YY 0600.4-2013Lung ventilators for medical use—Particular requirements for basic safety and essential performance - Part 4: operator-powered resuscitators (English PDF)

Foreword

The general title of YY 0600 is `` Special Requirements for Basic Safety and Main Performance of Medical Ventilators '', which consists of the following parts.

--- Part 1. Household respiratory support equipment;

--- Part 2. Home ventilator for ventilator dependent patients;

--- Part 3. Ventilator for emergency and transport;

--- Part 4. artificial resuscitator;

--- Part 5. Pneumatic emergency resuscitator. This section is Part 4 of YY 0600.

This section is drafted in accordance with the rules given in GB/T 1.1-2009.

This part is equivalent to the international standard ISO 10651-4.:2002 "Medical ventilator Part 4. Specific requirements for artificial resuscitators" (English Version), and made the following editorial changes.

--- Modify the standard name to "Special Requirements for Basic Safety and Main Performance of Medical Ventilators-Part 4. Artificial Resuscitators";

--- The international standards quoted in ISO 10651-4.:2002 are correspondingly adopted as national standards and industry standards.

Use these national standards and industry standards as the normative use; if there is no corresponding adoption as national standards and industry standards, the The cited international standards are used as norms.

1 Scope

This part of YY 0600 specifies special requirements for portable artificial resuscitators applicable to all ages, for Pulmonary ventilation is provided in separate personnel. For infants and children, artificial resuscitators are identified based on their weight range and their corresponding approximate age.

Electric resuscitators and pneumatic resuscitators are not included in the scope of this section.

Note: The basic principles of this section are listed in Appendix B. Article numbers with principle descriptions are marked with "*".

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document.

GB/T 4999-2003 Anesthesia breathing equipment term (ISO 4135.:2001, IDT) A valve that opens when the pressure in the compression unit of the resuscitator is lower than atmospheric pressure and inflates the compression unit with gas at ambient air pressure.

YY/T 0615.1-2007 Requirements for marked "sterile" medical devices Part 1. Requirements for final sterilized medical devices (EN 556-1.:2001, IDT) A valve that opens when the pressure in the compression unit of the resuscitator is lower than atmospheric pressure and inflates the compression unit through the compressed air source. The valve is unmanned Trigger.

YY 0801.1 Terminals for medical gas piping systems-Part 1. Terminals for compressed medical gases and vacuum (YY 0801.1-2010, ISO 9170-1.:2008, IDT) A component on an artificial resuscitator, such as an air bag or bellows, can send out a certain volume of gas when it is squeezed by the operator.

YY 1040.1 Conical joints for anesthesia and breathing equipment-Part 1. Taper heads and sleeves 1..1996, IDT) A connector at the patient connection port that is directly connected to a mask or a suitable mating airway device.

EN 148-1 Threads for respiratory protective masks-Part 1. Standard threaded connections (Respiratoryprotective) devices-Threadsforfacepieces-Part 1. Standardthreadconnection.) A valve in the respiratory system that allows gas to enter the lungs in the inspiratory phase and the atmosphere in the expiratory phase.

EN 868-1 Packaging materials and systems for sterilization of medical articles. Part 1. General requirements and test methods materialsandsystemsformedicaldeviceswhicharetobesterilized-Part 1. Generalrequirementsand testmethods.)

EN 1041 Information provided by medical device manufacturers (Informationsupplied by themanufacturerwithmedical devices.) prEN13544-2..2000 Respiratory therapy equipment-Part 2. Specific requirements for tubing and fittings (Respiratorytherapyequip-ment-Part 2. Specificationsfortubingandconnectors.)

3 Terms and definitions

The terms and definitions defined in GB/T 4999-2003 and the following apply to this document.

Note: Part of the definition comes from GB/T 4999, but for the sake of convenience, this section also includes them; GB/T 4999 gives the general equipment He defined that this section has been slightly modified because it is specific to resuscitators.

4 Connector

4.2 * Exhale connector for breathing gas If equipped with an exhalation port connector, it should be one of the following.

a) 30mm outer conical joint according to YY 1040.1;

b) Permanent or special connectors that are not compatible with YY 1040.1 and YY 0801.1;

It cannot be connected to the lumen of any breathing accessory.

4.4 * Airbag Inflation Valve Connector If the airbag inflation valve is equipped with a conical joint, it should be a special 32mm inner conical design and have a good fit with the gauge shown in Figure A.1. Cooperation, the error is within the allowable range.

5 Operating requirements

5.2 * Disassembly and assembly Resuscitators intended to be disassembled by the user, if disassembled for cleaning purposes, should be designed so that there is a risk of incorrect assembly between the various components lowest.

The manufacturer shall recommend a method of performance inspection performed after reassembly [see 10.2d)].

5.3 * Patient valve function after vomit contamination After testing in accordance with A.4.3, the resuscitator shall meet the requirements of 6.2, 6.4, 6.7.1 and 6.7.2.

5.6 * Airbag inflation valve There should be no manually operated device on the airbag inflation valve used with the resuscitator.

6 Ventilation requirements

6.1 * Supplemental oxygen and oxygen delivered According to the requirements of its corresponding classification (see 6.7.1), when tested by the method of A.4.6, the resuscitator is connected to the flow rate no higher than 15L/min oxygen source should provide at least 35% oxygen by volume; and the ability to provide 85% oxygen by volume (See note). The manufacturer should declare that it is conveyed at some representative flow rate (such as 2L/min, 4L/min, 6L/min, 8L/min, etc.) Range of oxygen concentration.

Note: The requirement of 85% volume fraction can be met by using accessories.

6.2 * expiratory impedance Without using positive end-expiratory pressure, test according to the method described in A.4.7, and the pressure generated at the connection port of the patient should not exceed 0.5kPa (~5cmH2O). [See also 10.2c) 8)].

6.3 * Inspiratory impedance According to the method described in A.4.8, the pressure generated at the connection port of the patient should not exceed 0.5kPa (~5cmH2O) at atmospheric pressure. [See also 10.2c) 8)].

6.4 * Patient valve failure Tested according to the method described in A.4.9, when the maximum flow rate of 30L/min is added according to the manufacturer's instructions, it should not cause more than Unexpected positive end expiratory pressure of 0.6 kPa (~6 cmH2O).

6.5 * Patient Valve Leak-Forward Leak When the resuscitator has a design feature of forward leakage, it should be explained in the instruction manual.

6.6 * Resuscitator Dead Space and Repeated Breathing Test according to the method described in A.4.10. According to the requirements of its corresponding classification, the dead space of the resuscitator should not exceed a minimum of 5mL (110%). Conveying capacity (see 6.7.1). During spontaneous breathing, excessive repeated breathing should not occur.

6.7 * Ventilation performance 6.7.1 * Minimum delivery capacity (Vdel)

According to the compliance, impedance, frequency, and breathing ratio given in Table 1, and test according to the method described in A.4.11, the minimum delivery capacity should conform to Table 1. Requirements.

6.7.2 * Pressure Limit

6.7.2.1 According to the method described in A.4.12, resuscitators designed for patients weighing less than 10 kg should be equipped with airway pressure limiting The pressure limit system does not exceed 4.5kPa (~45cmH2O). But it should be able to generate airway pressure of at least 3kPa (~30cmH2O).

Note: Super control device is available.

6.7.2.2 If a resuscitator designed for a patient weighing more than 10 kg is equipped with a pressure limitation system, Working pressure [see 10.2c) 9)]. Any pressure-limiting device that limits the pressure to less than 6kPa (~60cmH2O) should be equipped with a super-control device.

Home. If the override device is provided with a locking device, the override device should be designed so that the operator can Clearly identify the mode of operation (eg on or off). Compliance is checked by inspection.

7 Storage and handling conditions

7.2 * Operating conditions Test according to the method described in A.4.13, the resuscitator should be in the entire relative humidity range of 15% to 95% relative humidity, and in the following Meet the requirements of Chapter 6 in one of the temperature ranges.

8 Requirements for resuscitators or components in aseptic packaging

9 Mark

10 Information to be provided by the manufacturer in the operation and maintenance instructions

Appendix A (Normative appendix) experiment method