YY 9706.256-2023 English PDFUS$859.00 · In stock
Delivery: <= 7 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 9706.256-2023: Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Status: Valid
Basic dataStandard ID: YY 9706.256-2023 (YY9706.256-2023)Description (Translated English): Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: C39 Classification of International Standard: 11.040.55 Word Count Estimation: 45,435 Date of Issue: 2023-03-14 Date of Implementation: 2026-05-01 Older Standard (superseded by this standard): YY 0785-2010 Issuing agency(ies): State Drug Administration Summary: This standard specifies the special requirements for the basic safety and basic performance of clinical thermometers and their accessories. This document applies to all electronic clinical thermometers used to measure the temperature of patients, including medical electrical equipment for measuring and displaying body temperature. Clinical thermometers can be equipped with interfaces to contain secondary indicators, printing equipment and other auxiliary equipment to form a medical electrical system. This document does not apply to auxiliary equipment, nor does it apply to screen thermal imaging cameras used for non-invasive fever temperature screening of populations under indoor environmental conditions. YY 9706.256-2023: Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. ICS11:040:55 CCSC39 Pharmaceutical Industry Standard of the People's Republic of China Replace YY 0785-2010 Medical electrical equipment part 2-56: for body temperature Basic safety and basics of clinical thermometers for measuring Performance Specific Requirements measurement (ISO 80601-2-56:2017, MOD) 2023-03-14 release 2026-05-01 implementation Released by the State Drug Administration table of contentsPreface III Introduction V 201:1 *Scope, purpose and related criteria1 201:2 Normative references 2 201:3 Terms and Definitions 3 201:4 General requirements 6 201:5 General requirements for testing of ME EQUIPMENT 6 201:6 Classification of me equipment and me systems6 201:7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION 6 201:8 Protection against electric shock hazards for ME EQUIPMENT8 201:9 Protection against mechanical hazards by ME EQUIPMENT and ME SYSTEMS 8 201:10 Protection against unwanted or excessive radiation hazards (sources)8 201:11 Protection against extreme temperatures and other hazards (sources)8 201:12 Accuracy of controls and instruments and protection against hazardous outputs9 201:13 ME EQUIPMENT HAZARDOUS CONDITIONS AND FAULT CONDITIONS 10 201:14 Programmable electrical medical systems (PEMS) 10 201:15 Construction of ME EQUIPMENT 10 201:16 ME system 10 201:17 Electromagnetic compatibility of me equipment and me systems10 201:101 Laboratory performance requirements 10 201:102 *Clinical Accuracy Confirmation 12 201:103 * Probes, cable extensions and probe covers for probes 14 202 Electromagnetic Compatibility Requirements and Tests 15 202:6 Electromagnetic Compatibility 15 206 Availability 15 208 General requirements, tests and guidelines for alarm systems in medical electrical equipment and medical electrical systems 16 211 Requirements for medical electrical equipment and medical electrical systems used in home care environments 16 212 Requirements for medical electrical equipment and medical electrical systems used in emergency medical service environments 16 Appendix C (informative) Guiding requirements for marking and marking of me equipment and me systems 18 Appendix D (Informative) Symbols 20 Appendix AA (Informative) Special Guidance and Rationale 22 Appendix BB (Informative) Reference Temperature Source 32 Appendix CC (informative) Conforms to ISO /T R16142 Basic rules for the safety and performance of medical devices Reference 33 Appendix DD (Informative) Terminology 34 Reference 37 Figure AA:101 Example of temperature-time adjustments for predictive intermittent clinical thermometers 23 Figure AA:102 General structure of a clinical thermometer 24 Figure AA:103 DUT and RCT comparison point plot example 29 Figure AA:104 Example of a Bland-Altman plot [18] of the temperature difference (DUT minus RCT) of two thermometers versus the average output temperature 30 Table:201:101 Basic performance requirements for dispersion 6 Table:201:102 Subject Age Group 13 Table:201:C:101 External markings for clinical thermometers or parts thereof18 Table:201:C:102 Accompanying documents for clinical thermometers, overview 18 Table:201:C:103 Accompanying documents for clinical thermometers, instructions for use 19 Table AA:101 Tests required for clinical thermometers 26 Table AA:102 Examples of working conditions and reference temperature combinations for testing laboratory accuracy 26 Table AA:103 Example of Clinical Accuracy Confirmation Test Results 30forewordThis document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents" drafting: This document is Part 2-56 of Medical Electrical Equipment: The "Medical Electrical Equipment" series of standards have published the following parts: --- Part 1: General requirements and parallel requirements; --- Part 2: Special requirements: This document replaces YY 0785-2010 "Performance Requirements for Electronic Thermometers for Continuous Measurement of Clinical Thermometers", and is consistent with YY 0785-2010 In comparison, except for structural adjustments and editorial changes, the main technical changes are as follows: --- Added basic performance requirements (see:201:4:3); --- Changed the measurement range (see:201:12:1:101, 6:2 of the:2010 edition); --- Increased the relevant requirements in the general test (see:201:101:1); ---Changed the range of the maximum allowable error (see:201:101:2, 6:3 of the:2010 edition); --- Added confirmation of clinical accuracy (see:201:102); ---Deleted the relevant requirements of "self-inspection device" (see 6:10:5 of the:2010 edition); ---Deleted the relevant requirements of "maximum energy dissipation" (see 6:11:1 of the:2010 edition); --- Deleted the relevant requirements of "long-term stability" (see 6:11:2 of the:2010 edition); --- Deleted the relevant requirements of "body fluid protection" (see 6:11:3 of the:2010 edition); --- Added requirements for usability (see Chapter 206); --- Increased the requirements for equipment used in the home care environment (see Chapter 211); --- Added requirements for equipment used in emergency medical service environments (see Chapter 212): This document uses the redrafted method to revise and adopt ISO 80601-2-56:2017 "Medical Electrical Equipment Part 2-56: Used for body temperature measurement Special Requirements for Basic Safety and Essential Performance of Clinical Thermometers: This document incorporates the amendments to ISO 80601-2-56:2017/Amd1:2018, the clauses involved in these amendments have been adopted in It is indicated by a vertical double line (‖) in the outer margin: The main differences between this document and ISO 80601-2-56:2017 are as follows: --- Regarding normative reference documents, this document has made adjustments with technical differences to adapt to my country's technical conditions and adjustments Centrally reflected in:201:2 "Normative Reference Documents", the specific adjustments are as follows: ● IEC 60601-1:2012 is replaced by GB 9706:1-2020, which adopts international standards; ● Replace IEC 60601-1-2:2014 with YY 9706:102-2021, which adopts the international standard; ● Replace IEC 60601-1-8:2006 AMD1:2012 with YY 9706:108-2021, which adopts international standards; ● Replace IEC 60601-1-6:2010 AMD1:2013 with YY/T 9706:106-2021, which adopts international standards; ● Replaced ISO 14937:2009 with GB/T:19974, which is equivalent to the international standard; ● Replaced ISO 15223-1:2016 with YY/T 0466:1-2016, which is equivalent to the international standard; ● Replaced ISO 17664:2004 with YY/T 0802, which is equivalent to the international standard; ● Replace IEC 60601-1-11:2015 with YY 9706:111-2021, which adopts international standards; ● Replace IEC 60601-1-12:2014 with YY 9706:112-2021, which adopts the international standard; ● Removed ISO 14155:2011: --- The requirements for confirmation of clinical accuracy in the international text are revised to be carried out in accordance with the relevant regulations of clinical evaluation in my country (see:201:102): The following editorial changes have also been made to this document: --- The title of Appendix CC is retained, and the specific content of Appendix CC is deleted; --- Deleted "forehead skin" in the example of term:201:3:220: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is sponsored by the National Medical Electrical Appliance Standardization Technical Committee Medical Electronic Instrument Standardization Sub-Technical Committee (SAC/TC10/SC5) Focus on: The release status of previous versions of this document and the documents it replaces are as follows: ---First published as YY 0785-2010 in:2010; --- This is the first revision:IntroductionSafety standards for medical electrical equipment, also known as the 9706 series of standards, are proposed to be composed of general standards, collateral standards, specific standards, guidelines and interpretations constitute: ---General standard: The safety standard that medical electrical equipment should be generally applicable, that is, the equipment that meets the definition of medical electrical equipment should meet this Basic standard requirements: --- Parallel standards: safety standards that should be generally applicable to medical electrical equipment, but in most cases are limited to certain specific functions or special It is only the equipment that needs to meet the requirements of such standards: ---Special standards: Safety standards applicable to a certain type of medical electrical equipment, and not all medical electrical equipment have specific standards standard: ---Guidelines and interpretations: application guidelines and explanations for the relevant requirements of the standards involved: This document is mainly for electronic clinical thermometers that are currently on the market or will be on the market in the future: The purpose of a clinical thermometer is to provide an assessment of the true temperature of a reference body part: A patient's temperature is an important element in assessing their overall health: For vital signs, it is usually used in combination with blood pressure and pulse rate: One of the important purposes of a clinical thermometer is to determine whether a patient is febrile, afebrile, or Hypothermia, as fever indicates that the patient is ill: The temperature of each reference body part varies according to the thermal balance between heat generation, transfer, and loss [2]: Compare Clinical Thermometers The clinical body temperature can be confirmed by comparing the output temperature of the reference thermometer (which has a specific true temperature measurement uncertainty) with the output temperature of the reference thermometer The clinical accuracy of the meter: For balanced clinical thermometers, it can be adequately determined under laboratory conditions in which the two thermometers form a state of equilibrium clinical accuracy: For clinical thermometers operating in conditioning mode, laboratory validation alone is not sufficient because the temperature used to derive the output temperature Patient and environment characteristics are also included in the adjustment algorithm [3]: Therefore, the clinical accuracy of clinical thermometers operating in adjustment mode Clinical confirmation must be performed using statistical methods: Its output temperature needs to be compared with a reference clinical thermometer (the thermometer is measured at a specific reference body The temperature of the site has a specific clinical accuracy) compared to the output temperature: For clinical thermometers operating in the adjusted mode, the laboratory accuracy is verified in the direct mode, and the clinical accuracy is verified in the adjusted mode: Validation is performed in the mode of operation (operating mode), during which a sufficiently large cohort of human subjects is used: The purpose of this document is to: Validate the laboratory accuracy of all types of electronic clinical thermometers and operate in adjustment mode The clinical accuracy validation of clinical thermometers specifies the corresponding requirements and test procedures: An asterisk (*) as the first character of a heading, paragraph heading, or table heading indicates that there is a reference to the entry in Appendix AA: Nam or reason description: Medical electrical equipment part 2-56: for body temperature Basic safety and basics of clinical thermometers for measuring Performance Specific Requirements 201:1 *Scope, purpose and related criteria Except for the following, Chapter 1 of GB 9706:1-2020 applies: 201:1:1 Scope replace: This document specifies the special requirements for basic safety and basic performance of clinical thermometers and their accessories (hereinafter referred to as ME equipment): This article This part is applicable to all electronic clinical thermometers used to measure the body temperature of patients, including medical electrical equipment for measuring and displaying body temperature: Example 1: ME EQUIPMENT for determining cardiac output by thermodilution using an accessory (for example, a pulmonary artery catheter) is included within the scope of this document if it indicates body temperature: Example 2: ME EQUIPMENT using accessories (for example, Foley catheters with temperature probes) is within the scope of this document: Clinical thermometers can be equipped with interfaces to contain secondary indicators, printing equipment and other auxiliary equipment, thus forming a medical electrical system System: This document does not apply to assistive devices: It is also not suitable for non-invasive fever temperature screening of the crowd under indoor environmental conditions: Screen thermal imager (see IEC 80601-2-59 [4]): The inherent hazards of the intended physiological functions of ME EQUIPMENT or ME SYSTEMS are not included in the specific requirements of this document, but GB 9706:1- Except for 7:2:13 and 8:4:1 of 2020: Note 1: If a clause or subclause applies only to ME EQUIPMENT or ME SYSTEM, the title and content of the clause or subclause will state this: if you don't say If stated, the clause or subclause applies to both the relevant me equipment and me system: Note 2: Supplementary information can be found in 4:2 of GB 9706:1-2020: 201:1:2 Purpose replace: The purpose of this document is to develop specific requirements for the basic safety and essential performance of clinical thermometers and their accessories as defined in:201:3:207: Require: NOTE: Accessories are also included, as the combination of clinical thermometer and accessories is required to be safe and effective: Attachment to the basic safety and fundamentals of clinical thermometers can have a major impact: 201:1:3 Collateral Standards Supplement: This document refers to the applicable collateral standards listed in Chapter 2 of GB 9706:1-2020 and:201:2 of this document: YY 9706:102, YY/T 9706:106, YY 9706:108, YY 9706:111 and YY 9706:112 respectively in accordance with Chapter 202, Chapters 206, 208, 211 and 212 apply as amended: GB 9706:103 is not applicable: In the 9706 series of standards all Other published collateral standards apply as published: 201:1:4 Particular standards replace: In the 9706 series of standards, particular standards may modify, replace or delete general standards and parallel ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 9706.256-2023_English be delivered?Answer: Upon your order, we will start to translate YY 9706.256-2023_English as soon as possible, and keep you informed of the progress. 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