TS EN 60601-2-11 Electrical Medical Equipment - Part 2-11: Special Rules for Basic Safety and Required Performance of Gamma Ray Therapy Equipment

The IEC 60601-2-11 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Standards Organization (ISO), describes the criteria for basic safety and basic performance of gamma ray therapy devices, including multi-source stereotactic radiotherapy equipment.

This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-11 Electrical medical equipment - Part 2-11: Special rules for basic safety and required performance of gamma radiation therapy equipment.

This particular standard of the IEC 60601-1 series of standards describes the requirements that must be followed in the design and production processes by companies that manufacture gamma ray therapy equipment. This standard specifies the tolerance limits that must be avoided, interrupted or terminated beyond interlocks to avoid an unsafe situation for patients and operators. The type tests that must be done by the manufacturer companies and the field tests that are not mandatory by the manufacturer are included in the standard separately for each requirement.

In short, the purpose of the standard is to define the design features required for the safe operation of this type of equipment. It sets limits on the degradation of equipment performance in the event of a malfunction and sets certain basic safety and performance requirements for gamma beam therapy equipment.

IEC 60601-2A few standards that have been referred to during the implementation of the -11 standard and are indispensable are: IEC 60601-1-3 (general requirements for medical electrical equipment, basic safety and basic performance, assurance standard: radiation protection in diagnostic X-ray equipment), IEC TR 60788 (medical electrical equipment, defined glossary) and IEC 61217 (radiotherapy device, coordinates, movements and scales).

Tests in accordance with IEC 60601-2-11 standard are also carried out by our organization within the scope of medical device tests.