We are pleased to announce that Yaoshi has achieved the world’s first IECEE CB certification under IEC 81001-5-1:2021 for its Yetsea 300 series ultra-widefield scanning laser ophthalmoscope (SLO).
In addition, Yaoshi has obtained CB certifications for electrical safety and electromagnetic compatibility (EMC), demonstrating how we enable a comprehensive compliance framework that covers safety, performance and cybersecurity.
The IEC 81001-5-1 certification addresses cybersecurity throughout the life cycle of health software. This achievement represents the first application of this standard within the IECEE CB certification scheme globally.
Supporting secure healthcare technologies
With the increasing integration of digital technologies and software in healthcare, cybersecurity is becoming a key component of medical device safety.
IEC 81001-5-1 requires manufacturers to implement cybersecurity practices throughout the product life cycle, from design and development through testing and into post-market activities.
Through the certification process, we have independently verified that Yaoshi meets international requirements for both traditional safety and emerging cybersecurity expectations.
Enabling global market access
As part of the IECEE CB Scheme, this certification supports international acceptance of test results and facilitates entry into global markets.
By reducing the need for duplicate testing and certification, it helps streamline regulatory approval processes and accelerate time-to-market in regions such as Europe, North America and Japan.
Comprehensive assessment
By adopting an independent verification approach, we conducted a comprehensive evaluation of the Yetsea 300 series in accordance with IEC 81001-5-1 requirements.
At the product level, we performed threat modeling, risk assessment, penetration testing, vulnerability scanning, code auditing and software bill of materials (SBOM) review to identify potential cybersecurity risks.
At the system level, we assessed Yaoshi’s cybersecurity management processes and documentation, verifying that security practices are integrated across quality management, development, testing and post-market monitoring and response activities.
We continue to expand our global medical device testing and certification capabilities, supporting medical device manufacturers worldwide in addressing evolving requirements and strengthening trust in connected healthcare systems.
With a global network of medical device experts and strong technical expertise, we deliver integrated one-stop services covering product testing, auditing and certification.
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About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of over 100,000 dedicated professionals. With more than 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
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