YY 9706.280-2023Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency (English PDF)

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 2-80.

YY 9706.280-2023 and YY 9706.279-2023 jointly replace YY 0600.1-2007. With YY 0600.1-2007 In comparison, the main technical differences are as follows:

--- Divide the scope covered by YY 0600.1-2007 into two parts. one for patients with respiratory dysfunction (YY 9706.279-2023), and one for patients with respiratory insufficiency (YY 9706.280-2023);

--- Expand the scope to include respiratory support equipment and its accessories, where the characteristics of these accessories may affect the basic This safety or essential performance, not just respiratory support equipment itself;

--- Increased the basic performance of identifying respiratory support equipment and its accessories;

--- Added respiratory ventilation performance requirements and tests;

--- Added requirements for mechanical strength test;

---Increased the ability requirement to be operable while moving;

--- Added new symbols;

--- Increased the requirements for respiratory support equipment as part of the medical electrical system;

--- Added shell integrity test;

--- Added cleaning and disinfection procedure test;

--- Increased consideration of the contamination of the breathing gas delivered to the patient from the gas pathway.

This document is modified to adopt ISO 80601-2-80:2018 "Medical Electrical Equipment Part 2-80. Respiratory Devices for Respiratory Insufficiency Particular Requirements for Basic Safety and Essential Performance of Supporting Equipment".

The technical differences between this document and ISO 80601-2-80:2018 and their reasons are as follows:

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

--- Replaced ISO 4135:2001 with the normatively quoted GB/T 4999-2003 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 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 8836:2014 with the normative reference YY/T 0339 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 15223-1:2016 with the normative reference YY/T 0466.1-2016 to adapt to the technical conditions of our country;

--- Replaced ISO 17510:2015 with the normative reference YY/T 0671-2021 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 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 80369-1:2010 with the normative reference YY/T 0916.1 to adapt to the technical conditions of our country;

--- Replaced IEC 62366-1 with the normative referenced YY/T 1474 to adapt to the technical conditions of our country;

--- Replaced IEC 60601-1-2:2014 with the normative reference YY 9706.102-2021 to adapt to the technical conditions of our country;

--- Replaced IEC 60601-1-6 with the normative referenced YY/T 9706.106 to adapt to the technical conditions of our country;

--- Replaced IEC 60601-1-8 with the normative reference YY 9706.108 to adapt to the technical conditions of our country;

--- Replaced IEC 60601-1-11 with the normative reference YY 9706.111-2021 to adapt to the technical conditions of our country;

--- Replaced ISO 80601-2-72:2015 with the normative reference YY 9706.272 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 also been made to this document.

--- Deleted the term index of the international standard;

--- In the source part of 201.3.201, the reference without the date number is changed to the reference with the date code, and the specific clause will be referenced Amended from 201.3.210 to 201.3.205;

---Corrected the error of quoting GB/T 3767-2016 article number in 201.9.6.2.1.101, and included ISO 80601-2-80.2018b)

8.1 in h) and k) was changed to 8.6; 8.1 in h) and k) was changed to 8.2; the formulas and Parameter Description.

--- Amended the article number and content of 202;

---Corrected the error of quoting the article number in 202.6.2.1.3*, and changed the article pointed to by the specific conditions and configuration from 201.9.6.2.1.101 for 201.12.1.101 or 201.12.1.102;

--- Added the missing "201.7.9.2.9.101.1 Operating Instructions for Inexperienced Operators" in Appendix AA Fundamental";

---Appendix D amended the symbol 5 on the graphics and description of PHT substances.

Introduction

This document specifies specific requirements for respiratory support equipment intended to be used in a home care environment where the life support of the patient being cared for Not dependent on ventilator ventilation. Such respiratory support equipment is often used in places where the power source is unreliable. Such respiratory support equipment Usually administered by non-medical personnel (inexperienced operators) with varying degrees of training. Respiratory support equipment conforming to this document may also be used Other settings (i:e. healthcare facilities).

The development of the respiratory equipment industry in the world tends to be classified more and more finely. According to the degree of patients' symptoms and application scenarios, different categories are distinguished.

Home ventilators with the same function can serve different patients more accurately. Specifically, for chronic respiratory failure, such as moderate to mild COPD The patients themselves have a certain ability to move, and the treatment pressure is not great; other patients, such as patients with acute respiratory failure such as severe COPD, also have ALS patients with gradual freezing require relatively high pressure for treatment, and they need to be transferred to a professional hospital when they go outdoors to expand their range of activities or during an acute attack.

All medical institutions need ventilators with stronger functions. Therefore, ISO 10651-6:2004 (YY 0600.1-2007, MOD), under revision The ordering time is divided into two standards. ISO 80601-2-79:2018 and ISO 80601-2-80:2018.

For patients requiring stable ventilation, varying levels of respiratory support are required and, in some cases, need to change as the condition progresses.

This document applies to patients whose respiratory function has deteriorated so severely that they are unable to carry out the activities pursued and interfere with their daily life, Significant abnormalities in suction measurements or gas exchange. This best distinction is when lung function measures are no worse than.

FEV1/FVC (also known as Tiffeneau-Pineli index) < 70%; or FEV1< 50% predicted value Among them, FEV1 is the forced expiratory volume in one second, and FVC is the forced vital capacity.

The above-mentioned diseases requiring respiratory support, such as. severe chronic obstructive pulmonary disease (COPD), amyotrophic lateral sclerosis (ALS), severe bronchopulmonary dystrophy and muscular dystrophy. Respiratory support devices intended for use in these patient populations require a technical report in the event of a loss of essential performance. alert status. In the event of loss of artificial ventilation, the weakest of these patients may be harmed, but not seriously injured or killed Death. For these patients, ventilatory support during waking hours may be required to facilitate Mobility and functional independence in activities of daily living.

In this document, the principles of the text marked with an asterisk (*) are explained in Appendix AA; in accordance with ISO 16142-1:2016 See Appendix CC for the basic principles of safety and performance.

Medical Electrical Equipment Part 2-80. For Breathing Basic safety and Basic performance-specific requirements