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YY 9706.272-2021: (Medical electrical equipment - Part 2-72: Specific requirements for the basic safety and basic performance of household ventilators used by patients who rely on ventilators)
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(Medical electrical equipment - Part 2-72: Specific requirements for the basic safety and basic performance of household ventilators used by patients who rely on ventilators)
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YY 9706.272-2021
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Basic data | Standard ID | YY 9706.272-2021 (YY9706.272-2021) | | Description (Translated English) | (Medical electrical equipment - Part 2-72: Specific requirements for the basic safety and basic performance of household ventilators used by patients who rely on ventilators) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C46 | | Word Count Estimation | 85,858 | | Issuing agency(ies) | State Drug Administration | YY 9706.272-2021: (Medical electrical equipment - Part 2-72: Specific requirements for the basic safety and basic performance of household ventilators used by patients who rely on ventilators)
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(Medical electrical equipment Part 2-72.Specific requirements for the basic safety and basic performance of household ventilators used by patients who rely on ventilators)
ICS 11.040.10
C46
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0600.2-2007
Medical Electrical Equipment Part 2-72.
of home ventilators used by ventilator-dependent patients
Particular requirements for basic safety and basic performance
(ISO 80601-2-72.2015,MOD)
2021-09-06 Released 2024-05-01 Implementation
Released by the State Drug Administration
directory
Preface VII
Introduction X
201.1 Scope, Purpose and Related Criteria1
201.1.1 *Scope 1
201.1.2 Purpose 2
201.1.3 Tied standard 2
201.1.4 Particular Standard 2
201.2 Normative References 2
201.3 Terms and Definitions 4
201.4 General Requirements 7
201.4.3 Basic performance 7
201.4.3.101 *Requirement 7 of the basic performance supplement
201.4.6 *Part 7 of ME EQUIPMENT OR ME SYSTEM IN CONTACT WITH PATIENTS
201.4.10.2 * Supply grid for ME EQUIPMENT or ME SYSTEM 8
201.4.11.101 * Requirement for Compressed Gas Input Supplement 8
201.4.11.101.1 Overvoltage requirements 8
201.4.11.101.2 Compatibility Requirements 8
201.5 General Requirements for Testing of ME Equipment 9
201.5.101 *Requirements 9 supplemented by the general requirements for testing of ME equipment
201.5.101.1 Ventilator Test Conditions 9
201.5.101.2 *Gas flow and leakage specifications 9
201.5.101.3 * Ventilator test error 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS 9
201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTATION 9
201.7.2.3 *See attached document 9
201.7.2.4.101 Annex Supplementary Requirements 10
201.7.2.13.101 Requirement for supplemental physiological effects 10
201.7.2.17.101 Additional requirements for protective packaging 10
201.7.2.101 Additional requirements for external marking of ME EQUIPMENT or ME EQUIPMENT components 10
201.7.4.2 Control device 10
201.7.4.3 *Unit of measure 11
201.7.9.1 Outline supplementary requirements 11
201.7.9.2 Instruction Manual 11
201.7.9.2.1.101 Outline Supplementary Requirements 11
201.7.9.2.1.102 Outline Supplementary Requirements 12
201.7.9.2.2.101 * Warning and Safety Instructions Supplemental Requirement 13
201.7.9.2.8.101 * Requirement 13 for Initiator Supplement
201.7.9.2.9.101 *Requirement 13 of the Operating Instructions Supplement
201.7.9.2.9.101.1 *Instructions for inexperienced operators 13
201.7.9.2.9.101.2 * Operating Instructions for Clinicians 13
201.7.9.2.12 Cleaning, disinfection and sterilization 14
201.7.9.2.13.101 Requirements for maintenance supplement 14
201.7.9.2.14.101 * Additional requirements for accessories, additional equipment, materials used 14
201.7.9.3.1.101 * Outline Supplementary Requirements 15
201.7.9.3.101 Requirements for supplementary technical specification 15
201.8 ME EQUIPMENT PROTECTION TO ELECTRIC SHOCK HAZARD (SOURCE) 15
201.9 Protection of me equipment and me systems against mechanical hazards 15
201.9.4.3.101 Instability due to unwanted lateral motion Supplementary requirement 15
201.9.4.4 Handles and other carrying devices 15
201.9.6.2.1.101 Requirements for supplemental audible sound energy 15
201.10 Protection against unwanted or excessive radiation hazards (sources) 16
201.11 Protection against ultra-temperature and other hazards (sources) 16
201.11.1.2.2 *Applied section 16 that does not provide heat to the patient
201.11.6.4 Leak 17
201.11.6.6 * Cleaning and disinfection of ME EQUIPMENT or ME SYSTEM 17
201.11.6.7 Sterilization of ME EQUIPMENT or ME SYSTEM 18
201.11.8 ME EQUIPMENT POWER SUPPLY/SUPPLY NETWORK INTERRUPTION 18
201.11.8.101 Supplementary requirements for supply/mains interruption of ME EQUIPMENT 18
201.12 * Accuracy of controllers and instruments and protection of hazardous outputs 18
201.12.1 Accuracy of controllers and instruments 18
201.12.1.101 Breath Type 18
201.12.1.102 Volume Control Breath Type 18
201.12.1.103 Pressure-controlled breathing type 21
201.12.1.104 * Transmission ventilation monitoring device 23
201.12.4 Protection of hazardous outputs 24
201.12.4.4 Incorrect output 24
201.12.4.101 Oxygen monitor 24
201.12.4.102 * Measurement of airway pressure 24
201.12.4.103 * Measurement of expiratory volume and low volume alarm status 25
201.12.4.104 * End-tidal carbon dioxide monitoring device 25
201.12.4.105 *Maximum limiting pressure protection device 26
201.12.4.106 High pressure alarm status and protection device 26
201.12.4.107 * Blocking Alarm Status 26
201.12.4.108 * Partial blocking alarm status 26
201.12.4.109 Insufficient ventilation alarm status 27
201.12.4.110 Continuous positive pressure alarm status 27
201.12.4.111 * High leak alarm status 27
201.12.101 * Protection against accidental adjustment 27
201.13 ME EQUIPMENT HAZARDOUS SITUATIONS AND FAILURE STATES 27
201.13.2.101 * Supplementary provision 27 for single fault condition
201.13.101 Failure of a gas supplying the ventilator 28
201.13.102 * Independence of ventilation control function and related risk control measures 28
201.14 Programmable Medical Electrical System (PEMS) 28
201.14.1 Overview 28
201.15 Structure of ME equipment 28
201.15.101 Mode of operation 28
201.15.102 Inspection of accessories before use 28
201.15.103 Integrated dual branch VBS 28
201.16 ME System 29
201.16.1.101 General requirements for ME system supplements 29
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 29
201.101 Gas connection method 29
201.101.1 Connection of medical gas piping systems 29
201.101.2 VBS Connector 29
201.101.2.1 *General Requirements 29
201.101.2.2 Other specific ports 29
201.101.2.2.1 Patient connection port 29
201.101.2.2.2 Gas outlet and return port 29
201.101.2.2.3 * Manual vent 30
201.101.2.2.4 Elements sensitive to airflow direction 30
201.101.2.2.5 Accessory port 30
201.101.2.2.6 Monitoring probe port 30
201.101.2.2.7 Gas exhaust port 30
201.101.2.2.8 Oxygen inlet 30
201.102 Requirements for VBS and accessories 30
201.102.1 General requirements 30
201.102.2 Label 31
201.102.3 Breathing circuit 31
201.102.4 * Humidification 31
201.102.4.1 Humidifier 31
201.102.4.2 Heat and Moisture Exchanger (HME) 31
201.102.5 Respiratory system filters (BSF) 31
201.102.6 Respiratory system of ventilator 31
201.102.6.1 Leak from VBS 31
201.102.6.2 *Non-invasive ventilation 32
201.103 * Spontaneous breathing during interruptions in power supply 32
201.104 * Training 32
201.105 * Indication of running duration 32
201.106 Functional connections 32
201.106.1 General requirements 32
201.106.2 *Connection to Electronic Health Records 32
201.106.3 * Connection to distributed alarm system 33
201.106.4 Connection with remote control 33
201.107 Display Ring Diagram 33
201.107.1 Pressure-Volume Ring Diagram 33
201.107.2 Flow-Volume Ring Diagram 33
201.108 Power cords 33
201.109 Ventilator Safety 33
202 Electromagnetic compatibility requirements and tests 34
202.6.2.1.3 * Run Modes and Configurations 34
202.6.2.1.10 Compliance Criterion 34
206 Availability 34
208 General Requirements, Testing and Guidance for Alarm Systems in ME EQUIPMENT and ME SYSTEMS 35
208.6.8.3.101 Supplementary requirements for the inactive condition of the overall indefinite alarm signal 35
208.6.8.4.101 * Alarm Signal Inactive Condition Termination Supplemental Requirement 35
208.6.12.101 * Requirement 35 of the Alarm System Log Supplement
211 Requirements for ME EQUIPMENT and ME SYSTEMS used in a home care environment 36
211.8.4.101 *ME EQUIPMENT POWER SUPPLY/SUPPLY REQUIREMENTS FOR SUPPLY INTERRUPTIONS OF POWER SUPPLY 36
211.10.1.1 General requirements for mechanical strength 36
Appendix C (Informative) ME EQUIPMENT OR ME SYSTEM MARKING AND LABELING REQUIREMENTS GUIDELINES 37
Appendix D (Informative Appendix) Symbol 43
Appendix AA (Informative) Special Guidelines and Rationale 44
Appendix BB (Informative) Data Interface Requirements 59
Appendix CC (Informative Appendix) Reference Fundamentals 65
Appendix DD (Informative) Alphabetical index of defined terms used in this part 67
Reference 71
foreword
All technical content of this part is mandatory.
"Medical Electrical Equipment" is divided into two parts.
--- Part 1.General and side-by-side requirements;
--- Part 2.Specific requirements.
This part is part 2-72.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
This part is part 2 of YY 0600.2-2007 "Special Requirements for Basic Safety and Main Performance of Medical Ventilators. Dependent Breathing"
Compared with YY 0600.2-2007, the main technical changes other than editorial changes are as follows.
--- Increased the scope and expanded the scope to include the ventilator and its accessories (if the characteristics of these accessories will affect the basic safety of the ventilator)
full and basic performance), so the scope of application of this section is not limited to the ventilator itself (see.201.1.1);
--- Added the basic performance of the specified ventilator and its accessories (see.201.4.3);
--- Increased the ventilation performance test (see.201.4);
--- Increased the mechanical strength test (refer to YY 9706.111-2021) (see 211.10.1.1);
--- Added new symbols (see.201.7);
--- Added requirements for ventilators as components of medical electrical systems (see.201.6);
--- Added shell integrity test (see.201.11.6.6);
--- Added cleaning and disinfection procedure test (refer to YY 9706.111-2021) (see.201.11.6.6);
--- Increased the possibility of contamination when the breathing gas is delivered to the patient through the air path (see.201.11.6.6);
--- Modified the alarm state requirements for expiratory branch obstruction (continuous airway pressure) (see.201.12.4.107, 51.107 of the.2007 edition).
This section uses the redrafting method to modify the adoption of ISO 80601-2-72.2015 "Medical Electrical Equipment Part 2-72.Dependence on Ventilators"
Particular requirements for basic safety and basic performance of domestic ventilators used by patients.
Compared with ISO 80601-2-72.2015, the main differences are as follows.
--- Regarding normative reference documents, this part has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment.
The situation is reflected in the.201.2 "Normative Reference Documents", and the specific adjustments are as follows.
● ISO 594-1.1986 (see.201.101.2.1) is replaced by GB/T 1962.1 which is equivalent to adopting international standards;
● ISO 594-2.1998 (see.201.101.2.1) is replaced by GB/T 1962.2, which is equivalent to adopting international standards;
● ISO 4135.2001 (see.201.3) is replaced by GB/T 4999, which is equivalent to adopting international standards;
● Replace IEC 60601-1.2012 with GB 9706.1-2020, which is modified to adopt international standards (see full text);
● Replace ISO 32.1977 with GB 50751-2012 (see.201.7.2.101);
● Replacing ISO 5367.2000 with YY 0461 which is equivalent to adopting international standards (see.201.102.3);
● Replacing ISO 80601-2-55.2011 with YY 0601 modified to adopt international standards (see.201.12.4.101,.201.12.4.
104);
● Replacing IEC 60601-1-8.2012 with YY 9706.108-2021 modified to adopt international standards (see.201.3, 208,
208.6.12.101);
● Replacing ISO 9360-1.2000 with YY/T 0735.1 which is equivalent to adopting international standards (see.201.3,.201.102.4.2);
● Replace ISO 9360-2.2001 with YY/T 0735.2 which is equivalent to adopting international standards (see.201.102.4.2);
● Replace ISO 23328-1.2003 with YY/T 0753.1 which is equivalent to adopting international standards (see.201.102.5);
● Replacing ISO 23328-2.2002 with YY/T 0753.2 which is equivalent to adopting international standards (see.201.3.202,
201.102.5);
● Replacing ISO 8185.2007 with YY 0786 modified to adopt international standards (see.201.3,.201.102.3,.201.102.4.1);
● Replacing ISO 5359.2008 with YY/T 0799 which has been modified to adopt international standards (see.201.7.2.101,.201.101.1);
● Replace ISO 80369-1.2010 with YY/T 0916.1 which is equivalent to adopting international standards (see.201.101.2.2.5,
● Replace ISO 5356-1.2004 with YY/T 1040.1 which is equivalent to adopting international standards (see.201.101.2.1,
● Replacing IEC 60601-1-6.2010 (see.201.3, 206) with YY/T 9706.106 which is an international standard;
● Replaced IEC 60601-1-2.2014 with YY 9706.102-2021 (see 202);
● Replaced IEC 60601-1-11.2015 with YY 9706.111-2021 (see.201.11.6.6,.201.11.6.7, 211,
211.8.4.101, 211.10.1.1);
• ISO 7396-1.2007 is replaced by ISO 7396-1 (see.201.3,.201.4.11.101.1,.201.4.11.101.2).
Compared with ISO 80601-2-72.2015, this part has made the following editorial changes.
--- Deleted the foreword of ISO 80601-2-72.2015 and added the foreword of this part;
--- Added guidelines for Appendix C (see.201.7.2.4.101);
--- Added guidelines for Appendix D (see.201.7.2.13.101,.201.7.2.17.101);
--- Added guidelines for Appendix BB (see.201.106.2);
--- Added guidelines for Appendix CC (see.201.11.6.6);
--- Added the guidelines of Appendix DD (see note in.201.3);
--- Deleted Note 5 and Note 6 in.201.1.1;
--- Deleted ISO 7010-M002 in.201.7.2.3;
--- Modified "Table.201.D.1.101, Symbol 4" of.201.7.2.13.101 to "Table.201.D.2.101 Symbol 4";
--- Modified "Table.201.D.1.101" of.201.7.2.17.101 to "Table.201.D.2.101";
---Modified "Repeat 2)~9)" in 10) of.201.12.1.103 to "Repeat 3)~9)";
---Modified "Repeat 2)~10)" in 11) of.201.12.1.103 to "Repeat 3)~10)";
--- Modified "according to table.201.103 and table.201.104" in.201.12.4.103 to "according to table.201.104 and table.201.105";
--- Modified the content in Appendix AA, and changed "201.7.9.2.9.101.1" to "201.7.9.2.9.101.2";
--- Modified "201.9.6.2.101" in Table.201.C.103 to "201.9.6.2.1.101";
--- Modify "201.7.9.2.13b)" in Table.201.C.103 to "201.7.9.2.13.101b)";
--- Modified "201.7.9.2.13a)" in Table.201.C.103 to "201.7.9.2.13.101a)";
--- Modify "201.7.9.2.9.101b)" in Table.201.C.103 to "201.7.9.2.9.101.1b)";
--- Modify "201.7.9.2.9.101.2g)" in Table.201.C.103 to "201.7.9.2.9.101.2h)".
--- Deleted references, normatively cited documents IEC 60601-1-3.2008, ISO 10651-3, ISO 10651-6,
ISO 80601-2-12 and ISO 80601-2-70, added reference YY 0600.4, and adjusted the numbering of references.
Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Standardization Technical Committee of Anesthesia and Respiratory Equipment (SAC/TC116).
This section is drafted by. Shanghai Dräger Medical Equipment Co., Ltd., Shanghai Medical Equipment Testing Institute.
The main drafters of this section. Yan Cuiren, Yu Hongyi, Zhu Yancong, Ding Deping.
The previous versions of the standards replaced by this part are as follows.
---YY 0600.2-2007.
Introduction
This part of YY 9706 specifies specific requirements for domestic ventilators used by ventilator-dependent patients. Such ventilators are intended for
In a home care setting, patients using such devices rely on the ventilator for support to stay alive. In addition, such breathing is often used
Where the machine is located, its power source is often unreliable. Such ventilators are often used by non-healthcare workers (inexperienced operators) with varying degrees of training.
use under the supervision of the author). Ventilators that comply with this part may also be used in other settings (ie, healthcare facilities).
In this section.
--- "Chapter" means one of seventeen numbered sections within the Table of Contents, including all branches (eg Chapter 7 contains 7.1 and 7.2
etc.); and
--- "Article" refers to a numbered sub-clause (eg,.201.7.1,.201.7.2 and.201.7.2.1 are sub-clauses of.201.7).
In this section, when citing a chapter, use "Chapter X". In this section, when citing a supplement, only the number of the supplement is indicated.
In this section, the conjunction "or" is used as "inclusive or". Thus, a statement is true if any combination of its conditions is
reality.
The text format used in this part conforms to the usage specified in Annex H of Part 2 of the ISO /IEC Directives. In this section, the following
Auxiliary verbs have the following specific meanings.
--- "Should" means to comply with a requirement or a test that should be enforced in this part;
--- "Should" be expressed to comply with a requirement or a test recommended in this section, but not mandatory;
--- "Can" is used to describe the method allowed to achieve a requirement or a test.
In this part of the text, the chapter, article number and table title are marked with "*" to indicate that there is further explanation and explanation of the article in Appendix AA.
illustrate.
Medical Electrical Equipment Part 2-72.
of home ventilators used by ventilator-dependent patients
Particular requirements for basic safety and basic performance
201.1 Scope, Purpose and Related Standards
Except for the following, Chapter 1 of GB 9706.1-2020 applies.
201.1.1 *Scope
1.1 in GB 9706.1-2020 is replaced by the following.
This part specifies the basic safety and essential performance of ventilators (hereinafter also referred to as ME EQUIPMENT) used in combination with accessories.
Suction machine.
--- Intended for use in a home care environment;
--- Expected to be operated by inexperienced operators;
--- Intended for use on a ventilator to support the life of a patient.
Note 1.This type of ventilator is also suitable for patients who are not dependent on ventilation support.
Note 2.When used in a home care environment, the power source of such ventilators is often unreliable.
Note 3.This type of ventilator is also suitable for non-critical patient care work areas in professional health care facilities.
The provisions of this section also apply to accessories intended by the manufacturer for connection to the VBS or to the ventilator, and the
Characteristics may affect the basic safety and essential performance of the ventilator.
Examples. breathing circuit, connector, water cup, exhalation valve, humidifier, VBS filter, external power supply and distributed alarm system, etc.
If a chapter or an article applies only to ME EQUIPMENT, or only to ME SYSTEMS, the title and content of the chapter or article will state.
Otherwise, this chapter or this subclause applies to both the relevant ME EQUIPMENT and ME SYSTEM.
In addition to 7.2.13 and 8.4.1 of GB 9706.1-2020, the expected physiological effects of ME EQUIPMENT or ME SYSTEM within the scope of this part
The resulting hazards are not specifically required in this section.
Note 4.For more information, see 4.2 in GB 9706.1-2020.
This section does not apply to continuous positive airway pressure (CPAP) ME equipment, high frequency jet ventilators (HFJV) and high frequency oscillatory ventilators
(HFOV) [30].
This section does not apply to the requirements for iron armor and "iron lung" ventilators.
This section does not apply to the requirements for intensive care ventilators and their accessories.
This section does not apply to the requirements for anesthesia ventilators and their accessories.
This section does not apply to the requirements for emergency and transport ventilators and their accessories.
This section does not apply to ventilators and accessories for home care ventilatory support equipment (expected only to increase ventilation in spontaneously breathing patients)
piece requirements.
This section does not apply to the requirements for ME EQUIPMENT for the treatment of obstructive sleep apnea.
This part is a special standard in the series of "Medical Electrical Equipment".
201.1.2 Purpose
1.2 in GB 9706.1-2020 is replaced by the following.
The purpose of this section is to specify the basic safety and
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