Need help?

EN 13060:2025 Standard

wave
Save  

  Keywords:

#document #sterilization #requirements #used #small

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Wednesday 1st of April 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 13485:2016/AC:2018

Medical devices Regulation ((EU) 2017/745)

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

EN ISO 25424:2019/A1:2022

Medical devices Regulation ((EU) 2017/745)

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

EN 455-1:2020+A2:2024

Medical devices Regulation ((EU) 2017/745)

Medical gloves for single use - Part 1: Requirements and testing for freedom of holes

EN 455-2:2024

Medical devices Regulation ((EU) 2017/745)

Medical gloves for single use - Part 2: Requirements and testing for physical properties

EN 556-1:2024

Medical devices Regulation ((EU) 2017/745)

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN 556-2:2024

Medical devices Regulation ((EU) 2017/745)

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptica...

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0