YY 9706.261-2023 English PDFUS$1509.00 · In stock
Delivery: <= 9 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 9706.261-2023: Geometrical product specifications (GPS) - Geometrical tolerancing - Datums and datum systems Status: Valid
Basic dataStandard ID: YY 9706.261-2023 (YY9706.261-2023)Description (Translated English): Geometrical product specifications (GPS) - Geometrical tolerancing - Datums and datum systems Sector / Industry: Medical Device & Pharmaceutical Industry Standard Classification of Chinese Standard: J04 Classification of International Standard: 11.040.10 Word Count Estimation: 79,785 Date of Issue: 2023-01-13 Date of Implementation: 2026-01-15 Issuing agency(ies): State Drug Administration Summary: This standard specifies the basic safety and basic performance of pulse oximetry equipment. This standard applies to pulse oximetry equipment for human use and reprocessed pulse oximetry equipment. Pulse oximetry equipment includes pulse oximeter monitors, pulse oximeter probes and cable extensions for probes. This standard applies to, but is not limited to, pulse oximetry devices intended to estimate a patient's arterial oxygen saturation and pulse rate in professional healthcare settings, home care settings, and emergency medical services settings. This standard also applies to pulse oximetry devices for the compensation or mitigation of illness, injury or disability, and pulse oximetry devices intended to be used in extreme or uncontrolled environments outside the hospital or physician's office, such as: ambulance and aviation Transit, Supplemental Standards apply to pulse oximetry devices used in these environments. This standard does not apply to laboratories YY 9706.261-2023: Geometrical product specifications (GPS) - Geometrical tolerancing - Datums and datum systems---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. ICS 11.040.10 CCSC39 Pharmaceutical Industry Standard of the People's Republic of China Replace YY 0784-2010 Medical Electrical Equipment Part 2-61.Pulse Oxygen Particular requirements for basic safety and essential performance of equipment (ISO 80601-2-61.2017, MOD) Released on 2023-01-13 2026-01-15 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 7 201.5 General requirements for testing of ME EQUIPMENT 8 201.6 Classification of me equipment and me systems8 201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION8 201.8 Protection against electric shock hazards for ME EQUIPMENT 11 201.9 Protection against mechanical hazards by ME EQUIPMENT and ME SYSTEMS 12 201.10 Protection against unwanted or excessive radiation hazards12 201.11 Protection against extreme temperatures and other hazards12 201.12 Accuracy of controls and instruments and protection against hazardous outputs13 201.13 Dangerous situations and fault states 16 201.14 Programmable electrical medical systems (PEMS) 16 201.15 Construction of ME EQUIPMENT 17 201.16 ME system 17 201.17 Electromagnetic compatibility of me equipment and me systems18 201.101 * Pulse oximeter probes and probe cable extensions 18 201.102 Saturation pulse information signal 18 201.103 Functional connection 18 202 Electromagnetic Compatibility Requirements and Tests 19 206 Availability 19 206.5 Replace the requirement 20 in YY/T 1474-2016 208 General requirements, tests and guidelines for alarm systems in medical electrical equipment and medical electrical systems 20 211 Requirements for medical electrical equipment and medical electrical systems used in home care environments 20 212 Requirements for medical electrical equipment and medical electrical systems used in emergency medical service environments 20 Appendix C (informative) Guidance requirements for marking and marking of ME EQUIPMENT and ME SYSTEMS 21 Appendix D (Informative) Symbols 24 Appendix AA (Informative) Special Guidance and Rationale 26 Appendix BB (informative) The temperature at which the blood oxygen probe contacts the skin 33 Appendix CC (Informative) Determination of Accuracy 36 Appendix DD (Informative) Calibration Standard 44 Appendix EE (informative) Guidance on the assessment and recording of SpO2 accuracy in humans45 Appendix FF (informative) Simulators, calibrators and functional testers for pulse oximeter equipment 51 Appendix GG (informative) ME EQUIPMENT RESPONSE TIME CONCEPT 59 Appendix HH (Normative) Data Interface Requirements 63 Appendix II (Informative) References to Ground Rules 66 Appendix JJ (Informative) Terminology Index 67 Reference 71 Figure CC.1 synthetic calibration data (basic data) 37 Figure CC.2 Superimposition of fixed deviations on basic data 38 Figure CC.3 Superimpose a dip on the basic data 39 Figure CC.4 Local deviation definition diagram (the measured value SpO2 is a function of the reference value SR) 40 Figure CC.5 Definition diagram of local deviation and mean difference (the measured value SpO2 is a function of the reference value SR) 40 Figure CC.6 Average difference of PEFR data 43 Figure EE.1 Example of desaturation time curve 47 Figure FF.1 Example of a calibration curve for a pulse oximeter device (the relationship between the modulation ratio R of red/infrared light and arterial oxygen saturation) 53 Figure FF.2 Interface of a functional tester using photodiodes and LEDs interacting with a pulse oximeter probe 54 Figure FF.3 Interface of functional tester using dyeing mixture 55 Figure FF.4 Functional tester interface with liquid crystal regulator 55 Figure FF.5 Absorption of blue bandage material (measured in reflectance) for calibration of pulses with large variability between patients Special Tests for SpO2 Probes 57 Figure FF.6 High variability pulse oximetry probe, calibration in a controlled desaturation study of 5 test subjects57 Figure GG.1 Fidelity of pulse oximetry device performance as a function of pulse oximetry variation legend 60 Figure GG.2 Legend for the effect of different averaging times on fidelity 60 Figure GG.3 Alarm system delay composition Legend 61 Figure GG.4 Legend for the effect of different averaging times on a fast and noisy hypoxic signal62 Table.201.101 Basic performance requirements for dispersion 7 Table.201.C.101 External marking of pulse oximetry equipment, components or accessories 21 Table.201.C.102 Overview of Accompanying Documents 21 Table.201.C.103 Accompanying documents, instructions for use 22 Table.201.C.104 Accompanying documents, technical description 23 Table.201.D.101.1 Supplementary notation 24 Table AA.1 Qualitative assessment of pulse oximetry devices in shock and vibration environments 30 Table BB.1 Safe use time and source of pulse oximeter probe 34 Table EE.1 Example of target platform and range 47 Table HH.101 Parameters and units of measurement 63 Table HH.102 Equipment identification 64 Table HH.103 Operator-adjustable equipment settings 64 Table HH.104 Equipment Configuration 65 Table HH.105 Equipment Specifications 65 Table HH.106 Service monitoring indicators 65forewordThis 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. The "Medical Electrical Equipment" series of standards are divided into two parts. --- Part 1.General requirements and parallel requirements; --- Part 2.Special requirements. This document is Part 2-61. This document replaces YY 0784-2010 "Special Requirements for Basic Safety and Main Performance of Medical Electrical Equipment and Medical Pulse Oximeter Equipment" "Seeking", compared with YY 0784-2010, except for structural adjustment and editorial changes, the main technical changes are as follows. --- Added basic performance requirements (see.201.4.102); --- Increased availability requirements (see 206); --- Added requirements for household equipment (see 211); --- Increased requirements for first aid equipment (see 212). This document uses the redrafted method to revise and adopt ISO 80601-2-61.2017 "Medical Electrical Equipment Part 2-61.Pulse Oxygen Device Particular Requirements for Basic Safety and Essential Performance of Equipment". The technical differences between this document and ISO 80601-2-61.2017 and their reasons 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. ● Replace IEC 60601-1-2.2007 with YY 9706.102-2021, which adopts the international standard; ● Replace IEC 60601-1-6.2010 AMD1.2013 with YY/T 9706.106-2021, which adopts international standards; ● Replace IEC 60601-1-8.2006 AMD1.2012 with YY 9706.108-2021, which adopts international standards; ● Replace IEC 60825-1.2014 with GB 7247.1, which is equivalent to the international standard; ● Replaced ISO 7000 with GB/T 16273.1-2008, which is not equivalent to the international standard; ● Replaced ISO 7010.2011 with GB/T 31523.1-2015, which adopts international standards; ● Replace IEC 60601-1-11.2010 with YY 9706.111-2021, which adopts the international standard; ● Replace IEC 60601-1-12.2014 with YY 9706.112-2021, which adopts the international standard; ● Replaced IEC 60825-2.2004 amd1.2006 with GB/T 7247.2-2018, which is equivalent to the international standard; ● Replaced IEC 62366-1.2015 with YY/T 1474-2016 which was adopted equally; ● IEC 60068-2-31.2008 was deleted due to non-standard reference; ● IEC 60417 was deleted due to non-standard reference; ● Deleted ISO 14937.2009; ● Deleted ISO 14155.2011; --- In.201.11.6.5.101, the description of the scope of application has been added regarding the protection level; --- The requirements for confirmation of clinical accuracy in international documents are revised to be carried out in accordance with the relevant regulations of clinical evaluation in my country (see 201.12.1.101.2, EE.1). 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 0784 in.2010; ---This is the first revision, and the document number is YY 9706.261-2023.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 standards. generally applicable safety standards for medical electrical equipment, that is, equipment that meets the definition of medical electrical equipment should meet this basic basic standard requirements. --- Parallel standard. generally applicable safety standards for medical electrical equipment, but in most cases limited to certain specific functions or characteristics The equipment needs to meet the requirements of such standards. ---Specific standards. Safety standards applicable to a certain type of medical electrical equipment, and not all medical electrical equipment have specific standards. ---Guidelines and interpretations. application guidelines and explanations for the relevant requirements of the standards involved. In many medical fields, pulse oximetry is widely used to estimate arterial oxygen saturation and pulse rate. This document covers the prior art The basic safety and basic performance requirements that can be achieved within the scope. This document modifies and supplements GB 9706.1-2020 "Medical Electrical Equipment Part 1.General Requirements for Basic Safety and Essential Performance (hereinafter referred to as the General Standard). Appendix AA contains a rationale for some of the requirements, which includes the background and reasons for certain requirements, and the identification of related issues that need to be addressed. danger. An asterisk (*) used in this document as the first character of a heading or at the beginning of a paragraph or table heading indicates that there is a Specific guides and rationale for this project. Appendix BB is a literature survey regarding the determination of the maximum safe temperature between the pulse oximetry probe and patient tissue interface. Appendix CC discusses the formulas for evaluating the blood oxygen accuracy of pulse oximetry devices and the nomenclature of these formulas. Appendix DD presents guidance on when blood gas calibration of pulse oximetry equipment is required. Appendix EE presents guidelines for the calibration of pulse oximetry devices through controlled desaturation studies. Appendix FF is a tutorial describing the tester used with various pulse oximeters. Appendix GG describes the concept of pulse oximetry device response time. Appendix HH describes the data interface requirements. Appendix II is not adopted. Medical Electrical Equipment Part 2-61.Pulse Oxygen Particular requirements for basic safety and essential performance of equipment 201.1 Scope, Purpose and Related Standards Except as described below, Chapter 1 of the general standard applies. 201.1.1 *Scope replace. This document specifies the basic safety and essential performance of pulse oximetry equipment (hereinafter referred to as ME equipment). This document applies to pulse oximetry devices for human use and reprocessed pulse oximetry devices. ME EQUIPMENT including pulse oximetry monitoring meter, pulse oximeter probe, and probe cable extension. This document is intended for use in, but not limited to, the estimation of arterial Pulse oximetry device for oxygen saturation and pulse rate. This document also applies to pulse oximetry devices for the compensation or mitigation of illness, injury, or disability, and those For use of pulse oximetry equipment outdoors in extreme environments or in uncontrolled environments, such as ambulances and air transport, supplementary standards apply where pulse oximeters for use in these environments. This document does not apply to pulse oximetry equipment used in laboratory research, nor does it apply to oximeters that require the collection of blood samples from patients. This document does not apply to fetal pulse oximeters. This document does not apply to remote or slave (secondary) devices placed outside the patient's environment that display SpO2 values. Note 1 to entry. If a clause or clause clearly states that it applies only to me equipment or me systems, the title and text of the clause or clause will indicate that. If this is not the case, The relevant clause or subclause applies to both me equipment and me systems. Note 2 to entry. ME EQUIPMENT providing a selection of diagnostic and monitoring functions is expected to meet the requirements of the corresponding documentation when this function is configured. Intrinsic hazards arising from the intended physiological effects of me equipment or me systems within the scope of this document are not covered by the requirements specified in this document. In addition to.201.11 and general standards 7.2.13 and 8.4.1. Note 3.See 4.2 of the general standard, "general standard" refers to GB 9706.1-2020. 201.1.2 Purpose replace. The purpose of this document is to establish specific basic safety and essential performance requirements for pulse oximetry equipment (as defined in.201.3.217) and its accessories Require. NOTE. Accessories are included because the combination of the pulse oximeter and its accessories needs to be sufficiently safe. accessories for the basic safety and Basic performance has a significant impact. 201.1.3 Collateral Standards Supplement. This document refers to Chapter 2 of the General Standard as well as applicable collateral standards listed in.201.2 of this document. YY 9706.102, YY/T 9706.106, YY 9706.108, YY 9706.111 and YY 9706.112 are applicable to Article 202, Modifications in 206, 208, 211 and 212, GB 9706.103 does not apply, all other published parallel standards in the 9706 series of standards according to as published. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 9706.261-2023_English be delivered?Answer: Upon your order, we will start to translate YY 9706.261-2023_English as soon as possible, and keep you informed of the progress. The lead time is typically 6 ~ 9 working days. 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