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EN 13060:2025 Standard

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  Keywords:

#document #sterilization #requirements #used #small

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Thursday 11th of June 2026

  Description:

Sterilizers for medical purposes - Small steam sterilizers - Requirements and testing

  Purpose

This document specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids. This document applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer. This document applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm). The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971). This document does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products. This document does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases). This document does not specify requirements for the validation and routine control of sterilization by moist heat. NOTE  Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665. This document does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).

  Publication

Wednesday 1st of April 2026

  Related Standards

EN ISO 10993-15:2023

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and allo...

EN ISO 17665:2024

Medical devices Regulation ((EU) 2017/745)

Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterili...

EN 14180:2025

Medical devices Regulation ((EU) 2017/745)

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

EN ISO 14160:2021

Medical devices Regulation ((EU) 2017/745)

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues...

EN ISO 14971:2019

Medical devices Regulation ((EU) 2017/745)

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

EN ISO 7197:2024

Medical devices Regulation ((EU) 2017/745)

Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO 7197:2024)

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