Section 1 Design Specifications for Intelligent Medical Laboratories

Whether constructing a new laboratory, renovating, or expanding an existing one, the process is rigorous and complex, and must comply with the relevant design specifications and standards for laboratory construction. In laboratory design, spaces, workbenches, storage cabinets, ventilation facilities, lighting, and so on should all follow the corresponding regulations and requirements, in order to build an efficient, fully functional, and well-considered laboratory.

I. Design Principles and Basic Requirements for Medical Laboratories

  1. The site selection, design, and construction of a laboratory shall comply with the regulations and requirements of national and local environmental protection and construction authorities.

  2. The fire protection and safety egress arrangements of the laboratory shall comply with national fire protection regulations and requirements, while also taking into account the special requirements of biosafety; when necessary, the advice of the fire protection authority shall be sought in advance.

  3. Laboratory security shall comply with the security management regulations and requirements of the relevant national authorities for this type of facility.

  4. The building materials and equipment used in the laboratory shall comply with the regulations and requirements of the relevant national authorities governing the production, sale, and use of such products.

  5. Laboratory design shall ensure that the level of protection against biological, chemical, radiological, and physical hazards is controlled within an assessed, acceptable range, providing a safe working environment for associated office areas and adjacent public spaces, and preventing harm to the environment.

  6. Laboratory corridors and passageways shall not obstruct the passage of personnel and goods.

  7. Emergency evacuation routes shall be designed, and emergency exits shall be clearly marked.

  8. Room doors shall be fitted with locks as needed; locks shall be easy to open quickly from the inside.

  9. Where necessary (e.g., when hazardous materials are being handled legitimately), warnings and access restrictions shall be posted at room entrances.

  10. The risks of misuse, theft, and improper use of biological materials, samples, pharmaceuticals, chemicals, and confidential information shall be assessed, and corresponding physical safeguards shall be implemented.

  11. There shall be dedicated designs to ensure the safety of storage, transfer, collection, handling, and disposal of hazardous materials.

  12. Indoor environmental parameters of the laboratory—such as temperature, humidity, illuminance, noise, and cleanliness—shall meet work requirements and relevant hygiene requirements.

  13. Laboratory design shall also take into account energy conservation, environmental protection, and comfort requirements, and shall comply with occupational health requirements and ergonomic requirements.

  14. The laboratory shall have measures to prevent the entry of arthropods and rodents.

  15. The biosafety protection facilities of an animal laboratory shall also address the potential biological hazards arising from animal respiration, excretion, hair, scratching and biting, struggling, escape, animal experiments (e.g., exposure to toxic agents, medical examinations, sampling, dissection, testing, etc.), animal husbandry, and the disposal of animal carcasses and excreta.

  16. Animal housing facilities, experimental facilities, disinfection and sterilization facilities, and washing facilities with an appropriate level of protection shall be selected according to the species, body size, living habits, and experimental objectives of the animals.

  17. Air exhausted from animal laboratories shall not be recirculated.

II. Space Design Requirements for Medical Laboratories

Space planning is the most important part of laboratory design; adequate laboratory space is the foundation for ensuring testing quality and staff safety. Insufficient space is a safety hazard for the laboratory and affects the quality of laboratory work.

1. Rationalized Space

The rational allocation of space shall be determined according to the equipment to be placed. At the same time, the size of the laboratory space shall be determined with a view to future development, so that newly acquired instruments and equipment can be accommodated over a longer period, ensuring that clinical work is completed efficiently and safely.

2. Principles of Space Allocation

The general principle of space allocation is to make staff feel comfortable without creating waste, taking into comprehensive consideration the number of staff, analytical methods, and the size of instruments.

3. Work Space

The size of the work space shall allow the maximum number of staff to work at the same time. The effective space shall be divided into clean zones (offices, rest rooms, study rooms), buffer zones (storage areas, supply areas), and contaminated zones (work areas, washing areas, specimen storage areas). The work area shall include the area occupied by staff and the space for moving about. Work space and circulation space shall be translated into the area occupied on the floor.

III. Medical Laboratory Workbenches and Equipment

Ancillary facilities shall be designed to meet the functions of the laboratory to the greatest extent; the quality, type, and layout of workbenches and ancillary equipment affect the safety of the laboratory.

Workbenches are generally manufactured to standards and can be ordered or purchased directly from manufacturers. It is best to choose a small modular building unit that can be moved, rearranged, or reassembled at will. When selecting workbenches, the opinions of staff shall be sought. The principles for selecting workbenches are "shape, comfort, and function."

IV. Ventilation Design of Medical Laboratories

For laboratory safety, laminar-flow purification is not recommended for laboratories with north–south cross-ventilation; if the laboratory air cannot be convected, a central air handling system must be installed. However, at present, the vast majority of laboratories still widely use electric fans during hot summers, which can lead to the spread of infectious diseases in the laboratory. In particular, the use of electric fans shall be strictly prohibited in microbiological and biomedical laboratories.

Proper ventilation not only removes harmful odors and toxic gases from the laboratory but also ensures the normal operation of equipment.

It is currently advocated that in general laboratories, and in areas where vapors and biochemically hazardous agents are used, the air exchange rate should be 12 air changes per hour. In some areas the air exchange rate reaches 16 air changes per hour. In designing heating, ventilation, and air-conditioning systems, the intended use of each room shall be carefully and fully understood in order to achieve the desired requirements. Rooms with chimneys or biosafety cabinets—where biohazardous materials are handled or animals are housed (rare in clinical laboratories)—require a single-pass air system.

Rooms in which large amounts of smoke are generated and in which autopsies and histological analyses are performed shall be equipped with special ventilation equipment.

"Open laboratories" usually include both hazardous and non-hazardous operations. To allow laboratory air to be recirculated, additional equipment must be used to heat, cool, dehumidify, or filter the air; a recirculating air handling system can be installed to reduce energy costs.

To evaluate the efficiency of each laboratory's air handler, the air exchange capacity shall be monitored periodically.

V. Power Supply and Communications in Medical Laboratories

1. Design of the Power Supply Required by Instruments

In designing the power supply for laboratory instruments, the designed power supply shall fully take into account rational layout, safety, and convenience of use; in addition to meeting current usage needs, the future development of the laboratory shall be considered, with sufficient expansion capacity to meet the laboratory's needs. The following points shall be noted in instrument power supply design:

(1) The amount of electricity and the number of electrical outlets required by all instruments in the laboratory.

(2) Whether the power outlets are three-pin or two-pin.

(3) The distribution of power outlets, to ensure safe and convenient use.

(4) The voltage (220 V or 380 V) and power required by each instrument.

(5) Computers are now widely used in laboratories; the outlets required for computers shall be fully considered.

2. Lighting Design

The number of lighting fixtures required in a laboratory is determined by the following factors: the type of work, the color of the work surfaces, the colors of the ceiling and walls of the workroom, the distance between fixed lighting and the work surfaces, and the size of the space to be illuminated.

Once the above factors and the required illuminance standards have been determined, a certain number of lighting fixtures that meet the illuminance standards can be selected.

International Codes and Standards

  1. ABSA — Relevant design requirements of the American Biological Safety Association
  2. ACGIH — Relevant design requirements of the American Conference of Governmental Industrial Hygienists
  3. AIA — Relevant design requirements of the American Institute of Architects
  4. ANSI — Relevant design requirements of the American National Standards Institute
  5. ASHRAE — Relevant design requirements of the American Society of Heating, Refrigerating and Air-Conditioning Engineers
  6. ASTM — Relevant design requirements of ASTM International (American Society for Testing and Materials)
  7. NFPA — Relevant design requirements of the National Fire Protection Association (USA)
  8. NIH — Relevant design requirements of the National Institutes of Health (USA)
  9. NRC — Relevant design requirements of the U.S. Nuclear Regulatory Commission
  10. World Health Organization (WHO) Laboratory Biosafety Manual
  11. U.S. CDC/NIH Biosafety in Microbiological and Biomedical Laboratories
  12. American Institute of Architects — Planning and Design Manual for Biomedical Research Laboratories

Chinese Codes and Standards

  1. GB/T 19489-2004 Laboratories — General Requirements for Biosafety
  2. GB/T 50346-2004 Architectural and Technical Code for Biosafety Laboratories
  3. WS 233-2002 General Safety Guidelines for Microbiological and Biomedical Laboratories
  4. GB/T 50073-2001 Code for Design of Clean Rooms (Clean Factory Buildings)
  5. JGJ 71-1990 Code for Construction and Acceptance of Cleanrooms
  6. JGJ 16-2008 Code for Electrical Design of Civil Buildings
  7. GB 50303-2002 Code for Acceptance of Construction Quality of Building Electrical Engineering
  8. GB 50015-2003 Code for Design of Building Water Supply and Drainage
  9. GB 50242-2002 Code for Acceptance of Construction Quality of Building Water Supply, Drainage and Heating Engineering
  10. GB 50019-2003 Code for Design of Heating, Ventilation and Air Conditioning
  11. GB 50243-2002 Code for Acceptance of Construction Quality of Ventilation and Air-Conditioning Engineering
  12. GB 50210-2001 Code for Acceptance of Construction Quality of Building Decoration and Finishing Engineering
  13. JGJ 91-93 Code for Design of Scientific Laboratory Buildings
  14. Jianbiao 127-2009 Construction Standard for Centers for Disease Control and Prevention
  15. GB 50189-2005 Design Standard for Energy Efficiency of Public Buildings