The IEC 60601-1 standard prepared by the International Electrotechnical Commission (IEC), an affiliate of the International Organization for Standardization (ISO), applies to the basic safety and basic performance of medical electrical equipment and medical electrical systems. This standard has been published in our country by the Turkish Standards Institute with the following title: TS EN 60601-1 Electrical Medical Equipment - Part 1: General Rules for Basic Safety and Required Performance.
The mentioned standard is also applicable to equipment used to relieve or alleviate illness, injury or disability. The IEC 61010-2 series of in vitro diagnostic equipment that does not fall under the definition of a medical device is covered by this standard. The purpose of the IEC 60601-1 standard is to determine general requirements and to form the basis for certain standards.
The assurance standards included in the IEC 60601-1 series specify general requirements for basic safety and basic performance.
Unless otherwise specified, the requirements of the IEC 60601-1 standard apply to normal use and reasonably foreseeable misuse. In addition, before the implementation of this standard, a risk management process in accordance with the ISO 14971 standard must be carried out. The compatibility of the medical device is checked by risk management assessment. Businesses must implement a risk management process and demonstrate acceptable levels of risk and persistent risks are acceptable.
Manufacturers are required to report the expected service life of the medical device and equipment in the risk management file.
A well-designed medical device not only improves the lives of patients and healthcare professionals but also protects them. Therefore, compliance with the IEC 60601-1 standard is very important in medical devices. 60601 test standards ensure that medical devices operate safely for all users.
Within the scope of medical device tests by our institution, Tests in accordance with the TS EN 60601-1 standard are also performed.
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.
