DIN 58946-7:2014-01

This standard specifies requirements and the appropriate tests for the installation of steam sterilizers and their supply of resources. It also includes requirements for the environmental conditions and for the operator in the sterilization of medical devices with moist heat. NOTE 1 Some places of this standard indicate to any requirements of specific product information on the installation and operation of steam sterilizers. NOTE 2 Although the scope of this standard is limited to medical devices, it specifies requirements and provides guidance that may apply to other products, devices and applications. Sections 5.2, 5.4 and 5.8 of this standard are not usually on small sterilizers in accordance with DIN EN 13060 apply. This standard supports the requirements of DIN EN ISO 17665-1. NOTE 3 DIN EN 285 and DIN EN 13060 requiremen technical requirements and requirements for carrying out the tests for steam sterilizers for use in health care facilities. This draft standard contains no requirements relating to occupational safety and safeguards of the sterilizer. It assumes, however, that are designed to operate such facilities available and operational. NOTE 4 Attention is drawn to the Medical Devices Operator Ordinance and the Ordinance on Industrial Safety. This draft standard contains no requirements for technical properties and the use of failure-detection systems. NOTE 5 At the present time no generally accepted performance criteria for failure-detection systems. failure-warning systems are in practice also been referred to as eg 'Batch monitoring systems.'