ISO 15190:2003
(Main)Medical laboratories — Requirements for safety
Medical laboratories — Requirements for safety
ISO 15190:2003 specifies requirements for safe practices in the medical laboratory.
Laboratoires de médecine — Exigences pour la sécurité
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 15190
First edition
2003-10-15
Medical laboratories — Requirements for
safety
Laboratoires de médecine — Exigences pour la sécurité
Reference number
ISO 15190:2003(E)
©
ISO 2003
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ISO 15190:2003(E)
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ISO 15190:2003(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 1
4 Risk group classification. 3
5 Management requirements . 4
5.1 Management responsibilities. 4
5.2 Management of staff health. 4
6 Designing for safety. 4
6.1 Preliminary considerations. 4
6.2 General design requirements . 4
6.3 Physical conditions . 5
7 Staffing, procedures, documentation, inspection and records . 6
7.1 Laboratory Safety Officer. 6
7.2 Procedures . 6
7.3 Safety programme audits and inspection .7
7.4 Safety manual. 8
7.5 Records. 8
8 Identification of hazards. 9
9 Reporting of incidents, injury, accidents and occupational illnesses . 9
10 Training . 9
11 Personnel responsibilities . 10
11.1 Food, drink and like substances . 10
11.2 Cosmetics, hair, beards and jewellery. 10
11.3 Immunization status . 10
11.4 Personal property . 11
11.5 Festive decorations . 11
12 Clothing and personal protective equipment (PPE), including gloves, eye, face, foot and
respiratory protection. 11
12.1 Protective clothing in the laboratory . 11
12.2 Protective clothing outside the laboratory. 11
12.3 Face and body protection . 11
12.4 Gloves . 11
12.5 Footwear . 12
12.6 Respiratory protection. 12
12.7 Handwashing. 12
12.8 Training . 13
12.9 Equipment. 13
12.10 Eyewash stations . 13
12.11 Emergency showers . 13
13 Good housekeeping practices. 14
14 Safe work practices . 14
14.1 Safe work practices with all material of biological origin. 14
14.2 Special requirements for working in microbiology laboratories . 15
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ISO 15190:2003(E)
15 Aerosols .15
16 Microbiological safety cabinets, chemical safety hoods and cabinets.16
17 Chemical safety .16
17.1 Measures to avoid chemical contamination.16
17.2 Emergency measures applicable when chemical contamination has occurred .17
17.3 Discarded chemicals.17
18 Radiation safety.17
18.1 Radionuclides.17
18.2 Radiation protection advisors, officers, and supervisors.17
18.3 Workplace monitoring .18
18.4 UV and laser light sources (including light from high-intensity sources) .18
18.5 Microwave equipment.18
19 Fire precautions.19
19.1 Construction .19
19.2 Secondary exits.19
19.3 Alarm systems.19
19.4 Fire risk reduction strategies.19
19.5 Storage of flammable materials.19
19.6 Fire safety training programmes .20
19.7 Firefighting equipment .20
20 Emergency evacuations .20
21 Electrical equipment .20
22 Transport of samples.21
23 Waste disposal .21
Annex A (informative) Action-plan outline for implementation of this International Standard .23
Annex B (informative) Laboratory safety audit.25
Annex C (informative) Decontamination, cleaning and disinfection following a spillage.35
Bibliography.37
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ISO 15190:2003(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 15190 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro
diagnostic test systems.
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ISO 15190:2003(E)
Introduction
This International Standard specifies requirements to establish and maintain a safe working environment in a
medical laboratory. As with all such safety guidelines, there are requirements to ensure that there is a named
person ultimately responsible and that all employees take personal responsibility for
their own safety at work and,
the safety of others who may be affected by it.
Every task requires risk assessment, with the aim that hazards be eliminated wherever possible. Where this
cannot be done, the risk from each hazard is reduced to as low a level as practicable, using the following
order of priority:
a) by substitution;
b) by containment; or
c) by the use of personal protective measures and equipment.
Safety is the primary consideration; cost is of secondary importance.
While this International Standard is intended for use throughout the currently recognized disciplines of medical
laboratory services, other services and disciplines may find it useful and appropriate. However, medical
laboratories handling human pathogens requiring containment levels 3 and 4 will need to meet additional
requirements to ensure safety.
While this International Standard is not intended to provide guidance on accreditation, it may be used for such
purposes by a government, professional, or other authoritative body.
International, national or regional regulations or guidelines may apply to specific topics covered in this
International Standard.
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INTERNATIONAL STANDARD ISO 15190:2003(E)
Medical laboratories — Requirements for safety
1 Scope
This International Standard specifies requirements for safe practices in the medical laboratory.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 15189:2003, Medical laboratories — Particular requirements for quality and competence
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 15189 and the following apply.
3.1
aerosols
system of particles dispersed in a gas, smoke, or fog
3.2
antisepsis
method for avoiding infection in a wound or during a clinical procedure by the use of a chemical agent such as
an antiseptic
[BS 6324-1]
3.3
antiseptic
chemical germicide formulated to be used on skin or tissue
3.4
biological agent
any microorganism, including those which have been genetically modified, cell cultures and human
endoparasites, which may be able to provoke any infection, allergy or toxicity
NOTE For classification of biological agents into risk groups, see Clause 4.
3.5
cleaning
process to remove any type of contamination, visible or not
3.6
control of infection plan
set of procedures to be used to limit spread of infection in either a hospital or a laboratory
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ISO 15190:2003(E)
3.7
decontamination
procedure that eliminates or reduces microbial or toxic agents to a safe level with respect to the transmission
of infection or other adverse effects
3.8
disinfectant
agent capable of causing disinfection
[BS 6324-1]
3.9
disinfection
process to reduce the number of microorganisms, but not usually of bacterial spores, without necessarily
killing or removing all organisms
3.10
ergonomics
study of the efficiency of persons in their working environment
NOTE This term includes biomechanics, work physiology, anthropomorphy and man-machine interfaces.
3.11
extraction hood
fume hood
cabinet or cover above a laboratory device for the extraction of air or fumes which prevents their general
circulation
3.12
hazard
potential source of harm
[IEC 61010-1:2001]
3.13
hazardous waste
waste that is potentially flammable, combustible, ignitable, corrosive, toxic, reactive, or injurious to people or
the environment
3.14
material safety data sheet
MSDS
technical bulletin providing detailed hazard and precautionary information
3.15
microbiological safety cabinet
MSC
biological safety cabinet
ventilated enclosure, intended to offer protection to the user and the environment from the aerosols arising
from handling of potentially hazardous and hazardous microorganisms, with means for filtering air discharged
to the atmosphere
NOTE Adapted from EN 12469:2000.
3.16
microorganism
microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material
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ISO 15190:2003(E)
3.17
noise
unwanted sound in the form of acoustic energy which may adversely affect health
3.18
personal protective equipment
material, including clothing, used to prevent contamination of a person by chemical or biological matter
3.19
radionuclide
natural or synthetically produced unstable nucleus of an atom that emits ionizing radiation
3.20
risk
combination of the probability of occurrence of harm and the severity of that harm
3.21
safety hood
covering over a medical laboratory workplace or device intended to reduce risk to a laboratory worker
3.22
spill kit
set of equipment used for the removal of chemical or microbiological material from a laboratory surface or
apparatus
3.23
splash guard
device used to prevent personal contamination by a liquid
3.24
sterilization
validated process used to render a product free from microorganisms
3.25
technical area
space in a medical laboratory allocated for the preparation or examination of samples
3.26
tissue
any coherent collection of animal or plant specialized cells
4 Risk group classification
Biological agents are classified into four risk groups:
a) Risk Group I (low individual and community risk)
This group includes those microorganisms, bacteria, fungi, viruses and parasites which are unlikely to
cause disease in healthy workers or animals (e.g. non-pathogenic biological agents).
b) Risk Group II (moderate individual risk, limited community risk)
This group includes pathogens that can cause human or animal disease, but under normal circumstances
are unlikely to be a serious hazard to healthy laboratory workers, the community, livestock or the
environment (e.g. Staphylococcus aureus, Listeria monocytogenes). Laboratory exposures rarely cause
infection leading to serious disease; effective treatment and preventive measures are available and the
risk of spread is limited.
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ISO 15190:2003(E)
c) Risk Group III (high individual risk, low community risk)
This group includes pathogens that usually cause serious human or animal disease, or which can result
in serious economic consequences but do not ordinarily spread by casual contact from one individual to
another, or that can be treated by antimicrobial or antiparasitic agents (e.g. Salmonella typhi, prion).
d) Risk Group IV (high individual risk, high community risk)
This group includes pathogens that usually produce very serious human or animal disease, often
untreatable, and may be readily transmitted from one individual to another, or from animal to human or
vice-versa, directly or indirectly, or by casual contact (e.g. smallpox virus).
Medical laboratories dealing with Risk Groups III and IV infectious agents will need to meet additional
requirements to ensure safety.
NOTE In Europe, “Risk Groups I, II, III and IV” are termed “Hazard Groups 1, 2, 3 and 4”. For the purposes of this
International Standard, the terms may be considered interchangeable and local usage will determine the actual
terminology required. Risk Groups II, III and IV may also be termed “pathogens” or “infectious agents”.
5 Management requirements
5.1 Management responsibilities
Laboratory management shall have responsibility for the safety of all employees and visitors to the laboratory.
The ultimate responsibility shall rest with the laboratory director or a named person of equivalent standing.
5.2 Management of staff health
All personnel shall have documented evidence of training related to potential risks associated with working
with any medical (clinical) laboratory facility.
All personnel should be advised to inform their family doctor/personal physician that they work in a medical
laboratory. All personnel should be strongly encouraged to have immunizations to prevent infections
associated with organisms to which the person is likely to be exposed. For example, all personnel working
with or handling human blood, sera, body fluids or human tissue should be offered hepatitis B vaccine.
Records of immunizations should be kept in accordance with ISO 15189.
6 Designing for safety
6.1 Preliminary considerations
When new construction is being considered, or where a laboratory is already established and structural
changes are proposed, appropriate national and local building regulations and building codes containing
specific architectural safety standards for laboratories shall be followed. No structural or engineering work
shall be undertaken without the appropriate permission being given by the laboratory director or his/her
nominated representative.
NOTE International and national standards bodies are sources of helpful information.
6.2 General design requirements
Laboratories shall be designed to ensure that containment of microbiological, chemical, radiological and
physical hazards is appropriate to the level of assessed risks in technical work areas, and provides a safe
working environment in associated office areas and adjoining public space to limit risk to the surrounding
community. Corridors and passages to the exits shall be clear of obstructions.
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ISO 15190:2003(E)
The laboratory should be designed to ensure a clear separation of phlebotomy facilities where they are
included in the laboratory area, sample reception, administrative and analytical areas. Each area should have
environmental controls and facilities, furnishings, work surfaces and floor finishes appropriate to the activity
being performed there. There should be sufficient unobstructed space for safe working, including adequate
space around large pieces of equipment for maintenance personnel. There should be suitable and adequate
designated spaces, proximal to, but safely separated from, laboratory working space for the safe and secure
storage of samples, chemicals, records, and for rubbish or designated laboratory waste prior to disposal.
Dedicated handwashing sinks should be fixed within all areas where biological materials are handled.
Wherever possible, hand-operated sink handles should be replaced with motion-, elbow-, knee- or foot-
operated equipment. Sinks installed for hand washing in areas where biological materials are handled should
have unimpeded drainage (i.e. no stoppers in the basin) and the temperature of the hot water supplied should
be such that hands can be held comfortably in the water flow.
A water temperature of 45 °C is recommended.
NOTE If taps (faucets) are hand-operated, it is good practice to turn them on using a paper towel or similar material
to avoid hand contamination.
In designing the air-circulating system for the medical laboratory, effective separation between contaminated
areas should be considered. Each area should have an individual air-circulating system.
6.3 Physical conditions
6.3.1 Lighting
Laboratories shall be illuminated naturally or artificially to a level that is optimal for safe working. Glare and
distracting reflections should be minimized.
6.3.2 Temperature
Any equipment generating excessive heat or chill shall be isolated from the general workspace. Personal
protective equipment, including thermal protective gloves and appropriate clothing, shall be provided to allow
for personnel safety and comfort.
Ambient temperature in laboratories should be controlled as far as possible to a level compatible with
laboratory worker comfort.
6.3.3 Ventilation
Any equipment with the potential to generate exhaust fumes or emit excessive heat, steam, odour or toxicity
shall be isolated from the general workspace and placed under a suitable extraction hood. If such
arrangements are not possible, special arrangements for worker comfort shall be provided.
Local natural or mechanical ventilation is advised where unpleasant or nauseous odours could arise from
certain manual processes.
Ambient humidity and changes of air in laboratories should be made compatible with laboratory worker
comfort and safety.
Air flowrates should be monitored regularly to ensure adequate ventilation and should be engineered to avoid
dispersion of potentially infectious agents and toxic fumes.
Ventilation ducts should be isolated from the general workspace in order to avoid dispersion or airborne
infectious agents or smells in the rest of the workplace.
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ISO 15190:2003(E)
6.3.4 Noise
Excessive noise levels shall be avoided within the laboratory workspace. Selection and location of equipment
shall take account of individual pieces of equipment and their contribution to the cumulative noise levels in the
work place. Steps shall be taken to minimize or attenuate noise generation.
6.3.5 Ergonomic factors
Laboratory activity, workspace and equipment (e.g. chairs, laboratory workstations, computer keyboards and
displays), as well as vibration-producing and ultrasonic equipment, etc., shall be designed or positioned to
reduce the risks of ergonomic distress disorders and accidents.
6.3.6 Design for working with viable pathogens
All laboratories working with viable biological agents shall have design characteristics appropriate to the
containment of microorganisms of moderate to high risk to the individual. Laboratories designed to work with
organisms of Risk Group III or above shall include design characteristics for greater containment.
6.3.7 Door signs
Laboratories shall be identified at each entrance and exit point, with emergency exits marked so as to
distinguish them from normal exits. Signs at each site shall include the internationally accepted hazard
indicators (e.g. biohazard, fire, radioactivity) and other relevant statutory signs.
6.3.8 Laboratory security
Laboratory entrances shall have lockable doors. These door locks shall not prevent exit in an emergency.
Laboratory access shall be restricted to authorized personnel. Locks may be required for internal doors, to
restrict entry while high-risk samples are being examined. Additional security measures, such as lockable
doors, locked freezers, limited access to specific personnel, etc., may be required when storing high-risk
samples, cultures, chemical reagents or supplies. The threat of theft and tampering with biological agents,
samples, drugs, chemicals and confidential information should be assessed, and appropriate steps taken to
prevent these acts from happening.
7 Staffing, procedures, documentation, inspection and records
7.1 Laboratory Safety Officer
An appropriately qualified and experienced Laboratory Safety Officer shall be designated to assist the
managers with safety issues. This person shall develop, maintain and monitor an effective l
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