International standards have always been an important source of China’s medical devices standards. In 1988, China began adopting the IEC 60601 serial standards to Chinese standards, ensuring the safety of medical electrical equipment sold in the Chinese market. These adopted standards are known as the GB 9701 serial standards in China. In the following years, China adopted the IEC 60601 standards successively.
China started the adoption of IEC 60601 3rd Edition in 2012. This process lasted a very long time until the first batch of adopted standards were published in April 2020.
The first four adopted standards released include:
- GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
- GB 9706.203-2020 Medical electrical equipment—Part 2-3: Particular requirements for the basic safety and essential performance of short-wave therapy equipment
- GB 9706.212-2020 Medical electrical equipment—Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
- GB 9706.237-2020 Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
These standards are planned to come into force in May 2023.
GB 9706 serial standards play a pivotal role in maintaining the safety of all medical electrical products sold in the Chinese market. For each adoption, both the changes between the new and old versions and the modifications made from IEC standards will significantly impact the industry.
In this round of adoption, 35 new GB 9706 standards are planned to be developed by adopting 35 corresponding IEC 60601 standards. As for the core standard, GB 9706.1-2020, which comes from IEC 60601.1:2012, the following changes have been made:
In terms of differences between the new and old versions, the 2020 version puts forward more requirements on equipment’s basic performance, life expectancy, risk management, differentiated protection for operators and patients, testing methods for protection against electric shock, as well as fire prevention.
In terms of the modifications from the IEC standard, the modifications mainly lie in the following three aspects.
- Coordination with other Chinese standards. GB 9706.1 references 40 Chinese standards instead of IEC standards, among which 10 standards are adopted from ISO and IEC standards with modifications.
- More requirements on power plugs, especially for AC networks.
- ISO 13854:2017 was referenced for determining the parameters of acceptable safety gaps.
Apart from GB 9706.1-2020, there are 34 other supplementary and application-specific standards that will be used to support the implementation of GB 9706.1-2020 on specific products. However, absence of most of these supporting standards means GB 9706 serial standards still cannot be used as the evaluation standards for market access. According to an officer from NMPA/Medical Device Standards Management Centre, all standards of the standard series are expected to be published within one year. Considering that a transition period of three years for GB 9706 standards to be implemented has been determined, the later the supporting standards are released, the less time enterprises have to adjust their production. It is necessary to urge authorities to reconsider the transition period or release these standards as early as possible, so the industry has enough time to make corresponding adjustments.