In the ISO 10651-6 standard developed by the International Standards Organization (ISO), the safety and performance characteristics and test methods of respiratory support devices used for home patient care are described. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 10651-6 Lung ventilators for medical use - Certain features for basic safety and required performance - Part 6: Respiratory support devices for home patient care.
This standard specifies the basic safety and performance requirements for respiratory support devices (ventilators) designed for home care use. Devices covered by this standard are generally suitable for home care and are not intended for use in hospitals or healthcare facilities. This standard is intended to be used in conjunction with the IEC 60601-1 standard. ISO 10651-6 replaces and supersedes the requirements of the IEC 60601-1 standard. IEC 60601-1 is the fundamental standard for the safety of all medical electrical equipment used by or under the supervision of qualified personnel in general medical and patient settings. It also includes specific requirements for ensuring safety.
Respirator requirements designed for anesthesia applications are included in the ISO 8835-5 standard.
A few standards that are referred to as normative in the implementation of the ISO 10651-6 standard and are indispensable for its implementation are: ISO 32, ISO 4135, ISO 5356-1, ISO 5356-2, ISO 5359, ISO 5362, ISO 5367, ISO 7396-1, ISO 14937 , ISO 15001, ISO 15223 and IEC 60079-4.
Our organization also provides safety and performance testing services of respiratory support devices used for ISO 10651-6 home patient care within the scope of laboratory services.
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.
