The result of such a long-time delay in adopting the latest standard is increased cost and time delays for manufacturers.If they do have 3 rd party Edition 2 reports, they only need to do a subset of the tests locally.
![]() On April 9, 2020, NMPA and Standardization Administration of the Peoples Republic of China (SAC) jointly published GB 9706.1:2020, which is equivalent to Edition 3.1 of IEC 60601-1. The implementation date will be May 1, 2023. Whats New GB 9706.1:2020 has undergone major changes compared to GB 9706.1-2007: Expand the scope of Electrical Safety Introduce requirements of Essential Performance Introduce requirements of Expected Service Life Mandate Risk Management throughout the product life cycle. Require risk-based safety management rather than testing-based management Pay more attention to mechanical safety, providing different means of operators and patients protections (MOOP and MOPP), modifying electric shock protection requirements, and adding fire protection requirements Incorporate the requirements of GB 9706.15 (IEC 60601-1-1) and YY 0708 (IEC 60601-1-4), which are to be abolished when GB 9706.1:2020 takes effect Transforming GB 9706.1-88 into GB 9706.1:2020 Over the years, China regulatory authorities have made enormous efforts to catch up with international electrical safety standards but has always been lagging behind the revisions of its international counterparts. In 1983, the Technical Committee 10 (TC 10, same role as SC62A of TC62 in IEC) published General Safety Requirements for Medical Electrical Equipment based on IEC 601-1:1977. The corresponding China national standard is GB 9706.1-88, equivalent to IEC 60601-1:1977Amendment 1, was issued in 1985 for the first time in China The next version, GB 9706.1-1995, became effective on December 1, 1996. The revised GB 9706.1-2007, in equivalence to the IEC 60601-1:1988 Amendment 2, became effective on July 1, 2008. For the Edition 3, China Medical Device Standards Management Center has organized relevant parties to incorporate the IEC 60601-1 Edition 3. However, due to the modification of IEC standard, the publication of China standard delayed accordingly. GB 9706.1-2020, equivalent to of IEC 60601-1 Edition 3.1, was officially released on April 9, 2020 and will be officially implemented on May 1, 2023. Iec 60601 1 3Rd Edition Verification And ValidationKey Takeaways for Foreign Manufacturers When implemented, overseas manufacturers need to pay attention to the following: The GB 9706.1-2020 is in line with the IEC 60601-1 Edition 3.1 which is accepted worldwide No longer need to consider the requirements of the IEC 60601-1 Edition 2 in the R D phase and verification and validation stages More documents need to be provided in type testing Third parties produced reports, such as those from UL, CSA, TV and VDE, might be recognized by 2023. Key Takeaways for China Domestic Manufacturers There is no significant impact for domestic manufacturers that export abroad and are already implementing the IEC 60601-1 Edition 3.1 The impact is greater for domestic manufacturers that implement GB 9706.1-2007. It will take considerable time and cost to rebuild the risk management system, and the modification of the product design might be needed. For an English copy of the GB 9706.1:2020, please email us at infoChinaMedDevice.com. Iec 60601 1 3Rd Edition How To Incorporate ChinaWe have experienced engineers on-site to help you with type testing or guide you how to incorporate China mandatory technical standards into your design control. We have obtained certificates for many electronical equipment such as: CT-accelerator for radiotherapy X-ray imaging equipment Full Field Digital Mammography systems Digital Breast Tomosynthesis Mammography system Mammography diagnostic workstation RF generator Gamma cameras and detector Radiotherapy navigator And more For more information, please email InfoChinaMedDevice.com. China Med Device Blogs Market Access NMPA (CFDA) Updates CRO Updates Search NMPA (CFDA) Updates Receive Updates in Your Inbox. 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