产品策划设计开发控制程序指南性文件风险管理报告打印

1、.：.； - 8 -Project name:Homecare Muti-parameter Recorder (H10)Document name:Risk management reportWritten: Date:Auditor: Date:Approved: Date:Revision RecordVer.Revision descriptionReviserDateTable of ContentsTOC o 1-2 h u HYPERLINK l _Toc24395 Table of Contents PAGEREF _Toc24395 - 2 - HYPERLINK l _To

2、c32174 Chapter1 Summary PAGEREF _Toc32174 - 3 - HYPERLINK l _Toc06 Chapter2 Category PAGEREF _Toc06 - 4 - HYPERLINK l _Toc32059 Chapter3 General Introduction PAGEREF _Toc32059 - 6 - HYPERLINK l _Toc11619 3.1 Product Overview PAGEREF _Toc11619 - 6 - HYPERLINK l _Toc18471 3.2 Intended Use PAGEREF _Toc

3、18471 - 6 - HYPERLINK l _Toc24150 3.3 Composition PAGEREF _Toc24150 - 6 - HYPERLINK l _Toc28614 Chapter4 Members and Responsibility of Risk Management PAGEREF _Toc28614 - 7 - HYPERLINK l _Toc26923 Chapter5 Determination of Safety Characteristics PAGEREF _Toc26923 - 8 - HYPERLINK l _Toc14031 Chapter6

4、 Summarization of the Risk Management PAGEREF _Toc14031 - 12 - HYPERLINK l _Toc6040 Chapter7 Evaluation of the Residual Risk PAGEREF _Toc6040 - 31 - HYPERLINK l _Toc29330 Chapter8 Completeness Evaluation of Risk PAGEREF _Toc29330 - 32 - HYPERLINK l _Toc6741 Chapter 9 Information updating and risk ma

5、nagement after manufacturing PAGEREF _Toc6741 - 33 - HYPERLINK l _Toc9957 Appendix A. Analysis method PAGEREF _Toc9957 - 34 - HYPERLINK l _Toc11230 A.1Harm analysis method PAGEREF _Toc11230 - 34 - HYPERLINK l _Toc14954 A.2 Risk estimate method PAGEREF _Toc14954 - 34 - HYPERLINK l _Toc7699 Appendix B

6、. Analysis Method PAGEREF _Toc7699 - 35 - HYPERLINK l _Toc19999 B.1 Estimation of the severity of each hazard PAGEREF _Toc19999 - 35 - HYPERLINK l _Toc21012 B.2.Estimation of the likelihood of each hazard PAGEREF _Toc21012 - 36 - HYPERLINK l _Toc23129 B.3.Estimation of the acceptability of each risk

7、 PAGEREF _Toc23129 - 37 - HYPERLINK l _Toc21454 Appendix CAbbreviations used PAGEREF _Toc21454 - 38 - HYPERLINK l _Toc1169 Appendix DContents of Tables PAGEREF _Toc1169 - 39 -Chapter1 SummaryStandard informationStandardISO14971:2021NameMedical devices-Application of risk management to medical device

8、sTest product informationNameHomecare Muti-parameter RecorderModelH8ConfigurationMainframe,BP cuff,SpO2 sensor, ECG cable and electrodes,Android PadPhotoH8ConclusionAll known or foreseeable hazards have been analyzed. After carrying out corresponding risk control measures, have not introduced any ne

9、w hazards, and there are no ALARP or N/ACC risk, so the risk/benefit analysis is not necessary.Fail itemNothingRemarkNothingChapter2 CategoryCategoryThis document is established according to standard ISO14971:2021 the risk management for medical devices. The goal is to systematically carry out the e

10、ffective management of the various risk processes for the companys R&D and manufacture of Homecare multi-parameter recorder, The document is the instructive direction for design, confirmation, production and sales, and for CE authentication, FDA authentication and SFDA authentication constituent.Rel

11、ative supporting documentItemStandardDescription1MDD 93/42/EECMedical Devices Directive: COUNCIL DIRECTIVE 2007/47/EC of 5 September 2007 concerning medical devices2ISO 780:1997Packaging Pictorial marking for handing of goods3EN 980:2021Terminology, symbols and information provided with medical devi

12、ces-Graphical symbols for use in the labeling of medical devices4EN 1041: 2021Terminology, symbols and information provided with medical devices-Information supplied by the manufacturer with medical devices5IEC/TR 60878:2021Graphical symbols for electrical equipment in medical practice6EN ISO 13485:

13、 2021Medical devices Quality Management Systems Requirements for Regulatory Purposes7EN ISO14971: 2021Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)8EN ISO 14155: 2021Clinical investigation of medical devices for human subjects Good

14、 clinical practice9EN ISO10993-1: 2021/AC:2021Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management(ISO10993-1:2003)10IEC 62133:2021 RLVSecondary cells and batteries containing alkaline or other non-acid electrolytes Safety requirements for portable sealed

15、secondary cells, and for batteries made from them, for use in portable applications11EN 62304:2006/AC:2021 Medical devices - software-software lifecycle processes12EN 62366:2021Medical devices-Application of usability engineering to medical devices13EN ISO 81060-1:2021Non-invasive sphygmomanometers

16、- Part 1: General requirements and test methods for non-automated measurement type14EN 1060-3:1997 +A2:2021Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems15EN 1060-4:2004Non-invasive sphygmomanometers-Part 4: Test procedures

17、 to determine the overall system accuracy of automated non-invasive sphygmomanometer16IEC 60601-1：2005+A1：2021Medical electrical equipment; Part 1: General requirements for basic safety and essential performance17EN IEC 60601-1-2: 2007Medical electrical equipment Part 1: General requirements for saf

18、ety -2 Collateral standard: Electromagnetic compatibility - Requirements and tests18IEC 60601-1-6: 2021Medical electrical equipment-Part 1-6:General requirements for basic safety - Collateral Standard: Usability19EN 60601-2-47:2001Medical electrical equipment - Part 2-47: Particular requirements for

19、 the safety, including essential performance, of ambulatory electrocardiographic systems20IEC 60601-2-49: 2021Medical electrical equipment - Part 2-49: Particular requirements for the safety of multifunction patient monitoring equipment21IEC 80601-2-30: 2021+AMD1:2021 CSVMedical electrical equipment

20、 Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers22ISO 80601-2-61: 2021Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipmentChapter3 General I

21、ntroductionProduct OverviewZTE homecare multi-parameter recorder is mainly composed of host recorder(H8),3-Lead ECG cable, blood pressure cuff and SPO2 probe which for monitoring the physiological data of ECG,SPO2 and NIBP at home. It can realize data transmission between the H8 and the android Pad

22、through the unique data transmission interface. Moreover, The recorder equipped transmission and realize users registration and users historical data records. The equipment operating system customized for android 4.4.2 system, elaborate design is easy to operate and carry.Intended UseThis recorder i

23、s mainly used in household mode, intended use for measuring the physiological data of elder people, provide a convenient measurement of electrocardiogram (ECG),SPO2 and non-invasive blood pressure. Provide reference data for the doctor and clinical diagnosed.CompositionThe homecare multi-parameter r

24、ecorder includes the following components: Power supply module, Display module, User interface, Signal collection & process module, Control module, and NIBP module, , ECG module, SpO2 module.Chapter4 Members and Responsibility of Risk ManagementMemberDepartmentPositionResponsibilitySignatureDirector

25、Research and development departmentTechnology managerBe responsible for planning, approval and application of risk management report.MemberResearch and development departmentmanagerAnticipate the activities of planning, writing, evaluation and application of risk management report.Research and devel

26、opment departmentengineerProvide information and experiences from the viewpoint of technology;Anticipate the activities of risk analysis and review; Review the activities of risk management;Provide risk control methods in the viewpoint oftechnology.Manufacture departmentmanagerProvide information an

27、d experiences from the viewpoint of manufacturing;Anticipate the activities of risk analysis and review; Review the activities of risk management;Provide risk control methods in the viewpoint ofmanufacturing.Market departmentmanagerProvide information and experiences from the viewpoint of product co

28、ntrol, sale and after sale service;Anticipate the activities of risk analysis and review; Review the activities of risk management;Provide risk control methods in the viewpoint ofproduct control, sale and after sale service.Quality department Quality directorAnticipate the activities of risk analysi

29、s and review;Verification the effect of risk management methods.Quality department Test operator(When necessary) test product.Chapter5 Determination of Safety CharacteristicsTable 1 Qualitative and quantitative analysis of the characteristicsNoSafety-related characteristics that could have impact on

30、 safetyYes/NoSafety-related characteristics identification1What is the intended use and how is the medical device to be used?Yes Condition: The homecare multi-parameter recorder can be used in home, lab environment.Intended use: The H10 used in household mode, intended use for measuring the physiolo

31、gical data of elder people, provide a convenient measurement of electrocardiogram (ECG), SPO2 and non-invasive blood pressure. Provide reference data for the doctor and clinical diagnosed.Patient: AdultMethod: SpO2 Measuring Range: 0%100%. HR: 20bpm300bpm. NIBP Measuring range: SBP 40270mmHg(Adult)D

32、BP 10215mmHg(Adult) Pmean 20235mmHg(Adult)User/operator: clinicians and home-care operators are users of the device. 2Is the medical device intended to be implanted?NoThe recorder is for non-invasive use only.3Is the medical device intended to contact the patient or other persons?YesThe cuff/sensor/

33、electrode contact the patients skin.Working mode: the contact consists of short-term contact (one contact or multiple contacts range(s) within 24 hours) and long-term contact (one contact or multiple contacts accumulated range(s) between 30days and 25 hours).4What materials or components are incorpo

34、rated in the medical deviceYesABS, Terylene, stainless steel, silicone, coupling gel - 11 -or are used with, or are in contactwith, the medical device?5Is energy delivered to or extracted from the patient？YesThe recorder delivers energy of light and electricity to the patient.6Are substances deliver

35、ed to or extracted from the patient?No7Are biological materials processed by the medical device for subsequent re-use, transfusion ortransplantation?NoNo biological materials processed.8Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological cont

36、rolsapplicable?NoThe SpO2 sensor, cuff ,ECG probe should be cleaned before use.9Is the medical device intended to be routinely cleaned or disinfected by the user?YesThe device shall be cleaned if it is regarded as necessary for the hospital regulations.10Is the medical device intended to modify the

37、patient environment?NoThe medical device isnt intended to modify the patient environment.11Are measurements taken?YesDuring measurement, if sensor/cuff isimproperly placed, it may affect the accuracy of the measurement results.12Is the medical device interpretative?YesHomecare multi-parameter record

38、er provides this function.In the measurement, the device captures the blood pressure information, blood saturation information, pulse rate information, ECG signal , thus obtaining the BP values, SpO2 values, PR values, ECG waveform.13Is the medical device intended for use in conjunction with other m

39、edical devices, medicines or other medical technologies?NoThe device shall not be used in conjunction with other medical devices.Advice not used with defibrillator or MRI equipment.14Are there unwanted outputs of energy or substances?YesThere may be unwanted outputs of energy under the fault conditi

40、ons, e.g., leakage current.15Is the medical device susceptible to environmental influences?YesIn the allowable range, temperature, humidity and atmospheric pressure have no effect on themeasurement results. But the patient movement may affect the measurement results.The measurement is susceptible to

41、 strong electricalinterference, such as power-line and electrical static.16Does the medical device influence the environment?YesThe system may generate unexpected EMI17Are there essential consumables or accessories associated with the medical device?YesSpO2 sensor, cuff, ECG cable and electrodes18Is

42、 maintenance or calibration necessary?No19Does the medical device contain software?YesThe device contains embedded software.20Does the medical device have a restricted shelf-life?YesThe material aging, will lost asepsis function.21Are there any delayed or long-term use effects?e.g., ergonomics and a

43、ccumulativeeffects.YesLong time SpO2 measurement will make patient feeling uncomfortable due to the raising temperature inside the clips.22To what mechanical forces will the medical device be subjected?YesThe device will be subjected to unexpected impact, vibration, dropping or crushing.23What deter

44、mines the lifetime of the medical device?YesCorrect operation and good maintenance24Is the medical device intended for single use?No25Is safe decommissioning or disposal of the medical device necessary?YesAccord with local environment safeguard.26Does installation or use of the medical device requir

45、e special training?YesThe user need to read user manual for correct operation.27How will information for safe use be provided?YesThe information for safe must be provided.28Will new manufacturing processes need to be established or introduced?NoNow throughput meets requirement.29Is successful applic

46、ation of the medical device critically dependent/on human factors such as the userinterface?29.1Can the user interface design features contribute to use error?YesThe user need to read user manual and familiar with the user interface.29.2Is the medical device used in anenvironment where distractions

47、can cause use error?YesTo be used in an un-allowed environment, may cause use error.29.3Does the medical device have connecting parts or accessories?Yes SpO2 sensor, cuff, Temperature probe, ECG cable and electrodes.29.4Does the medical device have a control interface?YesThe device is controlled by

48、operating the buttons.29.5Does the medical device display information?NoThe device displays the information including physiological parameters like SpO2 value,BP value, PR value, etc., and icons like battery status , and parameters setting options.29.6Is the medical device controlled by a menu?NoThe

49、 device is not controlled by a menu.29.7Will the medical device be used by persons with special needs?YesClinicians and home-care operators who are properly trained can use the device.29.8Can the user interface be used to initiate user actions?YesThe user initiates the 3 measuring physiological para

50、meters30Does the medical device use an alarm system?No31In what way(s) might the medical device be deliberately misused?YesIt may be deliberately misused when the device is broken, the accessories are damaged, and the Li-ion battery is out of power.32Does the medical device hold data critical to pat

51、ient care?YesHR and BP data are important to patient and doctor.33Is the medical device intended to be mobile or portable?Yes34Does the use of the medical device depend on essential performance?YesThe use of the device shall follow the proper performance that is described in the user manual. - 12 -C

52、hapter6 Summarization of the Risk ManagementTable 2Summarization of the Risk ManagementItemPotential HazardsDescriptionS (F/B)LF/BRF/BRisk Reduction MeasureVerificationCompanion new hazardALOR1Energy harms1.1Electrical Shock1.1.1Electrical shock caused by current leakageUncontrolled current leakage

53、to the enclosure and patient leakage,patient auxiliary leakage2/24/2ALARP/ ACCFor BF type device, the current leakage and patient auxiliary leakage must be conformed the requirementsin IEC60601-1Test according to the item & in IEC60601-1NOYES1.1.2Electrical shock caused by current le

54、akageWhen SFC, uncontrolled current leakage to the enclosure and patient leakage, patient auxiliaryleakage2/24/2ALARP/ ACCWhen SFC, for BF type device, the current leakage and patient auxiliary leakage must be conformed the requirements in IEC60601-1Test according to the item & in IE

55、C60601-1NOYES1.1.3Poor safety performancePoor safety protection performance caused by cleaning and sterilization2/24/2ALARP/ACCThe component materials must meet the chemical and electrolytic resistance criterion. Cleaning and Sterilizing the relevant components must follow the procedure and warnings

56、 described in the usermanual.Test according to the item 11.6.6 in IEC60601-1NOYES1.1.4Electrical shockCaused by contacting parts intended to connect patient and batterysimultaneously2/24/2ALARP/ACCThe User Manual should warn that do not open the access cover of battery arbitrarily, even touch the ba

57、ttery andapplication parts simultaneously.Verify the user manual to ensure the contentNOYES - 23 -ItemPotential HazardsDescriptionS (F/B)LF/BRF/BRisk Reduction MeasureVerificationCompanion new hazardALOR1.1.5Poor safety and using performanceCaused by aging materials or components2/24/2ALARP/ACCThe a

58、ging type test should be carried, and indicated the valid period in the user manualDesign control, and verify the user manual to ensure the contentNOYES1.1.6Electrical shockCaused by dropping of the knob key2/24/2ALARP/ACCThe knob should be designed to not tofall off or pull out accidentally, and ca

59、n bear the shock and drop testDesign control, andtest the item in IEC 60601-1NOYES1.1.7Electrical shockCaused by poor insulation of enclosure2/24/2ALARP/ ACCThe enclosure must meet the design insulation requirement, and design protective earthing besides basicinsulationTest according to the

60、 item & 8.8.3 &8.9 in IEC60601-1NOYES1.2Heat harms1.2.1Heat dissipationLong term patching of SpO2 sensor/ECG electrodes may cause heat accumulated on the skin and may damage theskin.2/23/2ALARP/ACCDescription and warning in the user manual, and the design lower power consumption probe, and c