医疗器械安全有效的基本要求清单英文版Word版

1、3. Safe and effective basic requirements list of medical devicesItem numberRequirementApplicablemethods to prove complianceDocuments that provide objective evidence for complianceAGeneral principleA1Medical devices should be designed and manufactured in the expected conditions and purposes, use

2、d according 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 accep

3、ted, and 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 dev

4、ices should 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 expe

5、cted improper 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

6、.7.1EN1041Test 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.2.7.1

7、EN1041Test 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 e

8、valuation 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 performa

9、nce.YIEC60601-1-2ISO 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

10、 basic 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

11、of materials, 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 co

12、nsidered 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 a

13、nd frequency 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 administratio

14、n, whose 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 producti

15、on should 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

16、 environment 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

17、 should（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

18、 devices 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 steril

19、e medical 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 pr

20、oduced 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 u

21、sing should 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 label

22、s shall 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 anima

23、l derived 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, te

24、sting 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 c

25、ontaining 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

26、 best 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 cell

27、s and 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

28、 combination 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 e

29、rror connection 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 c

30、aused 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 w

31、ith the 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.YIEC60601-1IEC60601-1-2IS

32、O 14971IEC 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.YI

33、EC60601-1IEC60601-1-2ISO 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 14971EN10

34、41ManualRisk 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 t

35、he risk 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 des

36、ign and 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 w

37、aste.NNo 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.。YME

38、DDEV.2.7.1EN1041Clinical 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 standa

39、rd unit 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

40、will not 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 s

41、hall ensure 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

42、devices 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 exp

43、ected 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 dos

44、e and 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 softwa

45、re should 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 device

46、s with 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 me

47、dical 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 medical

48、 internal power supply, medical devices shall have power supply state detection function.YEN1041IEC 60601-1ManualTest reportB9.3Patient safety needs guarantee through the external power supply, medical devices shall include the display of power failure alarm system.YEN1041IEC 60601-1ManualTest repor

49、tB9.4Medical devices intended for monitoring patients with one or more clinical parameters shall be provided with appropriate alarm systems, so that serious deterioration in the patient's health and life or the life danger could be warned. NNo monitoring to patientsB9.5Medical devices design and

50、 production shall have the method of reducing electromagnetic interference.YIEC 60601-1-2ISO 14971EN1041Test reportRisk management reportManualB9.6Medical devices design and production shall ensure products enough electromagnetic anti-interference ability to make sure products operation expectedly.

51、YIEC 60601-1-2EN1041 ISO 14971Test reportManualRisk management reportB9.7Medical devices design and production shall ensure the patients, users and others free from suffering the accident electric shock in normal use or a single fault after production installment and maintenance accordingly.YIEC 606

52、01-1-2ISO 14971Test reportRisk management reportB10Protection against mechanical risksB10.1Medical devices design and production shall protect patients and users from suffering the mechanical risk caused by encountered resistance, unstable components and moving parts while moving.YEN1041 ISO 14971Ma

53、nualRisk management reportB10.2The design and production of medical devices should reduce the risk product vibration causes to a minimum, unless the vibration is the requirement of specific performance of medical devices. If feasible, method limiting vibration especially for vibration source should

54、be adopted.YEN1041ISO 14971ManualRisk management reportB10.3The design and production of medical devices should reduce the risk product noise causes to a minimum, unless the noise is the requirement of specific performance of medical devices. If feasible, method limiting noise especially for noise s

55、ource should be adopted.NThere is not noise source in the product.B10.4The design and structure of terminals and connectors connected with electricity or gas or supplying electricity and gas operated by users shall reducing the operating risk as far as possible.YIEC 60601-1IEC 60601-1-2ISO 14971Test

56、 reportRisk management reportB10.5If some parts of medical devices need to connect or reconnect before use or in use, its design and production should reduce the risk of wrong connection to minimum.YIEC 60601-1ISO 14971Test reportRisk management reportB10.6The accessible medical devices parts not including the parts providing heat expectedly or owning a given temperature component and regional, and surroundings sha