YY 9706.272-2021Medical electrical equipment - Part 2-72: Particular requirements for the basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (English PDF)

Foreword

This document was issued on 6 September 2021 by the National Medical Products Administration and takes effect on 1 May 2024.

It is a YY standard without the /T suffix: compliance is mandatory in China.

It is classified under Chinese classification C46.

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

1 Scope

YY 9706.272 is the mandatory Chinese standard for home ventilators used by ventilator-dependent patients, the machines that keep someone alive at home rather than in an intensive care unit. That setting is what shapes the requirements: no clinician is present, the power supply is a domestic socket that can fail, the operator is a family member, and the patient cannot breathe without the machine. The standard sets the particular requirements for basic safety and essential performance on top of the general medical electrical safety standard, covering the delivered ventilation, the alarms and how they must be noticeable in a home, the battery endurance and the fault behaviour. Being a YY standard without the /T suffix, compliance is compulsory in China. It takes effect in May 2024.