TS EN 60601-2-46 Electrical Medical Equipment - Part 2-46: Specific Features for Basic Safety and Required Performance of Operating Tables

Medical Device Tests

TS EN 60601-2-46 Electrical Medical Equipment - Part 2-46: Specific Features for Basic Safety and Required Performance of Operating Tables

The IEC 60601-2-46 standard, prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Organization for Standardization (ISO), describes the safety requirements that operating room tables should have, including portable ones, with or without electrical components. . This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-2-46 Electrical medical equipment - Part 2-46: Certain features for the basic safety and required performance of operating tables.

TS EN 60601-2-46 Electrical Medical Equipment - Part 2-46: Specific Features for Basic Safety and Required Performance of Operating Tables

Operating tables are designed taking into account the different postures that should be given to patients during surgical interventions, and the safety of patients and operators during their use is essential. Stainless steel and high-quality components are used in the production of operating tables in accordance with operating room conditions. With high technology and production quality, operating tables are included in the scope of electrical medical equipment and in this respect, they must meet basic safety and performance criteria. The IEC 60601-2-46 standard is a special standard designed for this purpose.

The safe production of operating tables must comply with the requirements in the Medical Device Regulation issued by the Ministry of Health along with the said standard. This regulation explains the basic requirements that medical equipment and accessories must carry and aims to ensure that patients, operators and third parties are protected against dangers that may arise in terms of health and safety during their use.

The scope of the standard includes examination chairs and beds, dental chairs, patient support systems for diagnosis and therapy devices, patient transfer devices, delivery room tables. and medical beds are not included. Separate standards have been developed for these.

Tests in accordance with IEC 60601-2-46 standard are also carried out by our organization within the scope of medical device tests.

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