医疗器械风险分析报告英文版RiskAnalysisreport

1、Risk An alysis reportProduct:Electrical Lice CombType/Model:Effective date:Docume nt No.:5/24/2021-5/23/2021RM-9022-02Versio n:A0Departme nt:Tech ni cal Departme ntMadeCheckApprovalContents1Foreword32Scope33Application information33.1Policy, directive and standard33.2The information of product43.3Ot

2、her source of information43.4Team of risk management43.5Instruction of product54Risk analysis54.1Risk analysis procedure54.2Intended use/intended purpose and identification of characteristics related to the safety54.3Identification of known or foreseeable hazards and Estimation of the risk(s) for ea

3、ch hazard94.4Risk Estimation105Risk evaluation126Risk control126.1Risk reduction and implementation of control measure(s)126.2Risks arising from risk control measures166.3Completeness of risk evaluation167Overall residual risk evaluation168Information of in production and use169Conclusion18Page 10 o

4、f 33RISK ANALYSIS REPORT1. ForewordThis article is the report of the risk analysis of this product. This report shows all the potential risks and the reason cause these risks happen, also estimate the rate and the level of all kinds of risks maybe cause the serious result, if a item can not be accep

5、table, which need to adopt a measure to reduce the risk level and estimate the rate and level after. Finally, make all the items acceptable.2. ScopeThis report is applicable to the product of Electrical Lice Comb which including the following parts:1. PCB2. Metal comb3. Alkaline battery4. Plastic en

6、closure3. Application information:3.1 Policy, directive and standard1) 93/42/EEC (MDD) Medical Devices Directive2) Regulation (EU) 2021/745 (MDR) Medical Device Regulation3) ISO 13485:2021 Medical device-Quality management system-requirements for regulatory4) EN ISO 14971:2021 Medical devices - Appl

7、ication of risk management to medical devices5) IEC 60601-1:2005+A1:2021/EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance6) IEC 60601-1-2:2007/EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for saf

8、ety - Collateral standard: Electromagnetic compatibility - Requirements and tests7) IEC 60601-1-11:2021 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrica

9、l systems used in the home healthcare environment3.2 The information of productDesign program, Schematic, Standard of product, PCB layout, Instruction of product.3.3 Other source of informationCustomer suggesti on. Record of accide nt, Professi onal docume ntary Internet3.4 Team of risk management:N

10、ameTitleThe duty in the risk man ageme ntGen eral Man agerProvide the resources n eeded; approve the pla ns and the reports of risk man ageme ntMan ageme nt Represe ntativeSupervise, orga nize and impleme nt the risk man ageme nt activities; participate in the risk analysis and evaluation.Head of Te

11、ch ni cal Departme ntResp on sible for product tech ni cal and quality risk man ageme nt; participate in the risk an alysis and evaluation. Organize to make the risk management plan and report.Head of Product Departme ntProvide in formatio n related to risk duri ng product ion process; impleme nt ri

12、sk con trol measures in the process of product ion, reduce or elim in ate the risk; participate in the risk analysis and evaluation.Head of Quality Departme ntValidate the results of risk con trol measures; participate in the risk analysis and evaluation.Head of Market ing Departme ntResp on sible f

13、or track ing the quality of products sold, and collect the related information; participate in the risk an alysis and evaluati on.3.5 Instruction of productRefer to Operati ng Manu als.4. Risk analysis4.1 Risk analysis procedureRefer to Risk Man ageme nt Pla n (Docume nt No.:RM-9022-01 Versio n: AO)

14、4.2 Intended use/intended purpose and identification of characteristics related to the safety (Annex C of EN ISO 14971:2021)NOItemsThe specialty of characterC.2.1What is the inten ded use and how is the medical device to be used?To be used for remov ing lice from head hair.NOItemsThe specialty of ch

15、aracterC.2.2Is the medical device inten ded to be impla nted?NoC.2.3Is the medical device inten ded to be in con tact with the patie nt or other pers ons?Head scalp con tact through the metal comb.C.2.4What materials or comp onents are utilized in the medical device or are used with, or are in con t

16、act with, the medical device?NoC.2.5Is en ergy delivered to or extracted from the patie nt?NoC.2.6Are substa nces delivered to or extracted from the patie nt?NoC.2.7Are biological materials processed by the medical device for subseque nt re-use, tran sfusi on or tra nspla ntati on?NoC.2.8Is the medi

17、cal device supplied sterile or inten ded to be sterilized by the user, or are other microbiological con trols applicable?Non- sterileC.2.9Is the medical device inten ded to be rout in ely clea ned and disi nfected by the user?Yes, user should clea n the teeth of the metal comb regularly with the bru

18、sh provided.C.2.10Is the medical device inten ded to modify the patie nt en vir onment?NoC.2.11Are measureme nts take n?NoC.2.12Is the medical device in terpretative?YesC.2.13Is the medical device inten ded for use in conjun cti on with other medical devices, medic ines or other medical tech no logi

19、es?NoC.2.14Are there unwan ted outputs of en ergy or substa nces?NoC.2.15Is the medical device susceptible to en viro nmen tal in flue nces?NoC.2.16Does the medical device in flue nee the en viro nment?NoC.2.17Are there esse ntial con sumables or accessories associated with the medical device?AA 1.5

20、V alkaline batteryNOItemsThe specialty of characterC.2.18Is maintenance or calibrati on n ecessary?NoC.2.19Does the medical device contain software?NoC.2.20Does the medical device have a restricted shelf-life?NoC.2.21Are there any delayed or Ion g-term use effects?N/AC.2.22To what mecha ni cal force

21、s will the medical device be subjected?NoC.2.23What determines the lifetime of the medical device?The lifetime of electro nic comp onentsC.2.24Is the medical device inten ded for sin gle use?N/AC.2.25Is safe decommissi oning or disposal of the medical device n ecessary?No, dispose of gen eral electr

22、ical device in accorda nee with local laws and regulati ons.C.2.26Does in stallati on or use of the medical device require special tra ining or special skills?No, but the user should carefully read the in structi ons before use.C.2.27How will information for safe use be provided?By operati ng man ua

23、l, labels, war ning marks.C.2.28Will new man ufacturi ng processes n eed to be established or in troduced?NoC.2.29Is successful applicati on of the medical device critically depe ndent on huma n factors such as the user in terface?YesC.2.29.1Can the user in terface desig n features con tribute to us

24、e error?NoC.2.29.2Is the medical device used in an en viro nment where distracti ons can cause use error?NoC.2.29.3Does the medical device have conn ect ing parts or accessories?NoC.2.29.4Does the medical device have a con trol in terface?NoC.2.29.5Does the medical device displayNoNOItemsThe special

25、ty of characterin formati on?C.2.29.6Is the medical device con trolled by a menu?NoC.2.29.7Will the medical device be used by pers ons with special n eeds?NoC.2.29.8Can the user in terface be used to in itiate user acti ons?N/AC.2.30Does the medical device use an alarm system?NoC.2.31In what way(s)

26、might the medical device be deliberately misused?NoC.2.32Does the medical device hold data critical to patie nt care?NoC.2.33Is the medical device inten ded to be mobile or portable?YesC.2.34Does the use of the medical device depe nd on esse ntial performa nee?Yes4.3 Identification of known or fores

27、eeable hazards and Estimation of the risk(s) for each hazardKnown or foreseeable hazards in both normal and single fault conditions are identified based on Annex E of EN ISO 14971:2021HazardHazard No.Foreseeable sequenee of eve ntsHazardous situati onHarmPrelimi nary control measuresBiohazard, chemi

28、cal hazard or hazard caused by accessory agi ngH1Toxicity of raw materials for the product (such as ABS).Sufferers have con tact with the products with over-limit toxicity.Sufferers skin become irritatedStrictly follow “ Con trol Procedure for Purchasing .En vir onmen tal hazardH21、Temperature &

29、 humidity in workshop cannot meet requireme nt.Sufferers have con tact with the non-safeSufferers skin become irritated or in fectedStrictly follow“ Con trolProcedure forWorki ngEnvironment &etc.2、Warehouse en viro nment cannot meet requireme nt, duct.“ Co ntrol Procedure for Product Prot

30、ectio n.In formatio n hazardH3Strictly follow related procedure.Guara ntee the printing quality.H4Un defi ned or illegible marki ng for protecti on measures on pack ingSufferers use the product un der non-safe status.Sufferers may feel discomfort.Strictly follow “Instruction for Medical Device &

31、 Regulati on for Marking and Pack ing .H5Tedious or un defi ned description for no tice and operati ng steps on in structi onUsers cannot use the product.Users cannot use the product.Use hazard & fun cti on failureH61.Product cannot be used as expected (normal status) due to not pay ing atte nti

32、 on to the no tice & graphic represe ntati on on in structi on. 2.Shri nkage for certain parts, assembly not in place or omitted duri ng check ing 3.Basic performa nee of product cannot meet sta ndard requireme ntProducts cannot be used as expected and sufferers may have access to defective prod

33、uct.Product may not fun cti on properly. Sufferers may feel discomfort.Strictly follow“Instruction for Medical Device & Regulati on for Marking and Packing and related check ing procedure.4.4 Risk Estimation Criteria 4.4441 Severity levels: accord ing to the pote ntial risk severityCategoryDescr

34、iptio nLevelNegligibleInconvenience or temporary discomfort1Min orResult in temporary injury or impairme nt not2CategoryDescriptio nLevelrequiri ng professi onal medical in terve ntio nSeriousRequires in patie nt hospitalisati on or proIon gati on of existi ng hospitalizati on; Results in medical or

35、 surgical in terve nti on to preve nt perma nent impairme nt to body structure or a body function; Led to foetal distress, foetal death or a congen ital abno rmality/birth defect.3CriticalLed to a serious deterioration in health of a patient, user, or others; Results in a life threate ning ill ness

36、or injury; Results in a perma nent impairme nt of a body structure or body function.4CatastrophicLed to a death5442 Probability estimation: according to the risk happening rateCategoryProbabilityLevelImprobable: impossible to happe n-5The rate is less tha n 101Remote: happe ning rate is very low.-4-

37、5The rate is betwee n 10and 102Occasi on al: Happe ning at low rate-3-4The rate is betwee n 10and 103Probable: re-happe ning-2-3The rate is betwee n 10and 104Freque nt: can not avoid-2The rate is more tha n 105443 Risk acceptability of ALARP and ACCMethods of determ ining acceptable risk in clude th

38、e follow ing:using applicable sta ndards that specifyrequireme nts, followi ng appropriate guida nee and compar ing levels of risk evide nt from medical devices already in use.Risk should only be accepted in a particular situati on if it is outweighed by ben efits.Risks can be categorized into the f

39、ollowing three regions, see below tableRISK = LEVEL X RATERisk levelAcceptability14ACC (ACC is short of acceptable risk )59ALARP ( As Low As Reas on ably Practicable)10 25NACC(ACC is short of un acceptable risk)The three-region concept of risk is illustrated in below Table:Severity ProbabilityNeglig

40、ible 1Min or2Serious3Critical4Catastrophic5Improbable 1ACCACCACCACCALARPRemote 2ACCACCALARPALARPNACCOccasi onal 3ACCALARPALARPNACCNACCProbable 4ACCALARPNACCNACCNACCFreque nt 5ALARPNACCNACCNACCNACCEstimati on of the risk(s) for each hazard is show n in table in 4.3, and the risk required to be con tr

41、olled is show n in table in 6.1It needn ' t to deal with the risk which in ACC and it must adopt measures for which in NACC and ALARP5. Risk evaluationAfter evaluation, for each identified hazard, according to the criteria defined in the risk management plan,We decide risk men ti oned in below c

42、lause 6 of this report should be reduced by releva nt con trol measures, other estimated risk(s) is so low that risk reduction need not be pursued. The results of this risk evaluation have been recorded in the risk management file.6. Risk control6.1 Risk reduction and implementation of control measu

43、re(s)R means RiskS means Severity O mea ns OddsThe "R units with different colors in the below table mean the different risks. (ACC, ALARP, NACC) Please refer to 4.4.3.For risk that required to be reduced, we con trol the risk(s) so that the residual risk(s) associated with each hazard is judge

44、d acceptable, see below tableHazard No.HazardRisk Estimate (Before risk con trol)Risk con trol measuresVerificati onRisk Estimate (After risk con trol)Residual riskAcceptabilitySORSORH1Toxicity of raw materials for the product (such as ABS).224Strictly follow “ Con trolProcedure for Purchas ingValid

45、111No new riskACCH2Temperature & humidity in workshop cannot meet requireme nt, etc.2.Warehouse en vir onment cannot meet requireme nt, etc.224Strictly follow “ Control Procedure for Working Environment & “ Control Procedure for Product Protectio n .Valid111No new riskACCH3Un defi ned or ill

46、egible marking on product224Strictly follow related procedure.Guara ntee the printing quality.Valid111No new riskACCH4Un defi ned or illegible marking for protection measures on pack ing224Strictly follow "Instruction for Medical Device & Regulati on for Marking and Pack ing.Valid111No new

47、riskACCH5edious or un defi ned description for notice and operat ing steps on in structi on224Strictly follow "Instruction for Medical Device & Regulati on for Marking andPack ing .Valid111No new riskACCH61.Product cannot be used as expected (normal status) due to not pay ing atte nti on to

48、 the no tice & graphic represe ntati on on in structi on.2.Shrinkage for certain224Strictly follow "Instruction for Medical Device & Regulation for Marking and Packing andrelated check ing procedure.Valid111No new riskACCparts, assembly not in place or omitted duri ng check ing3.Basic p

49、erforma nee of product cannot meet sta ndard requireme ntPage 12 of 336.2 Risks arising from risk control measuresThis risk man ageme nt can not add the new risk into the process6.3 Completeness of risk evaluationThe risk(s) from all identified hazards have been evaluated. The results of this assess

50、ment havebee n recorded in the risk man ageme nt file7. Overall residual risk evaluation:The residual risks after risk control is the unapt use which caused by the user not following the in structio n.8. Information of in production and use Accordingto the message ofmedic ine and the experie nee of

51、same product, adopt the above measures of risk con trol, it is great reduce the rate of harms happe ning and predict the risks. We can predict and con trol the risk and harms after modify the process ing program in producti on.Appropriate methods are in place to obtai n releva nt product ion and pos

52、t-product ion in formati on.Message collect ion of in producti on and after product ionMessage in producti on and after product ionObtai n way and timesDepartme ntThe cha nge of rules or sta ndardInternet & professi onal web stati onTech ni cal departme ntAdverse eve ntsReport of adverse eve nts

53、 & in ter netQuality departme nt & Tech ni cal departme ntNotice and call backFollow ing the no tice of call backMarketi ng departme ntSupervisi on departme ntsReport of supervisi onQuality departme ntCustomers complai ntsCustomer compla int and the in vestigati on and an alysis.Marketi ng d

54、epartme ntDesig n cha ngeDesig n cha nge reviewTech ni cal departme ntThe quality of purchaseSupplier reviewPurchas ing departme ntProblems in producti onPFMEA and SOPProduct Departme ntStorage and tran sportStorage and Logistics Departme ntReview the message of in/after producti onPlease connect wi

55、th the risk man age team in time after get the messages, risk man ageteam willreview and an alysis these messages and formulate the corresp ond risk con trol program,According to the result of review, should to evaluate whether the following factors exist.a. Should have the hazards that not be revie

56、wed before.b. Whether the one or more than one hazards become ACC&ALARP to NACC which caused by the new hazards.It is happe ning of the above, we should re-review the new hazards whether in flue nt the curre nt risk control management. If one or more hazards out of the current risk management, we will re-view the curre n