Safety requirements for medical laboratories

1 Scope

This standard specifies the requirements for safe behavior in medical laboratories.

2 Normative references

The following references are essential for the application of this standard. For dated references, only the referenced version shall apply. For undated references, the latest version (including all revisions) shall apply: ISO 15189:2003 Medical laboratories - Particular requirements for quality and competence.

3 Terms and definitions

This standard adopts the terms and definitions specified in ISO 15189 and the following.

3.1 Aerosol

A system formed by particles dispersed in a gas, smoke or mist.

3.2 Antiseptic

A method of using chemical agents such as antiseptics to prevent infection in wounds or clinical procedures.

3.3 Antiseptics

Chemical agents used to sterilize skin or tissue.

3.4 Biological agents 

All microorganisms that may cause infection, allergy or poisoning, including genetically modified, cell cultured and parasitic on the human body. Note: For the risk classification of biological agents, see Section 4.

3.5 Cleaning (decontamination)

The process of removing visible or invisible contamination.

3.6 Infection control plan

A set of procedures used in hospitals or laboratories to limit the spread of infection.

3.7 Decontamination

The process of removing or reducing microorganisms or toxins to a safe level of infectivity or other harmfulness.

3.8 Disinfectant

A preparation with disinfecting effect.

3.9 Disinfection

The process of reducing the number of microorganisms (usually excluding bacterial spores) without killing or eliminating all microorganisms.

3.10 Ergonomics

The discipline that studies the efficiency of people in the working environment.

Note: This term includes biomechanics, labor physiology, simulated human body and human-machine interface.

3.11 Exhaust (fume)

A cabinet or a place above laboratory equipment to exhaust air or smoke to prevent it from circulating in the room.

3.12 Hazard

A potential source of harm.

[IEC 61010-1:2001]

3.13 Hazardous wastes

Waste that is potentially flammable, combustible, explosive, corrosive, toxic, reactive, harmful to humans or the environment.

3.14 Material Safety Data Sheet

Technical notice providing detailed hazard and warning information.

3.15 Microbiological safety cabinet

Biological safety cabinet

Exhaust cabinet. Protects the operator and the environment from exposure to aerosols generated when handling potentially hazardous and dangerous microorganisms by filtering the gases exhausted to the atmosphere.

Note: Adapted from EN 12469:2000

3.16 Microorganisms

Cellular or non-cellular microorganisms that can replicate or transfer genetic material.

3.17 Noise

Harmful sound in the form of sound energy that may have an adverse effect on health.

3.18 Personal protective equipment

Apparatus (including clothing) to protect personnel from chemical or biological contamination

3.19 Radionuclides

Natural or synthetic unstable nuclei that emit ionizing radiation.

3.20 Risk

The combination of the probability of a hazard occurring and its severity.

3.21 Safety shield

A device placed above a medical laboratory workplace or equipment to reduce the risk to laboratory workers

3.22 Spill kit

A set of tools used to remove chemicals or microorganisms from laboratory surfaces or equipment

3.23 Splash shield

A device used to protect personnel from liquid contamination.

3.24 Sterilization

An effective process to make an object free of microorganisms.

3.25 Technical area

An area in a medical laboratory designated for sample preparation or testing.

3.26 Tissue

A collection of cells composed of specialized cells of animals or plants adhered together.

4 Risk classification

Biological factors are divided into 4 risk levels:

• Level I risk (low risk for individuals, low risk for groups)

Microorganisms (such as bacteria, fungi, viruses) and parasites that do not cause disease in healthy workers or animals (such as non-pathogenic biological factors)

• Level II risk (medium risk for individuals, limited risk for groups) Pathogens that can cause disease in humans or animals, but generally do not pose a serious risk to healthy workers, groups, livestock or the environment. Laboratory exposure rarely causes infection that causes serious diseases: effective treatment and prevention measures are available, and the risk of transmission is limited.

• Level III risk (high risk for individuals, low risk for groups)

Pathogens that can cause serious diseases in humans or animals, or cause serious economic losses, but are usually not transmitted between individuals due to accidental contact, or can be treated with antibiotics or antiparasitic drugs. 

• Risk level IV (individual high risk, group high risk)

Pathogens that can cause very serious diseases in humans or animals, are generally incurable, and are easily transmitted between humans, animals, or animals directly or indirectly or by accidental contact (such as smalpox virus). Medical laboratories that handle infectious agents of risk levels III and IV should meet additional requirements to ensure safety. 

5 Management requirements

5.1 Management responsibilities

Laboratory management shall be responsible for the safety of all employees and laboratory visitors. The ultimate responsibility shall be borne by the laboratory director or a designated person of equivalent position.

5.2 Employee health management

All personnel shall have documentation indicating that they have received relevant training on the potential risks of using medical (clinical) laboratory facilities. It is recommended that all personnel inform their doctors that they work in a medical laboratory. All personnel should be strongly advised to receive immunizations to prevent infection based on the organisms to which they may be exposed. For example, hepatitis B vaccine should be provided to all personnel who work with or handle human blood, serum, body fluids or human tissue. Immunization records should be maintained in accordance with ISO 15189.

6 Safety design

6.1 Anticipatory considerations

When considering the construction of a new laboratory or planning structural modifications to an existing laboratory, the appropriate national and local building regulations, including laboratory-specific building safety standards, should be followed. Construction or engineering work is prohibited without the permission of the laboratory director or his designated representative. Note: Helpful information is available from international and national standardization bodies.

6.2 General design requirements

The design of the laboratory should ensure that the level of protection against microbiological, chemical, radiological and physical hazards in technical work areas is controlled at a level appropriate to the assessed risk level, and provide a safe working environment for associated office areas and adjacent public spaces to reduce the risk to the surrounding community. Corridors and passages leading to exits should be barrier-free.

The design of the laboratory should ensure clear separation of blood collection areas (when blood collection areas are located within the laboratory area), sample reception areas, management areas and analysis areas. Each area should have a controlled environment with facilities, furniture, work surfaces and floors suitable for the work to be carried out in the area. There should be sufficient unobstructed space for safe work, including space around large equipment for maintenance personnel. Adequate space should be designed adjacent to (but safely separated from) laboratory work areas for the safe and secure storage of samples, chemicals, records, and for the storage of garbage and specific laboratory waste prior to disposal. Dedicated hand washing sinks should be installed in all areas where biological materials are handled. Whenever possible, manual taps should be replaced with automatic ones, or operated by the elbow, knee or foot. The drainage system of hand washing sinks installed in areas where biological materials are handled should drain water without obstruction (i.e., there should be no water retention plugs in the sink). The temperature of the hot water supplied should be comfortable for the hands to be placed in the water flow. The water temperature is based on 45°C.

Note: If manual taps are used, it is good practice to use paper towels or similar materials to prevent hand contamination when opening and closing.

The design of the Ventilation system of the medical laboratory should take into account the effective isolation of contaminated areas from each other. Each area should have its own independent ventilation system.

6.3 Physical Environment

6.3.1 Lighting

The lighting or artificial lighting in the laboratory should be suitable for safe work, and strong light and reflected light should be minimized.

6.3.2 Temperature

Equipment that generates excessive heat or cold air should be isolated from the general work area. Personal protective equipment, including heat-insulating gloves and clothing, should be provided to ensure the safety and comfort of personnel.

The room temperature of the laboratory should be controlled as much as possible to make the laboratory staff comfortable.

6.3.3 Ventilation

All equipment that may generate excessive smoke, heat, steam, odor or harmful substances should be isolated from the general work area and equipped with appropriate exhaust devices. If this is not possible, special arrangements should be made for the staff to ensure their working comfort. Local natural or artificial ventilation can be used for operations that may produce unpleasant odors. The indoor humidity and air exchange of the laboratory should make the laboratory staff comfortable and safe. The air flow rate should be monitored regularly to ensure adequate ventilation, and the potential infectious agents and harmful gases should be prevented from spreading in engineering. The ventilation ducts should be isolated from the general work area to prevent the spread of airborne infectious agents or odors to other work areas.

6.3.4 Noise

Excessive noise levels in laboratory work areas should be avoided. Equipment should be selected and placed with consideration of its own noise level and its contribution to the total noise level in the work area. Measures should be taken to minimize or reduce noise generation.

6.3.5 Ergonomic factors

Laboratory activities, workspaces and equipment (such as chairs, laboratory workbenches, computer keyboards and monitors), as well as equipment that generates vibrations and ultrasonic waves, should be designed or positioned to reduce the risk of ergonomic defects or accidents.

6.3.6 Design for work with live pathogens

All laboratories working with live pathogens should have a special design suitable for protecting microorganisms that pose a moderate to high risk to individuals. Laboratories intended to work with microorganisms of sub-level or higher risk levels should have a special design for a higher level of protection.

6.3.7 Door signs

Each exit and entrance of the laboratory should be distinguishable, and emergency exits should be marked to distinguish them from ordinary exits. Markings should include international or national hazard signs (such as: biological hazard signs, fire signs and radioactive signs) and other relevant regulatory signs.

6.3.8 Laboratory security

The laboratory entrance should have a lockable door. The door lock should not hinder emergency evacuation. Access to the laboratory should be limited to authorized personnel. Doors in the room should be locked as needed; access should be restricted when high-risk samples are being tested. Other security measures should be taken for the storage of high-risk samples, cultures, chemical reagents or supplies, such as lockable doors, lockable freezers, and access restrictions for special personnel. The risk of theft and improper use of biological materials, samples, drugs, chemicals and confidential information should be assessed, and appropriate measures should be taken to prevent it.

7 Staff, procedures, documents, inspections and records

7.1 Laboratory Safety Officer

A laboratory safety officer with appropriate qualifications and experience should be appointed to assist management in safety matters. The safety officer should develop, maintain and supervise an effective laboratory safety program. An effective laboratory safety program should include education, guidance and training, audits and evaluations, and procedures to promote safe laboratory behavior.

The laboratory safety officer should have the authority to stop unsafe activities. If a safety committee is established, the laboratory safety officer should at least be a member of the committee if not the director.

7.2 Procedures

The laboratory's standard operating procedures should include detailed instructions on any hazards involved and how to perform the work with minimal risk. The management responsible for work area activities should review and update these procedures at least once a year. A written plan, including a hazard information system, should be in place and should include the following:

• Arrangements for visitors/contractors;

• Health monitoring of employees;

• Arrangements for conducting risk assessments, recording results and taking action;

• Procedures for monitoring the identification (including appropriate labeling requirements), safe storage and disposal of chemicals and other hazardous materials;

• Procedures for safe behavior when handling hazardous materials;

• Procedures to prevent theft of high-risk/contaminated materials;

• Methods for identifying training needs and teaching materials;

• Procedures for obtaining, maintaining and distributing Material Safety Data Sheets (MSDS) for all materials used in the laboratory (ensuring that this information is available to employees 24 hours a day);

• Emergency procedures, including spill response plans (see Appendix A for action plans and Appendix C for spill decontamination):

• Incident records/reporting and investigation;

• Disposal of clinical waste.

7.3 Review and Inspection of Safety Plan

7.3.1 Review of Safety Plan

The safety plan should be reviewed and audited at least once a year (by appropriately trained personnel) to include, but not limited to, the following elements

• Safety and health policy;

• Written work procedures, including safe work behaviors;

• Education and training of laboratory-related personnel;

• Supervision of personnel;

• Regular inspections;

• Hazardous materials and substances;

• Health monitoring;

• First aid services and equipment;

• Accident and illness investigation;

• Health and safety committee review;

• Records and statistics;

Review of safety plans with follow-up requirements to ensure that all actions required by the audit have been completed. 

Note: Checklists tailored for each area can effectively assist the audit (see Appendix B for guidance on laboratory safety audits)

7.3.2 Safety Inspections

Laboratory management is responsible for ensuring that safety inspections are performed. The workplace should be surveyed/inspected at least once a year to ensure that

• fire emergency equipment, alarm systems and evacuation procedures are functioning and functioning properly;

• procedures and items for hazardous material spill protection (including emergency showers) are functioning properly;

• storage of flammable, combustible, infectious, radioactive and toxic materials is properly protected and controlled;

• decontamination and waste disposal procedures are functioning properly.

It is good practice for the safety committee to participate in safety surveys. Regular safety inspections help alert all personnel to potential hazards, ensure compliance with relevant regulations, and strengthen supervisors' accountability.

7.4 Safety Manual

A safety manual required for all employees should be readily available in the work area. The manual should be specific to the needs of the laboratory and include (but not limited to) the following areas:

• Fire protection;

• Electrical safety;

• Chemical safety;

• Radiation;

• Microbiological hazards;

• Hazardous waste disposal.

The safety manual should include detailed instructions for evacuating the work area and incident handling plans (see Appendix A for more information on action plans). Laboratory management should review and update the safety manual at least once a year.

Other sources of information available in the laboratory include (but are not limited to) Material Safety Data Sheets (MSDS) for all chemicals and preparations involved in the experiment. Other reference materials include textbooks and authoritative journal articles.

7.5 Records

7.5.1 General

Records should be kept in accordance with ISO 15189. It should be noted that international, national or local regulations or guidelines may apply.

7.5.2 Records of occupational diseases, injuries and adverse events.

There should be a mechanism to record and report occupational diseases, injuries, adverse events or accidents and the corresponding actions taken, while respecting personal privacy. Personnel training records should be maintained, including annual updates on safety instructions and safety readiness status for each employee.

7.5.3 Risk assessment records

There should be a formal risk assessment system. In addition to the required formal risk assessment of the workplace, the use of safety checklists is also an appropriate method to record and document the review plan (see 7.3).

Note: A mechanism for recording safety audits and incident trend analysis can help ensure the implementation of remedial actions. 7.5.4 Hazardous waste records

Hazardous waste disposal records should be an integral part of the safety plan. Records of hazardous waste disposal, risk assessments, safety investigations and actions taken should be accessible and maintained for the period required by national or local regulations.

8 Hazard identification

Hazard areas should be systematically and clearly identified and appropriate to the hazards. In some cases, both signs and physical barriers should be used to identify hazardous areas.

Specific hazardous materials used in laboratory experiments or laboratory equipment should be clearly identified. All entrances and exits to work areas should be marked with the hazards present. Particular attention should be paid to fire hazards and flammable, toxic, radioactive, hazardous and biological hazardous materials. The laboratory manager should be responsible for regularly reviewing and updating the hazard identification system to ensure that it is appropriate for existing known hazards. This activity should be carried out at least once a year. Maintenance personnel, contractors and subcontractors who are not laboratory employees should be made aware of any hazards they may encounter. Employees should be trained, familiar with and have special written instructions on emergency procedures. Potential risks to the health of pregnant women should be identified and reviewed. Risk assessments should be conducted and recorded.

9 Reporting of incidents, injuries, accidents and occupational illnesses

The laboratory shall have procedures for reporting laboratory incidents, injuries, accidents, occupational illnesses and potential hazards. All incident (including injury) reports shall be documented and shall include a detailed description of the incident, an assessment of the cause, recommendations for preventing similar incidents and the actions taken. Incident reports (including remedial actions) shall be reviewed by senior management, the safety committee or the laboratory safety officer

10 Training

The laboratory director shall ensure the implementation of the safety training program for all relevant laboratory personnel (including transportation and cleaning personnel).

Training in safe work behaviors should be emphasized.

A comprehensive training program begins with a written plan and should include orientation for new employees and periodic retraining for experienced employees. All employees should be required to read the applicable safety manual before working in a particular area. Written confirmation that the employee has received appropriate training and has read and understood the safety manual should be included, including the implementation date of the above activities.

The safety training program should include at least fire and preparedness, chemical and radiation safety, biological hazards and infection prevention. The curriculum should be tailored to the position and should take into account pregnancy, immune deficiency and physical disabilities. There should be a system in place to assess each employee's understanding of the information provided to him or her.

11 Personal Responsibility

11.1 Food, Beverages and Similar Items

Food, beverages and similar items should only be prepared and consumed in designated areas. Food and beverages should only be stored in designated dedicated refrigerators outside the laboratory area and should not be placed where reagents, blood or other infectious materials are stored. Refrigerators should be appropriately labeled to indicate their intended use. Smoking is prohibited in technical work areas.

11.2 Makeup, Hair, Beards and Jewelry

The use of makeup and handling of contact lenses in technical work areas is prohibited.

Long hair should be tied back. It is important to keep hair away from moving equipment. Males with beards should follow the same precautions as for hair. Rings, earrings, watches, bracelets, necklaces and other jewelry should not be worn in technical areas of the laboratory if there is any risk of being caught in equipment or contaminated with infectious materials or chemicals.

Note 1: Hand cream may be used.

Note 2: Disposable hair and beard wigs may be used.

11.3 Immunization Status

All laboratory personnel should be actively encouraged to receive immunizations to prevent possible infection by the organisms they are exposed to. Hepatitis B vaccine should be offered to all personnel who work with or handle human blood, serum, body fluids or tissues. Immunization records should be maintained in accordance with national or local requirements.

Immunization programs for specific laboratories should be developed based on documented laboratory infection risk assessments and recommendations from local public health authorities. International, national or local regulations or guidelines may apply.

Note: Many laboratory-acquired infections can be effectively prevented through active immunization programs. Vaccines should be selected based on the potential hazards of the institution or environment.

11.4 Personal belongings

Personal belongings, clothing and cosmetics should not be kept in designated areas where contamination may occur.

Secure storage, such as locked cabinets, should be provided.

11.5 Festive decorations

Festive or other decorations that are potentially contaminating and/or a fire hazard should not be used in technical work areas.

Decorations should not be attached to light sources, lighting fixtures or technical equipment at any time.

12 Safe work practices

12.1 Safe work practices for all biogenic materials

In all medical laboratories, procedures and procedures for handling, testing and disposing of biogenic materials should utilize good microbiological practice standards. Work practices should reduce the risk of contamination. Work practices in contaminated areas should prevent personal exposure. Quality control materials and reference materials that are potentially infectious or toxic should be stored, handled and used in the same manner as samples of unknown risk.

Note 1: Many of these products are made from mixed materials from complex sources. If samples are damaged or leaking when received, they should be opened by trained personnel wearing appropriate personal protective equipment to prevent leakage or aerosols. Such containers should be opened in a biological safety cabinet. If contamination is excessive or the sample is considered unacceptably damaged, the sample should be safely discarded without opening. The sender should be informed immediately.

Mouth pipetting is prohibited.

Laboratory personnel should be trained in the safe handling of sharp instruments and devices. Sharps, including used needles, should not be manually cut, bent, broken, re-capped or covered, or manually removed from syringes. Work Behavior

The goal of the review should include minimizing the use of sharps. Sharps, including needles, glasses, and disposable scalpels, should be placed in puncture-resistant containers immediately after use. National or local regulations may apply. Sharps containers should be replaced before they are two-thirds full. Disposal of these containers and their contents should be in accordance with local guidelines. National or local regulations may apply.

NOTE 2: Special conditions may apply to certain blood collection systems.

12.2 Special requirements for work in microbiology laboratories

These requirements apply generally to other medical laboratory disciplines, wherever practicable. All specimens, cultures and waste should be assumed to contain active biological agents associated with the transmission of infectious diseases and handled in a safe manner. All potentially infectious or toxic quality control and reference materials should be treated in the same manner as for specimens of unknown risk when stored, handled and used.

Long-wear gowns may be worn throughout the handling of specimens, sera or cultures. Long-wear gowns should be closed at the front and neck and the cuffs of long sleeves should be tight. Long-wear gowns should preferably be made of moisture-resistant material. Gloves should be worn as a protective barrier to prevent contamination of the hands when handling specimens and cultures. In any case, gloves should be removed when work is completed to avoid contamination of the workplace. Wearing gloves should not be considered a substitute for thorough hand washing. Thorough hand washing should always be performed after removing gloves. It is best to use an Electronic ignition device to inoculate the microorganisms with ring-shaped bacteria.

13 Aerosols

Laboratory work activities should be designed and implemented to reduce personnel exposure to hazardous aerosols of chemical or biological origin. Sample centrifugation should only be performed in a covered safety container:

All samples subjected to vortex mixing should be placed in covered containers. It is particularly recommended to use local ventilation protection devices on large analytical equipment that can generate aerosols, and to use customized exhaust devices when operating small instruments. Local exhaust is essential where harmful chemical gases may occur.

14 Biological safety cabinets, chemical safety hoods and cabinets

If laboratory employees are exposed to samples of industrial and Class II risks, the air in the biological safety cabinet can only be recirculated after passing through a high-efficiency ion filter (hepa filter) before exhaust: If laboratory work involves microbial cultures of Class II or higher risk levels, recirculation of air is prohibited.

In some areas, double hepa filters are required.

Biological safety cabinets and chemical safety cabinets should be installed by qualified personnel and verified annually. Biosafety cabinets should be monitored frequently to ensure their design performance. Inspection records and any functional test results should be kept. The cabinet should have a verification label as proof of inspection.

The placement, design and type of biological safety cabinets used should be consistent with the risk protection level required for safe work.

All biological safety cabinets should be used in a way that does not reduce their functionality.

The ventilation of biological safety cabinets, chemical safety cabinets and cabinets should be consistent with the microbiological and/or chemical risk level and safety requirements.

15 Chemical safety

15.1 Measures to avoid chemical contamination

In all medical laboratories, the regulations and procedures for the storage, handling, use and disposal of chemicals should comply with good chemical laboratory practice standards

The nature and risk of each product should be marked on each storage container in accordance with international standards, and the containers of products in use should be clearly and unambiguously marked.

Adequate control measures should be in place for chemical, physical and fire hazards. These measures should be monitored regularly to ensure their effectiveness. Records of monitoring results should be kept.

Dangerous liquids such as acids and bases should be stored below eye level. Large containers should be stored securely close to the ground and at a height that ensures safe and ergonomic access. Appropriate equipment should be provided for the safe handling, storage and use of compressed gases and cryogenic materials in accordance with national or local requirements, and safety devices (such as chains and racks) should be installed to prevent accidental movement of cylinders, reagents or glassware. All personnel should be required to work according to safe operating procedures, including the use of safety equipment or devices that are considered appropriate for the work being performed. In the laboratory area, all personnel should wear appropriate protective clothing at all times. If the activity required, appropriate personal protective equipment should also be added.

15.2 Emergency measures to be taken in case of chemical contamination

Eyewash facilities should be provided in all laboratory areas where chemical contamination may cause eye damage. Showers should be provided in places where there is a chemical hazard of a large area of body contamination risk. Appropriate chemical leakage control measures should be in place, including neutralizers, leakage shielding and absorbents suitable for chemicals used in the workplace.

15.3 Disposal of chemicals

There should be clear written procedures for the disposal and safe disposal of each chemical used in the laboratory, including a fully detailed description of local legal procedures to ensure full compliance with its mechanism to safely and legally remove these substances from laboratory control.

16 Radiation Safety

16.1 Radionuclides

Before approving the use of radionuclides, the laboratory director shall evaluate the reasons, limits and locations for the proposed use. The laboratory shall maintain adequate records of the acquisition, use and disposal of radionuclides. All radioactive chemicals shall be stored safely and securely. All laboratory personnel who operate or come into contact with radionuclides shall receive instruction and training in the basics of radioactivity and related techniques and radioactive protection, and shall comply with radioactive safety regulations and procedures.

The laboratory shall have appropriate written standard operating procedures and local regulations that meet the needs of the work. The procedures shall include clear operating instructions detailing the measures to be taken in the event of radiation accidents and leaks; summaries of these operating instructions shall be prominently displayed in workplaces where radionuclides are used.

The procedures shall detail the safe disposal of unused radioactive materials, materials mixed with radioactive materials or contaminated materials.

Appropriate approved warning and prohibition signs shall be displayed.

16.2 Radiation Protection Advisor, Safety Officer and Supervisor

Laboratories engaged in radioactive work should seek advice from a locally authorized Radiation Protection Advisor (RPA) on radiation protection practices and legal requirements, including all required laboratory design and equipment standards, and develop appropriate measures to ensure compliance. The laboratory manager should appoint a Radiation Protection Officer (RPO), who should report to the RPA. The RPO has the specific responsibility for designing, implementing and maintaining an operational radiation protection program.

The RPO should report to the laboratory director on administrative matters and to the RPA on professional matters.

The laboratory should appoint a number of Radiation Protection Supervisors (RPS) to supervise the daily work related to ionizing radiation to ensure good radiation behavior. The RPS should report to the laboratory RPO. The establishment, role and responsibilities of the RPA, RPO and RPS should be stipulated by local regulations. In places where there are no legal provisions, it is strongly recommended to establish a radiation safety committee. Note 1: The RPA should be a qualified and appropriate person, usually with a status equivalent to that of the laboratory director. Provide information and advice based on expert consultation. Note 2: Other authorities of the RPA may be based on their other titles.

16.3 Supervision of the workplace

A systematic supervision plan should be established to ensure comprehensive and regular supervision of the workplace. Supervision records should be kept. Routine cleaning and decontamination programs should be established and implemented.

The use of radionuclides should be reviewed regularly, work behaviors should be monitored regularly and improvements should be made as required by the RPA and RPO. Remedial actions or procedural changes should be recorded and kept for the period required by regulations or local regulations.

Radioactive waste should be identified and stored in a dedicated safe and radiation-proof storage facility. The nature and extent of the risk should be clearly marked on each discarded package. Storage and disposal should comply with regulations and local regulations.

16.4 Ultraviolet and laser light sources (including high-intensity light sources)

Where ultraviolet and laser light sources are used, appropriate and adequate personal protective equipment should be provided, appropriate approved signs should be displayed, and training should be provided for the safe use of the equipment. These light sources should only be used for the purpose for which they are designed.

The external installation of such light sources can only be opened by qualified maintenance personnel of such equipment.

16.5 Microwave equipment 

Microwave equipment should be regularly inspected, monitored and maintained to ensure that its performance and safety standards are maintained. High-power microwave and electromagnetic wave devices should be specially protected and equipped with additional protective devices and protective covers. When placing such devices, possible performance interference with other equipment should be taken into account. Signs should be posted to warn that it may affect people wearing pacemakers. People wearing pacemakers are prohibited from approaching places with high-power microwave and electromagnetic wave devices.

Combustibles should not be placed in microwave equipment.

17 Fire protection

17.1 Building

The building specifications should be based on the type of hazards contained in the laboratory. The main exit route should be pointed out. If the medical laboratory is located in a building with inpatients, it should be separated from the medical area by a fire-proof structure. Explosion-proof lights and explosion-proof switches should be installed where flammable gases are stored. Electrical equipment used in such areas should be specially designed.

17.2 Auxiliary exits

Auxiliary exits should be provided to ensure that personnel can evacuate the laboratory safely.

The designated fire exit should lead to the fire zone.

17.3 Alarm Systems 

Automatic smoke and heat detection and alarm systems should be available in all laboratory areas where flammable gases or liquids are used or stored. Alarm systems should be tested regularly to ensure proper function and all personnel should be familiar with their operation.

17.4 Strategies to Reduce Fire Risks

Store only the minimum amount of flammable gases and liquids in technical areas of the laboratory.

Note: In some areas, "minimum amount" is interpreted as the amount consumed in one working day.

Flammable gases and liquids should only be used in well-ventilated areas.

Work that releases flammable vapors should be performed in a laboratory fume hood or cabinet. Flammable liquids and gases should be kept away from heat and ignition sources, including motors and direct sunlight. Emergency shut-off valves and pipes in gas supply ducts should be installed in accordance with national or local regulations. A spill kit should be readily available to control the release of small amounts of flammable materials. In the event of a spill, seek immediate assistance from the fire department. National and local regulations apply.

17.5 Storage of flammable items

Containers for flammable liquids or gases should be as small as possible and meet the needs of the laboratory. Containers for flammable liquids should be covered when not in use.

Flammable gases or liquids should only be stored in approved storage cabinets or warehouses. Storage should comply with current national standards. Refrigerated flammable liquids should only be stored in spark-free "explosion-proof" refrigerators. Note: Household refrigerators are not suitable for this purpose.

Metal containers for large quantities of flammable liquids should be fixed and connected to a common ground point to avoid static electricity. Portable safety containers should be used to store, transport and distribute flammable liquids. Flammable liquids should be gently poured or transferred from storage tanks to small containers in a dedicated storage room or chemical fume exhaust. Metal containers should be well grounded.

17.6 Fire safety training plan

Fire safety guidance and training should be provided to laboratory staff and all personnel in the building. Content includes:

• Identification and evaluation of fire hazards;

• Development of a plan to reduce fire hazards;

• All actions to be taken in the event of a fire.

17.7 Firefighting equipment

Appropriate equipment should be available on site to extinguish controlled fires and to assist in the evacuation of personnel from the main fire

It is the responsibility of laboratory personnel to ensure the safe and orderly evacuation of personnel rather than to attempt to extinguish the fire. Appropriate fire extinguishing equipment and fire blankets should be selected, placed and maintained according to the type of fire that may occur in the laboratory and in accordance with the requirements of the local fire authorities.

18 Emergency evacuation

An action plan for emergency evacuation should be prepared. Similarly, the plan should take into account chemical, fire and microbiological emergencies. Measures should be included to make the remaining empty building as safe as possible. All personnel, including visitors, should be aware of the action plan, evacuation routes and assembly points for emergency evacuation. All personnel should participate in fire drills at least once a year.

19 Electrical equipment

The design and manufacture of electrical equipment should comply with appropriate safety requirements. Recognized standards include GB4793 Series 1 Safety requirements for electrical equipment for measurement, control and laboratory use. To ensure safety, some equipment must be connected to a backup power supply. New, modified or repaired electrical equipment must not be used until a qualified person (such as a qualified electrician or biomedical engineer) has completed electrical safety testing and confirmed that it meets the requirements for safe use. People who use electrical equipment should be trained in correct operation and should operate in a way that does not reduce electrical safety. Note: Some work requires the use of spark-proof or spark-free (inherently safe) equipment. People who use electrical equipment should regularly check for damage to the equipment that may cause electrical failures. If conductive liquid is accidentally spilled on the equipment, the equipment should be disconnected from the power supply and carefully dried. It should not be reactivated without the consent of a qualified person.

20 Transportation of samples

The laboratory director or designated person (such as a laboratory safety officer) should be responsible for providing appropriate guidance and instructions to all departments that submit samples to the laboratory. All specimens should be transported to the laboratory in a manner that prevents contamination of personnel, patients or the environment. Specimens should be transported in approved, intrinsically safe, leak-proof containers. Specimens transported within the institution's buildings should comply with the institution's safety transport regulations. Specimens transported outside the institution should comply with current regulations for the transport of infectious and other biological materials.

Specimens, cultures and other biological materials should be transported between laboratories or other institutions in a manner that complies with the institution's safety regulations. International and national regulations for the transport of hazardous materials by road, rail and water apply, as appropriate. Materials considered hazardous goods by national or international standards that are intended for domestic or international air transport should be packaged, labeled and documented in accordance with current national or international regulations or requirements.

21 Waste Disposal

The management of laboratory waste disposal should comply with national or local regulations. The objectives of laboratory waste management are as follows:

• To minimize the hazards of handling, collecting, transporting, handling and disposing of waste;

• To minimize its harmful effects on the environment.

All specimens, cultures and other biological materials that are no longer needed should be disposed of in specially designed, dedicated and labeled containers for the disposal of hazardous waste. Biological waste containers should not be filled to their designed capacity. Sharps (including needles, knives, metal and glass) should be disposed of directly in puncture-resistant containers. Laboratory management should ensure that hazardous waste is handled by appropriately trained personnel using appropriate personal protective equipment. Accumulation of garbage and laboratory waste is not permitted. Full containers should be removed from the work area regularly. They should be stored in a designated safe place, usually within the laboratory area, until decontamination or final disposal. Laboratory garbage and daily paper waste that is not contaminated with reagents or body fluids can be handled and disposed of as non-hazardous waste. Dispose of appropriately and safely at least once a day. All discarded laboratory microbiological specimens, cultures and contaminated waste should be rendered inherently biologically safe before being removed from the laboratory area. Biological safety can be achieved by autoclaving or other approved techniques or packaging in appropriate containers. The transportation of untreated waste is permitted as long as the packaging and transportation method meets the regulatory requirements for the transportation of hazardous waste to an appropriate location for safety purposes in an institution. Laboratory waste known to be uncontaminated can be handled and disposed of as non-hazardous waste.