The Standardization Administration of the People's Republic of China (SAC) approved the new medical electrical equipment standard GB 9706.1-2020.
GB 9706.1-2020 contains requirements concerning basic safety and essential performance that are generally applicable to medical electrical equipment. This standard plays a very important role in China’s medical device supervision and industry.
GB 9706.1-2020 is based on IEC 60601-1: 2012, Ed. 3.1.
The major the changes in this standard compared to the superseded version of it are in the following aspects:
- Level of risk analysis
- Changes in requirements
- Changes in test methods
- The requirement of new test equipment
- Improvement in product design
- Impact on implementation
Medical equipment that has been designed to meet IEC 60601-1: 2012 requirement will find its easy path to comply with GB 9706.1-2020. Older medical equipment will need to be tested against new standards to demonstrate compliance.
The GB 9706.1-2020 standard was approved on April 9, 2020 and will come into effect on May 1, 2023.