YY/T 1610-2025Anaesthetic and respiratory equipment - Passive humidifiers (English PDF)

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1: Structure and Drafting Rules of Standardization Documents".

Drafting.

This document replaces YY/T 1610-2018 "Medical Oxygen Humidifiers for Anesthesia and Respiratory Equipment" and is consistent with YY/T 1610-2018.

Compared to previous versions, aside from structural adjustments and editorial changes, the main technical changes are as follows.

---Gas flow and leakage specifications have been changed (see 4.3, 7.4 in the 2018 version);

---The requirements regarding appearance have been changed (see 5.1.1, Chapter 5 of the 2018 edition);

---The overflow requirements have been changed (see 5.1.4, 7.2 in the 2018 version);

---The overpressure requirement has been changed (see 5.1.5, Chapter 8 of the 2018 edition);

---The requirements for markings on the exterior of passive humidifiers or their components have been changed (see 6.2, Chapter 12, 2018 edition);

---The requirements for the instruction manual have been changed (see 6.4, Chapter 13 of the 2018 edition);

---The requirements for humidification output have been changed (see Chapter 7, 7.1 of the 2018 edition);

---The requirements for cleaning and disinfection have been changed (see Chapter 10, Chapter 11 in the 2018 edition);

---The requirements for respiratory system connectors and ports have been changed (see Chapter 11, Chapter 6 of the 2018 edition);

---The compatibility requirements with materials have been changed (see Chapter 13, Chapter 4 in the 2018 edition);

---Water level requirements have been added (see 4.1);

---Added passive humidifier test conditions (see 4.2);

---Increased the testing error for passive humidifiers (see 4.4);

---Added requirements regarding instability caused by unnecessary lateral movements (see 5.1.2);

---The requirement for audible sound energy has been increased (see 5.1.3);

---Added compatibility requirements (see 5.2);

---General requirements for mechanical strength have been added (see 5.3);

---Requirements for units of measurement have been added (see 6.3);

---Added technical specification requirements (see 6.5);

---Added system requirements (see Chapter 8);

---Added specific single fault states (see Chapter 9);

---Requirements for the respiratory system and accessories have been added (see Chapter 12);

---Biocompatibility requirements have been added (see Chapter 14);

---Fire protection requirements have been added (see Chapter 15);

---Availability requirements have been added (see Chapter 16);

---The requirement for pressure relief has been removed (see 7.3 in the 2018 version);

---The requirement for residual ethylene oxide has been removed (see section 10.3 of the 2018 edition);

---The requirement for microbial limits has been removed (see 10.4 in the 2018 edition).

This document is modified to adopt ISO 20789:2018 "Passive humidifiers for anesthesia and respiratory equipment".

The technical differences between this document and ISO 20789:2018, and the reasons therefor, are as follows.

---ISO 7396-1:2016 has been replaced with the normatively referenced GB/T 44059.1-2024 to adapt to my country's technical conditions;

---IEC 60601-1:2005 has been replaced with the normatively referenced GB 9706.1 to adapt to my country's technical conditions;

---ISO 80601-2-12:2011 has been replaced with the normatively referenced GB 9706.212 to adapt to my country's technical conditions;

---ISO 10993-1:2009 has been replaced with the normatively referenced GB/T 16886.1-2022 to adapt to my country's technical conditions;

---ISO 14971:2007 has been replaced with the normatively referenced GB/T 42062-2022 to adapt to my country's technical conditions;

---ISO 5367:2014 has been replaced with the normatively referenced YY/T 0461 to adapt to my country's technical conditions;

---ISO 15223-1:2016 has been replaced with YY/T 0466.1-2016 (normative reference) to adapt to my country's technical conditions;

---ISO 80369-1:2010 has been replaced with YY/T 0916.1-2021 (normatively referenced) to adapt to my country's technical conditions;

---ISO 5356-1:2015 has been replaced with YY/T 1040.1-2015 (normatively referenced) to adapt to my country's technical conditions;

---IEC 62366-1:2015 has been replaced with YY/T 1474-2016 (normative reference) to adapt to my country's technical conditions;

---ISO 80601-2-74:2017 has been replaced with the normatively referenced YY 9706.274 to adapt to my country's technical conditions;

---The normative reference ISO 16142-1:2016 has been removed to adapt to my country's technical conditions.

The following editorial changes have also been made to this document.

---Some unnecessary comments have been removed;

---The relevant content concerning ISO 16142-1:2016 in the introduction and Appendix A has been deleted;

Appendix D has been removed;

Appendix E has been removed;

---The ISO organization introduction and website address have been removed;

---Added explanation of C.3Pamb in Appendix C;

---The following editorial errors in ISO 20789:2018 have been corrected.

- Modify the traceability information within the square brackets in section 3.13 from "203.3.220" to "201.3.220";

- Change "10.1" in 12.2 to "12.1".

Please note that some content in this document may involve patents. The issuing organization of this document assumes no responsibility for identifying patents.

This document was proposed by the National Medical Products Administration.

This document is under the jurisdiction of the National Technical Committee on Standardization of Anesthesia and Respiratory Equipment (SAC/TC116).

Introduction

This document specifies the requirements for "cold bubbling or cold delivery" passive humidifiers for use in home care and medical facilities.

Request. Passive humidifiers are used to increase the moisture content of gases delivered to patients. Gases used for medical purposes may not contain sufficient moisture, which could...

Damage or irritation to the airway or the upper airway becoming dry and thickened by secretions in bypass patients. Insufficient moisture at the patient's connection point can lead to dryness of the upper airway.

Dryness, or drying of secretions in endotracheal tubes or tracheostomy tubes, can lead to tracheal stenosis or even airway obstruction [1][2].

Passive humidifiers increase the moisture content of the gas delivered to the patient by transferring moisture from a reservoir into the gas at room temperature, rather than...

The humidification chamber or breathing tubing is heated. Therefore, the output (mg/L) of these passive humidifiers is lower than that of active humidifiers. (Regarding active humidifiers...) for the basic safety and performance of the incubator, see YY 9706.274.

Since the safe use of passive humidifiers depends on the interaction between the passive humidifier and its accessories, this document focuses on the patient connection port.

Overall system performance requirements were proposed. These requirements apply to accessories such as breathing tubing.

Passive humidifiers are typically used with air and air-oxygen mixtures, and are preferably capable of using these gases.

When handling gas mixtures (such as helium/oxygen mixtures), care should be taken because their physical properties differ from those of air and oxygen.

An asterisk (*) as the first character of a heading, paragraph, or table title indicates the presence of guidelines or basic principles related to the project.

For details, see Appendix A.

Passive humidifiers for anesthesia and respiratory equipment

1 Scope

This document specifies the requirements for so-called "cold bubbling" or "cold transfer" humidification equipment (hereinafter referred to as passive humidifiers).

Note 1.Figures 1 and 2 illustrate these passive humidifiers. Passive humidifiers have their humidification chambers at room temperature, therefore their humidification output is lower than that of active humidifiers.

Low.

Figure 1.Cold Transfer Passive Humidifier

Figure 2 Cold Bubbling Passive Humidifier

This document also applies to accessories that the manufacturer intends to connect to passive humidifiers. Additionally, passive humidifiers integrated into other medical devices...

Humidifiers should meet the requirements of other medical device standards.

Example 1.The requirements in YY 9706.269 also apply to passive humidifiers integrated into an oxygen concentrator.

Example 2.The requirements in YY 9706.270 also apply to passive humidifiers integrated into sleep apnea treatment devices.

This document does not apply to active heated humidifiers, heated breathing tubing, or active heat and moisture exchangers (HMEs).

Note 2.YY/T 0461 specifies other safety and performance requirements for breathing tubing.

This document does not apply to returning a portion of the exhaled moisture and heat to the airway during inhalation without increasing heat or moisture content.

The requirements for passive HMEs are given in YY/T 0735.1 and YY/T 0735.2.

This document does not apply to nebulizers used to deliver fluids to patients; the requirements for these are given in YY/T 1743.

This document does not apply to devices commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation, and air conditioning systems, or those integrated into them.

Humidifier in an infant incubator.