Cómo garantizar que la calidad de los gases medicinales esté cualificada

“Una ingeniería de sistemas de gases medicinales segura y fiable” debe tener tres puntos principales: 1. La calidad (limpieza) de gases medicinales deben cumplir los requisitos de la farmacopea médica; 2. La seguridad y confiabilidad de la operación del equipo del sistema de gases medicinales; 3. Debe haber pruebas de terceros.

This article will explain how to ensure that the quality of medical gases is qualified.

1. Use the correct material: medical gas pipeline must use copper pipe for medical gas

The pipe of the medical gas pipeline shall comply with the hard-drawn seamless copper material of ASTM B819 (Standard Specification for Seamless Copper Tube for Medical Gas Systems). Medical gas copper pipes must be produced by professional manufacturers. Before the pipeline is shipped from the factory, the manufacturer should fill the tube with helium gas and sealing with a rubber stopper to prevent secondary pollution during transportation. When transporting, the pipe must be placed on the dedicated stand to prevent collisions. The manufacturer must indicate the wordsmedical gas pipeline onlyon the medical copper tube. The fittings of medical gas pipelines must also be produced and cleaned by professional manufacturers. It should be sealed with special cleaning bags and transported to the site. It can not be opened until ready for installation. This ensures that the tubing and fittings are not contaminated before installation.

2. Use the right medical gas device

Medical air compressors and medical vacuum pump system must be produced by professional manufacturers. This system meets the requirements of the NFPA 99 standard for setting up the primary risk system and also meets the requirements of ISO 9001 medical gas equipment. Equipment manufactured to industry standards must not be used in medical gas systems.

2.1 Medical air compressor unit system

Medical air compressor units must be oil-free: including multiple air compressors (One for use and one for preparation, two for use and one for preparation, three for use and two for preparation, etc.), anti-wear air receiver, unit control panel, CO and dew point monitor, redundant medical desiccant air dryer with clean control. The unit system is tested after being assembled by the professional manufacturer. After meeting the NFPA 99 medical gas standard, the inlet and outlet must be sealed to ensure no secondary contamination during transportation.

2.2 Vacío pump sistema

The vacuum pump system includes multiple vacuum pumps (one for use and one for preparation, two for use and one for preparation, three for use and two for preparation, etc.), vacuum tank, unit control panel, etc. The rack-mounted modular vacuum pump system is tested by the professional manufacturer after assembly. After meeting the NFPA 99 medical gas standard, the inlet and outlet must be sealed to ensure no secondary contamination during transportation.

2.3 Relevant equipment must be tested before leaving the factory, and it is sealed after conforming to the US NFPA 99 estándar.

Special medical gas outlets, medical area valve boxes, medical gas manifolds, etc. produced by professional manufacturers must be tested before leaving the factory. After reaching the US NFPA 99 standard and sealing them, they can be transported to the construction site. The seal can only be opened for installation.

2.4 Relevant equipment must meet US UL standards during installation

All medical gas pipelines, electrical sockets and wires, weak electrical intelligent signal lines and nurse call systems on the medical bed head units and medical pendants produced by professional manufacturers must meet the US UL standards during installation. After the manufacturer has finished testing, the whole is dust-proof packaged. Transport to the hospital construction site. Medical bed head units and medical pendants must be installed directly on the wall and on the ceiling. The medical gas pipeline can be directly butt welded and the wires can be directly butted.

3. Use the correct installation method

After the copper pipe for medical gas reaches the construction site, it should be placed in a special place and cannot be placed together with other pipes; this can prevent stringing or misuse.

The medical gas copper pipeline must be installed by professional medical gas pipeline installation personnel, and strictly in accordance with the construction plan and welding process to ensure the construction quality of the medical gas pipeline system. The important point is to eliminate the possibility of pollution during installation. If contamination occurs, it must be replaced, and cannot be cleaned on-site to prevent secondary pollution of the pipeline.

It is very important that when welding copper pipes. And it is necessary to use the nitrogen gas with the purity of 99.9% to continuously fill the pipes. The purpose is to prevent the generation of oxide particles and to prevent the generation of odors. And to ensure the quality of the welding and the cleanliness of the pipes. This ensures that the patient is using the clean and odor-free gas and the safe use of the medical device.

When soldering copper tubes, be sure to use more than 15% silver (silver solder) instead of soft solder (tin-lead solder). Silver welding is very important in fire prevention. If there is a fire in the ward, the pipe joint welded with tin-lead solder is easily melted, which will break the pipe, causing oxygen leakage and explosion. And more than 15% of the silver wire will not be easily melted. This is why the US standard requires welding with more than 15% of silver containing wire. The main purpose is to prevent fire.

Each copper tube for medical gas can only open the sealing plug at both ends when it is installed. All pipes that open the plug must be completely welded on the same day. The fittings are also opened before installation and quickly welded to avoid contamination of the fittings. After the welding of the pipe on the day, all the gas inlets and outlets must be sealed with the plug to avoid pollution.

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