YY/T 0316-2016 English PDF (YY/T0316-2016)

Delivery: 2 working-hours manually (Sales@ChineseStandard.net)
Need delivered in 3-second? USA-Site: YY/T 0316-2016
Get Quotation: Click YY/T 0316-2016 (Self-service in 1-minute)
Historical versions (Master-website): YY/T 0316-2016
Preview True-PDF (Reload/Scroll-down if blank)

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 riska...