Test procedures for medical electrical equipment in accordance with IEC 60601-1 were developed as part of the approval process for an ophthalmic laser system.
Tasks
To support a smooth approval process in China, all required product tests were described in detail, including their execution directly on the device. In addition, EXCO trained the staff of the Chinese test laboratory in both the execution and scope of the tests.
Implementation in detail
- The review covered the standard-required tests and limit values for dielectric strength, leakage currents, humidity preconditioning, transport stability, and power consumption.
- Measurement points and test methods were described in detail using images, tables, and excerpts from IEC 60601-1.
- Standard requirements were analyzed, reviewed, and implemented.
Client benefits
- The client was able to obtain approval for the medical device on the Chinese market.
Client
Medical device manufacturer
