GB/T 44008-2024General technical requirements of modular integrated system for emergency medical use (English PDF)

3 Terms and definitions

3.1 Module for medical use is defined as a functional unit that provides, separately, medical diagnosis, medical treatment, the related logistic support or a specific medical function, that can be flexibly combined with others and that is convenient to transport. A note states that the main structure of such a unit is normally a container or a shelter.

3.2 Modular integrated system for emergency medical use is defined as a combined space made up of medical modules, able to be moved quickly to a designated area and deployed there as an integrated whole, meeting the basic requirements of a medical treatment environment; it can be assembled and dismantled repeatedly and used again. A note gives the short form used throughout the document, integrated system.

4 Technical requirements

4.1 General. The system shall carry at least the facilities needed to sustain vital signs and to give emergency medical treatment. Once deployed, the main body is normally made up of three parts, medical treatment, wards and logistic support; the treatment part uses a high-strength material such as an air-beam tent for the corridor roof that links the medical modules, and the ward part may be placed next to the treatment part and connected to it. Modules are selected and combined as needed from emergency care, medical technical support, admission and treatment, information technology, logistic support, and medical waste and wastewater disposal; configuration follows Annex A, use follows Annex B, maintenance is described in Annex C and layout in Annex D. Functional units should be self-contained movable equipment that can be set up quickly and whose internal space can be adjusted within limits. Escape routes and emergency exits shall be provided together with fire-fighting facilities. Tents shall meet GB/T 3917.3 and GB/T 3923.1; containers shall meet GB/T 1413, GB/T 5338.1 and GB/T 17382; the main environmental parameters of a clean operating module shall meet GB 50333; the main functions of an intensive care unit shall meet WS/T 509; and an isolation unit shall meet WS/T 311. Shelters are of the fixed or the expandable kind, built from rigid materials into a movable whole, and shall be reasonably airtight, lighttight, watertight and thermally insulated. Materials shall be flame retardant, corrosion resistant, resistant to disinfection and easy to wipe clean. In the transport and storage state the preferred main structure is a shelter or container plus box sets. Tents shall have a service life of not less than 3 years and a storage life of not less than 10 years; shelters and containers not less than 20 years for both.

4.2 Application environment. On siting, the ground should be regular in shape, geologically stable, high-lying and free of flood threat; the site shall be level, open, well drained and firm, preferably with a natural slope of less than 5 %. Where the incident site is hard to reach, a site nearby should be chosen that suits helicopter connection without being affected by helicopter movements, and a site with access to municipal mains water or class III river water is preferred. A system for respiratory infectious disease should be placed on the upwind side of the least frequent annual wind direction, with the treatment modules at least 20 m from surrounding buildings or public areas. The system shall work normally in the natural environment of most of the country and shall still be usable after storage at the stated limits. Table 1 fixes those conditions: working temperature -40 °C to +46 °C; storage limit temperature -30 °C and +60 °C for shelters, containers, tents and the medical facilities fixed inside them, and, for other equipment, whatever its own manual requires; relative humidity not more than 95 %; wind speed not more than 9.4 m/s during deployment and withdrawal and not more than 20.7 m/s in operation; rainfall 2 mm/min for 1 h for tents and 6 mm/min for 1 h for shelters and containers; altitude not more than 3 500 m.

4.3 Shelter loading and module requirements. The floor shall carry, without plastic deformation or damage, a uniformly distributed load of 3 kN/m2, a concentrated load of 10 kN over an area of 500 mm x 500 mm, and a point load of 1 kN on each of four bearing points of 10 mm x 10 mm arranged at the corners of a square with 300 mm between the centres of adjacent points. The roof shall carry a uniformly distributed load of 2 kN/m2 and a concentrated load of 3 kN over an area of 300 mm x 600 mm. Temperature, relative humidity, illuminance, air supply rate and air change rate or fresh air volume inside each module should be controllable, and Table 2 sets values for twenty-six modules grouped as emergency care, medical technical support, admission and treatment, information technology, logistic support, and medical waste and wastewater disposal. Clinical modules are held at 18 °C to 26 °C or 20 °C to 26 °C with relative humidity in the band 30 % to 70 % or 30 % to 65 %; illuminance runs from not less than 100 lx in wards and delivery rooms to not less than 750 lx in the operating module, with the pharmacy at not less than 500 lx; supply air is not less than 6 changes per hour, and the air change rate is not less than 2 per hour or the fresh air volume not less than 40 cubic metres per hour per person, the isolation ward being set at not less than 12 changes per hour. Logistic modules are given an illuminance figure only, the fuel supply module none. Further sub-clauses place the emergency care module where an ambulance can reach it and stretcher trolleys and wheelchairs can be parked, ask the operating module to support remote consultation, apply GBZ 130 to the X-ray protection design of the imaging module and the equipment documents to magnetic resonance shielding, apply WS 310.1 to the sterile supply module, require enough general ward capacity and internal clearances for medical equipment to pass, require connecting corridors sized for the scale and flow of the system with a buffer zone between the contaminated and the clean corridor, require the information module to network internally by cable or radio and externally by mobile network or satellite, apply GB 5749 to the water of the domestic water supply module, leave the purified water quality of the medical water module to the relevant rules and the disinfectant water quality to the medical process, require the fuel supply module to support 48 h of full-load running with a refuelling interval of not less than 24 h, require the waste collection module to collect and bale waste in a closed way, and require the medical waste treatment module to render medical and domestic waste harmless with exhaust emissions meeting GB 18484 or local environmental rules.

4.4 External envelope. The envelope should meet requirements for heat insulation, sound insulation, vibration isolation, impact resistance, insect proofing, corrosion protection and sealing, and materials with few and tightly fitting joints should be chosen. Tent fabric shall meet GB/T 5455 for flame retardance. Sealed windows shall be used and wooden doors and windows are not preferred; glazing shall resist impact and be shatterproof. Door and window materials shall have a long service life, resist corrosion, not shed, be easy to maintain, light, strong, colourfast and well sealed.

4.5 Interior finishes. Shelter and container interiors shall meet GB 8410 and use materials that meet the flame retardance requirement. Finished surfaces shall resist weak acid and alkali attack, withstand medical detergents and disinfectants and offer some impact resistance and weathering resistance. Finishes and floors shall not generate or accumulate dust and shall be easy to sweep or wash. The harmful substance content of the materials shall meet GB 50325 and GB 18582.

4.6 Electrical system. Power shall be distributed on a central supply, zoned control basis, the main power module feeding zone power modules and those feeding the using modules, forming a three-phase four-wire network. One or more supply modes shall be supported, including but not limited to generating sets and a mains connection. Generating sets shall be provided so the system can run on its own, small sets shall be provided for key areas such as the operating room, and equipment with a high continuity requirement shall be given a dedicated uninterruptible supply. Over-voltage, under-voltage, earth leakage and overload alarm and protection shall be provided. Power and signal earthing shall follow GB 14050. The input of each using module shall have induced lightning protection and, where the application calls for it, direct strike protection; external cabling shall be protected by design. Electromagnetic compatibility of medical electrical equipment shall meet YY 9706.102. Warning lamps shall be fitted at the entrance of the operating, delivery and imaging modules. Modules needing sterilization, such as operating, clinical laboratory and ward modules, shall have germicidal lamps switched separately from the other lighting, with switches that are easy to identify and operate. Lighting shall use high-efficiency, high colour rendering sources; where LED luminaires are used, photobiological safety shall be tested to GB/T 20145 and reach the no risk class, free of blue light and ultraviolet hazard.

4.7 Intelligent systems. The system shall be able to communicate remotely and its modules shall interconnect easily. An emergency call and answer function for medical staff shall be provided. A video surveillance system shall be provided so that the condition of the casualties in each module can be watched in real time where needed. The power supply state of each module and the running state of important equipment such as ventilation, air conditioning and oxygen shall be monitored in real time. An electronic medical record system, a hospital information system, a laboratory information system and a picture archiving and communication system should be provided.

4.8 Water supply and drainage. A zoned arrangement should be used. Surface water used as a source shall meet GB 3838 and groundwater GB/T 14848. The medical water and domestic water modules shall be placed in clean, well ventilated areas, and floor drains shall be fitted where water can collect. External pipe runs should not be too long or too numerous, the pipe itself should be of a material that is easy to stow and quick to deploy, joints should be of the quick-insert kind, and there shall be no leakage or poor supply and drainage. Medical wastewater discharge shall meet GB 18466 and HJ 2029. For a respiratory infectious disease system there are three further requirements: water outlets shall be non-contact or non-manual, sanitary fittings shall be easy to clean and disinfect, and wastewater shall be disinfected before discharge.

4.9 Oxygen. Oxygen cylinders or oxygen generating equipment should be used, the generating equipment meeting YY 9706.269. External oxygen piping shall be of a material that is easy to stow and quick to deploy, with quick-insert joints and a good seal. External oxygen piping shall be designed for reliability and routed away from areas where an ignition source can arise; when the pipe is damaged at one point it shall be possible to shut off the pipe locally at both ends without affecting the other oxygen terminals. Supply pressure at the terminal shall be 0.4 MPa to 0.45 MPa. The oxygen supply module shall be designed with a back-up and fitted with an abnormality alarm.

4.10 Ventilation and air conditioning. Each module should have its own independent air conditioning system. Direct expansion units are preferred as the source of heating and cooling, with auxiliary heat sources such as electric heating or oil-fired warm air units. Exhaust shall be provided where odour, water vapour or damp work arises, and local exhaust in heavily contaminated modules such as the clinical laboratory and the sterile supply module. Airflow inside each module shall run from spaces at lower risk of contamination towards spaces at higher risk, with backflow and eddies kept to a minimum, preferably by top supply and bottom extract. Unless there is a special requirement, ozone generators or devices that produce harmful gases or can stimulate microbial mutation shall not be installed inside air handling units. Clean modules shall use a barrier type air cleaning device as the supply air terminal. Where highly hazardous volatile substances or gases are produced, a suitable negative pressure fume cupboard shall be provided with the fan at the end of the duct. A biological safety cabinet shall be provided in modules where pathogenic microorganism samples are handled, and no supply air outlet shall be placed above the working face of the cabinet or above other places where aerosols are generated. Where such a module is mechanically ventilated, the airflow arrangement shall meet GB 50346. Air handling units should be placed where routine inspection and replacement are easy. Exhaust from modules containing pathogenic microorganisms or other contaminants shall meet GB/T 29478 before discharge. Ventilation and air conditioning for a respiratory infectious disease system shall meet GB 50849, GB 50686 and GB/T 38800.

4.11 Module interfaces. Power distribution interfaces shall be of the quick-insert kind. Water supply and drainage shall use quick-insert connections with a self-closing function, as shall the integrated oxygen interface, whose pattern shall be uniform. Interfaces that join a connecting corridor shall be identical so that they are interchangeable, and shall be not less than 1.5 m wide by 1.8 m high. Each module interface shall keep the assembled system sealed without affecting the original function and performance of the module.

5 Deployment and withdrawal

5.1 Basic requirements. The supplier shall provide on-site deployment, use and maintenance instructions and the related drawings, stating the transport, site, equipment, personnel, water, power and fuel needed, laying down the operating method and the points to watch, and shall give training on site. Before dispatch the technical state of the system shall be confirmed, its functions and performance shown to be normal and the measures securing the shelters and containers for transport checked. The installation site should have power, water supply and drainage connections available; where there is an epidemic prevention requirement there shall also be drainage, sewage and waste disposal provision. Working equipment such as forklifts, cranes and hydraulic trolleys shall be provided.

5.2 Deployment. Before deployment the wind direction and the entrances of the site shall be assessed, the orientation of the system confirmed and the position of each module set out. The lifting or forklift method and the installation order shall be decided from the layout, the lifting capacity available, the site roads and the construction conditions. Deployment shall take not more than 24 h, measured from the moment the shelters or containers are unloaded into position to the moment the system is in place and the water, power and gas connections are finished, excluding the time to deploy the medical equipment. After installation and connection the system shall be commissioned and checked, and no leakage shall appear at the internal and external interface joints.

5.3 Lifting and forklift handling. Handling shall use the lifting lugs on top of the shelter or container, the slots underneath or other interfaces left for the purpose. Before handling, large items of equipment or fittings inside shall be secured against sliding or overturning. During handling and placing, cables, pipework and fragile items already laid shall be protected.

5.4 Withdrawal. Before withdrawal the system shall be thoroughly cleaned and disinfected inside and out and medical waste dealt with under the relevant rules. During withdrawal, materials shall be boxed as the use and maintenance instructions require and fragile items protected. After withdrawal, all materials shall be placed in the shelters or containers and secured for transport.

6 Marking, packaging, transport and storage

6.1 A product nameplate shall be fitted in a conspicuous place giving the product name, the manufacturer, the product code, the product number, the date of manufacture, the outside dimensions and the weight. Warning and operating markings shall be placed where they can be seen. It should be possible to read the name of a package, its installation order and the overall installation order by scanning a two-dimensional code on the packaging.

6.2 Medical instruments, facilities, cables and pipework that are moved shall each be packed in their own packing case and secured reliably in the stated position and by the stated method.

6.3 Transport shall be in shelter or container form, the securing interfaces meeting GB/T 17382, and the system shall suit road, rail, air and sea transport.

6.4 Storage shall be in a ventilated, cool place, protected from damp and rain and not liable to contamination.

6.5 The storage place shall meet the relevant fire protection requirements.

A Annex A (normative) Configuration requirements for the integrated system

A.1 The functional modules may be combined flexibly as the task requires to form integrated systems of different size and capability, and Table A.1 sets out the configurations. The table lists the twenty-six modules down the side and five system types across the top: the full-element type in a non-infectious and an infectious variant, the minimum type, the typical basic type and the typical infectious disease type. Three symbols are used, a filled circle for a module that shall be fitted, an open circle for an optional module and a dash for one that does not apply.

A.2 Notes to the table describe what each type is for. The full-element type is aimed at completing the whole treatment and support chain in a natural disaster or an epidemic. The minimum type is aimed at the emergency stage, completing urgent surgical intervention and treatment without admitting casualties. The typical basic type is aimed at the treatment stage of a field mobile hospital, with a casualty throughput of 150 to 200 people, two surgical procedures completed at a time, 20 wounded admitted and four intensive care beds provided. The typical infectious disease type is aimed at epidemic control, with the isolation and admission of 100 infectious patients.

B Annex B (normative) Requirements for the use of the integrated system facilities

B.1 General requirements for use. The water, power, gas, network and information connections of the system shall be confirmed and the equipment of each module shall be running normally, with maintenance staff told at once of any abnormality. Staff shall be posted in the information module to watch video surveillance, power distribution, air conditioning and oxygen equipment in real time and report abnormalities. Cable plugs shall be inserted and withdrawn with the power off. High-power appliances shall not be added at will, so that cables and components are not damaged by the load. Operators of medical equipment shall be specially trained and pass before they operate it, and each item shall be operated as its manual requires. Water and fuel shall be supplied in advance according to how much the system uses. Disinfection of the system shall follow GB 15982.

B.2 Use of a respiratory infectious disease system. To keep the virus from spreading in the air there are four further requirements. Sharp objects shall not pierce or strike the internal finished surfaces of the negative pressure area, that is the side walls, ceiling, floor, doors and windows, so that the seal of the negative pressure environment is kept. Staff shall be posted in the command and communication module to watch the negative pressure operation in real time and report abnormalities. Medical staff and the people who use and maintain the system shall be trained in the working flows for people and for goods. The doors on the two sides of a pass box shall be interlocked and the interlock shall not be damaged; a pass box shall only hold materials or items for a short time, and a failure of the interlock shall be reported at once.

C Annex C (informative) Maintenance of the integrated system

C.1 Maintenance of the system covers ten matters: dedicated maintenance staff on duty; a quick response and prompt clearance of any fault in the facilities or equipment; the safekeeping by a named person of product drawings, acceptance records, inspection and monitoring records, accident records and repair records; the writing of working instructions covering at least the operation and maintenance of equipment and facilities and the replacement of wearing parts and consumables, common faults and how to clear them, emergency measures for fire, earthquake, flood and long power cuts, and periodic inspection of the system; verification or calibration of the instruments in the system as required, with prompt replacement of anything abnormal; periodic patrol of pipework and cables; periodic checks on the door and opening seals, replacing them when they age or break; periodic checks on the fire extinguishers, replacing them when they expire; sealing checks at the module joints after extreme weather such as high wind, rain or snow; and a check of every module by the maintenance staff after the patients have left, a full check every three months while the system is out of use and a full check before use whenever it has stood idle for more than a month, with the inspection and maintenance recorded.

C.2 Maintenance of a respiratory infectious disease system adds two further matters. For the ventilation system: check the equipment before running it and start only when it is confirmed normal; carry out periodic maintenance checks and cleaning and deal with faults at once; check the filters at each stage periodically in the light of the outdoor conditions and replace them periodically; check the supply and exhaust facilities and ductwork periodically for leakage or damage caused by ageing sealing material; and collect and treat removed exhaust HEPA filters centrally. For the daily monitoring of the air isolation pressure gradient: keep air flowing from higher to lower pressure areas and find and correct the cause of any abnormal pressure state; when starting and stopping the ventilation system, watch the starting and stopping order of the supply and exhaust fans and observe and record the pressure difference in the negative pressure areas, looking for positive pressure or pressure reversal; and strengthen the monitoring of fan failure alarms and of the pressure difference alarms on the air filters at each stage of the supply and exhaust systems, replacing blocked filters promptly so that the fans keep running normally.

D Annex D (informative) Assembly layout of the integrated system

D.1 Figure D.1 shows the typical full-element deployment layout in two versions, one for the non-respiratory infectious disease mode and one for the respiratory infectious disease mode.

D.2 Figure D.2 shows the minimum integrated system, formed by drawing together the triage, operating, imaging, clinical laboratory, information and communication and power distribution modules; it is aimed at the emergency stage, completing urgent surgical intervention and treatment without admitting casualties.

D.3 Figure D.3 shows the typical basic integrated system, formed from the triage, operating, imaging, clinical laboratory, sterile supply, pharmacy, oxygen supply, blood supply, general ward, intensive care ward, information and communication, sanitary, domestic water, medical water, waste collection and power distribution modules; it is aimed at the treatment stage of a field mobile hospital, with a casualty throughput of 150 to 200 people, two surgical procedures completed at a time, 20 wounded admitted and four intensive care beds.

D.4 Figure D.4 shows the typical respiratory infectious disease integrated system, formed from the triage, medical staff working area, imaging, clinical laboratory, sterile supply, pharmacy, oxygen supply, medical water, isolation ward, intensive care ward, information and communication, sanitary, waste collection and power distribution modules; it is aimed at epidemic control, with the isolation and admission of 100 infectious patients.