The extensive and in-depth application of information technology makes the information security issues more complex, how to effectively carry out information security risk analysis, analysis of the organization of the existence of security gaps and timely repair to minimize the organization's security risks, has become an important part of the research in the field of information security. This article is my analysis of security risk for you to organize the sample report, just for reference.
Part I:
Product Name:*** Name on the registration standard***
Risk evaluation of personnel and background:*** Task Force Leader, medical point of view of the doctor, technical point of view of the designers, the application point of view, the market point of view, and to provide proof of the qualifications of the personnel, such as the trained qualifications, titles Grade***
Compilation: Date:
Approval: Date:
1. Basis for Preparation
1.1 Relevant Standards
1*** YY0316-2003 Medical Devices - Risk Management Application to Medical Devices <
2*** GB9706.1-1995 Medical Electrical Devices Part I: General Safety Requirements;
3*** IEC60601-1-4: 1996 Medical Electrical Devices - Part I: General Safety Requirements - Part 2: Parallel Standards: Medical Electrical Devices - Part 3: Parallel Standards: Medical Electrical Devices - Part 4: Parallel Standards: Medical Electrical Devices - Part 4: Parallel Standards: Medical Electrical Devices - Part 1: General Safety Requirements -4: Parallel standards: Programmable electrical systems for medical applications
4*** Product standards and others
1.2 Product information
1*** Instruction manuals
2*** Hospital usage, maintenance records, customer complaints, accident records, etc.
3*** Specialty Articles in the literature and other information
2. Purpose and Scope
This paper is a report on risk management for XXXX, in which all possible hazards and the causes of each hazard are determined. For each hazard, the severity of possible damage and the probability of occurrence of the hazard are estimated. In case of an unacceptable level of risk, control measures were taken to reduce the risk, and the residual risk after the risk measures were evaluated. Finally, the level of all residual risks was brought to an acceptable level.
This report applies to the ...... product, which is in the design and development phase*** or in small batch production***.
3. Product Description
The object of this risk management is ......***It would be best if photos or pictures could be included***, product overview, mechanism, uses Indications:
Contraindications:
The device consists of the following parts:***Textual description or schematic diagram*** < /p>
4. Determination of Intended Use of the Product and Safety-Related Characteristics
**Answer, in order, the questions used in Appendix A to determine the characteristics of a medical device that may affect safety***
4.1 What is the intended use of the product, what is its intended purpose? How will it be used?
Factors to consider: the intended user and their mental, physical, skill level, cultural background and training
Ergonomic issues, the environment in which the medical device is to be used and by whom it is to be installed
Whether the patient will be able to control and influence the use of the medical device
Whether the medical device is to be used for life-supporting or life-supporting
Whether the medical device will be used for life-supporting or life-supporting in the event of a Whether special intervention is required in the event of medical device failure
Whether there are specific problems with the design of the interface that could lead to inadvertent errors in use ***See 4.27***
Which of the following roles does the device play in the diagnosis, prophylaxis, treatment, palliation, or compensation of trauma, anatomical correction, or control of pregnancy
4.2 Whether the medical device is intended to be used in conjunction with patients or other persons, how, and for how long?
Factors to consider: nature of anticipated exposure: surface contact, invasive contact, and *** or **** implantation
duration of each exposure
frequency of each exposure
4.3 What materials and *** or **** components are included in, used with, or come into contact with the medical device?
Factors to consider: are the safety-related properties known
4.4 Is there energy given to or taken from the patient?
Factors to be considered: form of energy delivered and its control, quality, quantity and duration
4.5 Is there a substance given to or taken from the patient?
Factors to be considered: whether the substance is supplied or extracted
Single substance or several substances
Maximum and minimum rates of delivery and their control
4.6 Is the biomaterial processed by the medical device and then reused?
Factors to be considered: mode of handling and type of substance handled*** e.g., automated blood transfusion, dialysis***
4.7 Is the medical device supplied in a sterile form or intended to be sterilized by the user or sterilized by other microbiological control methods?
Factors to consider: Is the medical device expected to be used once or reused
Packaging, storage life of the medical device
Limitations on the number of reuse cycles
Limitations on the type of sterilization process used
4.8 Is the medical device expected to be routinely cleaned and sterilized by the user?
Factors to consider: type of cleaning or disinfecting agent used
Limitations on the number of sterilization cycles
The design of the medical device may affect the effectiveness of routine cleaning and disinfection
4.9 Is the medical device expected to improve the patient's environment?
Factors to consider: temperature, humidity, atmospheric composition, pressure, and light
4.10 Does the medical device take measurements?
Factors to consider: variability of measurements
Accuracy and precision of measurements*** CMC marking required for those with measurement capabilities***
4.11 Are medical devices analyzed?
Factors to be considered: does the medical device show conclusions from the input or information obtained*** Primarily soft***
Calculation methods used and confidence limits
4.12 Is the medical device expected to be used in conjunction with pharmaceuticals or other medical technologies?
Considerations to be taken into account: identification of potential use of pharmaceutical or other medical technologies and potential problems associated with interactions Patient compliance with treatment
4.13 Is there an undesired energy or substance output?
Energy-related factors to consider: noise and vibration, heat
Radiation*** including ionizing, non-ionizing, and ultraviolet, visible, and infrared*** contact temperatures
Leakage currents and electric and*** or*** magnetic fields
Material-related factors to consider: discharges of chemicals, wastes, and bodily fluids
4.14 Are medical devices environmentally sensitive?
Factors to consider: operating, transportation, and storage environments*** including light, temperature, vibration, leakage, sensitivity to changes in energy sources and forms of refrigeration, electromagnetic interference***
4.15 Does the medical device affect the environment?
Factors to be considered: impact on energy and cooling, emission of toxic substances and generation of electromagnetic interference
4.16 Does the medical device have basic consumables or fujian?
Factors to be considered: specification of consumables or accessories and restrictions on their selection by the user
4.17 Is maintenance and calibration required?
Factors to be considered: whether maintenance and *** or *** calibration are realized by the operator or the user or by specialized personnel Whether specialized substances or devices are needed for proper maintenance and *** or *** calibration
4.18 Does the medical device have a soft body?
Factors to consider: Is the softwares expected to be installed, validated, modified or replaced by the user and the *** or *** operator
4.19 Does the medical device have a storage life limit?
Factors to be considered: labeling or indication and disposition of such medical devices
4.20 Are there delayed and ***or*** long-term use effects?
Factors to consider: ergonomics and cumulative effects
4.21 What kind of mechanical force is the medical device subjected to?
Factors to consider: Are the forces on the medical device under the control of the user or controlled by interactions with other people
4.22 What determines the lifespan of a medical device?
Factors to consider: aging and battery depletion
4.23 Is a medical device expected to be single-use?
4.24 Does the medical device require safe decommissioning or disposal?
Factors to consider: scrap from disposal of the medical device itself. ***For example, does the medical device contain toxic or hazardous materials, or materials that can be recycled for use***
4.25 Does the installation or use of the medical device require specialized training?
Factors to be considered: including trial implementation and delivery to the end user
Is it likely or possible that the device will be installed by personnel who do not have the necessary skills
4.26 Is it necessary to establish or introduce a new manufacturing process?
The introduction of a new manufacturing process into a production installation must be considered as a potential source of new hazards*** e.g. new technology, new scale of production***
4.27 Does the successful use of a medical device depend decisively on human factors, e.g. user interface? Factors to consider: User interface design features that can cause errors in use and cannot be easily misused
4.27.1 Does the medical device have a connecting part or accessory?
Factors to consider: potential for miswiring, differentiation, similarity to other product wiring, wiring force, feedback on wiring integrity, and overly tight and loose wiring
4.27.2 Does the medical device have a control interface?
Factors to consider: spacing, coding, grouping, graphical displays, feedback modes, errors, slippage, control differentiation, visibility, direction of initiation or changeover, whether the control is continuous or intermittent, and reversibility of binding or movement
4.27.3 Does the medical device display information?
Factors to consider: visibility in different environments, orientation, overall and perspective view, clarity of displayed information, units, color coding, accessibility of deterministic information
4.27.4 Is the medical device controlled by a menu?
Factors to consider: complexity and number of levels, knowledge of status, set paths, method of orientation, number of steps per action, clarity of sequence, storage issues, importance of control functions related to accessibility
4.28 Is the medical device expected to be mobile or action-oriented?
Factors to be considered: necessary clamping, handles, wheels, brakes, mechanical stability and durability
5. Hazard Determination
***Answer according to Appendix D to include at least five aspects, including energetic, biological, environmental, use, and maintenance, with an emphasis on analyzing the hazards and their causes, and may also be enumerated in accordance with the characteristics of the product itself, but requires that Classification of hazards against 3. the intended use of the product and the determination of safety-related features of the problem; first use professional knowledge to intuitively find the potential causes, and further analysis of the causes can be applied FMEA *** Failure Mode and Effects Analysis ***, FTA *** Fault Tree Analysis *** method. ***
6. Risk Evaluation
6.1 Evaluation Guidelines*** Same as in the Risk Management Plan***
6.1.3 Guidelines for Risk Acceptability
Risk = Severity Level × Probability Level
6.2 Risk Evaluation Chart
7. Risk Control
Through the above evaluations it can be seen that The acceptable level of risk of the product, no further control measures need to be taken for risks in the widely acceptable zone ......***Serial number of the enumerated hazards***, and further measures must be taken for control of risks in the reasonably practicable and inadmissible zones.
8. Residual Risk Evaluation
After taking risk reduction measures, the risk of hazards such as ...... has been reduced to a broadly acceptable level and the risk of hazards such as ...... has been reduced to a reasonably acceptable level. ***Also state whether any new risks have been introduced as a result of the risk reduction measures, and if so, reevaluation and control must be performed***
If there are greater risks that are not reducible, information and literature on the medical benefits of the intended use, and the intended purpose, must be collected and reviewed in order to determine whether the benefits outweigh the full residual risk Table 3 Risk levels after control measures are taken
9. Post-production information
Since this product has not yet been precisely produced, it will be analyzed, evaluated, and controlled once it is formally produced ......
10. Conclusion
After analyzing and evaluating the hazards, the risks arising from the hazards are acceptable, and therefore the product is safe.
Part II:
Serum Alkaline Phosphatase Assay Kit*** ALP*** Safety Risk Analysis Report
1. General Provisions
Serum Alkaline Phosphatase Assay Kit*** hereinafter referred to as the ALP Test Kit*** is a clinical test of in vitro diagnostic reagents in the chemical reagents of the enzyme reagents. Because the test is not performed inside or on the surface of the human body, it does not pose an immediate risk to the patient or person being tested. However, in some cases, indirect risks may be posed by the hazards associated with in vitro diagnostic reagents that result in or contribute to erroneous decisions. In addition, use-related hazards and their concomitant risks should also be given consideration. This safety risk analysis report is mainly based on Appendix A, "Characterization Issues Used to Determine the Possible Safety Impacts of Medical Devices" and Appendix B, "Guidelines for Risk Analysis of In Vitro Diagnostic Medical Devices" in the requirements of YY/T0316-2000, "Medical Devices I Risk Management I Part I Application of Risk Analysis", as well as GB7826-87, "Systematic and Reliable Analysis Techniques for Failure Mode and Effect Analysis*** FMEA*** Program" for a comprehensive safety risk analysis.
2. Qualitative and quantitative determination of medical devices
2.1 Intended use and purpose
ALP test kit is a kind of in vitro diagnostic reagent, according to the principle of biological enzyme reaction and photochemical reaction, through the measurement of absorbance change per unit time, to realize the determination of ALP in the sample. The intended use of the ALP test kit is for the diagnosis of hepatobiliary and skeletal disorders.
2.2 Product contact with patients or other personnel
The ALP test kit is an in vitro diagnostic reagent, and has no contact with patients, and generally does not come into contact with the operator panel.
2.3 Safety of product manufacturing materials
ALP test kit, manufacturing raw materials are AR-grade chemical analysis of pure, the chemical substances used in the kit are the current clinical biochemical reagents, NaN3 has a certain degree of toxicity but the content is very small, the rest of the material is non-toxic, so in the use of the kit should be avoided as much as possible to contact with the panel and so on. Waste bottles, waste liquid disposal should be in line with environmental requirements.
2.4 Whether there is energy applied to the patient or obtained from the patient
No energy applied to the patient or obtained from the patient.
2.5 Is there a substance provided to or obtained from the patient
The ALP assay kit does not come into contact with the patient, but indirectly, blood is drawn from the patient by medical personnel.
2.6 Whether kits are processed by instruments for reuse
Pipette extractions from ALP test kits are single-use and are not processed for reuse.
2.7 Whether the product is supplied in sterile form or prepared for use by the user after sterilization
The product is analytically pure for medical chemical reagents, prepared, tested and packaged in a class 100,000 clean room, and does not require sterilization by the user for use after processing.
2.8 Whether to improve the patient's environment
Not applicable
2.9 Whether to have the function of measurement
ALP test kits with the help of the instrument to measure the ALP content of human serum, the reagent itself does not have the function of measurement.
2.10 Whether processed for analysis
Not applicable
2.11 Whether used in conjunction with pharmaceuticals or other medical technologies
Must be used on a biochemistry analyzer with a certain absorbance accuracy
2.12 Whether there is an output of unwanted energy and material
Not applicable
2.13 Whether environmentally sensitive
The ALP Test Kit measures the ALP level of human serum by means of an instrument. 2.13 Environmental sensitivity
The ALP test kit requires protection from light, low temperature, and dryness for transportation and storage, and no special requirements for handling.
2.14 Consumables
ALP test kits generally do not require the use of consumables, but if necessary, the appropriate amount of distilled water for calibration or dilution.
2.15 Maintenance and calibration
Not applicable
2.16 Whether the device has a soft body
Not applicable
2.17 Storage life
ALP test kits require a storage environment in line with the provisions of the technical standards, the storage period of six months, by the kit special packaging listed in the date of production and the storage period.
2.18 Delayed/long-term use effect
ALP test kits can not be delayed due to chemical instability during use.
2.19 Mechanical forces applied
Not applicable
2.20 Factors determining the life of the product
Regulated, correct use and conditions of transportation and storage are essential to ensure that the product reaches its designed life.
2.21 Intended use
Pipette extraction for ALP testing is single-use.
2.22 Hazards affecting the environment
The product is created in a class 100,000 workshop, through the preparation, mixing, testing, packaging, there is no volatile gas exclusion, the product is used together with the blood samples in accordance with the unified destruction of medical waste.
2.23 Whether the user requires special training
Users do not need special training, but must meet the qualifications of the hospital biochemical testing personnel, under the guidance of professionals or read the instruction manual in detail can be operated.
2.24 batch inhomogeneity and inconsistency
Batch inhomogeneity and inconsistency directly affects the test results, resulting in the risk of disease misdiagnosis, it must be controlled within the batch precision, batch-to-batch precision and accuracy and other relevant indicators.
2.25 ***Same Interference Factors
In addition to the biochemical analyzer should be surrounded by no strong electromagnetic field interference, ALP test kits in the use of the process of R1 and R2 and the sample volume volume ratio, temperature and reaction time on the success or failure of the test results have a direct impact.
2.26 Labeling errors
Improper labeling, directly affecting the transportation and storage of the product and the authenticity of the test results, labeling, including single bottle labeling and box labeling and transportation and storage labeling, such as double reagent R1, R2 labeling errors, the misuse of the R1 for the R2, resulting in test failures, the expiration date of the labeling is unclear, the misuse of expired products caused by the distortion of the test results, light protection, low temperature storage labeling is unclear resulting in the product's success or failure. Low-temperature storage labeling is not clear, resulting in product deterioration and so on.
2.27 Inappropriate instructions
Inappropriate instructions can not guide the operation of such as R1, R2 ratio, the amount of sample, temperature, time *** incubation time, reaction time, measurement time *** validity of the use of time after the first bottle, the operation of prohibited contact with the panel, etc. Requirements should be in line with the relevant provisions, otherwise it will lead to detection errors or harm to the environment.
2.28 Energy hazards
Not applicable
2.29 Biological hazards
Not applicable
3. Risk estimation and prevention
3.1 Risks of the intended use and purpose
The ALP test kit is to determine the level of ALP in serum. for clinical determination of hepatobiliary and skeletal system disorders. Strict control of intra-batch precision, inter-batch precision, accuracy and stability is carried out in each batch of products. The products have been tested by the Department of Laboratory Medicine of the Second Xiangya Hospital of Central South University and the Department of Laboratory Medicine of Hunan Tumor Hospital in the clinic with 80 cases of clinical comparative tests using imported and domestic reagents of the same type, which meets the requirements for the test and the provisions of the registered product, so that the risk of using the accuracy and reliability has been reduced to an acceptable limit.
3.2 Risk of contact with patients or others
Testing personnel operate in accordance with the relevant operating procedures of the laboratory, the reagent will not come into contact with the operator's panels, mucous membranes, in the product instruction manual precautions have been clearly prompted, in case of contact with the panels, mucous membranes, immediately rinse with tap water, there is no risk of injury to the operator.
3.3 Risk of material safety
The chemicals used in the reagents are all domestic clinical biochemical reagents, although they contain NaN3 with a certain degree of toxicity, but the content is very small, and at the same time, they are not corrosive to the panel, and in the product specification, after the use of waste liquids and waste bottles required to unify the treatment of waste according to the medical waste, to prevent the hazards caused by, we believe that the risk of material safety has been reduced to an acceptable limit. has been reduced to an acceptable limit.
3.4 Risk of exerting or obtaining energy from the patient
Not applicable
3.5 Risk of obtaining substances from the patient
Patient blood tests are performed by professionals who take blood samples with disposable sterile syringes and then send them to be examined, so there is no risk of obtaining substances from the patient in the process of reuse of the ALP test kit.
3.6 Risk of reuse after instrumentation
The single bottle of the product is a liquid packaging bottle for multiple consumptive uses, and the reagent extracted by each pipette is for single use, so there is no risk of reuse after instrumentation*** sterilization***.
3.7 Risk of Sterility Use
ALP kits are clinical chemistry reagents and there is no risk of sterility use.
3.8 Risks of improving the patient environment
3.9 Risks of measurement
Not applicable
3.10 Risks of analytical processing
Not applicable
3.11 Risks of using in combination with pharmaceuticals or other medical devices
There is the effect of the absorbance accuracy of the biochemical analyzers, the accuracy of the thermostat, on the results of the test. As long as the instrument according to the test room routine maintenance, maintenance, to ensure the accuracy and function of the instrument, the inspector is a qualified professional test medical personnel, so the risk can be minimized.
3.12 Energy and material output risk
Not applicable
3.13 Risk of environmental sensitivity
The product requires a low temperature of 2 ℃ ~ 8 ℃ to prevent deterioration of the product stored in a low light to prevent deterioration in the product instruction manual for the use and storage, the risk of environmental sensitivity has been minimized.
3.14 Supporting the use of consumption risk
Not applicable, if necessary, a small amount of distilled water, distilled water quality should be in line with the biochemical laboratory distilled water requirements, there is no risk of water quality.
3.15 Maintenance and calibration risk
Not applicable
3.16 Soft risk
Not applicable
3.17 Storage Life Risk
In the product standard, product packaging logo and product instructions for use, the storage life of six months, the stability of the test sampling expiration of the product in one month, the performance Meet the requirements of the standard indicators, so the risk of storage life has been minimized.
3.18 Prolonged or long-term use of the effect of risk
Product standards and instructions stipulate that the use of expired products is strictly prohibited, so there is no extended use of the effect of risk.
3.19 Risk of mechanical force
3.20 Risk of determining the life of the product
Chemical reagents require protection from strong sunlight, and product deterioration affects the life of the product. Avoiding storage at high or low temperatures and preventing icing from destroying the molecular structure of the reagent are clearly defined in the product standards, instruction manuals and package markings. Therefore the factors that determine the product life have been minimized.
3.21 Risks of Intended Use
The product's single-package vial is a liquid, multiple-consumption package, and the reagents extracted by the pipette are for one-time use, and the blood specimens mixed with it must be disposed of and destroyed after use, so the risk of intended use is basically impossible.
3.22 Risk of environmental impact
Products in the production and transportation, storage, use of the whole process, will not cause harm to the environment, after use according to the relevant provisions of the hospital laboratory, according to the unified disinfection of medical waste, so the risk of environmental impact has been reduced to the minimum acceptable
3.23 Risks of professional training of personnel
Personnel engaged in hospital biochemical testing are all qualified in the field of biochemical testing. Biochemical testing personnel are professionals with certain knowledge and skills, the product has minimized the risk of professional training of personnel.
3.24 Risk of batch unevenness and inconsistency
In the product standard strict control of the reagent PH, CV *** intra-batch ****, CV *** inter-batch ****, accuracy, etc., and as a mandatory inspection of the factory project, so the risk of unevenness and inconsistency of the batch has been minimized.
3.25 *** same interference risk
Hospital biochemical testing room itself built in the outside interference source is very small, to ensure that the instrument's ability to prevent interference, the instrument has the temperature, time control accuracy, as long as the operator in accordance with the requirements of the instruction manual and the Ministry of Health developed the "National Clinical Laboratory Operating Procedures" for the operation, the risk of *** the same interference has been reduced to a minimum.
3.26 Marking error risk
In the product standard, the product marking, including single-package bottle marking, box *** in the packaging *** marking box transportation and storage marking made detailed provisions, and single-package bottle marking, box marking as a mandatory pre-factory inspection of the special case, a variety of marking to set the content of the provincial standardization of medical devices technical committee expert review, to modify and The risk of marking errors has been minimized.
3.27 Risk of inappropriate instructions
The content of product instructions is specified in the product standard, and is assessed as a mandatory inspection of the product before leaving the factory, and the format, content and safety precautions of the product instruction manuals have been evaluated, modified and improved by experts, so the risk of inaccurate product instructions has been minimized.
3.28 Energy risk
Not Applicable
3.29 Biological risk
Not Applicable
4 Through the above hazard determination, risk estimation, and prevention and resolution of the whole process of the test kit from the production of raw materials, configuration, testing, marking, packaging, transportation, storage, methods of use and safety precautions, storage, and post-use treatment. From the registered product standards and instruction manuals and enterprise regulations on product quality of the whole process of control and risk prevention measures, it can be seen that the company's production of reagent kit products to minimize the risk of safety coefficients to meet the user can accept the water to ensure that the product is safe and effective.
Part III:
Risk analysis report on safety production
1 xx overall situation of the work of safety production risk control
Requirements:
***1*** Introduction of the company and the unit of the annual task of risk control measures to complete the situation. situation, and the reasons for non-completion.
***2***Summarize and refine the effectiveness and deficiencies of the unit's risk control work in the five major categories of safety production, especially the control model formed in the risk control work of the power grid, device, and personal ****operation***.
2 xx year safety production risk control work and effectiveness
2.1 Strengthen the grid implementation of risk control, to ensure system safety and stability
2.2 Implementation of device risk control, to ensure the safe and reliable implementation of important devices
2.3 Strengthening of personal risk control, and actively prevent the risk of personal fatal accidents
2.4 Implementation of the
2.4 Implement social impact risk pre-control measures to maintain the company's good image
2.5 Implement environmental and occupational health control measures to ensure the physical and mental health of employees
2.6 Strengthening emergency management to improve the ability to protect power against disasters
3 xx production safety risk analysis
3.1 Grid safety risk
3.2 Device safety risk
3.3 Personal safety risk3.4 Social impact risk
3.5 Environmental and occupational health risk
4 Suggested measures for controlling production safety risks in xx
Related Requirements:
***1***Risk prevention and control measures should be operable as far as possible, listing the specific implementation plans, specifying the responsible units and departments, supervisory and inspection units and departments, and the relevant measures. departments, supervision and inspection units and departments, and completion time.
***2***Risk prevention and control measures should be prepared according to the assessed risks one by one.
4.1 Risk control measures for power grid safety
4.2 Risk control measures for installation safety
4.3 Risk control measures for personal safety
4.4 Risk control measures for social impacts
4.5 Risk control measures for the environment and occupational health
4.5 Risk control measures for the environment and occupational health