ISO 15190:2003

Medical laboratories - Requirements for safety

ISO 15190:2003 specifies requirements for safe practices in the medical laboratory.

Laboratoires de médecine — Exigences pour la sécurité

General Information

• Status: Withdrawn
• Publication Date: 26-Oct-2003
• Withdrawal Date: 26-Oct-2003
• ICS: 11.100.01 - Laboratory medicine in general
• Technical Committee: ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
• Drafting Committee: ISO/TC 212/WG 1 - Quality and competence in the medical laboratory
• Current Stage: 9599 - Withdrawal of International Standard
• Start Date: 24-Feb-2020
• Completion Date: 13-Dec-2025

Relations

• Consolidated By: ISO/IEEE 11073-10406:2012 - Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG)
• Effective Date: 06-Jun-2022
• Revised: ISO 15190:2020 - Medical laboratories - Requirements for safety
• Effective Date: 20-Aug-2016

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 2003
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

©  ISO 2003
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2003 — All rights reserved

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
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

iv © ISO 2003 — All rights reserved

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.
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.
vi © ISO 2003 — All rights reserved

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
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
2 © ISO 2003 — All rights reserved

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.
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.
4 © ISO 2003 — All rights reserved

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.
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 laboratory safety
programme.
An effective laboratory safety programme should include education, orientation and training, audit and
evaluation, and programmes to promote safe laboratory practice.
The Laboratory Safety Officer shall be authorized to stop activities that are unsafe. If there is a Safety
Committee, the Laboratory Safety Officer shall be at least an ex officio member of this Committee, if not its
chairholder.
7.2 Procedures
The standard operating procedures for the laboratory shall include detailed instructions concerning any
hazards involved and how to carry out the procedure with minimum risk. Procedures shall be reviewed and
updated at least annually by the management representative responsible for the work place activity. A written
plan, including protocols for hazard communication, shall be developed. The plan shall include the following:
6 © ISO 2003 — All rights reserved

a) arrangements for visitors/contractors;
b) staff health surveillance;
c) arrangements for risk assessments to be carried out, findings recorded, and action to be taken;
d) procedures for monitoring inventory for identification of chemical and other hazardous materials, including
appropriate labelling requirements, and safe storage and disposal;
e) procedures for safe practices in handling hazardous materials;
f) procedures to prevent theft of high risk/contaminated materials;
g) methods for identifying training needs and documentation;
h) procedures for obtaining, maintaining and distributing Material Safety Data Sheets (MSDS) for all
materials used (to ensure that employees have 24-h access to this information);
i) procedures for the safe decontamination and maintenance of equipment;
j) emergency procedures including spillage protocols (see Annex A on action plans and Annex C on
decontamination of spills);
k) incident recording/reporting and investigation; and
l) disposal of clinical waste.
7.3 Safety programme audits and inspection
7.3.1 Safety programme audits
The safety programme shall be audited and reviewed at least annually (by appropriately trained personnel)
including, but not limited to, the following elements:
a) safety and health policy;
b) written work procedures that include safe work practices;
c) education and training of laboratory-associated staff;
d) supervision of workers;
e) regular inspections;
f) hazardous materials and substances;
g) health surveillance;
h) first aid services and equipment;
i) investigation of accidents and illnesses;
j) health and safety committee review;
k) records and statistics;
l) review of safety programme with requirement for follow-up to ensure that all required actions arising from
the audit are completed.
NOTE Checklists, tailored to the area to be surveyed, are effective aids to auditing (see Annex B on conducting a
laboratory safety audit).
7.3.2 Safety inspection
Laboratory management is responsible for ensuring that safety inspections are undertaken.
Work sites shall be surveyed/inspected at least annually. This is to ensure
a) the proper state of readiness and function of fire emergency apparatus, alarms and evacuation
procedures,
b) the status of procedures and materials for hazardous spillage containment, including emergency showers,
c) the proper containment and control for the storage of flammable and combustible, infective, radioactive,
toxic materials, and
d) the status of decontamination and disposal procedures.
It is good practice for the safety committee to participate in safety surveys. Regular safety inspections also
serve to remind all personnel of potential hazards, ensure compliance and reinforce supervisor responsibility.
7.4 Safety manual
A safety manual shall be readily available in work areas as required reading for all employees. The manual
shall be specific for the laboratory's needs including, but not limited to, the following major categories:
a) fire prevention;
b) electrical safety;
c) chemical safety;
d) radiation;
e) microbiological hazards; and
f) hazardous waste disposal.
The safety manual shall include detailed instructions for workplace evacuation and the protocol for dealing
with an incident (see Annex A for more information on action plans). The Safety Manual shall be reviewed and
updated at least annually by laboratory management.
Other information sources available in the laboratory shall include, but shall not be limited to, MSDS on all
chemicals and agents handled in the laboratory and other reference materials including texts and authoritative
journal articles.
7.5 Records
7.5.1 General
Records shall be kept in accordance with ISO 15189. It should be noted that international, national or regional
regulations or guidelines may apply.
7.5.2 Occupational illness, injury, and adverse incident records
There shall be a mechanism for recording and reporting occupational illness, injury, adverse incidents or
accidents, and consequential actions, while at the same time respecting the confidentiality of individuals.
Personnel training records shall be kept. They should include dates of safety orientation and annual updates
of safety preparedness for each employee.
8 © ISO 2003 — All rights reserved

7.5.3 Risk assessment records
There shall be a formalized system of risk assessment. In addition to any formal workplace risk assessments
that may be required, a safety checklist can be a satisfactory way to record and document the review
programme (see 7.3).
NOTE Records of safety audits and examination of trends of incidents can provide mechanisms that help to ensure
remedial actions are taken.
7.5.4 Hazardous waste records
Hazardous waste disposal records shall be an integral part of the safety programme. Records of hazardous
waste disposal, risk assessments, safety surveys and consequential actions shall be retained in an accessible
file for the period of time required by national or local legislation.
8 Identification of hazards
Hazardous areas shall be systematically and clearly identified, and be appropriate to the hazard concerned. In
certain circumstances, it may be appropriate to identify the hazardous area using both signs and physical
barriers.
Specific hazardous materials to be used within the laboratory or laboratory units shall be clearly identified.
All entrances and exits to work areas shall be marked as to the hazards present within. Special attention shall
be paid to fire hazards and flammable materials, and to toxic, radioactive, harmful or biologically hazardous
materials. Laboratory managers are responsible for regularly reviewing and updating this hazard-identification
system to ensure its relevance to the hazards known to be present. This activity shall be carried out at least
annually.
Maintenance personnel who are not part of the laboratory staff, contractors and subcontractors shall be made
aware of any hazards they may encounter.
Employees shall be trained, familiar with, and have specific written instructions concerning emergency
procedures.
Identification and review of the potential hazards to the health of pregnant women shall be undertaken. A risk
assessment shall be carried out and recorded.
9 Reporting of incidents, injury, accidents and occupational illnesses
The laboratory shall have a programme for reporting laboratory incidents, injuries, accidents and occupational
illnesses, as well as potential hazards.
Reports shall be filed for all incidents, including injuries, and shall include a detailed description of the incident,
an assessment of the cause, recommendations for preventing similar incidents, and actions taken to
implement the recommendations.
Incident reports, including remedial actions, shall be reviewed by a senior manager, the safety committee or
the Laboratory Safety Officer.
10 Training
The laboratory director shall ensure that worker safety training programmes are implemented for all
laboratory-associated personnel, including transport and cleaning staff.
Training in safe work practices should be emphasized.
A comprehensive training programme begins with a written plan, and should include an introduction for new
employees as well as periodic retraining for experienced employees. Employees shall be required to read the
appropriate safety manual before beginning to work in an area. Confirmation in writing should be obtained
from the staff member that they have received appropriate training and that safety manuals have been read
and understood, including the dates when these were carried out.
At a minimum, a safety training programme shall address fire prevention and preparedness, chemical and
radiation safety, and biological hazards and infection prevention. The curriculum should be tailored according
to the employee’s job description, and should include appropriate considerations for conditions such as
pregnancy, immunodeficiency and physical disability. There should be a system for evaluating each
employee’s understanding of the information given to them.
11 Personnel responsibilities
11.1 Food, drink and like substances
Food, drink, and like substances shall be allowed only in areas designated for their preparation and
consumption.
Food and drink for consumption shall be stored only in specifically designated refrigerators located in
nonlaboratory areas. Food shall not be stored where reagents, blood or other potentially infectious material
are stored.
Refrigerators shall be appropriately labelled to indicate their intended use.
Smoking shall be prohibited in the technical work area.
11.2 Cosmetics, hair, beards and jewellery
Application of cosmetics and the handling of contact lenses shall be prohibited in technical work areas.
Long hair shall be secured back. It is important to keep hair out of moving equipment. Men with beards shall
observe the same precautions provided for hair.
Rings, earrings, wristwatches, bracelets, necklaces and other jewellery shall not be worn in laboratory
technical areas if there is any danger of them being caught in equipment or contaminated by infectious
substances or chemicals.
NOTE 1 Hand creams may be used.
NOTE 2 Disposable hair- and beard-covers may be used.
11.3 Immunization status
All laboratory workers should be strongly encouraged to have immunizations to prevent infections associated
with organisms to which the person is likely to be exposed.
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 national, regional and local
requirements.
The immunization programme for a given laboratory should be based upon a documented laboratory infection-
risk assessment, and on advice from local public health officials. International, national or regional regulations
or guidelines may apply.
NOTE Many laboratory-acquired infectious diseases can be effectively prevented through an active immunization
programme. The selection of vaccines for use can vary, based upon the potential hazards of the institution or setting.
10 © ISO 2003 — All rights reserved

11.4 Personal property
Personal property, clothing and cosmetics shall not be placed in designated areas where contamination can
occur.
Secure storage such as lockers should be provided.
11.5 Festive decorations
Festive and other decorations that present potential contamination and/or fire hazards shall not be used in
technical work areas.
Decorations should never be attached to lights, light fixtures or technical instruments.
12 Clothing and personal protective equipment (PPE), including gloves, eye, face,
foot and respiratory protection
12.1 Protective clothing in the laboratory
The laboratory shall ensure that an ample supply of clean protective clothing (e.g. coats and gowns),
appropriate to the level of risk, is available for those working in or visiting within the laboratory.
When not in use, clean protective clothing shall only be hung on hooks provided for that purpose. These
hooks shall be away from radiators, steam pipes, heating instruments, and open flames. Contaminated
protective clothing should be placed and transported in appropriately identified bags that prevent leakage.
They should be appropriately washed to ensure chemical and biological decontamination.
Protective clothing shall be changed at appropriate intervals to ensure cleanliness and shall be changed
immediately if it is known to be contaminated with hazardous materials.
Protective clothing shall be removed before leaving the laboratory area.
NOTE Disposable plastic aprons or fluid-resistant gowns can be required if there is a significant probability that
potentially hazardous substances will be splashed on the worker or visitor. Other personal protective equipment, such as
gloves, goggles, masks, capes and face shields may also be required in these situations.
12.2 Protective clothing outside the laboratory
Phlebotomists and other workers whose duties take them out of the laboratory shall be required to wear clean
coats or gowns while working with patients.
12.3 Face and body protection
Splash guards or similar devices shall be available for use if there is the potential for splashing of samples or
reagents to occur.
Aerosol-generating procedures performed on samples potentially containing microorganisms should be
performed within a microbiological safety cabinet.
Approved safety glasses, facial shields or other eye and face protection shall be available to be worn when
handling hazardous materials.
Contact lenses offer no protection from splashes. Additional eye protection shall be worn with contact lenses.
12.4 Gloves
Gloves shall be available for use in laboratory operations to provide protection from chemicals, biological
hazards, radioactive contamination, cold and heat, product contamination, sharp edges and abrasions.
Gloves shall meet comfort, fit, flexibility, grip, abrasion resistance, puncture resistance and tear resistance
requirements for the type of manipulation performed, and shall adequately protect from the hazards involved.
Laboratories shall provide unpowdered gloves and/or alternative materials for workers who suffer from
allergies and other reactions, e.g. reaction to natural latex, talc, starch or vinyl.
Laboratory workers shall be traine
...