EN ISO 11140-1 Sterilization of Healthcare Equipment - Chemical Indicators

Material Testing

EN ISO 11140-1 Sterilization of Healthcare Equipment - Chemical Indicators

EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 11140-1 standard. It is designed to explain the properties and test methods of chemical indicators used in the sterilization of healthcare equipment.

EN ISO 11140-1 Sterilization of Healthcare Equipment - Chemical Indicators

It describes the general requirements and test methods for indicators used to monitor the attainment of one or more of the process parameters, indicating the exposure of sanitary articles to sterilization processes through physical and chemical change. A sterilization process is described here. It is not dependent on actions on the presence or absence of a living organism.

In other words, this standard includes requirements and test methods for indicators used to monitor that one or more process parameters determined for a sterilization process have been reached, indicating that they have been exposed to the sterilization process through physical or chemical change in the indicator substance.

The ISO 11140-1 standard sets performance requirements for chemical indicators designed to be used in conjunction with steam, dry heat, ethylene oxide, alpha or beta radiation, low temperature steam and sterilization processes using formaldehyde or evaporated hydrogen peroxide. Additional requirements for indicators intended for use with other sterilization methods are not specifically provided in this standard. Only general conditions apply for these. Requirements for specific test indicators are discussed in other sections of this standard.

The use of this part of the ISO 11140 standard may include hazardous materials, operations and equipment. However, the standard is not intended to address all security issues for use. It is the responsibility of those who use the standard to create appropriate occupational health and safety practices.

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