Health really matters

IEC International Standards for medical equipment take centre stage in China

By Claire Marchand

The medical devices industry encompasses a wide range of items and technologies, from the simplest wound dressing to highly sophisticated diagnostic and therapeutic equipment. Globally, the sector is worth more than USD 360 billion (2014) and is expected to grow steadily in the future.

Medical Forum speakers The speakers at the IEC International Medical Equipment Standards Forum

Expanding sector

Worldwide, demand for medical care keeps growing, for a number of reasons. They include aging populations in most regions and increased access to medical services in developing countries. This increasing demand for care drives the need for more medical electrical equipment (MEE) and medical electrical systems (MES). Technology also plays a role in this expansion as traditional manual or mechanical medical equipment and devices, such as blood pressure meters, are being replaced by their electronic equivalent.

Wide scope of application

When MEE and MES are mentioned, the word "hospital" springs to mind as it represents the environment in which they are most widely deployed for diagnostics, surgical intervention, post-surgery care, irradiation and other therapies. However, MEE and MES are also found in other treatment centres. They are used in dental, skin, aural and ophthalmic care, and also for rehabilitation and assistive care.

International Standards for MEE and MES are prepared by a number of IEC Technical Committees (TCs) and Subcommittees (SCs). IEC TC 62: Electrical equipment in medical practice, is central to this process. Its main publication of the IEC 60601 family is, together with its collateral standards, the essential foundation for Standards for MEE and MES. They reference many International Standards prepared by more than two dozen other IEC TCs and SCs.

Raising awareness in China

China’s medical device industry has been growing rapidly in recent years and the government and enterprises are increasingly paying attention to and placing emphasis on participation in international standardization.

Taking the opportunity offered by the 73rd China International Medical Equipment Fair (CMEF), IEC TC 62, together with China Standard Committee for Medical Electrical Equipment and China Standard Committee for X-Ray Medical Devices and Tools, organized the first “IEC International Medical Equipment Standards Forum” in Shanghai on 16 May 2015. Also on the organization board were ReedSinoPharm China, the Liaoning Medical Device Test Institute and the Shanghai Testing and Inspection Institute for Medical Devices.

The half-day event focused on International Standards for medical equipment as well as mechanisms and strategies for enterprises participating in international standardization. The accent was on the challenges posed by novel technologies and the third edition of IEC 60601 on standards for medical equipment.

Attendees included standards developers, medical industry experts, medical equipment and service companies, manufacturers, research institutes and media representatives.

High-level presentations

Chaired by Yan Kang, Chairman of IEC SC 62B: Diagnostic imaging equipment, the Forum saw eight speakers taking the floor to address the audience on specific topics.

Jingli Li, Director of the Center for Medical Device Standardization Administration, CFDA, gave an introduction on the medical device standardization administration in China. She explained in details the standardization structure for medical device in China, the process of standards development and encouraged more active participation from private companies. Today, industry participation in this sector is about 46%.

Li was followed by Dennis Chew, Regional Director of the IEC Asia-Pacific Regional Centre (IEC-APRC), who provided an overview of the IEC including its management structure and the process for developing an International Standard. He also talked about the different types of publications to meet different needs, saying that medical equipment is covered under the IECEE CB Scheme.

On IEC 60601

Zhuohui Sun, Manager of Regulatory Affairs at GE Healthcare China, gave an industry perspective on the standardization structure for medical devices in China and the challenges associated with the implementation of the IEC 60601 series and the use of different versions, especially with respect to its generic requirements in Part 1 and specific requirements in other parts.

The IEC 60601 series of International Standards also formed the core of Norbert Bischof’s address. He gave an overview of IEC work in the medical sector and a detailed explanation of the structure of IEC TC 62 and its Subcommittees and the challenges and benefits in implementing IEC 60601 in its current modular approach.

Importance of participating in standards development

Jiahua Huang, Director of the Shanghai Testing and Inspection Institute for Medical Devices, emphasized that it is not enough to continue with passive usage but to actively track and participate in the development of international standards to facilitate implementation. He also enumerated the key characteristics required of an expert, including solid technical expertise, strong communication skills, familiarity with the IEC/ISO Directives and a good command of the English language.

Robotics in the medical field

Gurvinder S. Virk, Convenor of IEC SC 62A JWG 9* on medical electrical equipment andsystems using robotic technology, explained the distinction between industrial and service robots, the need for robot standards, and made a detailed comparison between robots as machines and robots as medical devices. He also presented the work of JWG 9 on IEC TR 60601-4-1, Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy.

Virk added that robotics is moving towards new service application domains and new challenges are emerging for personal care robots and medical robots. For him, standardization is vital to ensure safety and success for the new and upcoming international robot markets.

The benefits of participating in IEC work

Jianjun Wang, Deputy Director of Liaoning Medical Device Test Institute, gave examples of how Chinese companies have benefited by networking with international experts. Some of the benefits include having a better understanding of the requirements expressed in certain clauses. He added that by participating in the IEC, Chinese enterprises will have a better understanding on the changes and trends of international medical device standards and be able to develop and upgrade their products to the latest standards.

The Forum made important contributions to promoting participation of Chinese medical equipment enterprises in international standardization, and to strengthening exchanges between Chinese and international standardization experts. Because of this extremely successful outcome, the organizers are making plans to hold the Forum on an annual basis in conjunction with the CMEF.

* JWG 9 is linked with ISO/TC 184/SC 2

Medical Forum speakers The speakers at the IEC International Medical Equipment Standards Forum...
Forum audience ...and the audience
doctors working with medical robotics Standards for state-of-the-art medical equipment and medical robotics were central to the Forum presentations and discussions