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  1. 14 Απρ 2020 · Download now. The following ISO standards are available in read-only text format: ISO 13485:2016 Medical devices — Quality management systems – Requirements for regulatory purposes. ISO 374-5:2016 Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risk.

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  3. 25 Μαΐ 2022 · Find the ISO 13485:2016 standard free online on ANSI’s website. Please follow the steps in this article to access the standard.

  4. This third edition of ISO 13485 cancels and replaces the second edition (ISO 13485:2003) and ISO/TR 14969:2004, which have been technically revised. It also incorporates the Technical Corrigendum ISO 13485:2003/Cor.1:2009 .

  5. Learn all you need to know about a medical device QMS in our ISO 13485 Foundations Course for beginners. Accredited by ASIC. Enroll today for free.

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