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1、3. Safe and effective basic requirements list of medical devicesItem numberRequirementApplicablemethods to prove complianceDocuments that provide objective evidencefor complianceAGeneral principleA1Medical devices should be designed and manufactured in the expected conditions and purposes, used acco
2、rding to the expected use by prospective users, If applicable, who own the corresponding technical knowledge, experience, education background, training, medical and hardware conditions. When medical devices are used, the potential risk and benefit to the patients in comparison should be accepted, a
3、nd high level of health and safety protection methods are necessary. prospective usersprospective usersYIEC60601-1IEC60601-1-2ISO 14971MEDDEV.2.7.1EN 1041IEC 62304Test reportClinical evaluation reportRisk management report-FMEAManual -Caution -NoticeSoftware validation reportLabelA2Medical devices s
4、hould be designed and manufactured following the safety principle and given consideration to the existing technical ability to ensure the residual risk of each hazard acceptable using the principles below:（1）Known or anticipated hazard should be identificated, and risk of expected use and expected i
5、mproper use should be assessed.（2）Risk during medical devices design and production processes should be eliminated as far as possible.（3）The full protection measures such as alarm should be adopted to reduce the residual risk as far as possible.YIEC60601-1IEC60601-1-2EN60601-4ISO 14971MEDDEV.2.7.1EN
6、1041Test reportClinical evaluation reportRisk management report-FMEAManual -Caution-Noticelabel（4）The residual risk should be informed.A3Medical devices used under regulations should be up to its expected performance and need its scope of applicationYIEC60601-1IEC60601-1-2EN60601-4MEDDEV.2.7.1EN1041
7、Test reportClinical evaluation reportSoftware validation reportManualA4The degradation degree of medical devices characteristics and performance under the condition of normal use and maintenance shouldnt affect its safety in its life cycle. YIEC60601-1MEDDEV.2.7.1ISO 14971Test reportClinical evaluat
8、ion report Risk management reportFMEAA5Medical devices design, production and packaging should be able to guarantee the transportation and storage conditions of the specification, such as temperature and humidity changes, and wont make the adverse impact of product characteristics and performance.YI
9、EC60601-1-2ISO 14971EN1041ISO 15223-1Manual-Transpiration and storageRisk management reportTest report-Transpiration and storageA6All risks and unintended effects should be minimized and be acceptable to ensure that benefits in normal use outweigh the risks.YISO 14971Risk management reportBThe basic
10、 principles of safety and performance of medical devicesB1Chemical, physical and biological propertiesB1.1The material should be able to guarantee medical devices meet the requirements in part A. Special attention:(1) The toxicity, flammability should be especially considered in the selection of mat
11、erials, if applicable.NThis product will not be in contact with patients directly.(2) The compatibility of the material, biological tissues, cells and body fluid should be considered based on the scope of application.(3)The hardness, wear resistance and fatigue strength properties should be consider
12、ed in the material selection, if applicable.B1.2Medical devices design, production and packaging should reduce the risk of the contaminants and residues to people engaged in the transportation, storage, use and patients as far as possible. Special attention should be paid to the contact time and fre
13、quency of exposed tissue of human body with the outside.YISO 14971Risk management reportB1.3Medical devices design and production should be able to ensure the product can be used safely when contacting other materials, substances and gas in normal use. If medical devices were for administration, who
14、se design and production should be in conformity with the relevant provisions of the pharmaceutical management, and whose performance shouldnt be changed in the normal use NThis product will not be changed performance when it contacts with other material.B1.4Medical devices design and production sho
15、uld reduce the risk the leachable or leakage caused as far as possible and special attention should be paid to its carcinogenic, teratogenic and reproductive toxicity.YIEC60601-1-2Test reportB1.5Medical devices design and production should consider the characteristics of production and its use envir
16、onment to reduce the risk of materials unexpected entry and exit to product.YISO 14971IEC60601Risk management reportTest reportB2Infection and microbial contaminationB2.1Medical devices design and production should reduce the risk of patients, users and others infection. Medical devices design shoul
17、d（1）be of easy operation（2）reduce the microbial leakage from products and / or microbial exposure in use as much as possible.（3）prevent microbial contamination of medical instruments and sample from people.NThis product is irrelevant to infection and microbiology contamination risk.B2.2Medical devic
18、es marked with the microbiological requirements should be in compliance with the microbiological requirements prior to use.NThis product has no requirements on microbiology.B2.3Sterile medical devices shall be in compliance with the aseptic requirements prior to use.NThis product is not sterile medi
19、cal device.B2.4Medical devices which are sterile or marked with microbiological requirements should be processed, manufactured or sterilized adopting the method verified.NThis product is not sterile medical device, and has no requirements on microbiology.B2.5Sterile medical devices shall be produced
20、 in the corresponding control state such as the corresponding level of purifying the environment.NThis product is not sterile medical device.B2.6Non sterile medical devices packaging should maintain products integrity and cleanliness. The packaging of products needing to be sterilized before using s
21、hould reduce microbial contamination of the product as far as possible and shall be suitable for corresponding sterilization method. NThis products packaging is not need to be sterilized.B2.7If medical devices can be listed in both sterile and non-sterile states, The product packaging or labels shal
22、l be distinguished.NThis product is not sterile medical device.B3Medicine and mechanical combination productB3.1The safety, quality and performance of medicine and mechanical combination should be verified.NNon-medicine and mechanical combination product.B4Biogenic medical devicesB4.1The animal deri
23、ved tissues, cells and material which are contained in the medical devices shall comply with the relevant regulations, and meet the requirements of the applicable scope. Sources of animals shall be kept for future reference. Animal tissues, cells and other material processing, preservation, testing
24、and handling process should provide patients, users and others if applicable, with the best safety protection. Viruses and other infectious sources shall adopt the validated removal or inactivation treatment method especially.NNo tissue or cell from animals in the product.B4.2Medical devices contain
25、ing human tissues, cells and other substances should choose the appropriate source, donors, in order to reduce the risk of infection. Human tissues, cells and other material processing, preservation, testing and handling process should provide patients, users and others if applicable, with the best
26、safety protection. Viruses and other infectious sources shall adopt the validated removal or inactivation treatment method especially.N No tissue or cell from human beings in the product.B4.3The processing, preservation, testing and handling process of medical devices containing microbial cells and
27、other substances, cell and other material should provide patients, users and others if applicable with the best safety protection.NNo microbial cells in the product.B5Environmental characteristicsB5.1If medical devices were used combined with others expectedly, the safety of whole system after combi
28、nation shall be ensured and the performance of the apparatus or equipment shouldnt be weakened.Any limitations of combination use shall be specified on the label and /or instructions. Liquid, gas transmission or mechanical coupling connection system shall reduce the safety risk to users that error c
29、onnection causes from both design and structure as much as possible.YIEC60601-1ISO 14971MEDDEV.2.7.1Manual Test reportRisk management reportLabelB5.2 B5.2.1Medical devices design and production should eliminate and reduce these risks as far as possible, the risks to patients, users or others caused
30、by the physical or ergonomics.YIEC60601-1IEC60601-1-2ISO 14971ManualRisk management reportTest reportB5.2.2The wrong operation risk caused by the ergonomics, human factors and the use environment.YIEC60601-1IEC60601-1-2ISO 14971ManualRisk management reportTest reportB5.2.3The risk associated with th
31、e reasonable foreseeable external factors or environmental conditions, such as magnetic field, electromagnetic effect, the external electrostatic discharge, radiation brought by diagnosis and treatment, pressure, humidity, temperature, pressure and acceleration change.YIEC60601-1IEC60601-1-2ISO 1497
32、1IEC 60068-2-6ISO 2248Test report Risk management reportManualB5.2.4The risk caused by possible contact with the material, liquid and gas during normal use.YIEC60601-1ISO 14971Test report Risk management reportManualB5.2.5The risk caused by software and its running environment compatibility.YIEC6060
33、1-1IEC60601-1-2ISO 14971Test report Risk management reportManualB5.2.6The risk caused by unexpected entrance of material.YIEC60601-1ISO 14971Test report Risk management reportB5.2.7The risk of interference caused by common use with other medical devices in clinical use.YIEC60601-1ISO 14971EN1041Manu
34、alRisk management reportTest reportB5.2.8The risk caused by material aging, measurement or control accuracy reduction of medical devices that cannot be maintained or calibrated, such as implant products.NRegular maintainment is possible.B5.3Medical devices design and production should reduce the ris
35、k of burning and explosion in the normal use and single fault condition as much as possible, especially medical devices which are exposure to combustible, flammable or used with combustible materials or favorable fuel.YIEC60601-1IEC60601-1-2ISO 14971Test reportRisk management reportB5.4The design an
36、d production of medical devices needing to be adjusted, calibrated and maintained shall ensure the safety of the corresponding process.YIEC60601-1IEC60601-1-2ISO 14971Risk management reportTest reportB5.5The design and production of medical devices should be conducive to the safe disposal of waste.N
37、No relation to disposal of wasteB6Medical devices with functions of diagnosis or measurementB6.1The design and production of medical devices with functions of diagnosis or measurement shall put full consideration to accuracy, precision and stability.Accuracy should have a limitation value.。YMEDDEV.2
38、.7.1EN1041Clinical Evaluation reportManualB6.2The design of numerical range of any measurement, monitoring or display shall be consistent with the principles of ergonomics.YMEDDEV.2.7.1EN1041Clinical Evaluation reportManualB6.3The measurement value expressed shall be the Chinese general standard uni
39、t and be understood by users.YMEDDEV.2.7.1EN1041Clinical Evaluation reportManualB7Radiation protectionB7.1General requirements: medical devices design, production and packaging shall put full consideration to reduction of patients, users and others exposure to radiation as far as possible and will n
40、ot affect its functions.YMEDDEV.2.7.1EN1041ISO 14971Clinical Evaluation reportManualRisk management reportB7.2The expected radiation: the radiation dose of medical devices applying radiation into treatment and diagnosis should be controlled. The design and production of these medical devices shall e
41、nsure the repeatability and the error of relevant adjustable parameters in the allowable range. If expected radiation of medical devices may be harm, they should have corresponding sound and light alarm function.YEN1041ISO 14971ManualRisk management reportB7.3The unexpected radiation: medical device
42、s design and production shall reduce the risk of patients, users and others exposure to unexpected, stray and scattering radiation.YEN1041ISO 14971ManualRisk management reportB7.4Ionizing radiation: the radiation dose, geometric distribution and energy distribution or quality of medical of expected
43、radiation ionizing radiation should be controlled. The design and production of medical devices of ionizing radiation intended for diagnostic radiology shall ensure patients and users radiation absorbed dose to a minimum while making them achieve its clinical need of image quality, and the dose and
44、harness type, energy and energy distribution when applicable shall be monitored and controlled.NOur product doesnt emit ionizing radiation.B8Medical devices with software and independent medical device softwareB8.1The design of medical devices with software or independent medical device software sho
45、uld ensure the repeatability, reliability and performance. When a single fault happens, appropriate measures shall be taken to eliminate and reduce the risk as far as possible.YISO 14971IEC 60601-1-4EN1041Risk management reportSoftware validation report ManualB8.2The software of medical devices with
46、 software or independent medical device software should be affirmed by latest technology, and the development cycle, the risk management requirements, verification and validation requirements shall be considered.YISO 14971IEC 60601-1-4Risk management reportSoftware validation reportB9Active medical devices and devices connected with themB9.1When a single fault of active medical devices happens, appropriate measures shall be taken to eliminate and reduce the risk as far as possible.YISO 14971IEC 60601-1Risk management reportTest reportB9.2Patient safety needs guarantee through the