The ISO 11140-1 standard has been designed by the International Standards Organization (ISO) to describe the properties and test methods of chemical indicators used in the sterilization of healthcare materials.
This standard was also published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 11140-1 Sterilization of healthcare materials - Chemical indicators - Part 1: General features. In fact, this standard is based on a European standard.
This standard describes general requirements and test methods for indicators that demonstrate exposure to sterilization processes through physical and chemical exchange of healthcare materials and are used to monitor the acquisition of one or more of the process parameters. Here, a sterilization process is described. 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.
Within the framework of laboratory test services, ISO 11140-1 Health materials sterilization and chemical indicators test services are also provided by our organization.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
