Suzhou Branch of Jiangsu Medical Devices Laboratory completed the installation and commissioning of the full IEC system_Century Wisdom (Suzhou) Testing Technology Co., Ltd

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Suzhou Branch of Jiangsu Medical Devices Laboratory completed the installation and commissioning of the full IEC system

Release time:

2015-02-04 17:56

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2015 is a special year, with the full implementation of the medical device electromagnetic compatibility standard, Century Huize with Jiangsu Medical Device Inspection Institute Suzhou Branch completed the installation and commissioning of a full set of IEC system, this system fully meets the three-phase 100A test, the weight of instruments and equipment more than 3000kg, using the most mainstream immunity manufacturers Switzerland EMTEST products, in the medical device inspection institute has a very high occupancy rate.

The capabilities of this IEC test system are as follows.

1, electrostatic discharge immunity test: test capacity of 30KV

2, electrical fast transient pulse group immunity test: test capacity of 5.5KV, three-phase 100A

3, surge (shock) immunity test: test capacity of 7KV, three-phase 100A

4, frequency magnetic field immunity test: test capacity of continuous 100A / m, short time 1000A / m

5, voltage transient, short-term interruption and voltage change immunity test: three-phase 100A, to meet the three-phase simultaneous / phase by phase drop

6, infusion pump frequency magnetic field immunity test: continuous 400A / m

7, cochlear implant immunity test: magnetic field up to 1200A/m, electric field up to 200V/m

When the product fades out of the box, only to find the equipment is so high!

Attachment: "Office of the State Food and Drug Administration on YY 0505-2012 medical device industry standard implementation of the relevant work requirements notice

Food and Drug Administration Office of Machinery [2012] No. 151

Provinces, autonomous regions, municipalities directly under the Central Food and Drug Administration (Drug Administration), the State Food and Drug Administration Medical Device Standards Management Center.

YY 0505 medical electrical electromagnetic compatibility standards as GB 9706.1 medical electrical safety standards alongside the general safety standards for medical electrical equipment, for the control of product electromagnetic compatibility indicators to ensure the safety of the people with the armament plays an important role. In accordance with the relevant standards revision plan, the State Food and Drug Administration revised the completion of YY 0505-2012 "medical electrical equipment Part 1-2: Safety General Requirements parallel standards: electromagnetic compatibility requirements and testing" standard (hereinafter referred to as EMC standards), instead of the original YY 0505-2005 standards. To ensure the smooth and orderly implementation of the standard, the relevant work requirements are hereby notified as follows.

First, medical device manufacturers as the first responsible for ensuring product quality, should actively study EMC standards, fully understand and master the standard requirements, make full use of a variety of social testing resources, from the product development stage, to do the corresponding standard implementation preparatory work.

After the release and implementation of EMC standards, medical device manufacturers should immediately in the development, production and other processes to implement EMC standards, and in accordance with the "issued to further strengthen and standardize the registration of medical devices management notice" (State Food and Drug Administration [2008] No. 409) requires the organization of production to ensure that the product meets the requirements of EMC standards.

Second, since the date of implementation of EMC standards, the first time to declare the registration of Class III medical electrical equipment in the registration declaration should be submitted by the medical device testing agency issued by the EMC standard requirements of the test report. Prior to this application for registration and acceptance and has been approved for registration of Class Ⅲ medical electrical equipment, re-registration and then submit the corresponding test report to meet the requirements of EMC standards.

Since the implementation of electromagnetic compatibility standards one year later, the first time to declare the registration of Class II medical electrical equipment, in the registration declaration should be submitted by the medical device testing agency issued by the electromagnetic compatibility standards in line with the test report. The first time to declare the registration of Class I medical electrical equipment submitted to the full performance test report containing EMC standard requirements. Prior to the application for registration and acceptance and has been approved for registration of Class I, Class II medical electrical equipment, re-registration and then submit the corresponding test report to meet the requirements of EMC standards.

Third, medical electrical equipment in the implementation of GB 9706.1 standard full test, electromagnetic compatibility performance in accordance with the electromagnetic compatibility standard requirements for the implementation of the test, and the test involving electromagnetic compatibility performance issued the corresponding format requirements of the test report. (Test report format is published separately)

If the medical device testing organization with GB 9706.1 standard inspection qualification does not have the electromagnetic compatibility standard inspection qualification, according to the unit's work procedures for the implementation of subcontracting testing, with the electromagnetic compatibility standard inspection capability of the medical device testing organization should actively undertake the subcontracting testing. Subcontractors should be responsible for GB 9706.1 and the EMC standard test report issued by the subcontracted party, and according to the work procedures of the unit after the audit issued the corresponding test report.

Manufacturers should ensure that the implementation of GB 9706.1 standards and EMC standards testing of products consistent and timely communication with relevant medical device testing organizations to inform the problem and assist in the detection work. Different medical device testing organizations should also do a good job of coordination and communication between the supervision of enterprises to do a good job.

For the significant problems found in the testing process, such as the basic performance criteria, model coverage and other issues, should be detailed in the test report in the comments on the issue and indicate their views for the specific technical review department reference.

Fourth, food and drug supervision and management departments at all levels should urge enterprises to organize production in accordance with regulatory requirements, and in the registration review process to strictly review whether the EMC standard requirements.

Fifth, the medical device testing organizations with electromagnetic compatibility standards should fully estimate the amount of testing, increase the construction of electromagnetic compatibility testing laboratory, strengthen internal management, and full communication with enterprises, reasonable selection of testing methods, improve testing efficiency, to ensure that the registration testing projects and other medical device testing organizations subcontracted testing projects within the contracted time frame.

The State Food and Drug Administration encourages medical device testing organizations to actively cooperate with the corresponding high-quality electromagnetic compatibility laboratory resources outside the system to build, and will apply for certification of electromagnetic compatibility testing projects will be processed as soon as possible.

Sixth, in the implementation of EMC standards, such as the emergence of different medical device testing organizations or technical review departments and other units of the standard terms, requirements, such as different understanding of the full implementation of the standard as a whole, common problems, the relevant units can apply to the State Food and Drug Administration Medical Device Standards Management Center, according to its situation, to decide whether to start the expert consultation mechanism, and according to the procedure by expert consultation Propose solutions, reported to the State Food and Drug Administration Medical Device Regulatory Division.

Seven, test diagnostic medical electrical equipment implementation GB/T 18268.1: 2010 "measurement, control and laboratory electrical equipment electromagnetic compatibility requirements Part I: General Requirements" standard, can refer to the implementation of this notice.

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