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YY 9706.284-2023Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment (English PDF)

医用电气设备第2-84部分：紧急医疗服务环境用呼吸机的基本安全和基本性能专用要求

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

March 14, 2023

Implementation date

May 1, 2026

Scope

YY 9706.284-2023 is the English-translated version of 医用电气设备第2-84部分：紧急医疗服务环境用呼吸机的基本安全和基本性能专用要求.

YY 9706.284-2023 is the Chinese pharmaceutical industry standard for the basic safety and essential performance of the ventilator used in the emergency medical services environment, alone or with its accessories.

It is part 2-84 of the YY 9706 series and applies together with the general standard GB 9706.1-2020, which it modifies clause by clause, covering invasive and non-invasive ventilation by professional carers outside the hospital and during transport within it, the compatibility with medical gas piping systems and pressure regulators, the test errors of the ventilator, the alarms and the environmental conditions of use. Issued on 14 March 2023, it applies from 1 May 2026.

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Document preview — YY 9706.284-2023

National Standard of the People's Republic of China

ICS: 11.040.11
Classification: C 46
Replacing: YY 0600.3-2007

Issued by: National Medical Products Administration of the People's Republic of China

Preface
Introduction
201.1 Scope, purpose and related standards
201.2 Normative references
201.3 Terms and Definitions
201.4 General requirements
201.4.11.101.2 Compatibility requirements for medical gas piping systems
201.4.11.101.3 Compatibility requirements for pressure regulators
201.5 General requirements for testing of ME EQUIPMENT
201.5.101.3 * EMS ventilator test error
201.6 Classification of me equipment and me systems
201.7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTS
201.8 Protection against electric shock hazards for ME EQUIPMENT
201.9 Protection against mechanical hazards by ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted or excessive radiation hazards
201.11 Protection against extreme temperatures and other hazards
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.13 Hazardous situations and fault conditions for ME EQUIPMENT
201.14 Programmable electrical medical systems (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME system
201.106 Display Ring Diagram
201.107 Ventilatory pauses of limited duration
202 Electromagnetic Compatibility Requirements and Tests
206 Availability
208 General requirements, tests and guidelines for alarm systems in medical electrical equipment and medical electrical systems
212 Requirements for medical electrical equipment and medical electrical systems for emergency medical service environments
Appendix C (informative) Guidance on marking and labeling requirements for me equipment and me systems
Appendix D (informative) Symbols on the logo
Appendix AA (informative) Specific guidelines and rationale
Appendix BB (Informative) Data Interface
Appendix CC (Informative) Basic Principles Index Reference

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. "Medical Electrical Equipment" is divided into two parts.

--- Part 1. General and parallel requirements;

--- Part 2. Special requirements. This document is Part 2-84.

This document replaces YY 0600.3-2007 "Special Requirements for Basic Safety and Main Performance of Medical Ventilators Part 3. First Aid and Rescue Compared with YY 0600.3-2007, except for structural adjustment and editorial changes, the main technical changes in "Use of Ventilator" are as follows:

---Changed the scope, including EMS ventilator and its accessories, the characteristics of these accessories will affect the emergency medical service environment ventilator Basic safety or basic performance, that is, not only the ventilator itself in the emergency medical service environment (see 201.1.1, 2007 version of Chapter 1);

---Changed the basic performance of the emergency medical service environment ventilator and its accessories (see 201.4.3, 50 and 51 of the 2007 edition);

--- Changed the environmental condition test (passed YY 9706.112) (see 212, 53 of the 2007 edition);

---Changed the alarm state test (passed YY 9706.108) (see 208, 51 of the 2007 edition);

---Changed the electromagnetic interference test (passed YY 9706.102) (see 202, 36 of the 2007 edition);

--- Added the following content.

- determine the probability of component failure during the expected service life (see 201.4.4);

- New safety signs (see 201.7 and 201.11.7);

- Vocabulary and semantics of ISO 19223:2019 (see 201.7.9.2.9.101);

- Infection of respiratory gases delivered from the airway to the patient (see 201.7.9.2.12);

- test for instability caused by unwanted lateral movement (see 201.9.4.3.101);

- Audible sound energy test (see 201.9.6.2.1.101);

- The maximum specific enthalpy requirement of transported gas (see 201.11.1.2.2);

- cleaning and disinfection testing (see 201.11.6.6 and 201.11.6.7);

- ventilator performance test (see 201.12.1.101, 201.12.1.102 and 201.12.1.103);

- Other ventilation mode performance testing and disclosure requirements (see 201.12.1.103);

- Requirements for oxygen inhalation monitoring equipment (see 201.12.4.101);

- 93% oxygen input gas (see 201.12.4.103);

- Requirements for emergency medical service environment ventilators as part of an ME system (see 201.16);

- Electromagnetic interference test (pass YY 9706.102) (see 202);

- Include usability engineering process (YY/T 9706.106) (see 206);

- Alarm status test (pass YY 9706.108) (see 208);

- Environmental condition test (pass YY 9706.112) (see 212.4.2.2.1);

- Shell integrity test (pass YY 9706.112 waterproof) (see 212.8.1.1).

This document is modified to adopt ISO 80601-2-84:2020 "Medical Electrical Equipment Part 2-84. Ventilators for Emergency Medical Service Environments Particular Requirements for Basic Safety and Essential Performance".

The technical differences between this document and ISO 80601-2-84:2020 and their reasons are as follows:

--- Replaced IEC 60068-2-64:2008 with the normatively quoted GB/T 2423.56 to adapt to the technical conditions of our country;

--- Replaced IEC 61672-1:2013 with the normatively quoted GB/T 3785.1 to adapt to the technical conditions of our country;

--- Replaced IEC 60601-1:2005 AMD1.2012 with the normatively quoted GB 9706.1-2020 to adapt to my country's technical standards technical conditions;

--- Replaced ISO 80601-2-12:2020 with the normatively quoted GB 9706.212 to adapt to the technical conditions of our country;

--- Replaced ISO 4871:1996 with the normatively quoted GB/T 14574 to adapt to the technical conditions of our country;

--- Replaced ISO 9000:2015 with the normatively quoted GB/T 19000 to adapt to the technical conditions of our country;

--- Replaced ISO 14937:2009 with the normatively quoted GB/T 19974 to adapt to the technical conditions of our country;

--- Replaced ISO 7010:2019 with the normatively quoted GB/T 31523.1 to adapt to the technical conditions of our country;

--- Replaced ISO 32:1977 with the normatively quoted GB 50751 to adapt to the technical conditions of our country;

--- Replaced ISO 5367:2014 with the normative referenced YY/T 0461 to adapt to the technical conditions of our country;

--- Replaced ISO 16142-1:2016 with the normative reference YY/T 0467 to adapt to the technical conditions of our country;

--- Replaced ISO 23328-1:2003 with the normative referenced YY/T 0753.1 to adapt to the technical conditions of our country;

--- Replaced ISO 23328-2:2002 with the normative reference YY/T 0753.2 to adapt to the technical conditions of our country;

--- Replaced ISO 5359:2014 AMD1.2017 with the normative reference YY/T 0799 to adapt to the technical conditions of our country;

--- Replaced ISO 80369-1:2018 with the normative reference YY/T 0916.1 to adapt to the technical conditions of our country;

--- Replaced ISO 8836:2014 with the normative referenced YY/T 0339 to adapt to the technical conditions of our country;

--- Replaced ISO 9360-1:2000 with the normative referenced YY/T 0735.1 to adapt to the technical conditions of our country;

--- Replaced ISO 9360-2:2001 with the normative reference YY/T 0735.2 to adapt to the technical conditions of our country;

--- Replaced ISO 17510:2015 with the normative reference YY/T 0671 to adapt to the technical conditions of our country;

--- Replaced ISO 17664:2017 with the normative reference YY/T 0802 to adapt to the technical conditions of our country;

--- Replaced ISO 5356-1:2015 with the normative referenced YY/T 1040.1 to adapt to the technical conditions of our country;

--- Replaced ISO 62366-1:2015 with the normative reference YY/T 1474 to adapt to the technical conditions of our country;

--- Replaced ISO 18562-1:2017 with the normative reference YY/T 1778.1 to adapt to the technical conditions of our country;

--- Replaced IEC 60601-1-10:2007 AMD1.2013 with the normative referenced YY/T 9706.110 to adapt to my country's Technical conditions;

--- Replaced IEC 60601-1-11:2015 with the normative reference YY 9706.111 to adapt to the technical conditions of our country;

--- Replaced IEC 60601-1-12:2014 with the normative reference YY 9706.112-2021 to adapt to the technical conditions of our country;

--- Replaced ISO 80601-2-74:2017 with the normative reference YY 9706.274-2022 to adapt to the technical conditions of our country. The following editorial changes have been made to this document.

--- Modified the chapter number corresponding to 201.102.3;

--- Deleted Note 2 in 201.1.2;

--- Deleted the note in 201.7.2.18;

--- Modify "ii)" and "iv)" in 201.107.2c)3) to "i)" and "i)";

--- Modify "202.4.3.1* Acceptance Criteria" to "202.6.2.1.3* Operation Mode and Configuration", and "202.8.1.101* Supplementary "General Requirements" is changed to "202.6.2.1.10* Conformity Criteria" to facilitate clause 1 with the same content as in YY 9706.102 To; and modify all 202.4.3.1 in this document to 202.6.2.1.3, 202.8.1.101 to 202.6.2.1.10;

--- Deleted the language requirements in Table BB 104 in Appendix BB;

--- Corrected editorial errors in ISO 80601-2-84:2020.

- Modify "5hPa(L/s)-1 10%" in Table 201.102 to "5hPa(L/s)-1±10%";

- In 201.7.2.4.101a) 1), modify "meet the requirements of 201.102.101" to "meet the requirements of 201.102.1";

- Change "Table 201:D 2.101, Safety Sign 9" in 201.11.7dd)3) to "Table 201:D 2.101, Safety Sign 8"; replace In Table 201.104 of Appendix AA, "Table AA 2 Flow Rates and Pressure Drops for Linear Regulators and Parabolic Regulators" is changed to "Table

AA 2 The pressure drop of the endotracheal tube at the specified flow";

- Change "201.7.2.101i)" in Table 201:C 101 of Appendix C to "201.7.2.101d)i)", and replace "201.7.2.101 bb)i)" is changed to "201.7.2.101d)i)";

- Change "bb)~ee)" to "aa)~dd)" in Clause 201.11.6.6 of Appendix AA, change "d)" to "dd)", and replace "c)" is changed to "cc)";

- Amend "Table AA 1" in Clause 201.102.6 of Appendix AA to "Table AA 4";

- Change "50>=Vinsp>=300" in Table AA 4 of clause 201.102.6 of Appendix AA to "300>=Vinsp>=50", and replace "50mL>=Vinsp>=300mL, Qleak=122mL/min" was changed to "300mL>=Vinsp>=50mL, Qleak= 122mL/min", refer to figure AA 4 index number description 2 "50mL>=Vinsp>=300mL in ISO 80601-2-12 "Leakage limit of 300mL >= Vinsp >= 50mL in ISO 80601-2-12", and the index "Qleak when 50mL>=Vinsp>=300mL" in Explanation B of serial number is changed to "Qleak when 50mL<=Vinsp<=300mL Qleak";

- Delete Appendix DD.

Introduction

The requirements are followed by a description of the relevant tests. Items marked with an asterisk (*) have rationale in Appendix AA. these requirements Principle knowledge is considered to contribute to the correct application of this specific standard, and any version should be updated when the clinical application changes or the technology is updated. It will also be used when making required revisions.

Medical Electrical Equipment Part 2-84. For use in emergency medical service environments Particular requirements for basic safety and essential performance of ventilators

201.1 Scope, purpose and related standards

Except as described below, Chapter 1 of the general standard applies.

201.1.1 *Scope 1.1 in GB 9706.1-2020 is replaced by the following:

This document specifies ventilators for emergency medical service environments (hereinafter referred to as EMS ventilators, also referred to as ME) for use in combination with accessories. equipment) for basic safety and essential performance.

This document applies to patients who are expected to be operated by professional nursing staff in an EMS environment and require different levels of artificial ventilatory support.

Ventilators for use in emergency medical services settings for invasive or non-invasive ventilation (including ventilator-dependent patients).

Note 1. EMS ventilators can also be used for transport within professional healthcare facilities.

*An EMS ventilator is not considered to be using a physiological closure unless the EMS ventilator uses the patient's physiological variables to adjust the ventilatory therapy settings. ring control system.

This document also applies to accessories intended by the manufacturer to be connected to the ventilator breathing system or to the EMS ventilator, the characteristics of which may Affect the essential safety or essential performance of the EMS ventilator.

Note 2 to entry. If a chapter or clause clearly states that it applies only to me equipment or me systems, the title and text of the chapter or clause will state that. If this is not the case, The relevant clause or subclause applies to both me equipment and me systems.

Note 3. See General Standard 4.2. This document does not apply to.

--- Intensive care ventilator or accessories;

---Household ventilators or accessories used by ventilator-dependent patients;

--- Ventilators or accessories in anesthesia applications;

--- Ventilator or accessories of ventilation support equipment (expected only to increase the ventilation of spontaneously breathing patients);

---Obstructive sleep apnea treatment medical electrical equipment;

--- Manual resuscitator;

---Pneumatic emergency resuscitator;

--- Continuous positive airway pressure (CPAP) medical electrical equipment;

--- High frequency jet ventilators (HFJVs);

---High-frequency oscillatory ventilators (HFOVs).

Note 4. The EMS ventilator can include high-frequency jet or high-frequency wave ventilation mode.

--- Ironclad or "iron lung" ventilators.

In addition to the general criteria 7.2.13 and 8.4.1, hazards arising from the intended physiological effects of me equipment or me systems within the scope of this document Risks are not specifically required in this document.

201.1.2 Purpose

replace.

The purpose of this document is to establish basic safety and essential performance requirements for EMS ventilators and their accessories as defined in 201.3.201.

Accessories are included because the combination of the EMS ventilator and accessories needs to have an acceptable risk. Attachment possible to EMS ventilator

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 76 pages — is available in the English PDF.

Similar standards

YY 9706.272-2021|YY 9706.112-2021|YY 0600.5-2011|YY 9706.287-2025|GB 9706.212-2020|YY 0600.4-2013

Editions of YY 9706.284

Edition	Title	Revision	Status
YY 9706.284-2023	Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment	current edition	Current
YY 0600.3-2007	Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment	previous edition	Superseded

This page sells the current edition, YY 9706.284-2023. Earlier editions are listed for reference only.

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