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YY/T 0316-2016 English PDF (YYT0316-2016)

YY/T 0316-2016 English PDF (YYT0316-2016)

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YY/T 0316-2016: Medical devices - Application of risk management to medical devices

YY/T 0316-2016
Medical devices - Application of risk management to medical devices
ICS 11.040.01
C30
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0316-2008
medical instruments
Application of Risk Management to Medical Devices
(ISO 14971.2007, revised edition, IDT)
2016-01-26 release
2017-01-01 implementation
State Food and Drug Administration released
Directory
Foreword Ⅲ
Introduction IV
1 range 1
2 Terms and definitions 1
3 General Requirements for Risk Management 4
3.1 Risk Management Process 4
3.2 Management responsibilities 6
3.3 Qualifications 6
3.4 Risk Management Plan 6
3.5 Risk Management Documents 7
4 Risk Analysis 7
4.1 Risk Analysis Process 7
4.2 Medical Devices Intended Use and Identification of Safety Related Features 7 4.3 Danger (source) identification 7
4.4 Estimating the Risks of Each Hazard 8
5 Risk Evaluation 8
6 Risk Control 8
6.1 reduce risk 8
6.2 Risk Control Program Analysis 8
6.3 The implementation of risk control measures 9
6.4 Residual risk assessment 9
6.5 Risk/Benefit Analysis 9
6.6 Risks arising from risk control measures 9
6.7 Integrity of risk control 10
7 Evaluation of the acceptability of the integrated residual risk 10
8 Risk Management Report 10
Post production and production information
Appendix A (informative) Description of the requirements of the principle 12 Appendix B (Informative) Medical Device Risk Management Process Overview 19 Appendix C (informative) Medical devices and safety-related features to identify the problem 21 Appendix D (informative) Concept of risk for medical devices 26
Appendix E (Informative) Examples of Hazardous (Source), Foreseeable Event Sequence and Hazard Situations 40 Appendix F (Informative) Risk Management Plan 45
Appendix G (informative) risk management technical information 47
Appendix H (informative) Guide to in vitro diagnostic medical device risk management 50 Appendix I (Informative) Biological Risk (Source) Risk Analysis Process Guide 63 Appendix J (informative) safety information and residual risk information 65 References 66
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY/T 0316-2008 "medical device risk management of medical devices." And YY/T 0316-2008 In addition, editorial changes in addition to the main technical changes are as follows. --- For and GB/T.20000.4-2003 "Standardization Guide Part 4. Standards related to the content of safety," the term Consistently, the following eight terms and definitions have been revised. --- "damage" revised as "injury" and revised the definition;
--- "Hazard" revised as "dangerous (source)", and revised the definition; --- "Hazardous situation" revised as "dangerous situation" and revised definition; --- Revised the definition of "residual risk";
--- Revised "risk" definition;
--- Revised "risk analysis" definition;
--- Revised the definition of "risk assessment";
--- "Safety" revised to "safety", and revised the definition.
--- According to ISO 14971.2007 (2007-10-01 more), amended the risk management process in Figure 1 Schematic. This standard uses the translation method identical with ISO 14971.2007 "medical device risk management application of medical devices," a more correct version. Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents. This standard proposed by the State Food and Drug Administration.
This standard by the National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC221) centralized. This standard was drafted by Beijing Guo Yi Huaguang Certification Co., Ltd. The main drafters of this standard.Wang Huifang, Zheng a 菡, Milan British, Chen Zhigang. This standard replaces the standards previously issued as.
--- YY/T 0316-2000, YY/T 0316-2003, YY/T 0316-2008.
introduction
This standard contains requirements for manufacturers to provide a systematic application of experience, knowledge and judgment management and the use of medical devices Risk framework.
This standard was developed specifically for use by manufacturers of medical devices/systems that have established the principles of risk management. For other manufacturers, as in In other health care industries, this standard can be used as an informative guide for establishing and maintaining risk management systems and processes. This standard covers the risk management process, the main risk to the patient, but also includes the operator, other personnel, other equipment and the environment risks of.
As a general concept, certain activities involving individuals, organizations or governments may expose these or those stakeholders to danger Risk (source), or may cause loss or damage to the valuable items of the stakeholder. Because of each stakeholder, there is injury The probability and severity of different values, risk management is a complex issue. It is generally accepted that the concept of risk has two components.
a) the probability of injury occurring;
b) the consequences of the injury, ie, its severity.
Due to the diversity of stakeholders, including physicians, organizations providing health care, government, industry, patients and members of the public, The concept of medical device risk management is particularly important. All stakeholders must understand that the use of medical devices entails some degree of risk. Each stakeholder is at risk The acceptability of the risk is influenced by the risk perception of the two components above and the stakeholders' risk perception. Risk per stakeholder Being informed of the cultural background, socio-economic and educational background of the community concerned, the actual and perceived health status of the patient, and many other factors The impact may vary greatly. The way of cognitive risk should also be taken into account, for example, whether it is unconscious about exposure to danger (source) Avoidable, artificial, negligent, caused by little known reasons, or whether it is a vulnerable group in society. Use of medical equipment The decision of the particular clinical procedure requires that the remaining risk be balanced against the expected benefits of the clinical procedure. Such judgments should be considered and medical treatment The intended use, performance and risks associated with the device, and the risks and benefits associated with the clinical procedure or the environment in which it is used. Only understand the patient individual Some of these judgments can be made by qualified physicians on the health status and patient's personal opinion. As one of the stakeholders, manufacturers should take into account the generally accepted state of the art technology, the safety of medical devices, including The acceptability of the risk is judged in order to determine the suitability of the medical device for its intended use. This standard specifies a process, according to In this process, manufacturers of medical devices can identify hazards associated with medical devices (sources), evaluate and evaluate the winds associated with these hazards (sources) Risk, control these risks and monitor the effectiveness of this control. For any particular medical device, other international standards may require the application of a specific risk management method. medical instruments
Application of Risk Management to Medical Devices
1 Scope
This standard specifies a procedure for manufacturers to identify hazards associated with medical devices [including in-vitro diagnostic (IVD) medical devices] (Source), estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of controls. The requirements of this standard apply to all stages of the life cycle of medical devices. This standard is not for clinical decision-making.
This standard does not provide acceptable levels of risk.
This standard does not require manufacturers have an appropriate quality system. However, risk management can be a component of a quality management system section.
2 Terms and definitions
The following terms and definitions apply to this standard.
2.1
Accompanying documents accompanying document
Along with the medical device, providing information to the responsible party for the installation, use, and maintenance of the medical device and providing the operator or user with a letter Interest, especially on safety information.
Remark Reprinted from IEC 60601-1-2005, definition 3.4.
2.2
Harm harm
Damage to the human body or to human health, or damage to property or the environment. [GB/T.20000.4-2003, Definition 3.3]
2.3
Dangerous (source) hazard
Potential causes of injury.
[GB/T.20000.4-2003, Definition 3.5]
2.4
Dangerous situation hazardoussituation
Personnel, property or the environment is exposed to one or more hazards (sources) situation. [GB/T.20000.4-2003, Definition 3.6]
Note. See Appendix E for a description of the relationship between "dangerous (source)" and "dangerous situation". 2.5
Intended to use intendeduse
Expectedpurpose
Follow the manufacturer's specifications, instructions and information for the intended use of the product, process or service. 2.6
In vitro diagnostic medical device invitrodiagnosticmedicaldevice
IVD Medical Devices IVDmedicaldevice
Manufacturers anticipate medical devices for the purpose of examining samples taken from the human body to provide diagnostic, monitoring or compliance information. Example.
Reagents, calibrators, sample collection and storage devices, controls and related instruments, appliances or articles. Note 1. Can be used alone or with accessories or other medical devices. Note 2. Adapted from GB/T 29791.1-2013, the definition of 3.29.
2.7
Life-cycle
In the life of a medical device, from the initial concept to the final phase of its decommissioning and disposal. 2.8
Manufacturer manufacturer
Design, manufacture, package or label medical devices, assemble systems, or retrofit medical devices prior to listing and/or putting into service Natural or legal persons who are responsible, regardless of whether the above work is done on their own or by a third party. Note 1. Note that the national regulations may apply to the manufacturer's definition. Note 2. For the definition of mark, see YY/T 0287-2003, Definition 3.6. 2.9
Medical equipment medicaldevice
The intended use of the manufacturer is for human use, either individually or in combination, for one or more of the following specific purposes. Equipment, apparatus, machinery, appliances, implants, in vitro reagents or calibrators, software, materials, or other similar or related items. These purposes are. --- Disease diagnosis, prevention, custody, treatment or remission;
--- Diagnosis, monitoring, treatment, mitigation or compensation of injury; --- physiological structure or physiological process of research, substitution, regulation or support; Support or sustain life
--- Pregnancy control;
--- Medical equipment disinfection;
--- Provide medical information through in vitro examination of samples taken from the human body. Its main design role acting on the body surface or in the body is not obtained by pharmacological, immunological or metabolic means, but it is possible that these Means to participate and play a supporting role.
Note 1. This definition was developed by the Global Harmonization Task Force (GHTF). See references [38]. [YY/T 0287-2003, definition 3.7]
Note 2. Products that may be considered as medical devices in some jurisdictions but without a coordinated approach are. --- Aid for disabled/physically handicapped persons;
--- Devices for the treatment/diagnosis of animal diseases and injuries; --- Medical device accessories (see Note 3);
--- Disinfection substances;
--- Meet the above definition requirements, but under different control, containing animal and human tissue instruments. Note 3. When the attachment is intended for use by medical devices in conjunction with the medical device to which they belong, specifically intended for the intended purpose, the medical device should also comply with this standard Request.
2.10
Objective evidence objectiveevidence
Data that supports the existence or authenticity of things.
Note. Objective evidence can be obtained by observation, measurement, experiment or other means. [GB/T 19000-2008, definition 3.8.1]
2.11
After production post-production
Part of the product life cycle after the design has been completed and the medical device is manufactured. Example.
Transportation, storage, installation, product use, maintenance, repair, product change, decommissioning and disposal. 2.12
Procedure
The path specified for carrying out an activity or process.
[GB/T 19000-2008 definition 3.4.5]
2.13
Process process
A set of activities that transform inputs into outputs that interact or interact with each other. [GB/T 19000-2008, Definition 3.4.1]
2.14
Record record
A document setting out the results achieved or providing evidence of the activities completed. [GB/T 19000-2008, definition 3.7.6]
2.15
Residual risk residualrisk
Risks still exist after the implementation of risk control measures.
Note 1. Rewritten from GB/T.20000.4-2003, the definition of 3.9.
Note 2. Definition of GB/T.20000.4-2003 3.9 The term "protective measures" is used instead of "risk control measures". However, in the text of this standard, "Safeguards" is just one of the risk control options described in 6.2.
2.16
Risk
The combination of the probability of injury and the severity of the injury. [GB/T.20000.4-2003, Definition 3.2]
2.17
Risk analysis
Systematic use of existing information to identify hazards (sources) and to estimate risks. [GB/T.20000.4-2003, Definition 3.10]
Note. Risk analysis includes a review of the sequence of different events that may present a hazardous situation and injury. 2.18
Risk assessment riskassessment
Including risk analysis and risk assessment of the entire process.
[GB/T.20000.4-2003, Definition 3.12]
2.19
Risk control riskcontrol
Make decisions and implement measures to reduce or maintain the risk at a defined level. 2.20
Risk estimation riskestimation
The process used to assign a probability of injury and the severity of the injury. 2.21
Risk assessment riskevaluation
The process of comparing the estimated risk with a given risk criterion to determine the risk acceptability. 2.22
Risk management riskmanagement
Systematic use of management policies, procedures and practices for risk analysis, evaluation, control and monitoring. 2.23
Risk management document riskmanagementfile
A set of records and other documents produced by risk management.
2.24
Safety safety
Free from the unacceptable state of risk.
[GB/T.20000.4-2003, Definition 3.1]
2.25
Severity
Danger (Source) A measure of the likely consequences.
2.26
Top management topmanagement
A person or group of people who command and control the manufacturer at the highest level. Note rewritten from GB/T 19000-2008, the definition of 3.2.7.
2.27
Use error useerror
Due to the negligence of an action or action, a medical device response that is different from the manufacturer's expectation or user expectation is created. Notes 1. Usage errors include negligence, mistakes and errors.
Note 2. See YY/T 1474-2016, Appendix B and D.1.3.
Note 3. Patients with unexpected physiological responses are generally not considered wrong to use. (YY/T 1474-2016, Definition 3.21)
2.28
Verification
Confirmation that the requirement has been satisfied by providing objective evidence. Note 1. The term "Verified" is used to indicate the corresponding status. Note 2. Identification may include the following activities, such as.
--- Transformation method to calculate;
--- The new design specifications have been confirmed with similar design specifications for comparison; --- Test and demonstration;
--- File review before the release.
[GB/T 19000-2008, definition 3.8.4]
3 General requirements for risk management
3.1 Risk Management Process
Manufacturers should establish, document, and maintain an ongoing process throughout their life cycle to identify medical devices Hazard (source), estimating and assessing the risks associated with, controlling these risks and monitoring the effectiveness of such controls. This process should include the following elements. ---Risk Analysis;
---Risk Assessment;
---risk control;
--- Production and production of information.
When a documented product realization process, such as the one described in Chapter 7 of YY/T 0287-2003, the process should include wind The appropriate part of the risk management process.
Notes 1. The documented quality management system process can be used to systematically address safety issues, especially in complex medical devices and systems (Source) and dangerous situations to make early judgments.
Note 2. A schematic of the risk management process is shown in Figure 1. Depending on the particular life cycle phase, each element of risk management can have different priorities. In addition, A medical device risk management activity may be appropriately repeated or performed in multiple steps. Appendix B includes each of the risk management processes A more detailed overview of the steps.
Check compliance by checking the appropriate documentation.
Figure 1 Risk management process diagram
3.2 Management responsibilities
Top management should provide evidence of the commitment to the risk management process in the following areas. --- Make sure to provide adequate resources;
--- Ensure that qualified personnel are assigned to risk management (see 3.3). Top management should.
--- Provide a guideline for the determination of risk acceptability criteria and documentation, this policy should ensure that the guidelines are based on the applicable country or Regional regulations and related standards, taking into account available information such as the generally accepted state of the art and known interest-related Party's attention.
- Review the suitability of the risk management process at planned intervals to ensure the continued effectiveness of the risk management process and Any decisions and activities taken are documented. If the manufacturer has the appropriate quality management system, these reviews can be regarded as quality Volume management system assessment part.
Note. Documents may be integrated into documents produced by the manufacturer's quality management system and may be referenced in risk management documents. Check compliance by checking the appropriate documentation.
3.3 Personnel qualifications
Persons performing risk management tasks should have the knowledge and experience appropriate to the tasks assigned to them. Where appropriate, include a specific doctor Therapeutic devices (or similar medical devices) and their use of knowledge and experience, related technologies or risk management techniques. Appropriate qualifications should be maintained Set records.
Note. The risk management tasks can be performed by re...

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