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EN 556-2:2024 Standard

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  Keywords:

#devices #medical #requirements #designated #part

  Directive

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

  Last Official Journal reference

Monday 15th of June 2026

  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

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

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

EN ISO 11137-2:2015

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

EN ISO 17511:2021

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, t...

EN ISO 25424:2019/A1:2022

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...

EN ISO 15223-1:2021

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223...

EN ISO 14971:2019/A11:2021

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

Medical devices - Application of risk management to medical devices (ISO 14971:2019)

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