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YY/T 1406.1-2016: Medical device software--Part 1: Guidance on the application of ISO 14971 to medical device software
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Medical device software--Part 1: Guidance on the application of ISO 14971 to medical device software
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YY/T 1406.1-2016
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Basic data | Standard ID | YY/T 1406.1-2016 (YY/T1406.1-2016) | | Description (Translated English) | Medical device software--Part 1: Guidance on the application of ISO 14971 to medical device software | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 11.040.01 | | Word Count Estimation | 55,575 | | Date of Issue | 2016-03-23 | | Date of Implementation | 2017-01-01 | | Regulation (derived from) | Notice of the General Administration of Food and Drug Administration (No. 74 of 2016) | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1406.1-2016: Medical device software--Part 1: Guidance on the application of ISO 14971 to medical device software
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Medical device software - Part 1. Guidance on the application of ISO 14971 to medical device software
ICS 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Medical device software
Part 1. YY/T 0316 for use in medical devices
Software guide
Medicaldevicesoftware-Part 1. GuidanceontheapplicationofISO 14971
(IEC /T R80002-1..2009, IDT)
2016-03-23 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface III
Introduction IV
1 General 1
1.1 Scope 1
1.2 Normative references 1
2 terms and definitions
3 General requirements for risk management 2
3.1 Risk management process 2
3.2 Management responsibilities 5
3.3 Personnel Qualification 6
3.4 Risk Management Plan 7
3.5 Risk Management Document 9
Risk analysis
4.1 Risk analysis process 10
4.2 Identification of intended use of medical devices and safety-related features 11
4.3 Hazardous (Source) Identification 12
4.4 Estimate the risk of each dangerous situation 13
5 Risk Assessment 16
6 Risk Control 16
6.1 Reducing risk 16
6.2 Analysis of risk control scheme 17
6.3 Implementation of risk control measures
6.4 Surplus risk assessment 24
6.5 Risk/Benefit Analysis
6.6 Risks arising from risk control measures
6.7 The integrity of risk control
Evaluation of Acceptability of Consolidated Residual Risk
8 Risk Management Report 26
9 Post-production and post-production information 27
A discussion of the definition of Appendix A (informative)
Appendix B (Informative Appendix) Software Cause Example 31
Appendix C (informative) Software Potential risks associated with software 40
Appendix D (informative) Life Cycle/Risk Management Matrix
Appendix E (informative) Safe use case 47
Reference 48
Define the index of the term 49
Figure 1 Schematic diagram of the relationship between hazard (source), event sequence, hazardous situation and injury - from YY/T 0316-2016 Appendix E 15
Figure 2 Risk control measures to prevent incorrect software output FTA caused by injury icon 18
Figure A.1 Event sequence, injury and hazard (source) relationship 29
Table 1 Requirements for documents in risk management documents, except for the requirements of YY/T 0316-2016 9
Table A.1 Relationships between Hazardous (Source), Predictable Event Sequence, Dangerous Situation and Possible Injury 29
Table B.1 Examples of software functional area reasons
Table B.2 Examples of software reasons for side effects
Table B.3 Methodologies for ensuring risk control measures as expected 39
Table C.1 Potential risks associated with software avoidance
Table D.1 Life Cycle/Risk Management Relationships Table 44
Foreword
YY/T 1406 "Medical Device Software" consists of the following components.
- Part 1. YY/T 0316 Guidelines for use in medical device software;
- Part 2. Confirmation of software for medical device quality system;
Part 3. Process reference model for the medical device software life cycle process (YY/T 0664).
This part is part 1 of YY/T 1406.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part uses the translation method equivalent to the use of IEC /T R80002-1..2009 "Medical Device Software Part 1. ISO 14971
Medical Device Software Guide "(English version).
The text in this part of the box directly quoted from the YY/T 0316-2016 standard, in front of the text that "YY/T 0316-
2016 original ".
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This section is proposed by the State Food and Drug Administration.
This part of the State Food and Drug Administration Medical Device Standard Management Center.
This part of the drafting unit. Beijing Guohua Huaguang Certification Co., Ltd., Shanghai Medical Devices Testing Institute, Shenyang Neusoft Medical System Limited
the company.
This part of the main drafters. Wang Zhiqiang, by Hong Shun, Milan Ying, He Jun, Lu E, Zheng Yi Han, Chen Zhigang.
Introduction
Software is often an integral part of medical device technology. It is safe and effective for medical devices that contain software
, The need to know the intended use of the software, and to prove that the implementation of the software to meet the intended use without causing any unacceptable risk.
Although the software itself is not a dangerous (source), but the software may lead to dangerous situations, it is important to understand this. Should always be systematically
Point of view to consider the software, software risk management can not be isolated from the system alone.
Complex software designs may involve complex sequence of events that may cause dangerous conditions. Software risk management task package
Including identifying the sequence of events that cause a dangerous situation, identifying which locations in these event sequences can interrupt the sequence, prevent injury or reduce
Damage probability.
The sequence of software events that trigger dangerous situations can be divided into two categories.
a) The event sequence is manifested as an unpredictable response to the input of the software (an error in the software specification);
b) The sequence of events is caused by coding errors (errors in software implementation).
Because of the difficulty of properly standardizing and implementing complex systems and the difficulty of fully validating complex systems, these categories are
Is unique.
Because it is difficult to estimate the probability of a software error that can cause a dangerous situation, and because the software will not be lost in use because of loss
So the software risk analysis, should be concerned about the identification of potential software functions and will lead to the identification of dangerous anomalies - not
Estimate the probability. The risk of software anomalies in most cases only needs to assess the severity of the injury.
Risk management is usually challenging, especially when it comes with software. The following article contains additional details about the software features,
This provides a guide for understanding YY/T 0316-2016 from the software level.
● Structure of this part.
This section follows the structure of YY/T 0316-2016 and provides guidance for each risk management activity associated with the software.
Due to the iterative nature of the risk management activities in the software lifecycle, there are some intentional redundancy in the information provided.
Medical device software
Part 1. YY/T 0316 for use in medical devices
Software guide
1 General
1.1 Scope
This part of the YY/T 0316-2016 "Medical Device Risk Management for Medical Device Application" included in the requirements
YY/T 0664-2008 "Medical Device Software Software Life Cycle Process" refers to the medical device software that provides a guide to this section and
Do not increase or change the requirements of YY/T 0316-2016 or YY/T 0664-2008.
When the software is used as a medical device/system, this section is for risk management practitioners who need to implement risk management and who need to understand how
Foot software used by YY/T 0316-2016 for risk management requirements.
Regulators are aware that ISO 14971 is widely recognized worldwide as an important criterion for the implementation of medical device risk management.
YY/T 0664-2008 normative references to the requirements in YY/T 0316-2016. These two standards provide the basis for this part.
It should be noted that although YY/T 0316-2016 and this part are concerned with medical devices, this section can also be used for medical and health care
All software in a health environment implements a safety risk management process, whether or not the software is classified as a medical device.
This section does not involve.
- areas that have been covered by existing standards or planned standards, such as. alarms, usability projects, networks, etc.;
--- production or quality management system software;
--- software development tools.
This section is not intended as a basis for regulatory or certification activities.
The term "appropriate" in this section is used to indicate that, in a number of possibilities that satisfy the requirement, a particularly suitable one is recommended and does not refer or exclude
His possibility, or used to indicate that a practice is better but not a requirement. "Should" should not be understood as required.
1.2 Normative references
The following documents are indispensable for the application of this section. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all amendments) applies to this section.
YY/T 0316-2016 Medical Device Risk Management for Medical Devices (ISO 14971..2007, IDT)
YY/T 0664-2008 Medical Device Software Software Life Cycle Process (IEC 62304..2006, IDT)
2 terms and definitions
YY/T 0316-2016 and YY/T 0664-2008 are defined and the following terms and definitions apply to this document.
Note. The index of the definition term begins on page 49.
2.1
Diversity
A redundant form of redundant elements used in different (diverse) components, techniques, or methods to reduce common causes that all elements are
The probability of failure.
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