YY 0600.5-2011Lung ventilators for medical use—Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators (English PDF)

3.1 Random filesaccompanyingdocuments

Documents included with the resuscitator or resuscitator assembly, including information for the user, operator, installer or assembler It is all important information, especially information about security.

Note: Rewrite GB 9706.1-2007, definition 2.1.4.

3.2 Automatic pressure-cycle resuscitator

After the pressure set by the control device is reached, the resuscitator is switched from inspiratory phase to expiratory phase.

3.3 Automatictime-cycledresuscitator

A resuscitator that automatically controls the cycle between inspiratory and expiratory phases at time intervals set by the control device.

3.4 Automatic volume-cycle resuscitator

After the delivery capacity set by the control device is reached, the resuscitator is switched from inspiratory phase to expiratory phase.

3.5 Cardiopulmonary resuscitation

A combination of breathing assistance and chest compressions for patients who are judged to be cardiac arrest. [AHA CPR and First Aid Guide]

3.6 Clearly legible

Can make the operator or related personnel with normal vision see clearly.

Note: See 8.2.1.

3.7 * Delivered volume

Vdel The volume of gas delivered through the patient connection during the inspiratory phase.

3.8 On-demand valve

A component of the resuscitator that delivers the pressure-related airflow caused by the patient at the patient connection.

3.9 First responder

Trained personnel to provide initial response to respiratory emergencies. Example 1.

3.10 Gas-poweredemergencyresuscitator

Resuscitator Portable type that uses compressed gas as the power source and is expected to be used urgently to provide lung ventilation for resuscitated persons device.

3.11 Unexpected positive end-expiratory pressure

Unexpected PEEP inadvertentPEEP Unexpected positive pressure at the connection port of the end-expiratory patient.

3.12 Intermediatehose

A pipeline that transfers gas between resuscitator components.

3.13 Manual-cycledresuscitator

The inspiratory phase and the expiratory phase are controlled by the operator by repeatedly operating the resuscitator.

Note: In this document, on-demand valves that can be controlled by manual triggers are classified as "manual circulation resuscitators containing on-demand valves", rather than These countries commonly define "on-demand valves."

3.14 Minutevolume

Volume of gas inhaled or exhaled by the patient's lungs per minute.

3.15 Operator

Man operating a resuscitator.

Note: GB 9706.1-2007 was rewritten to define 2.12.17.

3.16 Patient-triggeredresuscitator

The cycle from expiration to inspiration is a resuscitator triggered by the patient's inspiration.

3.17 Patient-triggering

At the patient connection port, a pressure drop generated by the patient initiates a set inspiratory operation mode.

3.18 Patient valve

A valve in the breathing system of a resuscitator directs gas into the lungs during inhalation and directs gas from the lungs into the atmosphere during expiration.

3.19 Pressure-limiting device

A device that defines the maximum pressure in the respirator's respiratory system.

3.20 Resuscitator breathing system

Respiratory system bounded by low-pressure gas inlet, gas inlet and patient connection port, if provided, plus fresh gas inlet and The exhaust is bounded by the respiratory system.

3.21 Resuscitator dead space

The volume of gas that was previously exhaled in the respirator's respiratory system and delivered to the patient during the subsequent inspiratory phase.

3.22 Resuscitatorset

All necessary components to enable the resuscitator to be transported to an emergency ambulance and ready for immediate use.

3.23 Safety hazard

Potentially harmful effects directly on the patient, other people, animals, or the environment caused by the resuscitator.

Note: Rewrite GB 9706.1-2007, definition 2.12.18.

3.24 Single fault condition

In the resuscitator, only one safety-related dangerous protective measure fails, or only one external abnormality occurs.

Note: Rewrite GB 9706.1-2007, definition 2.10.11.

4.1 Overview

Transport, storage, installation, normal use and maintenance according to random documents.Under normal conditions and single failure conditions, the resuscitator should not Causes reasonably foreseeable hazards, and does not cause safety hazards that are not related to the intended application purpose.

A risk management process in accordance with YY/T 0316 shall be implemented. When implementing YY/T 0316.

a) The term "medical equipment" should be considered equivalent to a resuscitator.

b) The term "fault state" referred to in YY/T 0316 shall include, but shall not be limited to, a single fault as defined in this part of YY 0600 status.

c) Where YY 0600 specifies the measurable requirements for specific risks and meets these requirements, the requirements of these requirements Residual risk should be considered acceptable unless there is objective evidence to the contrary.

This part of YY 0600 specifies requirements that can generally be applied to risks related to resuscitators and is expected to be used as a tool in the risk management process. Hazards, and their associated risks and risk control measures.

Conditions or faults that can cause dangerous risks in safety have been pointed out in the clauses of YY 0600. In these cases, it is often necessary A risk management process is performed to determine what the actual safety hazard is and testing is required to show the known safety hazards Does not appear under specified conditions.

For each constituent component of a resuscitator, such as patented components, non-medical subsystems and legacy components, the manufacturer may not be able to Conforms to all procedures indicated in this part of YY 0600. In this case, the manufacturer should specifically consider whether additional risk control is needed Measures.

The requirements in this part of YY 0600 involve that if there is no unacceptable risk, the manufacturer decides the risk according to its acceptable risk regulations. Acceptability or unacceptability of risks.

Compliance is checked by inspection of risk management documents. If the manufacturer.

--- A risk management process has been established, --- an acceptable level of risk has been established, and --- It has been proven that the residual risk is acceptable (according to the regulations that determine acceptable risk).

Then the requirements of this chapter and all requirements related to risk management documents in this part of YY 0600 are considered to be in compliance.

4.2 Other test methods

If the same level of safety is available, the manufacturer may use a different type test method than detailed in this part of YY 0600. however In case of dispute, the methods specified in this section should be used as a reference method.

4.3 Acceptance criteria

Many of the test clauses in this part of YY 0600 set acceptance criteria for performance. These acceptance criteria should always be met.

When the performance level specified by the manufacturer in the random file is higher than the performance level specified in this part of YY 0600, the manufacturer specifies The level is the acceptance level and should be met.

5.1 Overview

5.1.6 * Respiratory filter Any respiratory system filter, whether integrated with the resuscitator or specified in the accompanying documentation for the resuscitator, shall meet Applicable parts in YY/T 0753.1 and YY/T 0753.2.

Compliance is checked according to the requirements of YY/T 0753.1 and YY/T 0753.2.

5.1.11 * Resuscitator assembly The resuscitator should be provided with the resuscitator assembly, or the resuscitator assembly should be recommended in the accompanying documents, including compliance with this part of YY 0600 Medical gas supply system in accordance with relevant requirements. Compliance is checked by inspection.

5.1.1 Structural materials

When selecting the constituent materials of all gas transmission components, consideration should be given to what is mentioned in the random file.

--- Can be managed by a resuscitator, and --- Chemical and physical characteristics of any substance that can be used to clean, disinfect or sterilize the resuscitator. Compliance is checked by examining risk management documents.

5.1.2 Faces, corners and edges

Damaged rough surfaces, sharp corners, open ends and sharp edges of tubular components should be avoided or covered. Special attention should be paid to hair Clearance of thorns. Compliance is checked by inspection.

5.1.3 Material filtration

Resuscitators and components should be designed and manufactured in such a way as to pose the greatest health risks in use as a result of leaching from substances in the resuscitator or its components small. Particular attention should be paid to the toxicity of materials and the compatibility of materials and substances in contact with gases during normal use. Compliance is checked by examining risk management documents.

5.1.4 Breathing circuit

Breathing tubes used for the respirator breathing system with an internal diameter greater than 18mm should meet the requirements of YY 0461. Compliance is checked according to the requirements of YY 0461.

5.1.5 Supply of sterile components

If the product is declared to be sterile on the label, it should be in accordance with GB 18278, GB 18279, GB 18280, GB 18281 or GB/T 19974 Sterilize by an appropriate and validated method specified in.

The packaging of aseptically supplied resuscitators or components should meet the requirements of GB 19633. Such packages should not be sealed once opened, Otherwise it should be clearly stated that the packaging has been opened.

Non-sterile packaging systems should be designed to maintain sterilized products at the expected cleanliness level before use, and should be designed to keep microorganisms Harm caused by pollution is minimal.

Compliance is checked by examining the methods of sterilization and disinfection in the random documentation and by examining the relevant verification reports.

5.1.7 Function Arrangement

Any single fault condition shall not cause any monitoring or alarm system function and related ventilation control specified in this part of YY 0600 Control function is a failure in which the monitoring or alarm system function fails at the same time, and thus the function of the monitored resuscitator cannot be checked. Failure.

Compliance is checked by simulating a single fault condition and visual inspection.

5.1.8 Protection against accidental adjustment

Means should be provided to prevent accidental changes to control settings including on-off switches, such as locks, guards, damping and braking And other mechanical technologies.

Compliance is checked by visual inspection according to the instruction manual.

5.1.9 Selector switch/control

For non-continuous adjustment control, measures should be provided to prevent the selector from staying in the middle position. Example 1. "On-Off" switch. Example 2. Oxygen concentration selector.

Example 3. Preset selector, discrete value of transmission capacity or frequency. Compliance is checked by inspection.

5.1.10 Accuracy of working data

When the resuscitator is used normally, the gas should be delivered with the accuracy indicated in the instruction manual. See 8.3.2.2.

Compliance is checked by the appropriate test methods in this part of YY 0600.

5.2 Connector

5.2.5 * Exhaust port connector If an exhaust connection is provided, it should be.

--- 30mm outer conical joint in accordance with YY 1040.1; or --- Incompatible with YY 1040.1 and YY 0801.1, and has the ability to prevent any breathing in accordance with YY 1040.1 or YY 1040.2 The accessory is connected to a dedicated connector in its cavity.

Compliance is checked by inspection and in accordance with the requirements of YY 1040.1, YY 1040.2 and YY 0801.1.

5.2.1 Connection to the medical gas supply system

If a removable hose assembly is provided to connect the resuscitator and the medical gas supply system, it shall comply with YY/T 0799. If the hose assembly It is permanently connected to the resuscitator and connected to the medical gas supply system in the following way.

--- Inserts in accordance with YY 0801.1, or --- Permanent connector.

Note: A permanent joint is a joint that can only be separated using a tool. Compliance is checked by inspection.

5.2.2 Connection to high pressure gas input

The connection of the hose to the high pressure gas inlet of the resuscitator should be as follows.

--- Non-interchangeable threaded joints in accordance with YY/T 0799, --- Inserts in accordance with YY 0801.1, or --- Permanent connector. Compliance is checked by inspection.

5.2.3 Patient connection port connector

The patient connector of the resuscitator should be a 15mm/22mm coaxial connector in accordance with YY 1040.1. Compliance is checked according to the requirements of YY 1040.1.

5.2.4 Mask connector

The mask should have a 22mm inner conical joint or 15mm outer conical joint that matches the corresponding joint specified in YY 1040.1. Compliance is checked according to the requirements of YY 1040.1.

5.2.6 Resuscitator suction branch joint

Resuscitator suction branch joints, if conical, should meet the requirements of YY 1040.1 and YY 1040.2.

Non-conical joints should not be matched with conical joints in accordance with YY 1040.1 and YY 1040.2. Unless it meets YY 1040.1 Engagement, disengagement and leakage requirements in YY 1040.2. Compliance is checked by inspection.

5.2.7 Emergency air intake

The emergency air intake should.

---provide;

--- Meet the requirements of 7.1.2.2 and 7.1.2.3; […]