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EN ISO 13485:2016/AC:2016 Standard

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  Keywords:

#quality #purposes #regulatory #requirements #systems

This standard is superseded by:
  •   EN ISO 13485:2016/AC:2018
  •   Directive

    Medical devices Directive (93/42/EEC)

      Last Official Journal reference

    Wednesday 14th of April 2021

      Description:

    Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

      Purpose

    Corrigendum for EN ISO 13485:2016

      Publication

    Friday 17th of November 2017

      Cessation

    This standard has been withdrawn on 2021-09-30

      Correction

    This standard is a correction for "EN ISO 13485:2016"

      Related Standards

    EN ISO 8359:2009/A1:2012

    Medical devices Directive (93/42/EEC)

    Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996)

    EN ISO 8835-2:2009

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    Inhalational anaesthesia systems - Part 2: Anaesthetic breathing systems (ISO 8835-2:2007)

    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 10328:2016

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    Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)

    EN ISO 10079-3:2009

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    Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source (ISO 10079-3:1999)

    EN ISO 10079-2:2009

    Medical devices Directive (93/42/EEC)

    Medical suction equipment - Part 2: Manually powered suction equipment (ISO 10079-2:1999)

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