YY/T 9706.106-2021 English PDF (YY/T9706.106-2021)

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YY/T 9706.106-2021: Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance -- Collateral Standard: Usability
YY/T 9706.106-2021
Medical electrical equipment - Part 1-6.General requirements for basic safety and essential performance - Collateral Standard. Usability
ICS 11.040
C30
People's Republic of China Pharmaceutical Industry Standards
Medical electrical equipment Part 1-6.Basic safety and
Common requirements for basic performance and parallel standard. usability
(IEC 60601-1-6.2013, MOD)
Released on 2021-03-09
2023-05-01 implementation
Issued by the National Medical Products Administration
Table of contents
Foreword Ⅲ
1 Scope, purpose and related standards 1
2 Normative references 1
3 Terms and definitions 2
4 General requirements 2
5 *Replace requirement 2 in YY/T 1474-2016
Appendix A (informative appendix) General guidance and principle explanation 4
Appendix B (informative appendix) The mapping between the elements in IEC 60601-1-6.2006 and the corresponding elements in IEC 62366.2007 7
Appendix C (informative appendix) The usability items provided in IEC 62366.2007 and the usability items used in other standards
Index between 8
Reference 11
Preface
The "Medical Electrical Equipment" series of standards is divided into two parts.
---Part 1.General and parallel requirements;
---Part 2.Special requirements.
This part is part 1-6.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
This part uses the redrafting law to amend and adopt IEC 60601-1-6.2013 Medical Electrical Equipment Part 1-6.Basic Safety and Basic Safety
The general requirements for this performance are collateral standards. Usability.
The technical differences between this part and IEC 60601-1-6.2013 and the reasons are as follows.
---Regarding normative reference documents, this section has made adjustments with technical differences to adapt to my country's technical conditions and adjustments.
The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows.
● Replace IEC 60601-1.2005 AMD1.2012 with GB 9706.1-2020 which is modified to adopt international standards;
● Replace ISO 14971.2007 with YY/T 0316 which is equivalent to adopting international standards;
● Replace IEC 60601-1-8.2006 AMD1.2012 with YY 9706.108 which is modified to adopt the international standard.
This section has made the following editorial changes.
---Add A.3 to Appendix A, giving the corresponding relationship between international standards and current Chinese national standards or industry standards;
---The title of Appendix B is retained, and the specific content of Appendix B is deleted.
Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents.
This part was proposed by the State Drug Administration.
This part is under the jurisdiction of the National Medical Electrical Appliance Standardization Technical Committee (SAC/TC10).
Drafting organizations of this section. Shanghai Medical Device Testing Institute, Shenzhen Mindray Biomedical Electronics Co., Ltd.
The main drafters of this section. He Jun, Shao Lingyun, Hu Sheng.
Medical electrical equipment Part 1-6.Basic safety and
Common requirements for basic performance and parallel standard. usability
1 Scope, purpose and related standards
1.1 *Scope
This part stipulates that manufacturers use to analyze, define, design, verify and confirm the basic requirements of medical electrical equipment (hereinafter referred to as ME equipment).
The process of availability related to safety and basic performance.
The usability engineering process evaluates and reduces the risks caused by usability problems such as correct use or incorrect use during normal use.
It can be used to identify risks associated with abnormal use, but not to evaluate or reduce such risks.
Unless there is objective evidence that is unacceptable (see 4.1.2 of YY/T 1474-2016), if the usability engineering process complies with this part
And the acceptance criteria specified in the availability confirmation plan are met (see 5.9 of YY/T 1474-2016), it can be considered as ME
The remaining risks defined in YY/T 0316 related to the availability of the equipment are acceptable.
Note. The asterisk (*) is used as the first character of the title or the beginning of a paragraph or table title, indicating that there is a guide or principle description related to it in Appendix A.
1.2 Purpose
The purpose of this section is to specify the general requirements added to the general standards and to serve as the basis for the specific standards.
1.3 Relationship with other standards
1.3.1 GB 9706.1
For ME equipment, this section is a supplement to GB 9706.1.
When citing GB 9706.1 or this part individually or in combination, the following agreement shall be adopted.
--- "General Standard" refers to the separate GB 9706.1-2020;
--- "This standard" refers to the general standard and this part.
1.3.2 Specific standards
The requirements in the specific standards take precedence over the provisions of this section.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article
Pieces. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB 9706.1-2020 Medical electrical equipment Part 1.General requirements for basic safety and basic performance (IEC 60601-1.
2012, MOD)
YY/T 0316 Application of medical device risk management to medical devices (YY/T 0316-2016, ISO 14971.2007 correction
Version, IDT)
YY 9706.108 Medical electrical equipment Part 1-8.General requirements for basic safety and basic performance
Requirements, testing and guidelines for alarm systems in medical electrical equipment and medical electrical systems (YY 9706.108-2021, IEC 60601-1-8.2006
AMD1.2012, MOD)
YY/T 1474-2016 Application of medical device usability engineering to medical devices (IEC 62366.2007, IDT)
3 Terms and definitions
The following terms and definitions defined in GB 9706.1-2020, YY 9706.108, and YY/T 1474-2016 apply to this document.
3.1
* Operator-equipment interface operator-equipment interface
The method by which the operator communicates with the ME equipment.
Note 1.Rewrite ANSI/AAMIHE74.2001, term 3.24.
Note 2.The accompanying documents are considered part of the ME equipment and the operator-equipment interface.
3.2
Operatorprofile operatorprofile
A summary of the mental, physical and demographic characteristics of the expected operator population, as well as any characteristics related to design decisions,
Such as vocational skills and job requirements.
4 General requirements
4.1 *Application conditions of ME equipment
ME equipment should provide sufficient availability to ensure that the risks arising from normal use and use errors are acceptable, see General
Standard 7.1.1 and 12.2.
If it meets 4.2 of this section and the remaining chapters and clauses, it can be considered to meet the requirements of this clause.
4.2 *ME equipment usability engineering process
The usability engineering process shall meet YY/T 1474-2016, except for.
---Planning and execution of production and post-production information in the context of the applicable usability engineering process in the YY/T 0316 architecture;
--- Usability engineering process maintenance.
When applying YY/T 1474-2016, the terms in this part and GB 9706.1-2020 should be used as follows.
---The term "medical equipment" should be regarded as ME equipment;
---The term "user" should be equivalent to the operator;
---The term "patient" shall include animals;
---The term "safety" should be equivalent to basic safety and basic performance;
---The term "user interface" should be equivalent to the operator-device interface;
---The term "user characteristics" should be equivalent to the operator profile.
Compliance is checked by checking usability engineering documents. If you check the availability engineering documentation and find that the manufacturer meets the following requirements
Requirements, it is considered that it meets the requirements of this chapter and all of this standard.
---Established a usability engineering process;
---Established acceptance criteria for usability; and
---Prove that the usability acceptance criteria are met.
5 *Replace the requirements in YY/T 1474-2016
In the requirements of YY/T 1474-2016, the following replacements shall apply.
Replace the first two paragraphs of Chapter 6 of YY/T 1474-2016 with the following, including Note 1 and Note 2.
The instruction manual shall include a brief description of the physical operation principle of the ME equipment and the significant physical and performance characteristics related to the usability.
description. If the technical specification is provided separately, it should include the same information.
Note. The main purpose of this description is to help the operator establish a correct mental model of the ME equipment.
The instructions for use should include an overview of the application specifications.
Appendix A
(Informative appendix)
General guidelines and principles
A.1 General Guidelines
This appendix provides a concise principle description of the important requirements in this section. Its purpose is to promote the
Part of the effective application and the circumstances in which these requirements apply to provide additional guidance.
A.2 Principle explanation of special chapters and clauses
The following is the principle explanation of the special chapters and clauses in this part, and their numbers correspond to the numbers of the chapters and clauses in the text.
Clause 1.1 Scope
This section focuses on the availability of the operator-device interface of ME equipment. In general, usability includes operator satisfaction and efficiency, etc.
characteristic. These characteristics may be related to the basic safety or basic performance of ME equipment. The reduction of these characteristics may increase the use of wrong
possibility. Some examples of characteristics that are not considered include the aesthetics of ME equipment or the amount of consumables consumed.
Clause 3.1 Operator-device interface
The operator-equipment interface includes all the interaction modes between the ME equipment and the operator, and between the operator and the ME equipment. These methods include
But not limited to.
---Marking and accompanying documents;
---light;
---Video display;
---button;
---touch screen;
---Sound and visual information signals;
---Alarm;
---Vibration signal;
---Keyboard and mouse; and
---Tactile control.
Clause 4.1 Application conditions for ME equipment
This section specifies specific risk requirements related to availability. Compliance with these requirements can be presumed to establish that the remaining risk has been reduced to a
The level of acceptance, unless there is objective evidence to the contrary. This follows the “this part or its parallel or special standard needles” declared in the general standard 4.2.
Requirements and acceptance criteria are put forward for certain specific risks. If these requirements are met, it should be presumed that the established residual risks have been reduced to an acceptable level.
The level of acceptance, unless there is objective evidence to the contrary".
The criteria for judging the acceptable risk are established in the availability confirmation plan. The plan stipulates the effectiveness of determining the availability of the main operational functions
Confirmation criteria.
Clause 4.2 Usability engineering process of ME equipment
The first edition of IEC 60601-1-6 was released in.2004, and proposed a usability engineering process suitable for ME equipment. IEC 60601-1-6 Section
The second edition was released in.2006 in order to keep the parallel standard consistent with the third edition of IEC 60601-1, mainly in IEC 60601-1.2005.
Including the ISO 14971 risk management process. The usability engineering process described in the second edition of IEC 60601-1-6 is the same as that described in the second edition of IEC 60601-1-6.
There is almost no difference in the first edition.
After the release of the first edition of IEC 60601-1-6, IEC /SC62A and ISO /TC210 formed a project team to develop a
The usability engineering process standard for all medical devices defined in the ISO quality system standard ISO 13485.2003.The project and extraction
The risk management process described in IEC 60601-1-4 and included in ISO 14971 is similar in scope. IEC 62366.2007
It is the product of the availability standards of IEC /SC62A and ISO /TC210.
The description of usability engineering in IEC 62366 is more mature and refined than the process description in the second edition of IEC 60601-1-6, but the two are based on
This is the same.
The scope of IEC 60601-1 and this part is limited to the type test of ME equipment, which does not extend to life cycle monitoring.
For this reason, the monitoring and planning of production and post-production information according to the requirements of the ISO 14971 framework does not include the
In the process of usability engineering. The requirements of IEC 62366 for regular maintenance are also not included in the availability engineering process.
Due to the risk management process in the front, a small part of the second edition IEC 60601-1-6 has been deleted from the general standard of usability engineering.
Content, for example, in IEC 62366, users are defined as "users of medical devices, such as those who operate or process equipment." This definition includes that
Those who clean, maintain, or install equipment. In IEC 60601-1.2005 A1.2012, these personnel are defined as "maintenance
Personnel". This chapter establishes a corresponding relationship between the requirements of the general process in IEC 62366 and the special application in ME equipment.
Clause 5 replaces the requirements in YY/T 1474-2016
Chapter 6 of YY/T 1474-2016 stipulates the general requirements for the materials that need to be included in the accompanying documents if the accompanying docume...