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Position: Chinese Standard in English/YY/T 9706.106-2021
YY/T 9706.106-2021   Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability (English Version)
Standard No.: YY/T 9706.106-2021 Status:valid remind me the status change

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Standard No.: YY/T 9706.106-2021
English Name: Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability
Chinese Name: 医用电气设备 第1-6部分:基本安全和基本性能的通用要求 并列标准:可用性
Chinese Classification: C30    Medical apparatus and devices in general
Professional Classification: YY    Professional Standard - Pharmaceutics
Issued by: National Medical Products Adminstration
Issued on: 2021-03-09
Implemented on: 2023-5-1
Status: valid
Language: English
File Format: PDF
Word Count: 9500 words
Price(USD): 285.0
Delivery: via email in 1 business day
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
Referred in YY/T 9706.106-2021:
*GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
*YY/T 0316-2016 Medical devices-Application of risk management to medical devices
*YY 9706.108-2021 Medical electrical equipment—Part 1-8:General requirements for basic safety and essential performance-Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
*YY/T 1474-2016 Medical devices-Application of risk management to medical devices
*GB/T 95-2002 Plain washers - Product grade C
*GB/T 2664-2009 Mens suits and coats
*GB 4706.1-2005 Household and Similar Electrical Appliances – Safety - Part 1: General Requirements
*GB 17625.1-2022 Electromagnetic compatibility—Limits—Part 1: Limits for harmonic current emissions (equipment input current ≤ 16A per phase)
*GB/T 14048.5-2017 Low-voltage switchgear and controlgear-Part 5-1:Control circuit devices and switching element-Electromechanical control circuit devices
*GB 17625.1-2022 Electromagnetic compatibility—Limits—Part 1: Limits for harmonic current emissions (equipment input current ≤ 16A per phase)
*QB/T 1333-2018 Handbag and Knapsack
*GB 2762-2022 National Food Safety Standard - Maximum Levels of Contaminants in Foods
*GB/T 22849-2014 Knitted T-shirt
*GB 5749-2022 Standards for drinking water quality
*GB 14748-2006 Safety Requirements for Wheeled Child Conveyances
*GB/T 1591-2018 High strength low alloy structural steels
*GB 4943.1-2011 Information technology equipment -Safety - Part 1: General requirements
*GB 2763-2021 National Food Safety Standard-Maximum Residue Limits for Pesticides in Food
*GB/T 35590-2017 Information technology―General specification for portable digital equipments used power bank
*QB/T 1858-2004 Perfume and cologne
*HG/T 20592-2009 Stee1 Pipe F1anges (PN designated)
*GB 3565-2005 Safety requirements for bicycles
*GB/T 39335-2020 Information security technology—Guidance for personal information security impact assessment
*GA 374-2019 Burglary-resistant electronic locks
*GB/T 19001-2016 Quality management systems―Requirements
*GB 4943.1-2022 Audio/video,information and communication technology equipment—Part 1: Safety requirements
*GB 4806.7-2016 National Food Safety Standard - Food Contact Plastic Materials and Articles
*GB/T 35590-2017 Information technology―General specification for portable digital equipments used power bank
*GB 150-2011 Pressure Vessels (Collection GB150.1~150.4-2011)
*GB/T 5750-2006 Standard examination methods for drinking water
*JB/T 10391-2008 Specification for Yseries(IP44)three asynchronous motor (Frame size 80~355)
*GB 14880-2012 National Food Safety Standard for the Use of Nutritional Fortification Substances in Foods
*GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
YY/T 9706.106-2021 is referred in:
*YY 9706.112-2021 Medical electrical equipment—Part 1-12:General requirements for basic safety and essential performance—Collateral Standard:Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
*GB/T 8145-1987 Gum rosin
*GB/T 8145-2003 Gum rosin
*GB/T 8145-2021 Gum rosin
*GB/T 20491-2006 Steel slag powder used for cement and concrete
*GB 11244-1989 General specifications for medical fiber endoscope
*GB 11244-2005 General requirements for the medical endoscope and endoscope accessories
*GB 19778-2005 Packaging glass containers—Release of lead cadmium arsenic and antimony—Permissible limits
*GB/T 13344-1992 Downhole drill hammers and bils
*GB/T 13344-2010 Downhole drill hammers and bits
*GB/T 13344-2019 Down-the-hole hammers and bits
*YY/T 0466.1-2009 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
*YY/T 0466.1-2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
*YY/T 0466.1-2023 Medical devices―Symbols to be used with information to be supplied by the manufacturer―Part 1:General requirements
*GB/T 14480.3-2008 Non-destructive testing - Equipment for eddy current examination - Part 3: System characteristics and verification
*GB/T 14480.3-2020 Non-destructive testing instruments—Equipment for eddy current examination—Part 3:System characteristics and verification
*YY 0666-2008 Method for the test of sharpness and strength of needles tips
*GB/T 7064-1996 Requirements for turbine type synchronous machine
*GB/T 7064-2002 Requirements for turbine type synchronous machine
*GB/T 7064-2017 Specific requirements for cylindrical rotor synchronous machines
*FZ/T 01026-1993 Quantitative Chemical Analysis of Quaternary Fibre Mixtures
*FZ/T 01026-2009 Textiles—Quantitative chemical analysis—Quaternary fibre mixtures
*FZ/T 01026-2017 Textiles - Quantitative chemical analysis - Multi-component fibre mixtures
Code of China
Standard
YY/T 9706.106-2021  Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability (English Version)
Standard No.YY/T 9706.106-2021
Statusvalid
LanguageEnglish
File FormatPDF
Word Count9500 words
Price(USD)285.0
Implemented on2023-5-1
Deliveryvia email in 1 business day
Detail of YY/T 9706.106-2021
Standard No.
YY/T 9706.106-2021
English Name
Medical electrical equipment—Part 1-6:General requirements for basic safety and essential performance—Collateral Standard:Usability
Chinese Name
医用电气设备 第1-6部分:基本安全和基本性能的通用要求 并列标准:可用性
Chinese Classification
C30
Professional Classification
YY
ICS Classification
Issued by
National Medical Products Adminstration
Issued on
2021-03-09
Implemented on
2023-5-1
Status
valid
Superseded by
Superseded on
Abolished on
Superseding
Language
English
File Format
PDF
Word Count
9500 words
Price(USD)
285.0
Keywords
YY/T 9706.106-2021, YY 9706.106-2021, YYT 9706.106-2021, YY/T9706.106-2021, YY/T 9706.106, YY/T9706.106, YY9706.106-2021, YY 9706.106, YY9706.106, YYT9706.106-2021, YYT 9706.106, YYT9706.106
Introduction of YY/T 9706.106-2021
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
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Keywords:
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