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1、Project name:Homecare Muti-parameter Recorder (H10)Document name:Risk management reportWritten: Date:Auditor: Date:Approved: Date:Revision RecordVer.Revision descriptionReviserDateTable of ContentsTable of Contents- 2 -Chapter1 Summary- 3 -Chapter2 Category- 4 -Chapter3 General Introduction- 6 -3.1
2、Product Overview- 6 -3.2 Intended Use- 6 -3.3 Composition- 6 -Chapter4 Members and Responsibility of Risk Management- 7 -Chapter5 Determination of Safety Characteristics- 8 -Chapter6 Summarization of the Risk Management- 12 -Chapter7 Evaluation of the Residual Risk- 31 -Chapter8 Completeness Evaluat
3、ion of Risk- 32 -Chapter 9 Information updating and risk management after manufacturing- 33 -Appendix A. Analysis method- 34 -A.1Harm analysis method- 34 -A.2 Risk estimate method- 34 -Appendix B. Analysis Method- 35 -B.1 Estimation of the severity of each hazard- 35 -B.2.Estimation of the likelihoo
4、d of each hazard- 36 -B.3.Estimation of the acceptability of each risk- 37 -Appendix CAbbreviations used- 38 -Appendix DContents of Tables- 39 -Chapter1 SummaryStandard informationStandardISO14971:2012NameMedical devices-Application of risk management to medical devicesTest product informationNameHo
5、mecare 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 new hazards, and there are no ALA
6、RP or N/ACC risk, so the risk/benefit analysis is not necessary.Fail itemNothingRemarkNothingChapter2 Category2.1 CategoryThis document is established according to standard ISO14971:2012 the risk management for medical devices. The goal is to systematically carry out the effective management of the
7、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.2.2 Relative supporting docume
8、ntItemStandardDescription1MDD 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 980:2008Terminology, symbols and information provided with medical devices-Graphical symbols f
9、or use in the labeling of medical devices4EN 1041: 2008Terminology, symbols and information provided with medical devices-Information supplied by the manufacturer with medical devices5IEC/TR 60878:2015Graphical symbols for electrical equipment in medical practice6EN ISO 13485: 2012Medical devices Qu
10、ality Management Systems Requirements for Regulatory Purposes7EN ISO14971: 2012Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)8EN ISO 14155: 2011Clinical investigation of medical devices for human subjects Good clinical practice9EN I
11、SO10993-1: 2009/AC:2010Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management(ISO10993-1:2003)10IEC 62133:2012 RLVSecondary cells and batteries containing alkaline or other non-acid electrolytes Safety requirements for portable sealed secondary cells, and fo
12、r batteries made from them, for use in portable applications11EN 62304:2006/AC:2008 Medical devices - software-software lifecycle processes12EN 62366:2008Medical devices-Application of usability engineering to medical devices13EN ISO 81060-1:2012Non-invasive sphygmomanometers - Part 1: General requi
13、rements and test methods for non-automated measurement type14EN 1060-3:1997 +A2:2009Non-invasive sphygmomanometers - Part 3: Supplementary requirements for electro-mechanical blood pressure measuring systems15EN 1060-4:2004Non-invasive sphygmomanometers-Part 4: Test procedures to determine the overa
14、ll system accuracy of automated non-invasive sphygmomanometer16IEC 60601-1：2005+A1：2012Medical electrical equipment; Part 1: General requirements for basic safety and essential performance17EN IEC 60601-1-2: 2007Medical electrical equipment Part 1: General requirements for safety -2 Collateral stand
15、ard: Electromagnetic compatibility - Requirements and tests18IEC 60601-1-6: 2010Medical 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 the safety, including essential performance, of ambulatory electrocardiog
