SIST EN 13060

SIST EN 13060 addresses:

small steam sterilisers

This European Standard specifies performance requirements and test methods for small steam sterilisers and sterilisation cycles used for medical purposes or for materials that may come into contact with blood or body fluids. This European Standard applies to automatically controlled small steam sterilisers that produce steam using electric heaters or using steam produced by a system outside the steriliser. This European Standard applies to small steam sterilisers used primarily for the sterilisation of medical devices and which cannot accommodate a sterilisation module (300 mm × 300 mm × 600 mm) with a chamber capacity of less than 60 l. Quality management and risk management requirements are addressed in other standards (e.g. EN ISO 13485, EN ISO 14971). This European Standard does not apply to small steam sterilisers used for the sterilisation of liquids or pharmaceuticals. This European Standard does not specify safety requirements related to the risks associated with the area in which the steriliser is used (e.g. flammable gases). This European Standard does not specify requirements for the validation and routine control of moist heat sterilisation. NOTE: The requirements for validation and routine control of moist heat sterilisation are specified in EN ISO 17665-1. This European Standard does not specify requirements for other sterilisation procedures that also use moist heat (i.e. formaldehyde, ethylene oxide).
Source: the Slovenian Standards Institute, taken from the website June 2022.