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BSI BS EN 13060:2025

Sterilizers for medical purposes. Small steam sterilizers. Requirements and testing
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BSI BS EN 13060:2025

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

PUBLISH DATE 2025
PAGES 126
BSI BS EN 13060:2025
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 Ă— 300 mm Ă— 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).
SDO BSI: British Standards Institution
Document Number EN 13060
Publication Date Aug. 28, 2025
Language en - English
Page Count 126
Revision Level
Supercedes
Committee CH/198
Publish Date Document Id Type View
Aug. 28, 2025 BS EN 13060:2025 Revision
Dec. 31, 2014 BS EN 13060:2014 Revision
Dec. 10, 2018 BS EN 13060:2014+A1:2018 Consolidated
Aug. 31, 2010 BS EN 13060:2004+A2:2010 Consolidated