The safety of medical devices

At SIQ, we started testing the safety of medical devices 25 years ago, mainly led by the desire to help Slovenian manufacturers place their innovative medical products on the Slovenian and international market.

In 2005, a new concept for testing the safety of medical devices was adopted, as the IEC 60601-1 standard (third edition) was published, which introduced a new method of conformity assessment as its first standard. In addition to the testing itself, it introduced a risk assessment review to be prepared by the manufacturer in accordance with ISO 14971 for medical devices. SIQ has successfully upgraded the knowledge of its employees and expanded the scope of the accredited standards at Slovenian Accreditation and within the IECEE international scheme.

As new medical devices emerge with the development of new treatment methods, we need to follow trends and upgrade our knowledge. Through memberships in the working body and expert groups within the IEC SC62A, we monitor the development of new standards and actively participate in their preparation. By regularly updating the scope of testing, we follow the requirements of our customers and provide them with quick access to the global market. We also offer our partners technical assistance in the developmental phase in the form of partial testing and the interpretation of the standards’ requirements. We currently have 25 standards related to the testing of various medical devices within the scope of Slovenian Accreditation, and 15 medical standards related to basic safety and essential technical properties within the international IECEE scheme.

In addition to the basic standard IEC 60601-1, collateral standards (IEC 60601-1-xx) and special (part 2) standards related to certain medical devices (IEC 60601-2-xx) also need to be taken into account when testing medical devices.

Some examples of the collateral standards (IEC 60601-1-xx):

• IEC 60601-1-2: Electromagnetic Compatibility
• IEC 60601-1-6: Usability
• IEC 60601-1-8: Alarms
• IEC 60601-1-11: Additional requirements for medical devices for use in an uncontrolled domestic environment

Some examples of the special standards (IEC 60601-2-xx):

• IEC 60601-2-10: Electrical and muscle stimulators
• IEC 60601-2-18: Endoscopes
• IEC 60601-2-22: Lasers
• IEC 60601-2-52: Hospital beds

At the end of 2020, Amendment A2 to the basic standard IEC 60601-1 was published, which introduced certain changes compared to the previous version. We anticipate that we will start safety testing according to Amendment A2 in the second half of 2021, as Amendment A2 is not yet harmonized within the European Union.