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The electromagnetic Compatibility standard YY0505-2012 for medical electrical equipment was issued and implemented

Release time:

2013-05-06 00:00

Source:

　　Electromagnetic compatibility refers to "the ability of a device or system to work normally in its electromagnetic environment without causing unacceptable electromagnetic disturbance to anything in the environment". In recent years, with the wide application of electronics and information technology in medical electrical equipment, and the rapid development of new communication technologies (such as personal communication systems, cellular phones, etc.) The electromagnetic environment is increasingly complex. On the one hand, it may be interfered by electromagnetic energy emitted by surrounding electrical equipment during its use, causing harm to patients; on the other hand, if its electromagnetic compatibility index does not meet the requirements, because it also emits electromagnetic energy, it may Affect the normal operation of radio communication services and other surrounding equipment. Therefore, electromagnetic compatibility indicators have increasingly become an important safety indicator for medical electrical equipment. Developed countries in the world have passed laws and regulations to enforce the electromagnetic compatibility test standards for medical electrical equipment.

　　In this case, in order to better ensure the safety of public equipment, the State Food and Drug Administration organized the National Medical Electrical Appliances Standardization Technical Committee, which is equivalent to the transformation of the international medical electrical equipment electromagnetic compatibility test standard IEC 60601-1-2, and the drafting has been completed. YY 0505-2012 "Medical Electrical Equipment Part 1-2: General Safety Requirements Collateral Standard Electromagnetic Compatibility Requirements and Tests" medical device industry standard, released on December 17, 2012, and will be formalized on January 1, 2014 implement. This standard is a basic general safety standard that medical electrical equipment must comply with.

　　In order to ensure the smooth implementation of the standard, the National Bureau has issued the "Notice on Printing and Distributing the Work Plan for the Implementation of the YY 0505-2012 Medical Device Industry Standard" (Food and Drug Administration [2012] No. 149) and "About the YY 0505-2012 Medical The Notice on Relevant Work Requirements for the Implementation of Device Industry Standards (Food and Drug Administration [2012] No. 151), which clarifies the specific requirements and time schedule for the implementation of standards. So far, the national bureau has approved medical device testing institutions in Beijing, Shanghai, Guangzhou, Tianjin, Hangzhou, Wuhan Medical Device Quality Supervision and Inspection Center, Jiangsu Province, Shenzhen Medical Device Testing Institute and other medical device testing institutions in accordance with the standard , the ability to carry out electromagnetic compatibility testing for medical electrical equipment provides technical support for related product testing.

　　Judging from the current preliminary statistics, the implementation of this standard will involve about 11,000 pieces of medical electrical equipment from 3-4,000 medical equipment manufacturers at home and abroad. As the first person responsible for product safety, manufacturers should attach great importance to the release and implementation of standards, actively study new standards, implement new standards in the entire process of R&D and production, and ensure that products meet the requirements of new standards. The food and drug supervision and management department will do a good job in the relevant supervision and inspection work after the implementation of the standard according to the regulations, and deal with the products whose safety indicators do not meet the requirements according to the law and regulations.

　　Through the implementation of this standard, the safety and effectiveness of my country's medical electrical equipment will be further improved, and the health and safety of the public will be protected. At the same time, backward products can be eliminated, product upgrading will be promoted, and the overall product quality and market of my country's medical electrical equipment will be improved. competitiveness and promote the healthy development of my country's medical device industry.

　　Attachment: Notice of the Office of the State Food and Drug Administration on the Relevant Work Requirements for the Implementation of YY 0505-2012 Medical Device Industry Standards

　　Food and Drug Administration [2012] No. 151

　　The Food and Drug Administration (Drug Administration) of all provinces, autonomous regions, and municipalities directly under the Central Government, and the Medical Device Standard Management Center of the State Food and Drug Administration:

　　YY 0505 medical electrical electromagnetic compatibility standard, as a general safety standard for medical electrical equipment alongside GB 9706.1 medical electrical safety standard, plays an important role in controlling the electromagnetic compatibility indicators of products and ensuring the safety of people's equipment. In accordance with the relevant standard formulation and revision plan, the State Food and Drug Administration revised and completed the YY 0505-2012 "Medical Electrical Equipment Part 1-2: General Safety Requirements Parallel Standard: Electromagnetic Compatibility Requirements and Tests" standard (hereinafter referred to as the electromagnetic compatibility standard) , to replace the original YY 0505-2005 standard. In order to ensure the smooth and orderly implementation of the standards, the relevant work requirements are hereby notified as follows:

　　1. As the first person responsible for ensuring product quality, medical device manufacturers should actively study electromagnetic compatibility standards, fully understand and master standard requirements, make full use of various social testing resources, and implement corresponding standards from the product development stage Preparation.

　　After the release and implementation of the electromagnetic compatibility standards, medical device manufacturers should immediately implement the electromagnetic compatibility standards in the whole process of research and production, and follow the "Notice on Further Strengthening and Standardizing the Provisional Regulations on Medical Device Registration Management" (National Food and Drug Administration) Supervisory Equipment [2008] No. 409) requires the organization of production to ensure that products meet the requirements of electromagnetic compatibility standards.

　　2. From the date of implementation of the EMC standard, Class III medical electrical equipment that is registered for the first time should submit a test report issued by a medical device testing agency that meets the requirements of the EMC standard. For Class III medical electrical equipment that has been applied for registration before and has been accepted and has been approved for registration, the corresponding test report that meets the requirements of the electromagnetic compatibility standard shall be submitted when re-registering.

　　One year after the implementation of the EMC standard, the first application for registration of Class II medical electrical equipment shall submit a test report issued by a medical device testing agency that meets the requirements of the EMC standard when registering. Class I medical electrical equipment declared for registration for the first time shall submit a full performance test report including the requirements of electromagnetic compatibility standards. For Class I and Class II medical electrical equipment that have been applied for registration before and have been accepted and approved for registration, the corresponding test report that meets the requirements of the electromagnetic compatibility standard shall be submitted when re-registering.

　　3. When implementing all items of the GB 9706.1 standard testing for medical electrical equipment, the electromagnetic compatibility performance should be tested in accordance with the requirements of the electromagnetic compatibility standard, and a test report with the corresponding format requirements should be issued for the testing involving electromagnetic compatibility performance. (The format of the test report will be published separately)

　　If a medical device testing institution with the qualification of GB 9706.1 standard inspection does not have the qualification for EMC standard inspection, it can carry out subcontracted inspection according to the work procedures of the unit. Package detection. The subcontractor shall be responsible for GB 9706.1 and the electromagnetic compatibility standard test report issued by the subcontractor, and shall issue the corresponding test report after reviewing the work procedures of the unit.

　　Manufacturers should ensure that the products tested by the GB 9706.1 standard and the electromagnetic compatibility standard are consistent, and communicate with relevant medical device testing agencies in a timely manner to report problems and assist in the relevant testing work. Different medical device testing institutions should also fully coordinate and communicate with each other, and supervise enterprises to do relevant work well.

　　For major problems found in the testing process, such as basic performance criteria, model coverage, etc., the relevant problems should be stated in detail in the remarks of the test report and their own opinions should be indicated for the reference of the specific technical review department.

　　4. Food and drug supervision and management departments at all levels should urge enterprises to organize production in accordance with regulations, and strictly examine whether they meet the requirements of electromagnetic compatibility standards during the registration review process.

　　5. All medical device testing institutions with the ability to undertake EMC standard inspections should fully estimate the amount of testing, increase the construction of EMC testing laboratories, strengthen internal management, fully communicate with enterprises, reasonably select testing methods, improve testing efficiency, and ensure The registration testing items and subcontracting testing items of other medical device testing institutions shall be completed within the time limit stipulated in the contract.

　　The State Food and Drug Administration encourages medical device testing institutions to actively cooperate with corresponding high-quality EMC laboratory resources in external systems, and will process applications for certification of relevant EMC testing items as soon as possible.

　　6. During the implementation of the EMC standard, if different medical device testing institutions or technical review departments have different understandings of the standard clauses and requirements, and other overall and common problems that affect the full implementation of the standard, the relevant units may report to the State Food and Drug Administration The Medical Device Standard Management Center of the State Food and Drug Administration submits an application, and it decides whether to start the expert consultation mechanism according to the situation, and proposes a solution through expert consultation according to the procedures, and reports it to the Medical Device Supervision Department of the State Food and Drug Administration.

　　7. The standard of GB/T 18268.1:2010 "Electromagnetic Compatibility Requirements for Electrical Equipment for Measurement, Control and Laboratory Use: General Requirements" shall be implemented for inspection and diagnosis medical electrical equipment, which may refer to this implementation notice.

　　State Food and Drug Administration Office

　　December 19, 2012

Century Wisdom (Suzhou) Testing Technology Co., Ltd

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