Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
The series standard of Medical electrical equipment is divided into two parts:
——Part 1: General and collateral requirements;
——Part 2: Particular requirements.
This part is Part 1-6.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This part has been redrafted and modified in relation to IEC 60601-1-6: 2013 Medical electrical equipment—Part 1-6: General requirements for basic safety and essential performance—Collateral standard: Usability.
The main technical differences with respect to IEC 60601-1-6: 2013 and the reasons are as follows:
——As for the normative references, adjustments of technical differences are made to this part to keep them in line with the technical conditions in China. The adjustments are embodied in a concentrated way in Clause 2 “Normative references”, specifically as follows:
● IEC 60601-1: 2005+AMD1: 2012 is replaced by GB 9706.1-2020 modified in relation to the international standard;
● ISO 14971: 2007 is replaced by YY/T 0316, which is identical to the international standard;
● IEC 60601-1-8: 2006+AMD1: 2012 is replaced by YY 9706.108, which is modified in relation to international standard.
Editorial changes have been made in this part as follows:
——A.3 is added to Annex A, which gives the corresponding relationship between international standards and current national standards or professional standards in China;
——The title of Annex B is retained and specific content of Annex B is deleted.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this standard shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
This standard is under the jurisdiction of National Technical Committee on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10)
Drafting organizations of this part: Shanghai Testing & Inspection Institute for Medical Devices, Shenzhen Mindray Biomedical Electronics Co., Ltd.
Chief drafters of this part: He Jun, Shao Lingyun and Hu Sheng.
Medical electrical equipment—
Part 1-6: General requirements for basic safety and essential performance—
Collateral standard: Usability
1 Scope, object and related standards
1.1 *Scope
This part specifies a process for a manufacturer to analyze, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment, hereinafter referred to as ME equipment.
This usability engineering process assesses and mitigates risks caused by usability problems as associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.
If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of YY/T 1474-2016), then the residual risks, as defined in YY/T 0316, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of YY/T 1474-2016).
Note: the asterisk (*) as the first character of a title or the beginning of a paragraph or table title indicates that there are guidelines or rationale related to it in Annex A.
1.2 Object
The object of this part is to specify the general requirements that are in addition to those of the general standard and to serve as the basis for special standards.
1.3 Related standards
1.3.1 GB 9706.1
For ME equipment, this part complements GB 9706.1.
When referring to GB 9706.1 or to this part, either individually or in combination, the following conventions are used:
——“the general standard" designates GB 9706.1-2020 alone;
——"this part" only designates YY/T 9706.106-2021;
——“this standard" designates the combination of the general standard and this part.
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirements in this part.
2 Normative references
The following referenced documents are indispensable for the application of this standard. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601-1: 2012, MOD)
YY/T 0316 Medical devices—Application of risk management to medical devices (YY/T 0316-2016, ISO 14971: 2007 corrected version, IDT)
YY 9706.108 Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, test and guidance 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 Medical devices—Application of usability engineering to medical devices (IEC 62366: 2007, IDT)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 9706.1-2020, YY 9706.108, YY/T 1474-2016 as well as the following apply.
3.1
*operator-equipment interface
means by which the operator and the ME equipment communicate
Note 1: It is revised from Term 3.24 in ANSI/AAMI HE 74: 2001.
Note 2: The accompanying documents are considered as part of ME equipment and operator-equipment interface.
3.2
operator profile
summary of the mental, physical and demographic traits of the intended OPERATOR population, as well as any special characteristics that can have a bearing on design decisions, such as occupational skills and job requirements
4 General requirements
4.1 *Conditions for application to ME equipment
The ME equipment shall provide adequate usability such that the risks from normal use and use error are acceptable (see 7.1.1 and 12.2 of the general standard).
Compliance with this subclause is considered to exist when compliance with 4.2 and other clauses and subclauses of this collateral standard is demonstrated.
4.2 *Usability engineering process of ME equipment
A usability engineering process complying with YY/T 1474-2016 shall be performed except:
——the planning for and execution of production and post-production monitoring in the context of applying usability engineering process within the framework of YY/T 0316; and
——maintenance of usability engineering process.
In applying YY/T 1474-2016, the terms in this part and those in GB 9706.1-2020 shall be used as follows:
——The term “medical device” shall assume the same meaning as ME equipment;
——The term “user” shall assume the same meaning as operator;
——The term “patient” shall include animals;
——The term “safety” shall assume the same meaning as basic safety and essential performance;
——The term “user interface” shall assume the same meaning as operator-equipment interface;
——The term “user profile” shall be equivalent to the operator profile;
Compliance is checked by inspection of the usability engineering file. Evidence of
compliance with this clause and all requirements of this standard referring to inspection of the usability engineering file are satisfied if the manufacture has:
——established a usability engineering process;
——established acceptance criteria for usability; and
——demonstrated that the acceptance criteria for usability have been met.
5 *Replacement of requirements given in YY/T 1474-2016
On the basis of the requirements of YY/T 1474-2016, the following replacements shall apply:
Replace the first two paragraphs including Note 1 and Note 2 of Clause 6 of YY/T 1474-2016 by:
The instruction for use shall include a brief description of the ME equipment, its physical operation principles and significant physical and performance characteristics relevant to its usability. The same information shall also be included in the technical description, if this is provided as a separate document.
Note: An important purpose of this description is to help operators to develop a correct mental model for ME equipment.
The instructions for use shall contain a summary of the application specification.
Foreword i 1 Scope, object and related standards 2 Normative references 3 Terms and definitions 4 General requirements 5 *Replacement of requirements given in YY/T 1474- Annex A (Informative) General guidance and rationale Annex B (Informative) Mapping between elements of IEC 60601-1-6: 2006 and related elements in IEC 62366: Annex C (Informative) References to items of usability provided in IEC 62366: 2007 and their use in other standards Bibliography
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
The series standard of Medical electrical equipment is divided into two parts:
——Part 1: General and collateral requirements;
——Part 2: Particular requirements.
This part is Part 1-6.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
This part has been redrafted and modified in relation to IEC 60601-1-6: 2013 Medical electrical equipment—Part 1-6: General requirements for basic safety and essential performance—Collateral standard: Usability.
The main technical differences with respect to IEC 60601-1-6: 2013 and the reasons are as follows:
——As for the normative references, adjustments of technical differences are made to this part to keep them in line with the technical conditions in China. The adjustments are embodied in a concentrated way in Clause 2 “Normative references”, specifically as follows:
● IEC 60601-1: 2005+AMD1: 2012 is replaced by GB 9706.1-2020 modified in relation to the international standard;
● ISO 14971: 2007 is replaced by YY/T 0316, which is identical to the international standard;
● IEC 60601-1-8: 2006+AMD1: 2012 is replaced by YY 9706.108, which is modified in relation to international standard.
Editorial changes have been made in this part as follows:
——A.3 is added to Annex A, which gives the corresponding relationship between international standards and current national standards or professional standards in China;
——The title of Annex B is retained and specific content of Annex B is deleted.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this standard shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
This standard is under the jurisdiction of National Technical Committee on Medical Electrical Equipment of Standardization Administration of China (SAC/TC 10)
Drafting organizations of this part: Shanghai Testing & Inspection Institute for Medical Devices, Shenzhen Mindray Biomedical Electronics Co., Ltd.
Chief drafters of this part: He Jun, Shao Lingyun and Hu Sheng.
Medical electrical equipment—
Part 1-6: General requirements for basic safety and essential performance—
Collateral standard: Usability
1 Scope, object and related standards
1.1 *Scope
This part specifies a process for a manufacturer to analyze, specify, design, verify and validate usability, as it relates to basic safety and essential performance of medical electrical equipment, hereinafter referred to as ME equipment.
This usability engineering process assesses and mitigates risks caused by usability problems as associated with correct use and use errors, i.e., normal use. It can be used to identify but does not assess or mitigate risks associated with abnormal use.
If the usability engineering process detailed in this collateral standard has been complied with and the acceptance criteria documented in the usability validation plan have been met (see 5.9 of YY/T 1474-2016), then the residual risks, as defined in YY/T 0316, associated with usability of me equipment are presumed to be acceptable, unless there is objective evidence to the contrary (see 4.1.2 of YY/T 1474-2016).
Note: the asterisk (*) as the first character of a title or the beginning of a paragraph or table title indicates that there are guidelines or rationale related to it in Annex A.
1.2 Object
The object of this part is to specify the general requirements that are in addition to those of the general standard and to serve as the basis for special standards.
1.3 Related standards
1.3.1 GB 9706.1
For ME equipment, this part complements GB 9706.1.
When referring to GB 9706.1 or to this part, either individually or in combination, the following conventions are used:
——“the general standard" designates GB 9706.1-2020 alone;
——"this part" only designates YY/T 9706.106-2021;
——“this standard" designates the combination of the general standard and this part.
1.3.2 Particular standards
A requirement in a particular standard takes priority over the corresponding requirements in this part.
2 Normative references
The following referenced documents are indispensable for the application of this standard. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.
GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601-1: 2012, MOD)
YY/T 0316 Medical devices—Application of risk management to medical devices (YY/T 0316-2016, ISO 14971: 2007 corrected version, IDT)
YY 9706.108 Medical electrical equipment—Part 1-8: General requirements for basic safety and essential performance—Collateral standard: General requirements, test and guidance 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 Medical devices—Application of usability engineering to medical devices (IEC 62366: 2007, IDT)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in GB 9706.1-2020, YY 9706.108, YY/T 1474-2016 as well as the following apply.
3.1
*operator-equipment interface
means by which the operator and the ME equipment communicate
Note 1: It is revised from Term 3.24 in ANSI/AAMI HE 74: 2001.
Note 2: The accompanying documents are considered as part of ME equipment and operator-equipment interface.
3.2
operator profile
summary of the mental, physical and demographic traits of the intended OPERATOR population, as well as any special characteristics that can have a bearing on design decisions, such as occupational skills and job requirements
4 General requirements
4.1 *Conditions for application to ME equipment
The ME equipment shall provide adequate usability such that the risks from normal use and use error are acceptable (see 7.1.1 and 12.2 of the general standard).
Compliance with this subclause is considered to exist when compliance with 4.2 and other clauses and subclauses of this collateral standard is demonstrated.
4.2 *Usability engineering process of ME equipment
A usability engineering process complying with YY/T 1474-2016 shall be performed except:
——the planning for and execution of production and post-production monitoring in the context of applying usability engineering process within the framework of YY/T 0316; and
——maintenance of usability engineering process.
In applying YY/T 1474-2016, the terms in this part and those in GB 9706.1-2020 shall be used as follows:
——The term “medical device” shall assume the same meaning as ME equipment;
——The term “user” shall assume the same meaning as operator;
——The term “patient” shall include animals;
——The term “safety” shall assume the same meaning as basic safety and essential performance;
——The term “user interface” shall assume the same meaning as operator-equipment interface;
——The term “user profile” shall be equivalent to the operator profile;
Compliance is checked by inspection of the usability engineering file. Evidence of
compliance with this clause and all requirements of this standard referring to inspection of the usability engineering file are satisfied if the manufacture has:
——established a usability engineering process;
——established acceptance criteria for usability; and
——demonstrated that the acceptance criteria for usability have been met.
5 *Replacement of requirements given in YY/T 1474-2016
On the basis of the requirements of YY/T 1474-2016, the following replacements shall apply:
Replace the first two paragraphs including Note 1 and Note 2 of Clause 6 of YY/T 1474-2016 by:
The instruction for use shall include a brief description of the ME equipment, its physical operation principles and significant physical and performance characteristics relevant to its usability. The same information shall also be included in the technical description, if this is provided as a separate document.
Note: An important purpose of this description is to help operators to develop a correct mental model for ME equipment.
The instructions for use shall contain a summary of the application specification.
Contents of YY/T 9706.106-2021
Foreword i
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 *Replacement of requirements given in YY/T 1474-
Annex A (Informative) General guidance and rationale
Annex B (Informative) Mapping between elements of IEC 60601-1-6: 2006 and related elements in IEC 62366:
Annex C (Informative) References to items of usability provided in IEC 62366: 2007 and their use in other standards
Bibliography
