IEC 60601 Testing

iec 60601 is used worldwide to help ensure the safety and effectiveness of electrical and electronic medical devices. We leverage our product certification and EMC expertise to assist in ensuring that your medical devices and products comply with the IEC 60601 standard and are ready for export to global markets.

JJR China combines industry experience with state-of-the-art laboratory testing facilities to provide a fULl range of medical device testing and certification services to ensure you meet the globally recognized IEC 60601 product safety requirements. Our services cover everything from product design and prototype evaluation to formal compliance testing, certification, and ongoing standards and regulatory advice. We can assist at any stage of your medical device project, ensuring the best certification choices for your products, markets, and business.

IEC 60601 Medical Safety Testing Services

Some of our IEC 60601 medical safety testing services include, but are not limited to:

- IEC 60601 training support - Customized internal or on-site client training

- Gap assessments based on the 60601 series, IEC 62304, IEC 62366, ISO 14971, and other standards

- IEC 60601 compliance consulting services

- Testing reports and certificates for the iecee cb scheme

- Risk management and integrated quality system (ISO 13485 and/or ISO 14971) assessments

- IECEE CB accREDitation for the international cb certification program

- Software and usability assessments supporting various IEC 60601 clauses

- emc testing and evaluation according to IEC 60601-1-2

- Support for home healthcare assessment under IEC 60601-1-11

- ce marking for Class I, IIa, IIb, and III devices

- Design and safety testing for electrical and electronic medical devices

Before we classify new devices as "safe" for use in medical environments and introduce them to the market, it is essential to determine whether the equipment can operate safely and effectively without causing injury and/or electromagnetic interference in the appropriate operating environment.

Support During Early Stages of Product Development

We can help you identify which standards apply to your devices, evaluate whether your design specifications meet requirements, and introduce effective risk management plans from the outset of your project. We also offer additional support and guidance for startups in the early stages of medical device development and design, ensuring early resolution of market entry barriers and the development of reliable regulatory and market strategies.

Risk Assessment and Documentation Management

We offer impartial third-party support at every stage of product development, from design consulting, comprehensive product safety testing, completing the Declaration of Conformity (DoC), to compiling and reviewing technical documentation. With world-class expertise in electrical and electronic medical device testing, our specialists provide you with consulting, guidance, and feedback throughout the product development process so that you can confidently bring your product to market.

Achieving ISO 14971 Compliance

When demonstrating compliance with the IEC 60601 series standards, applying risk management to medical devices is a mandatory requirement. Without this documentation, compliance cannot be achieved; we can assist you by providing ISO 14971 risk management support and guidance, including:

- Customized and one-on-one training

- Document and procedure reviews

- Creation of necessary documentation

- Gap analysis, remediation, and mitigation

CE Marking for Electrical Medical Devices

We provide guidance at every step of the medical device CE certification process to ensure a successful and efficient product launch.

IEC 60601 CB System Certification and CE Marking

IECEE CB certification meets most CE marking requirements for medical and electronic device safety in Europe, meaning you only need to test your product once at one location.