The-report-of-risk-management风险管理评审报告.doc

Technical File_ Risk Management ReportThe report of risk managementPRODUCT:TYPE:Effective date:Page:Document No.:Version:Department:MadeCheckApprovalContents1. Foreword32. Scope33. Application information:33.1 Policy, directive and standard33.2 The information of product43.3 Other source of information43.4 Terms and definitions43.5 Team of risk management:53.6 Instruction of product53.7 Product survey53.8 Class of this product53.9 Instruction of function53.10 Environment of use64. Risk analysis74.1 Risk analysis procedure74.2 Intended use/intended purpose and identification of characteristics related to the safety (annex A of ISO 14971:2007)74.3 Identification of known or foreseeable hazards and Estimation of the risk(s) for each hazard175. Risk evaluation236. Risk control236.1 Risk reduction and implementation of control measure(s)236.2 Risks arising from risk control measures266.3 Completeness of risk evaluation267. Overall residual risk evaluation:268. Information of in production and post production279. Conclusion27Magic stick RISK MANAGEMENT REPORT1. ForewordThis article is the report of the risk management 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 acceptable, 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 Allergy Reliever which including the following parts:1)3. Application information:3.1 Policy, directive and standard1) 93/42/EEC（“MDD”）the Directive of medical device.2) ISO 14971:2000 Medical devices Application of risk management to medical devices3) EN 60601-1:2006, EN60601-1-2:2007； No.Standard CodeStandard name1MDD 93/42/EECEuropean Medical Device Directive 2EN ISO 13485:2012Medical devices - Quality management systems - Requirements for regulatory purposes3EN ISO 14971:2012Medical devices. Application of risk management to medical devices4EN 60601-1:2006/AC:2010Medical electrical equipment - Part 1: General requirements for basic safety and essential performance5EN 60601-1-6:2007/AC:2010General requirements for safety-Collateral standard: Usability6EN 60601-1-11:2010Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment7EN60601-2-57:2011Particular requirements for the basic safety and essential performance of non-laser light8EN62471: 2008Photobiological safety of lamps and lamp systems9EN 60601-1-2:2007/AC:2010General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests10EN ISO 10993-5：2009Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity11EN ISO 10993-10:2010Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization 12EN980/EN ISO15223-1:2008Symbols for use in the labeling of medical devices13EN ISO 15223-1-2012Medical devices. Symbols to be used with medical device labels, labeling and information to be supplied. General requirements14EN1041:2008Information supplied by the manufacturer of medical devices15MEDDEV 2.12-1 v8_GUIDELINES-ON A MEDICAL DEVICES VIGILANCE SYSTEM3.2 The information of productDesign program, Schematic, Standard of product, Machine program, PCB layout, Instruction of product.3.3 Other source of informationCustomer suggestion, Record of accident, Professional documentary, Internet3.4 Terms and definitionsharmphysical injury or damage to the health of people, or damage to property or the environmenthazardpotential source of harmriskcombination of the probability of occurrence of harm and the severity of that harmrisk analysissystematic use of available information to identify hazards and to estimate the riskrisk evaluationprocess of comparing the estimated risk against given risk criteria to determine the acceptability of the riskrisk estimationprocess used to assign values to the probability of occurrence of harm and the severity of that harmrisk assessmentoverall process comprising a risk analysis and a risk evaluationrisk controlprocess in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levelsseveritymeasure of the possible consequences of a hazard3.5 Team of risk management:Name TitleThe duty in the risk managementProject leaderCommander of core team, in charge of this product of LLLT Portable, and estimate the risk in application.Estimate the harm level in medicineEstimate the potential disadvantage in design.Estimate the potential disadvantage in production Estimate the happening rate of hardware in technology3.6 Instruction of productRefer to*instruction (Version:B/01 issued date:2012-11-20)3.7 Product surveyApplied parts: Therapy LED cover and shell are applied parts.Object of risk control: this product adopt a special wavelength LED，it can emit the special light of 660nm and 940nm to permeate skin，the 660nm light is antiphlogistic effect, and the 940nm light is disinfection effect . Intended use and user: Rhinitis patientsUse circle: about 10000 circles(3000 treatments).3.8 Class of this product According to the standard of MDD 93/42/EEC, this product belongs to the class IIa.3.9 Instruction of functionThis device adopts the special, pure and narrow band of low level red light and infrared light (660nm and 940nm), the selected light can get about 1015mm depth into skin and provide inflammation and disinfection of skin,. The LEDs mainly effect (660nm) in nasal inflammation. Finally, this product belongs to the low level physical therapy, it very safety to user.3.10 Environment of use Environment of use: use in room, and please notice the following details：a）use in the temperture of 540 b）humidity：30%80% c）Atmospheric Pressure：800hPa-1060hPa d）power supply：DC 6V(CR 2032*2 Button cell) e) Request to operator: please follow the instruction before use, and make sure the operator and patient have no the color-blind man.Page 28 of 28 4. Risk analysis4.1 Risk analysis procedureRefer to Risk Management Plan (File No.:RMP01,Version No;A/0,Issued:2011/05/13) 4.2 Intended use/intended purpose and identification of characteristics related to the safety (annex A of ISO 14971:2012)NOItemsThe specialty of character4.2.1Purpose and how to usePurpose: this product can only effect in rhinitis patientsRequest of operator and training ：operator can operate it after looking product instruction, neednt a professional training. Use temperature: 540working humidity：30%80%RHStore and transport temperature: -2055Humidity of Storage and transport：less 93%RH4.2.2Whether this product contact with operator and suffer?Yes,4.2.3Do you know the safety of material of product?Yes4.2.4Have any energy need to trans to /or extract from suffer?Yes, a special visible light, invisible infrared light and heat trans to suffer4.2.5.2Have any object need to embedded to/or extract from suffer?No4.2.6Have any biology material be re-use in this product?No4.2.7Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable?No4.2.8Is the medical device intended to be routinely cleaned and disinfected by the user?Yes, if use to more than two people 4.2.9Dose it change the temperature/ atmosphere /pressure/humidity?No4.2.10Dose it be used for measurement?No4.2.11Dose it have the ability to process and analysis?No4.2.12Dose it be used for work with other medicine or machine?No4.2.13Dose it emit the energy or object which un-hoped?No4.2.14Dose it impacted by environment?Is the equipment suitable for working in high humidity environment?No4.2.15Dose it impact the environment?No4.2.16Dose it have the attachment or expendable product？Yes,with 2 CR 2032*2 Button cell for power supply4.2.17Dose it need to maintenance or calibration?No4.2.18Dose it have the software?Yes, it has the 8bit MCU of SONIX to control this device.4.2.19Dose it have the limit of store?Yes, please view the package or instruction.4.2.20Dose it have the effection of delay or long-time use.No4.2.21Dose it burthen any force?No4.2.22What determine the life of product?LED life, the total lifetime is at least 3000 treatments4.2.23Intended for single use?No, reuse 4.2.24Is safe decommissioning or disposal of the medical device necessary?No4.2.25.2Dose it need a professional training before use？No, just follow the instruction.4.2.26Dose it need to work into a new processing?No4.2.27Dose it well use determined by operator.Yes, do it as instruction.4.2.27.1Does the medical device have connecting parts or accessories?No4.2.27.2Does the medical device have a control interface?Yes,key switch for “on/off”4.2.27.3Does the medical device display information?No4.2.27.4Is the medical device controlled by a menu?No4.2.28Is the medical device intended to be mobile or portable?Yes4.2.29Is possible incorrect replacement method of battery, is battery connected in wrong polarity or with short-circuited?Overcharging? Over current and voltage?Yes, according to the specification replace the battery4.2.30Leakage, Battery is low capacity?Yes4.2.31Replacement of fuses, POWER SUPPLY CORDS and other partsnon4.2.32Is possible interruption of any one power-carrying conductorNo,there is a sleep current less than 15 uA after turn off4.2.33Is possible unintended movement of a componentNo 4.2.34Is possible accidental detachment of conductors and connectorsYes Battery door4.2.35Limits of touch current of accessible part exceed specified value?It the probability of a connection to a patient is so low that it is negligible in normal use, and the operator is appropriately instructed?Yes4.2.36Is it possible that the fixing of component and wire will be loss?No 4.2.37Is it possible mechanical damaged of wiring due to contact with moving part and sharp edge?No 4.2.38Is there any hazards associated with surfaces, corners and edgesNo 4.2.39Is there any significant Acoustic energy (including Infrasound and ultrasound)Yes,there is a hint sound less than 50DB as BIBI.BIBI.4.2.40Applied parts intended to supply heat to a patientYes4.2.41Is there any radiation to patientYes, visible light radiation(660nm red light) and invisible light radiation(940nm infrared light)4.2.42Is it possible that incorrect connection of accessible connectors, remove without the use of a toolNo4.2.43Is the equipment impacted electromagnetic phenomenaNoOther characteristicsIntended use and identification of characteristics related to the safety of the medical device from IEC 60601-1Additional Questions for Basic Safety and Essential Performance according to IEC/EN 60601-1:4.3Is there any essential performance, if yes, which function?No4.4How long is the expected service life of the medical device?LED life, the total lifetime is at least 3000 treatments4.5What particular risks addressed by IEC/EN 60601-1 are controlled by means other than these required by the standard? NO4.6What parts (accessories) of the medical device can come into contact with the patient but fall outside of the definition of applied parts (sub-clause 3.8)?NO, Plastic shell and silicon rubber sleeve are intended to contact with patient.4.7What are the single fault-conditions other that these identified in sub-clause 13.2 that are feasible for the medical device? Yes, Short-circuit of batteries terminal.4.8What components of the medical device are used outside their certified (specified) ratings?No4.9What components with high-integrity characteristics (sub-clause 3.17) are used in the medical device? NO5.1What combinations of simultaneous faults in the medical device are feasible?NO5.4 a)What are the least favourable working conditions for the medical device?Yes, Use temperature: 540working humidity：30%80%RH5.7What is the longest period (if longer than 2 days) for which the medical device could be exposed to high humidity?No5.9.2.3What electrical controls of the medical device are provided with handles, knobs, levers, etc.?NA7.2.2Is there manufacturers name or trademark marked on equipment and detachable components? If no, misidentification does not present an unacceptable riskYes. Trademark marked on equipment. No risk analysis need.7.2.5Model of equipment to be connected to equipment to provide power, is marked adjacent to the relevant connection point? If no, This connection can not result in an unacceptable riskNo, not to be connected to other equipment。7.3.3Are lithium batteries or fuel cells incorporated?No，this product dont use lithium batteries or fuel cells。7.4.2Can the setting of a control be changed?NA7.9.1What information for the medical device are provided in electronic format?No7.9.2.4Is battery employed?No.Not mains-operated ME EQUIPMENT with an additional power source7.9.3.2Is there any replaced component, such as fuse, power cordNA8.1 b) 1What parts of the medical device are in separate enclosures connected by power carrying conductor(s)?NA8.1 b) 2What components of the medical device can move unexpectedly during its expected service life?Yes8.1 b) 3What detachable conductors and connector is likely to be breaking free?yes8.3 d)What parts of the medical device, identified as coming in contact with the patient while not being applied parts themselves, are subject to the requirements for BF- or CF-type applied parts?This product belongs to BF type of instrument8.5.2.2What B-type applied parts of the medical device are not protectively earthed and, at the same time, not separated by one MOPP from protectively earthed accessible metal parts, that can make contact with source of voltage or leakage current above the permitted limits? No8.5.2.3What conductive parts on connectors on the patient leads for the medical device, at the end of the lead remote from the patient, are not separated from the all patient connections by one MOPP rated for the maximum mains voltage, and can come in contact with mains sockets, flat surface or other objects? NA8.6.3What moving parts of the medical device are protectively earthed and remain reliably so during the expected service live of the medical device?NA8.8.4.1What type(s) of insulation for the medical device require specific test protocols, other than these required by the IEC/EN 60601-1, for verifying their resistance to heat during the expected service life of the medical device?No,The temperature by normal use is far less than the temperature it can cause the insulate material break.8.10.1If components of the medical device are securely mounted for the expected service lifetime of the medical device?Yes，Battery cover may get loose or lost8.10.2If conductors in the medical device are secured Yes8.10.5What internal cables, wiring and cords are protected against damage to their insulation by contact with moving parts, friction at sharp corners and edges, or during assembly and opening and closing of access covers?Yes, The internal cables, wiring and cords have enough protection ability8.11.5What over-current releases, able to interrupt maximum fault currents, are provided on the supply leads of the medical device?NA9.2.1What moving parts of the medical equipment need to be exposed for the medical equipment to perform its intended function?NA9.2.2.4.4What protective measures against moving parts of the medical device or move of the medical device itself are implemented?NA9.2.2.5 c)What control devices of the medical device require continuous activation by the operator in order to enable its operation?NA9.2.2.6What parts of the medical device are used to position the patient or parts of the medical device itself?NA9.2.3.2What parts of the medical device require stopping means to prevent them from overtravel?No, it may hand closed in the treatment, after treatment it will self-closing9.2.4What emergency stopping device(s) are used with the medical device?No9.2.5What means for releasing of the patient quickly and safely in the event of breakdown of the medical device or failure of the power supply are provided?No9.3What rough surfaces, sharp corners and edges of the medical device are assessable during normal use? NO9.4.2.4.3What specific test protocols, other than these suggested by the IEC/EN 60601-1, are defined for verifying the ability of the medical device to move over a threshold?NO9.5.1What protection against expelled parts is provided?No9.6.1What levels of noise and vibration generated by the medical device require measurement against excessive levels?NO9.6.2.2What parts of the medical device are source of infrasound and ultrasound?NA9.7.2What parts of the medical device are pneumatic or hydraulic?NA9.7.4What parts of the medical device