Suggested region and language based on your location
Your current region and language
Show medical device safety with IEC 60601 testing and use your report for UKCA, CE certification and access to 50+ markets via the IECEE CB Scheme.
EN 60601 is the international standard for Basic Safety and Essential Performance of medical electrical equipment. It supports UKCA and CE certification by demonstrating compliance with UK and EU regulations and enables entry into 50+ markets via the IECEE CB Scheme.
BSI provides full end-to-end EN 60601 testing from our UK lab and global network. Our experts offer tailored gap analysis and risk-based evaluations to ensure your device is safe, compliant, and market-ready.
The IECEE CB Scheme streamlines international market access by allowing manufacturers to use a single IEC 60601 test report for certification in over 50 countries. BSI, as both a National Certification Body and a Certification Body Test Laboratory (CBTL), delivers the entire CB Scheme process in-house.
Our CB Test Certificates are widely accepted - including in the USA, EU, Canada, Japan, China, and Australia - reducing duplication, cost, and time to market. When combined with UKCA and CE certification, it offers a powerful route to global compliance.
EN 60601 is the key standard for medical electrical safety, mainly used for CE/UKCA certification and global market access via the IECEE CB Scheme.
EN 60601 refers to a series of international standards that pertain to the basic safety and essential performance of medical electrical equipment.
Find out more
EN 60601 specifies a set of requirements that medical electrical equipment and systems must meet to ensure safety and essential performance.
Find out more
This brochure explains how BSI helps medical device makers with 60601 testing, UKCA/CE marking, and CB Scheme certification for global access.
Find out more
Global expertise in medical device safety standards.
UKCA, CE, and CB Scheme certification from one source.
Fast, reliable testing with expert technical support.
World-class labs and local market knowledge.
BSI the Netherlands is a leading Notified Body (2797) achieving full-scope designation under MDR. We are also a full-scope UK Approved Body (0086) assessing medical devices against UK legislation. We review your medical device to ensure conformity against the relevant Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your device to the market. For more information visit our CE certification and UKCA certification dedicated webpages.
Whether you're ready to begin EN 60601 testing, need support with CE or UKCA marking, or want to explore CB Scheme certification, we're here to help.
