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SR EN 13060+A2:2010

Small steam sterilizers

This European Standard 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 European Standard 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 European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm) and with a chamber volume not exceeding 60 litres. This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products. This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases). The performance requirements specified in this document are not intended for the process to be effective in inactivati

Status : Withdrawn
Approval date : 7/30/2010
Publish date : 8/1/2010
Withdrawal date : 5/29/2015
Number of pages : 72
ICS : 11.080.10 Sterilizing equipment
Technical Committee : 377 - Medical devices

Relations with other standards: