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  • BSI
    BS EN 13060:2025 - TC Tracked Changes. Sterilizers for medical purposes. Small steam sterilizers. Requirements and testing
    Edition: 2025
    $819.89
    / user per year

Description of BS EN 13060:2025 - TC 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 × 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).

Standard NumberBS EN 13060:2025 - TC
TitleTracked Changes. Sterilizers for medical purposes. Small steam sterilizers. Requirements and testing
StatusDefinitive
Publication Date2025-09-04
DescriptorsSterilizers, Equipment safety, Performance, Dental equipment, Sterilization (hygiene), Test methods, Medical equipment, Steam sterilizers
ICS11.080.10 Sterilizing equipment
CommitteeCH/198
ISBN978 0 539 38757 5
PublisherBSI
Pages311



About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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