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medical electrical equipment testing

medical electrical equipment is a medical device used for the diagnosis, treatment and monitoring of patients, as well as for the elimination or alleviation of disease, injury or disability. with the rapid development of science and technology and the continuous improvement of people's living standards and health care awareness, the application scope and field of medical electrical equipment are becoming more and more extensive, and the control of its use risk and the improvement of quality are becoming more and more important.

the quality control of medical devices has always been the focus of national service.

service content

noa focus on the compliance and quality of electrical and electronic products, and establish a one-stop service platform for consulting, testing and certification. we provide professional testing services for medical electrical equipment. including active surgical instruments, ecg measurement and analysis equipment, physical therapy instruments, etc.

relevant standards

○ gb 9706.1/iec60601-1《medical electrical equipment—part 1: general requirements for basic safety and essential performance》

○ gb 9706.4/iec 60601-2-2《medical electrical equipment - part 2-2: particular requirements for the safety 0f high frequency surgical equipment》

○ gb 9706.25/iec 60601-2-27《medical electrical equipment part2:particular requirements for the safety of electrocardiographic monitoring equipment》

○ yy 0505/iec 60601-1-2《medical electrical equipment—part 1-2:general requirements for safety—collateral standard: electromagnetic compatibility—requirements and tests》

○ yy 9706.102/iec 60601-1-2《medical electrical equipment—part 1-2:general requirements for basic safety and essential performance—collateral standard: electromagnetic compatibility—requirements and tests》

○ gb 4824/cispr11《industrial, scientific and medical equipment—radio-frequency disturbance characteristics—limits and methods of measurement》

○ gb 4793.1/iec 61010-1《safety requirements for electrical equipment for measurement，control，and laboratory use - part 1: general requirements》

○ gb 4793.2/iec 61010-2-032《safety requirements for electrical equipment for measurement，control，and laboratory use - part 1: general requirements》

○ gb 4793.5/iec 61010-2-031《safety requirements for electrical equipment for measurement, control, and laboratory use - part 5: safety requirements for hand-held probe assemblies for electrical measurement and test》

service process

q&a

what are classⅰ, classⅱ, classⅲ medical devices?

classⅰ, classⅱ, classⅲ are classified according to the use safety of medical devices.

classⅰ is the medical devices with low risk, which can be guaranteed safe and effective by routine management.

classⅱ is a medical device with moderate risk, which needs strict control and management to ensure its safety and effectiveness.

classⅲ is a medical device with high risk, which requires special measures to be strictly controlled and managed to ensure its safety and effectiveness.

what is the standard difference between yy 9706.102-2021 and yy 0505-2012?

yy 9706.102-2021 replaced yy0505-2012. basic safety and electromagnetic compatibility requirements for medical electrical equipment me and medical electrical systems me systems have been added.

what is high frequency surgical equipment?

high frequency surgical equipment is expected to use high frequency current to perform surgical operations, such as biological tissue cutting (cutting) or coagulation (fixation), widely used in a variety of open surgery, endoscopic surgery and mechanical scalpel is difficult to access and perform surgery. it uses high density and high frequency current generated by electrode tip to heat local biological tissue, so that tissue components can be vaporized or burst, so as to achieve coagulation or cutting and other surgical purposes.

how to distinguish between gb 9706.1 and gb 4793.1 standard systems？

for safety protection, gb4793.1 is a protection requirement mainly for operators and the surrounding environment. gb9706.1 has a patient application part in addition to the operator and the surrounding environment, and also clearly puts forward specific requirements for the accuracy of work data and the prevention of dangerous output.

our advantage

authoritative qualification

noa has been approved by certification and accreditation administration of the people’s republic of china（cnca）(cnca-r-2002-051), and has obtained qualification of china inspection body and laboratory mandatory approval (cma),and has passed the multiple approvals of china national accreditation service for conformity assessment (cnas), international accreditation service (ias), united kingdom accreditation service (ukas), joint accreditation system of australia and new zealand (jas-anz). noa has been approved by state administration for market regulation of china, and has been recognized as inspection and testing institution of china's special equipment, as well as the qualification of china's national equipment supervision and engineering supervision. noa-dci is the notified body of the ce directive of the european commission. noa has been recognized by the international electrotechnical commission (iecq) by obtaining electronic component quality assessment system. it is also a national inspection and assessment notified body of import and export commodity in china.noa is a high-tech enterprise in shanghai.

improve performance, realize asset value appreciation, and service throughout the entire value chain

from pre-design to post-operation, noa has the ability to guarantee the whole life cycle of the business. noa, as an independent third-party inspection company, has a large number of domestic and international standards and specifications proficient in design, welding, non-destructive testing, painting, packaging and other fields the experienced team of professional engineers and inspection experts, with more than ten years of experience in the domestic market, is familiar with all aspects of the domestic industrial equipment supply chain, and can provide you with technical support services for the full life cycle of technical services in a timely manner, combining various products. inspection, certification, testing, consulting, and auditing services can provide you with one-stop all-round comprehensive services.

quality, efficiency and service

noa has formed a mature and solid operation system in the development of more than 20 years. we let technical experts who are familiar with market regulations and testing standards and have professional industry experience to carry out inspection, evaluation and design review work. while meeting the requirements of domestic and international standards, we ensure that customers can obtain satisfactory service results in the first time with accurate time-sensitive management methods, and ensure that customers can seize the opportunity in the market competition.

service area

noa inspection services currently cover europe, australia, russia, some middle east regions and most regions in china. noa can ensure the consistency and continuity of customer service in different regions, and eliminate the impact of unfamiliar environments on customer quality. the guarantees and the impact of project implementation enable customers to participate in different markets across the country or around the world with flawless quality.

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