SGS Explains the Reasons for the Delay in Adopting IEC 60601-1, 3.1 edition for Electrical Medical Equipment in China

Towards the end of 2018, official sources in China reported that there was finally movement towards the adoption of International Electrotechnical Commission (IEC) standard IEC 60601-1, 3.1 edition. Going further, one officer even suggested that the Chinese version, GB 9706.1:20xx, would be published sometime in 2019. SGS expert, Gavin-Y Yin, explains why there has been such a long delay.

China’s National Medical Products Administration (NMPA) currently accepts GB 9706.1:2007, analogous to IEC 60601-1:1988+A1:1991+A2:1995. This is despite the fact the newest version was published in 2005. Part of the reason for the delay in the adoption of the new version is that it does not fit well with the large volumes involved in China’s thriving medical device industry.

The conversion of ISO and IEC standards into Chinese standards means they are given either the prefix YY, for a specific industry standard, or GB, for a national standard. Whether a standard is YY or GB depends on a wide variety of factors, including the submitted date for approval, the importance of the standard (mandatory or recommended), and other regulatory consideration.

The delay in the adoption of IEC 60601-1, 3.1. Edition relates, in part, to the fact Chinese medical standards are different to those in other countries. In China, GB and YY standards are endowed with the regulatory requirements that all manufacturers must obey. These apply throughout the process – design, manufacturing, operation, usage and surveillance. Validation comes from letting NMPA test centers perform a type test before issuing a report denoting it has passed and is an officially accepted product. In some ways, Chinese standards have more regulatory power than those in other countries.

The reality of this system of conversion is that it works well for standards that refer only to test items. The difficulty with IEC 60601-1 3.1 edition is it includes clauses that do not relate to testing. For example, clause 14 relates to software evaluation – previously IEC 60601-1-4 – and the evaluation of risk management files. This is out of the scope of NMPA test centers, according to regulations for the supervision and management of medical devices in China. It is these differences that have led to the significant delay in the adoption of IEC 60601-1, 3.1 edition.

The process originally began with the creation of a special team by the Standardization Administration of the People's Republic of China (SAC) to evaluate the possibility of converting 3.1 edition into a Chinese standard. It was shown adoption would benefit China and so, in 2014, Technical Committee 10 (same role as SC62A of TC62 in IEC) operated by the CMTC Shanghai under SAC took the lead to begin transforming IEC 60601-1, 3.1 edition. This process took over a year to complete.

Following comments and a thorough verification of the content of the translated version, it was accepted and became a standard draft for approval in late 2015/early 2016. When, at the IEC TC62 annual meeting in Kobe, it was announced there would be some technical revisions to the existing 3.1 edition, thus creating edition 3.2 and with the possibility that it would be published in 2019, the Chinese project leaders postponed publication. This decision was then reaffirmed when 78 suggestions on edition 3.1 were selected by TC62/SC62 for further development in October 2016. A further suspension to the publishing of GB9706.1:20xx was then approved when the IEC/TC62 2017 annual meeting was cancelled and the proposed publication of 3.2 edition was delayed

In recent months, senior administrators have voiced the opinion that Chinese standardization must keep pace with international standards. This would mean restarting the process to adopt IEC 60601-1, 3.1 edition. Stakeholders operating in China need to stay alert to the situation concerning GB 9706.1:20XX to ensure they remain compliant when it is finally introduced.

SGS Medical Devices Services
SGS’s medical device testing, certification, audit and training services help companies navigate the complexities of international medical device regulations to bring their products to market quickly whilst ensuring compliance with the required regulations and standards. Learn more about SGS’s Medical Devices Services: [www.sgs.com/consumermedicaldevices]

For more information, please contact:

Gavin-Y Yin | 尹勇
Laboratory Manager, Medical Electrical Devices Lab
Tel: +86 21 6191 5607
Email: crs.media@sgs.com
Website: www.sgs.com/ee

About SGS
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 95,000 employees, SGS operates a network of over 2,400 offices and laboratories around the world.

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This release was published on openPR.