Medical Device EMC and Electrical Safety Testing
IEC 60601 is a harmonized standard for evaluating the electrical safety and effectiveness of medical devices and equipment. Recognized by medical device regulators in most markets worldwide, the standard’s current version is IEC 60601 3rd Edition, Am. 1.
Medical device regulators in markets including the US, Europe and Australia require electromagnetic compatibility (EMC) testing to ensure adequate safety and performance of devices for users and patients. Specifically, regulators require EMC testing to determine if a device can perform safely and effectively without causing electromagnetic disturbances in its appropriate operating environment.
The importance of following established medical equipment EMC and safety standards
It is important to understand these and related IEC 60601 requirements early in your device design process to help you choose appropriate components and build in construction that complies with the standard. If you do not follow specific aspects contained in IEC 60601 when designing your product, it can result in costly design modifications later.
Also, IEC 60601 compliance issues can result in delays when you prepare your medical device regulatory submission for a specific market, leading to delayed market entry. Emergo can assist with IEC 60601 compliance and regulatory submissions to the US Food and Drug Administration, European Notified Bodies for CE Marking and other regulators.
Currently, there are more than 50 standards under IEC 60601 that apply to specific electro-medical devices. These include:
- IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances-Requirements and tests
- IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard: Usability
- IEC 60601-1-11 Medical electrical equipment – Part 1-11: General requirements for basic safety and performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-1-12 Medical electrical equipment – Part 1-12: General requirements for basic safety and performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
Let Emergo advise you on 60601 regulatory requirements and appropriate testing firms
Emergo does not perform testing but we can assist you with IEC 60601 edition 3.1 compliance in support of regulatory submissions. Utilizing third-party expertise early in your device development process allows technical experts to spot design issues quickly to ensure compliance with applicable standards.
We have worked with thousands of medical device companies on issues involving IEC 60601 and EMC testing. We can assist you in identifying the requirements for your specific device and recommending highly qualified labs with deep medical device expertise that can perform services including:
- Training support for IEC 60601 2nd and 3rd editions
- Gap audits for IEC 60601 and ISO 14971 cross-conformity
- Early design review and prototype review for conformity to IEC 60601 2nd and 3rd editions
- Software and usability assessments for various IEC 60601 clauses
- EMC testing and assessments according to IEC 60601-1-2 4th edition
Contact us today for more information on EMC and electrical safety testing