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YY 9706.261-2023: Geometrical product specifications (GPS) - Geometrical tolerancing - Datums and datum systems
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Geometrical product specifications (GPS) - Geometrical tolerancing - Datums and datum systems
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YY 9706.261-2023
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Basic data | Standard 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
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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 contents
Preface 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 65
foreword
This 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.
Introduction
Safety 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.
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