The IEC 60601-1-11 standard prepared by the International Electrotechnical Commission (IEC), an organization affiliated to the International Standards Organization (ISO), describes the basic safety and performance criteria of medical electrical equipment and systems produced for health purposes in homes. This standard applies to all kinds of electrical medical devices used in homes, whether or not medical electrical equipment or system is designed for use by a specialist operator or trained healthcare personnel.
When the health environment at home is referred to, it is meant the places where a patient lives and the places where the patients are located both indoors and outdoors, except in the professional health facility environments where the patients who receive medical training are constantly.
This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-1-11 Electrical medical equipment - Part 1-11: General rules for basic safety and required performance - Auxiliary standard: eSpecifications for medical electrical equipment and medical electrical systems used in the vde health-related environment.
A few standards that have been referred to and indispensable during the implementation of the IEC 60601-1-11 standard are: CISPR 11 (radio frequency interference characteristics, limits and measurement methods), IEC 60068-2-27 (environmental test), IEC 60068-2-31 (environmental test), IEC 60068-2-64 (environmental tests), IEC 60529 (degree of protection provided by enclosures, IP code), IEC 60601-1 (general requirements for medical electrical equipment, basic safety and basic performance), IEC 60601 -1-2 (electromagnetic disturbances) and IEC 60601-1-6 (assurance standard: availability).
Tests in accordance with IEC 60601-1-11 standard are also carried out by our organization within the scope of medical device tests.
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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.
