67 Common Problems in Medical Device Testing(Part I)
Q: what should enterprises pay attention to when sending transformers for inspection?
A: The enterpris e needs to provide 2 times the number of secondary complete transformers, plus an unpainted (or disassembled) transformer.The specific specifications of the transformer (insulation grade, test voltage and current of each secondary, limit
value of thermal circuit breaker and structural drawing) shall be provided, stamped with the official seal of the unit, and the instructions consistent with the products used shall be provided.
Q. What materials do enterprises need to provide for ball pressure test of equipment submitted for inspection?
A. The enterprise needs to provide 5cm * 5cm structural samples with a thickness of more than 3mm consistent with the shell of the prototype and the supporting structure of the grid power supply.
Q. What should enterprises pay attention to when submitting high-frequency surgical accessories for examination?
A .Three high-frequency surgical accessories shall be submitted for safety inspection, and supporting high-frequency electric knife shall be provided. The safety classification may not be applicable. If the enterprise still needs to apply the safety classification, the
operation manual, technical requirements, external marks and the provided adapter host shall be consistent with the classification.
Q. What should enterprises pay attention to when sending neutral electrodes for inspection?
A. 40 pieces of neutral electrode shall be submitted for safety inspection (20 samples from the inspected batch, 20 samples within 30 days of expiration or after aging), and supporting high-frequency electric knife shall be provided. The safety classification may
not be applicable. If the enterprise still needs to apply the safety classification, the operation manual, technical requirements, external marks and the provided adapter host shall be consistent with the classification.
Q. What kind of equipment is applicable to the standard of yy0785-2010 Performance Requirements for Electronic Thermometers for Continuous Measurement of Cinical Thermometers?
A. This standard is applicable to equipment that continuously measures and displays human body temperature. For example, a monitor intended to be used in the mouth at the measuring part of the body temperature probe is applicable to this standard.
Thermometers intended to measure skin temperature are not within the scope of this standard. When submitting for examination, three thermometers and the resistance temperature corresponding table of the thermometer shall be provided.
Q. What is the amount of ECG electrodes required by enterprises for examination?
A. The total number of ECG electrodes suitable for YY/T0196-2005 is 50 (25 pairs of tests).
Q. When the independent software is tested according to GB/T 25000.51-2016, do product descriptions and user documentation sets need to be provided separately? What is the difference between the two?
A. The software manual shall provide product description and user document set: the content of the product description shall meet the content of software technical requirements 2.2.1, and the description of the description is mainly for potential users; The
contents of the user’s document set shall meet the contents of 2.2.2 of the software technical requirements. The description of the document set is mainly for the buyer’s users. It is necessary to describe the detailed operation steps (including pictures and text
instructions), including the operation manual, quick start manual, etc., but one of them shall include all the requirements of 2.2.2 of the technical requirements.
Q. Does the operating environment of the software submitted by the enterprise need to provide the minimum configuration of technical requirements?
A. Yes, When submitting software for inspection and testing, the enterprise needs to provide the equipment with the lowest configuration of the operation environment claimed in the technical requirements because the operation environment claimed may be
non- mainstream equipment environment.
Q. The product has internal power supply and charger. Can the charger not be composed? How should products be classified without composition?
A. The charger may not be used as an integral part, and a description that meets the requirements of 6.8.2 of GB9706.1-2007 needs to be added to the manual.
Q. The product design has an alarm function, how to determine the alarm priority?
A. First, research whether there are specific alarm priority requirements in the applicable standards of the product. If there is, it can be directly adopted. If not, the alarm priority should be designed according to the potential results caused by the failure of the alarm state given in Table 201 of YY0709-2009.
Q. Generally speaking, for active products: before the electrical safety (safety regulations) section issues a qualified report, what paper materials and number of copies need to be submitted in the end?
A. 3 copies of the final technical requirements of the paper file (including the electrical insulation diagram), 1 copy of the instruction manual [if the product is a medical electrical system, it also needs to include the instructions of the non -medical electrical
equipment in the composition and the certification documents of compliance with relevant standards (see Appendix DDD in GB9706.15)], 1 copy of the list of key components and 1 copy of the list of rectification changes (according to the final actual
rectification items), accessories (specifications and declaration of conformity of insulating materials such as transformer and shell) and stamped with official seal and cross seal.
Q. When registering a gastrointestinal nutrition pump, in addition to the basic GB9706.1, which standards should be cited and tested?
A. The gastrointestinal nutrition pump is not applicable to the old version of GB9706.27-2005, and the performance part of the technical requirements of the product can be tested according to the product’s own characteristics.
After the new version of GB 9706.224 is promulgated and implemented, it is necessary to add references to this standard, and design and test in strict accordance with the detailed requirements therein.
Q. What attention should be paid to when submitting blood glucose tester for review?
A. When the blood glucose meter is sent for inspection, the performance test shall be carried out according to GB / t19634-2005. Two main machines shall be provided with 400 test strips; If it is tested according to iso15197:2013, two equipment hosts and 500
test strips shall be provided; In addition, analog resistance strip or supporting quality control solution shall be provided.
Q. What is the network security detection of hardware?
A. The content of network security consists of two parts: data interface and user access control. The data interface consists of four parts: data interface name, transmission protocol, interface purpose and storage format (media transmission).
Source：Quality and Testing of Medical Devices
Editted and translated by BradyKnows
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