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EN ISO 13485:2016/AC:2018 Standard

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  Keywords:

#quality #purposes #regulatory #requirements #systems

  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

Wednesday 25th of March 2020

  Correction

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

  Related Standards

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EN ISO 10524-4:2008

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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)

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