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EN 556-2:2024 Standard

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  Keywords:

#devices #medical #requirements #designated #part

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Tuesday 8th of April 2025

  Description:

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

  Purpose

This document specifies the requirements for an aseptically processed medical device to be designated “STERILE”.

  Publication

Tuesday 8th of April 2025

  Related Standards

EN ISO 11137-1:2015

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Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

EN ISO 13408-1:2024

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Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2023)

EN ISO 10993-10:2023

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Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

EN 285:2015+A1:2021

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Sterilization - Steam sterilizers - Large sterilizers

EN ISO 10993-9:2021

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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation produc...

EN ISO 10993-12:2021

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

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