Related Standards

    EN 20594-1:1993/A1:1997

    Medical devices Directive (93/42/EEC)

    Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements (...

    EN ISO 10524-2:2006

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    Pressure regulators for use with medical gases - Part 2: Manifold and line pressure regulators (ISO 10524-2:2005)

    EN ISO 8835-3:2009

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    Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3...

    EN ISO 8835-3:2009/A1:2010

    Medical devices Directive (93/42/EEC)

    Inhalational anaesthesia systems - Part 3: Transfer and receiving systems of active anaesthetic gas scavenging systems (ISO 8835-3...

    EN ISO 8835-4:2009

    Medical devices Directive (93/42/EEC)

    Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

    EN ISO 8835-5:2009

    Medical devices Directive (93/42/EEC)

    Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

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