This standard specifies a procedure by which manufacturers can determine the hazards associated with medical devices and their accessories (including in vitro diagnostic medical devices), estimate and evaluate risks, control these risks, and monitor the effectiveness of controls. The requirements of this standard apply to all stages of the life cycle of medical devices. This standard is not intended for clinical judgments related to the use of medical devices. It does not specify acceptable risk levels. This standard does not require manufacturers to have an appropriate formal quality system. However, risk management can be an integral part of the quality system (for example: see Table G.1 in Appendix G). YY/T 0316-2003 Application of Medical Device Risk Management to Medical Devices YY/T0316-2003 Standard download decompression password: www.bzxz.net

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Pharmaceutical Industry Standard of the People's Republic of China
YY/T0316—2003/1S014971:2000YY31820G
Medical devices
Application of risk management to medical devices
Medlcal derlcesApplication of risk management to medical devices1S014971:2000, IDI)
20030620 issued
State Food and Drug Administration
2004-01-01 implementation
This standard is equivalent to 15014971:2000 Medical devices YY/TC316-2003/ISO14971:2000 Application of risk management to medical devices (English version on March 3). YYTJ316-300 cancels and replaces YY(8-2C02. All standards will be revised and published. The documents with the date indicated in the vehicle standard are applicable. The documents with the date indicated at the end of the standard are applicable. The latest cost (opening and any modification) is applicable. The requirements for the risk analysis part of the risk management process have been formulated as the industry standard YY/TJ316-2CUS. The extension of this standard only partially improves the requirements for risk detailed price, risk reduction and post-production information quotation. This standard covers the whole project requirements and increases the content and operability. Appendix 4 of the standard, Appendix R. Appendix, Appendix Appendix E, Appendix F and the attached are informative appendices, which are standard documents. The standard is issued by the Food and Drug Administration. The standard is issued by the following technical committees: Shenzhen Medical Device Quality Management and General Standardization Technical Committee, Beijing Huaguang Certification Co., Ltd. (formerly China Medical Device Quality Certification Center). The main authors of this standard are: Jun Bi, Xing Shuche, Zhang Minggong, Wang Huifang, and Cha Zhigang. The release status of the recommended standard version of this standard is: YY: T331-2000. TY/T 0316-2003/1S0 14971:200C Introduction
This standard aims to provide a framework for the effective management of risks associated with the use of medical devices. It includes requirements that provide a systematic framework for the use of these risks, knowledge and experience in risk management, through the activities of the manufacturer, the personnel and the organization concerned. Risk management is a complex problem that may expose one or more beneficiaries to the risk of loss or damage to a valuable product. For each beneficiary, there is a different estimate of the probability of a loss occurring, the likelihood of the loss occurring, and the likelihood of the loss occurring. Risk management is a complex problem.
It is generally accepted that risk factors have two components: the probability of a loss occurring, the likelihood of the loss occurring, and the severity of the loss. The acceptability of a risk to the beneficiary is influenced by the perceived risk of the components and the beneficiary. Due to the diversity of risk factors, including These concepts are particularly important for physicians, providers, governments, the industry, and the general public, and all beneficiaries of medical devices. All beneficiaries must understand that the use of medical devices inevitably carries a certain degree of risk, and that factors that affect beneficiaries' awareness of risk include social, economic, and educational factors, so as to understand the actual and perceived health status of beneficiaries. The awareness of risks should also be addressed, such as whether people are at risk unknowingly due to lack of understanding, or if a strong group of people seem to be at risk unknowingly, and whether the decision to use a medical device in a clinical procedure or seek to balance the risks with the benefits of the procedure should be based on the intended use or intended use of the device, performance, and risks associated with the clinical procedure or use environment. This should take into account the risks associated with the medical device and the intended or intended use, performance, and risks associated with the clinical procedure or use environment. Only a qualified consultant who understands the individual's health conditions and personal safety can make such a judgment. The manufacturer, under the overall consideration of the accepted technical requirements, makes a judgment on the safety of the medical device, including the acceptability of the risks, in order to decide whether to use the device in accordance with its related use or the date of its launch. This standard sets out a process for the preparation of medical device products and their hazards, estimate and evaluate the risks associated with the device, and monitor the effectiveness of the control measures for specific medical cases. Other standards The standard may require the application of a risk management method for medical devices. 1 Scope || TT || YY/T0316-2003/1N) 14971:2000 Medical device risk management for medical devices This standard specifies a process for the management of medical devices and their accessories (including diagnostic and therapeutic devices), to assess the risks associated with the medical devices and their accessories (including diagnostic and therapeutic devices), to assess the risks, to manage these risks and to monitor the effectiveness of the controls. The requirements of the standard apply to all stages of the medical device review process: The standard does not cover issues related to the warranty of medical devices. The main requirements are based on the risk level. Requirements must be in place for a formal quality system, although risk management can be achieved through the quality system: a group of organizations to implement the system (for example: the state of the center of the table. 1). 2 Terms and definitions
The following terms and definitions apply to this standard.
Accompanying document
Accompanying document
Accompanying medical devices or accessories, containing important information to provide medical devices to the user, the operator, the installer or the assembler (especially the price of the equipment after the change of the equipment): 5P9/05.149 definition 2.1 is benzene, 2.2 || tt||hazard
actual harm to human health, production or property: [JS/book 5.1SS9, definition 3.-]
hazard
harm requires a proven source.
[S0/IE\guide 51,1999. definition 3.
hazardous situation
personnel, production or property: an environment in which one or more hazards exist. [ISOIE guide,!, definition 3,]
intended ase/intended μurpnse Intended use or intended purpose
Specifications, instructions and information provided by the manufacturer. Use of the product, process or service 2.6
Manufacturer
The natural or legal person who designs, manufactures, labels, assembles or packages a medical device before it is marketed and/or invested in a business, regardless of whether the work is done by the manufacturer or by a third party. 2.7
medicaldevice
Medical devices
The following are intended for human use: alone, in combination, or for use with drugs, media, materials or other substances: 1
YY/T C315—2003/1SO14971:20Q0 The system needs the following: it is used on the human body surface and inside the body, and it is used to obtain the immunity of the patient. We can also participate in the whole production stage and play a certain auxiliary function: the diagnosis, treatment, monitoring and relief of the disease; the diagnosis, pre-treatment, monitoring, meal solution, compensation for the report or the number of plays: the solution or the single decision, less adjustment!
Pregnancy is light,
151348:1996.Definition 3.1
Objective evidence is based on the results of research, testing or other means to prove that the information is true G/T538-1004, meaning 2.:3:
Procedure
The process of conducting an activity is the process of controlling the results of an activity, G68519 definition 1.
Process press
The process of converting an object into a set of related resources and activities. [GE6365164.X.
Record record
Time! The completed activity or road plan maintenance fee is provided by the national recognized document GR/T635-194. Definition 3,15_
residual risk
residual risk
the system remaining after deep protection,
1SOE refers to the combination of the risk of occurrence of harm and the verticality of the production of the registered bitter product [SO:TEG 1:1SSS,3.
Risk analysis riskanalysis
Systematic use of available data to determine hazards and estimate risks. II [50/IX ISO:1941, 3.10
Risk assessment riskassessment
Includes risk factors and risk evaluation 150:1E Guide 1.1S99, Definitions 1.19
Risk control measures
The process of making decisions and implementing control measures to reduce risk or maintain risk at an initially determined level 2.17
Risk assessment riskevatualization
YY/T0316—2003/IS014971, 2000 Based on risk analysis, the judgment on whether the risk has reached an acceptable level based on given current social values. Based on TSU/IC Guide 51:11a, definitions 3-1 and 3, 2.18
Risk managementrlskmanagement
Systematic application of management policies, procedures and their implementation for risk management analysis, evaluation and risk management. 2.19
Risk managementFileTiskmanagementFileRisk management processProduction of risks, especially those related to the system and other practices2. 20
Safety:
Avoid unacceptable risks,
150 Guide 5]:190Definition
Severity
The degree to which a hazard may be present. Verificationverilieutiul
Verification verification and provision of objective evidence that specified requirements have been met. Nature: The planning and management of the facility is to control the short-term impact of the single-item activity in order to determine the price of the activity in accordance with the assumptions made in the price determination. [GB/6585-334, definition 2.7
3 Applicable requirements for risk management
3.1 National or regional regulatory requirements
Due to the wide range of differences in the national and local regulatory requirements of this standard, the above-mentioned medical facilities should be covered by 3.3 and .4 mid-term requirements. When applying 3.2 Risk management process
, the risks related to medical facilities should be judged and evaluated, and the relevant risks should be estimated and evaluated, and the effectiveness of the risk control system should be monitored. This document should include the following elements: 1. Risk analysis:
Risk assessment;
Risk control
Post-production information;
When there is a document for product planning, during the development process: The process includes the risk management process. 1: The product planning process can be used to systematically deal with safety issues, especially when the system and plan are able to detect incidents.
2. The risk management is light!
3. See the document,
Use the risk management document to check the content. 3
YY/T0316-2003/1S014971:2C00
3. 3 Management responsibilities
Manufacturer should:
Stage of use, judgment
A insurance can be reported t: Decision
Risk pull
To the long-term concern
All risks will be withdrawn
Cattle production experience
Feng Long Pu management process diagram
: Under the relevant national teacher training standards, family department increase area responsibilities, regulations market release risk decision method b to ensure the supply of appropriate funds!
) Confirm the accounts and assign trained personnel to implement the planned activities (see 3., d): Regularly check the results of the risk management process to ensure the suitability of the risk management knowledge and effectiveness. The above documents should be checked at the same time as the risk management personnel. At this point, the insurance supervision should ensure that the compliance of the insurance sales is: 3.4 Personnel qualifications
The person in charge of the work should make sure that only the personnel who are responsible for the work and have the necessary knowledge and capabilities for their tasks. 3.5 Risk Management Plan
For each medical device and accessory under consideration, a risk management plan should be prepared. The risk management plan is part of the risk management agreement. This plan includes the following: 1) Inspection plan:
c) Allocation of responsibilities,
) Requirements for evaluation of risk management activities
e) Risk acceptability criteria
YY/T0316--2003/[S014971;2000 Note: The risk assessment will determine the effectiveness of the risk management process. The attached guidelines are included in the medical life cycle plan. The requirements for changes should be kept in the risk management document. Use the risk plan document as the location for compliance inspection. 3.6 Risk management documents
All information on risk management activities for the medical device under consideration should be recorded. In the insurance purchase document,
there should be 1: a record of the risk management documents that constitute the core of the risk management process, 2: a document that includes the risk management plan and all other documents and the required documents, and at least include: all documents issued or issued in order to verify or promptly mention the scientific information in the risk plan. 4 Risk Analysis Figure 2 Steps 1.2, 3
4.1 Risk Analysis Procedure
Perform the standard risk analysis described in 4.2 to 4.4, and record the implementation and results of the risk analysis in the risk management document. If the risk analysis can be implemented in a typical case and the risk reduction rate is similar to that of the treatment, the type of cost can be used as the basis for the selection of the method and its response to different emergencies. In addition to the product records required by 4.3.1., the documentation for the implementation and conclusion of the risk analysis should at least include the following: a) Description and information of the medical device or accessory analyzed; b) Identification of the person and department that completed the risk analysis; c) Duration of the analysis.
If the risk analysis file is not available for verification of compliance: 4.2 Determination of the intended use, intended purpose, and safety-related characteristics of the medical device (step 1 in Figure 2) For the medical device in question, the manufacturer should also describe its speed of use, the expected number of days, and any foreseeable failure within the manufacturing process that could affect the safety of the medical device. The qualitative and quantitative list of the properties is listed, and when appropriate, the current limit is set (see Note 1). The above notes should be kept in the risk management document. Note: Attached to the new list of A cattle in the river. As the above book note 2, the risk of in vitro purgative therapy device is recorded in the risk classification method and the index. Note 3, the risk reduction record is recorded in the first word of each risk public female law attached rate if the limit is used! The legal inspection of the document is in compliance. YY/1:0316-2003/1S014971.2000 Wind area
I Sichuan 2 material ratio characteristics (4.2)
Judgment is sufficient to become the flow of harm 1.3
Estimate the loss of each type of harm (4. 2)
Information through "A control step
Suffering with obstacles:
Real children over the acceptance of the appropriate index free 0)
Benefits of the wind should be able to set up? (5.4
beautify the opening of his model of low-cost production. The
to the fixed fee? (6.T
all types of public hospitals are available
can be born)
risk report (
E-information planning market (US 9)
for medical light wall risk management activities of light medical diagram 2
4.3 determine the known or foreseeable intention treasure (the first step? 1YY/T0316-2003/150149 71.2000 The manufacturer shall write a list of other hazards related to the medical city, and the products shall be distinguished in advance, and the foreseeable consequences of the medical products in the dangerous situation shall be considered and recorded in the literature of the benefits and risks in order to ensure that the foreseeable consequences of the medical products in the dangerous situation shall be considered and recorded in the literature of the benefits and risks in the literature of the benefits and risks in order to ensure that the foreseeable consequences of the medical products in the dangerous situation in the literature shall be considered and recorded in the literature of the benefits and risks ...4 Estimate one or more risks for each hazard (step 3) For each identified hazard, one or more risks should be estimated using available resources or data in both normal and faulty network components. For hazards that cannot be ignored, a list of the hazard's potential consequences should be prepared. The risk estimates should be recorded in the risk management document as part of the risk management document using frequency estimates or qualitative or quantitative classification of severity. 1, risk package and analysis, only when the risk is reported can the risk be estimated, and the situation will not be disturbed.
Note? , the risk estimation can be a point of view or qualitative, the risk of failure caused by the risk of the film system is recorded on the H chapter of the in vitro diagnostic medical risk assessment, note 3, attached "let some months of risk analysis of the Institute of || tt || note: the idea of ​​risk estimation or effectiveness to charge special IT: has been the standard: || tt || and science and technology: || tt || has been approved or! The low-cost treatment does not require the reverse flow data package according to the three published academic requirements according to the report 1; by the Austrian period of use of the appropriateness of the Sichuan experiment: city pregnancy evidence || tt||First, appropriate adjustment,
Experts and people
-External help mother evaluation emergency situation,
Use gold network insurance general management document savings operation aggregation check and control: 5 risk price verification step 4)
For each defined complete harm system, select the criteria specified in the month insurance management. Personally determine whether one or more risks of the ancient plan can be reduced. In the case of Zhong Qing, 6.2 to 6 out of the request is not small, that is, 3.7), the comprehensive result of the risk half price is determined into the risk effect reasonable document, plan 1: E .?
Products with sustainable risk: related products can be a standard and can become risk-free, compared to the requirements of 3,
products with no risk planning and control methods are in line with the production 6 risk outlook and control steps 5 to 10!
6.1 Reduce risks
When you want to reduce risks, check the system according to the business age: the rules are effective and the order is not controlled, so as to save a lot of risks and judge the risks of the store. 6.2 Plan Analysis (Step 5)
System selection is separated from virtual identification Risk control measures should be taken to reduce the risk to an acceptable level: Risk control should be carried out in a way that does not involve a single risk factor. The two disks should be manufactured in the order specified, and the compensation should be achieved in a variety of ways: a) By using the inherent safety of the table:
Y/T0316--2003/15014971:2030
) Medical device cost reduction measures during the production process: ) Inform safety information.
Note that the area of ​​energy control technology can be increased in the reported severity, or the occurrence rate of the old or small, or stimulate the small note 2: Some technical standards have been described for many medical devices or pressure relief devices, and the safety of the products should be guaranteed. The above should be used as a risk management area. If the risk control measures selected are wrong during the risk reduction plan analysis, the manufacturer should remember the effectiveness of the risk control measures. If the manufacturer determines that it is a practical way to further reduce the risk, the manufacturer should conduct a risk/benefit analysis of the residual risk (see 6.5). Otherwise, the manufacturer should use the risk management method to check whether the risk control measures selected are suitable for the world. 6.3 Risk Implementation of control measures 1 Step 6: Manufacturers should implement the risk control measures selected in 6.2. The implementation of the risk control measures should be verified by the risk management documentation. The effectiveness of the risk control measures should be verified and the verification results should be recorded in the risk management document. The implementation of the risk control measures has been verified. This verification should also be verified by the risk management document. Check the compliance by checking the risk control document: 6.4 Residual risk assessment (step 1)
After the risk control measures are implemented, any risk that may occur should be verified by the risk management document. The risk management plan should be evaluated based on the risk management plan. If the residual risk does not meet the requirements of the standard, the reverse step should be adopted (6.2). If the residual risk is not considered acceptable, all relevant information required to explain one or more residual risks should be provided by the person in charge. The relevant documents should be checked for consistency: 6.5 Risk-Benefit Analysis (Step 1) If the risk management plan is used, the risk management document should be checked for consistency. The manufacturer shall collect and review relevant information and literature on the expected benefits of the product in order to quickly determine the residual risk. If the manufacturer determines that the residual risk is unacceptable, the manufacturer shall review the relevant information and literature on the expected benefits of the product and the expected future benefits. If the manufacturer determines that the residual risk is unacceptable, the manufacturer shall review the relevant information and literature on the expected benefits of the product and the expected future benefits. If the manufacturer determines that the residual risk is unacceptable, the manufacturer shall review the relevant information and literature on the expected benefits of the product and the expected future benefits. The manufacturer shall review the relevant information and literature on the expected future benefits of the product and the expected future benefits. The manufacturer shall review the relevant information and literature on the expected future benefits of the product and the expected future benefits. The manufacturer shall review the relevant information and literature on the expected future benefits of the product and the expected future benefits. The manufacturer shall review the relevant information and literature on the expected future benefits of the product and the expected future benefits. 6.7 Completeness of risk assessment (Step 1C) The system must ensure that all identified risks have been evaluated. The results of some of the risk management decisions should be recorded by the risk management team. 7 Evaluation of all residual risks (Step 11) After all risk control systems have been implemented and verified, the manufacturer should read the risk management documentation and note the risk neutrality of the plan. It should decide whether all residual risks caused by the product are acceptable. Apply the criteria established in the risk management training, and try to accept all residual risks. The manufacturer should collect and review relevant information and literature to determine whether the residual risks exceed the total residual risk. If The evidence does not support the argument that the company's risk management is not a guarantee of profitability. The path to profitability is uncontrollable. The risk management report should only be recorded in the risk management documents. The risk management documents should be checked for compliance. B. Risk Management Report Step 12)
YV/T0316-2003/I501497):2000 Risk Management Report: Risk analysis and risk assessment. The implementation and verification of risk control measures, as well as the acceptability assessment of the risk, should be part of the risk management documentation. This report should be carried out in accordance with the certificate or electronic sports body. Second, check the wind level management limit force method. 9 Post-production emergency (Step 13) The manufacturer should establish and maintain a systematic process to review the medical advice obtained in the post-production stage. Or similar device information. The total possible safety of the information should be evaluated as follows: a) Is there a previously unknown range of light?
Whether one or more of the wind paths are no longer acceptable: The product is evaluated to be failure-tolerant.
If any of the above items are met, the evaluation results should be used as a review by the risk management group (.4!, based on these new and related information about safety, the hospital should consider the risks that have been effectively treated and the necessary stages of the management process should be carried out. If "one or more risks will be accepted or there have been changes in the port, the impact of the risk control measures that have been implemented should be evaluated: the economic value introduction of the product risk management document
Jiang, the country and region of the production later, if there are circumstances, may require the production of the situation,
2; than 1s(1 13485,109r, of 4. ~+ Note 1: Information, in the medical landscape silver life cycle note what stage · from and start the example of the product film: technology, check the activity risk management process and the risk management document method of Western medicine compliance,? Sustainable production: The production can be a safe and reliable one, and it must meet the requirements of 3, and the production method must be controlled to meet the requirements of the production plan and the production process from step 5 to step 10!
6.1 Risk Reduction
When reducing risks, check the manufacturer and follow the regulations to reduce risks. 6.2 Program Analysis (Step 5)
Identify and select risk control measures, and determine the acceptable risk reduction methods. The risk control methods should have an acceptable risk reduction level. The manufacturing sequence should be in accordance with the manufacturer's instructions. There are multiple methods: a) Through the inherent safety measures in the production process of medical devices: b) Inform safety information.
Note that the control technology can reduce the severity of the reported risk, or the frequency of occurrence, or reduce the risk of the risk. Note 2: Some technical standards for many medical devices or pressure relief have been described, and the safety of the product should be guaranteed. The above should be used as a risk management area. If the risk control measures selected in the risk reduction plan analysis are determined to be effective, the manufacturer should conduct a risk-benefit analysis of the residual risk (see 6.5). Otherwise, the manufacturer should make sure that the risk control measures selected are effective. Use the methods of the risk management document to check whether they are sustainable. 6.3 Implementation of risk control measures 1 Step 6 The manufacturer shall implement the risk control measures selected in 6.2. The risk control measures shall be documented and the effectiveness of the risk control measures shall be verified and recorded in the risk management document. The implementation of the risk control measures has been verified. This bad verification should also be verified! Risk supervision documents. Use the method of checking the right risk control letter document to check compliance: 6.4 Residual risk evaluation (the first step)
After the risk control measures are implemented, any risk that may occur should be evaluated using the risk management plan. The evaluation results should be used in the risk management document.
If the residual risk does not meet the requirements of the standard, the reverse step (6, 2) should be adopted. If the residual risk is not considered acceptable, all relevant information required to explain one or more residual risks should also be provided by the person in charge.
The document should be checked with the introduction of the risk management document. 6.5 Risk-Benefit Analysis (Step 1)
If the criteria in the risk management guidelines are used to determine whether the residual risk is acceptable and further risk exploration is not practical, the manufacturer should collect and review relevant information and literature on the expected medical benefits of the product in order to quickly determine the residual risk of benefit. If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.5 Risk-Benefit Analysis (Step 2)
If the criteria in the risk management guidelines are used to determine whether the residual risk is acceptable and whether further risk exploration is not practical, the manufacturer should collect and review relevant information and literature on the expected medical benefits of the product in order to quickly determine the residual risk of benefit. If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.6 Risk-Benefit Analysis (Step 3)
If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.5 Risk-Benefit Analysis (Step 4)
If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.6 Risk-Benefit Analysis (Step 5)
If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.6 Risk-Benefit Analysis (Step 6)
If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.6 Risk-Benefit Analysis (Step 7)
If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.6 Risk-Benefit Analysis (Step 8)
If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.6 Risk-Benefit Analysis (Step 9)
If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.6 Risk-Benefit Analysis (Step 10) The risk assessment system should ensure that all identified risks have been assessed. The risk management system should record the results of the risk assessment and other related documents. The risk management system should also review the risk management documents. 6.7 Completeness of risk assessment (Step 1C) The system should ensure that all identified risks have been assessed. The risk management system should record the results of the risk assessment and other related documents. 7 Evaluation of all residual risks (Step 11) After all risk control systems have been implemented and verified, the manufacturer should read the risk management rules and regulations, and decide whether all residual risks caused by the product are acceptable. Apply the criteria established in the risk management plan, and try to accept all residual risks during the planned period. The manufacturer should collect and review relevant information and literature on the future benefits of the product, and decide whether the risks are sufficient to exceed the total residual risk. If The evidence does not support the argument that the company's risk management is not a guarantee of profitability. The path to profitability is uncontrollable. The risk management report should only be recorded in the risk management documents. The risk management documents should be checked for compliance. B. Risk Management Report Step 12)
YV/T0316-2003/I501497):2000 Risk Management Report: Risk analysis and risk assessment. The implementation and verification of risk control measures, as well as the acceptability assessment of the risk, should be part of the risk management documentation. This report should be carried out in accordance with the certificate or electronic sports body. Second, check the wind level management limit force method. 9 Post-production emergency (Step 13) The manufacturer should establish and maintain a systematic process to review the medical advice obtained in the post-production stage. Or similar device information. The total possible safety of the information should be evaluated as follows: a) Is there a previously unknown range of light?
Whether one or more of the wind paths are no longer acceptable: The product is evaluated to be failure-tolerant.
If any of the above items are met, the evaluation results should be used as a review by the risk management group (.4!, based on these new and related information about safety, the hospital should consider the risks that have been effectively treated and the necessary stages of the management process should be carried out. If "one or more risks will be accepted or there have been changes in the port, the impact of the risk control measures that have been implemented should be evaluated: the economic value introduction of the product risk management document
Jiang, the country and region of the production later, if there are circumstances, may require the production of the situation,
2; than 1s(1 13485,109r, of 4. ~+ Note 1: Information, in the medical landscape silver life cycle note what stage · from and start the example of the product film: technology, check the activity risk management process and the risk management document method of Western medicine compliance,? Sustainable production: The production can be a safe and reliable one, and it must meet the requirements of 3, and the production method must be controlled to meet the requirements of the production plan and the production process from step 5 to step 10!
6.1 Risk Reduction
When reducing risks, check the manufacturer and follow the regulations to reduce risks. 6.2 Program Analysis (Step 5)
Identify and select risk control measures, and determine the acceptable risk reduction methods. The risk control methods should have an acceptable risk reduction level. The manufacturing sequence should be in accordance with the manufacturer's instructions. There are multiple methods: a) Through the inherent safety measures in the production process of medical devices: b) Inform safety information.
Note that the control technology can reduce the severity of the reported risk, or the frequency of occurrence, or reduce the risk of the risk. Note 2: Some technical standards for many medical devices or pressure relief have been described, and the safety of the product should be guaranteed. The above should be used as a risk management area. If the risk control measures selected in the risk reduction plan analysis are determined to be effective, the manufacturer should conduct a risk-benefit analysis of the residual risk (see 6.5). Otherwise, the manufacturer should make sure that the risk control measures selected are effective. Use the methods of the risk management document to check whether they are sustainable. 6.3 Implementation of risk control measures 1 Step 6 The manufacturer shall implement the risk control measures selected in 6.2. The risk control measures shall be documented and the effectiveness of the risk control measures shall be verified and recorded in the risk management document. The implementation of the risk control measures has been verified. This bad verification should also be verified! Risk supervision documents. Use the method of checking the right risk control letter document to check compliance: 6.4 Residual risk evaluation (the first step)
After the risk control measures are implemented, any risk that may occur should be evaluated using the risk management plan. The evaluation results should be used in the risk management document.
If the residual risk does not meet the requirements of the standard, the reverse step (6, 2) should be adopted. If the residual risk is not considered acceptable, all relevant information required to explain one or more residual risks should also be provided by the person in charge.
The document should be checked with the introduction of the risk management document. 6.5 Risk-Benefit Analysis (Step 1)
If the criteria in the risk management guidelines are used to determine whether the residual risk is acceptable and further risk exploration is not practical, the manufacturer should collect and review relevant information and literature on the expected medical benefits of the product in order to quickly determine the residual risk of benefit. If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.5 Risk-Benefit Analysis (Step 2)
If the criteria in the risk management guidelines are used to determine whether the residual risk is acceptable and whether further risk exploration is not practical, the manufacturer should collect and review relevant information and literature on the expected medical benefits of the product in order to quickly determine the residual risk of benefit. If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.6 Risk-Benefit Analysis (Step 3)
If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.5 Risk-Benefit Analysis (Step 4)
If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.6 Risk-Benefit Analysis (Step 5)
If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.6 Risk-Benefit Analysis (Step 6)
If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.6 Risk-Benefit Analysis (Step 7)
If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.6 Risk-Benefit Analysis (Step 8)
If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.6 Risk-Benefit Analysis (Step 9)
If the evidence is that the residual risk is unacceptable, the manufacturer should conduct a 6.6 Risk-Benefit Analysis (Step 10) The risk assessment system should ensure that all identified risks have been assessed. The risk management system should record the results of the risk assessment and other related documents. The risk management system should also review the risk management documents. 6.7 Completeness of risk assessment (Step 1C) The system should ensure that all identified risks have been assessed. The risk management system should record the results of the risk assessment and other related documents. 7 Evaluation of all residual risks (Step 11) After all risk control systems have been implemented and verified, the manufacturer should read the risk management rules and regulations, and decide whether all residual risks caused by the product are acceptable. Apply the criteria established in the risk management plan, and try to accept all residual risks during the planned period. The manufacturer should collect and review relevant information and literature on the future benefits of the product, and decide whether the risks are sufficient to exceed the total residual risk. If The evidence does not support the argument that the company's risk management is not a guarantee of profitability. The path to profitability is uncontrollable. The risk management report should only be recorded in the risk management documents. The risk management documents should be checked for compliance. B. Risk Management Report Step 12)
YV/T0316-2003/I501497):2000 Risk Management Report: Risk analysis and risk assessment. The implementation and verification of risk control measures, as well as the acceptability assessment of the risk, should be part of the risk management documentation. This report should be carried out in accordance with the certificate or electronic sports body. Second, check the wind level management limit force method. 9 Post-production emergency (Step 13) The manufacturer should establish and maintain a systematic process to review the medical advice obtained in the post-production stage. Or similar device information. The total possible safety of the information should be evaluated as follows: a) Is there a previously unknown range of light?
Whether one or more of the wind paths are no longer acceptable: The product is evaluated to be failure-tolerant.
If any of the above items are met, the evaluation results should be used as a review by the risk management group (.4!, based on these new and related information, the hospital should consider the risk management process and the necessary stages of the treatment. If "one or more risks will be accepted or there are changes in the port, the risk control measures that have been implemented should be evaluated: the impact of the product risk management documents
Jiang, the product later has the national and regional laws, and there may be requirements for the production of the product,
2; than 1s(1 13485,109r, of 4. ~+ Note 1: Information, in the medical landscape silver life cycle note what stage · from and start the example of the product: technology, check the activity risk management process and the risk management documents of the method of western medicine compliance,Benefit analysis (step 1)
If the criteria in the risk management guidelines are used to determine whether the residual risk is acceptable and further risk exploration is not practical, the manufacturer should collect and review relevant information and literature on the expected future medical benefits to quickly determine the residual risk of the benefit: if the medical benefit is not sufficient to justify the residual risk, the residual risk of the plan is unacceptable. If the residual risk is too high, the manufacturer should conduct a risk assessment. The evaluation results should be recorded in the appropriate documentation provided by the manufacturer to explain the risk. The risk management documents and accompanying documents should be reviewed for compliance. 6. ... 6.7 Completeness of risk assessment (Step 1C) The system must ensure that all identified risks have been evaluated. The results of some of the risk management decisions should be recorded by the risk management team. 7 Evaluation of all residual risks (Step 11) After all risk control systems have been implemented and verified, the manufacturer should read the risk management documentation and note the risk neutrality of the plan. It should decide whether all residual risks caused by the product are acceptable. Apply the criteria established in the risk management training, and try to accept all residual risks. The manufacturer should collect and review relevant information and literature to determine whether the residual risks exceed the total residual risk. If The evidence does not support the argument that the company's risk management is not a guarantee of profitability. The path to profitability is uncontrollable. The risk management report should only be recorded in the risk management documents. The risk management documents should be checked for compliance. B. Risk Management Report Step 12)
YV/T0316-2003/I501497):2000 Risk Management Report: Risk analysis and risk assessment. The implementation and verification of risk control measures, as well as the acceptability assessment of the risk, should be part of the risk management documentation. This report should be carried out in accordance with the certificate or electronic sports body. Second, check the wind level management limit force method. 9 Post-production emergency (Step 13) The manufacturer should establish and maintain a systematic process to review the medical advice obtained in the post-production stage. Or similar device information. The total possible safety of the information should be evaluated as follows: a) Is there a previously unknown range of light? bzxz.net
Whether one or more of the wind paths are no longer acceptable: The product is evaluated to be failure-tolerant.
If any of the above items are met, the evaluation results should be used as a review by the risk management group (.4!, based on these new and related information about safety, the hospital should consider the risks that have been effectively treated and the necessary stages of the management process should be carried out. If "one or more risks will be accepted or there have been changes in the port, the impact of the risk control measures that have been implemented should be evaluated: the economic value introduction of the product risk management document
Jiang, the country and region of the production later, if there are circumstances, may require the production of the situation,
2; than 1s(1 13485,109r, of 4. ~+ Note 1: Information, in the medical landscape silver life cycle note what stage · from and start the example of the product film: technology, check the activity risk management process and the risk management document method of Western medicine compliance,Benefit analysis (step 1)
If the criteria in the risk management guidelines are used to determine whether the residual risk is acceptable and further risk exploration is not practical, the manufacturer should collect and review relevant information and literature on the expected future medical benefits to quickly determine the residual risk of the benefit: if the medical benefit is not sufficient to justify the residual risk, the residual risk of the plan is unacceptable. If the residual risk is too high, the manufacturer should conduct a risk assessment. The evaluation results should be recorded in the appropriate documentation provided by the manufacturer to explain the risk. The risk management documents and accompanying documents should be reviewed for compliance. 6. ... 6.7 Completeness of risk assessment (Step 1C) The system must ensure that all identified risks have been evaluated. The results of some of the risk management decisions should be recorded by the risk management team. 7 Evaluation of all residual risks (Step 11) After all risk control systems have been implemented and verified, the manufacturer should read the risk management documentation and note the risk neutrality of the plan. It should decide whether all residual risks caused by the product are acceptable. Apply the criteria established in the risk management training, and try to accept all residual risks. The manufacturer should collect and review relevant information and literature to determine whether the residual risks exceed the total residual risk. If The evidence does not support the argument that the company's risk management is not a guarantee of profitability. The path to profitability is uncontrollable. The risk management report should only be recorded in the risk management documents. The risk management documents should be checked for compliance. B. Risk Management Report Step 12)
YV/T0316-2003/I501497):2000 Risk Management Report: Risk analysis and risk assessment. The implementation and verification of risk control measures, as well as the acceptability assessment of the risk, should be part of the risk management documentation. This report should be carried out in accordance with the certificate or electronic sports body. Second, check the wind level management limit force method. 9 Post-production emergency (Step 13) The manufacturer should establish and maintain a systematic process to review the medical advice obtained in the post-production stage. Or similar device information. The total possible safety of the information should be evaluated as follows: a) Is there a previously unknown range of light?
Whether one or more of the wind paths are no longer acceptable: The product is evaluated to be failure-tolerant.
If any of the above items are met, the evaluation results should be used as a review by the risk management group (.4!, based on these new and related information about safety, the hospital should consider the risks that have been effectively treated and the necessary stages of the management process should be carried out. If "one or more risks will be accepted or there have been changes in the port, the impact of the risk control measures that have been implemented should be evaluated: the economic value introduction of the product risk management document
Jiang, the country and region of the production later, if there are circumstances, may require the production of the situation,
2; than 1s(1 13485,109r, of 4. ~+ Note 1: Information, in the medical landscape silver life cycle note what stage · from and start the example of the product film: technology, check the activity risk management process and the risk management document method of Western medicine compliance,
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