ISO 15190:2020 pdf download

ISO 15190:2020 pdf download Medical laboratories — Requirements for safety
3.7
decontaminationprocedure that eliminates or reduces microbial or toxic agents to a safe level with respect to thetransmission ofinfection or other adverse effects
3.8
disinfectant
agent capable of causing disinfection (3.9
3.9
disinfectionprocess to reduce the number of microorganisms (3.15), but not usually of bacterial spores, withoutnecessarily killing or removing all organisms
3.10
droplets
very small drop of liquid
Note 1 to entry: A small drop, such as a particle of moisture discharged from the mouth during coughing.
sneezing,or speaking.
Note 2 to entry: These can transmit pathogens and cause infection by dispersion into the air.
311
ergonomics
study of the efficiency and safety of persons in their working environment
Note 1 to entry: This term includes biomechanics, work physiology, anthropomorphy and man-machineinterfaces.
3.12
extraction hood
fume hood
laboratory device used for the extraction of air or fumes which prevents their general circulation
EXAMPLEFume/ventilation hood, cabinet or cover.
Note 1 to entry: These can recirculate if filtered air/made safe.
3.13
hazard
potential source of harm (3.13
SOURCE:ISO Guide 73:2009,3.5.1.4]
314
hazardous wastewaste that is potentially flammable, combustible, ignitable, corrosive, toxic, reactive, infectious orinjurious to people or the environment
3.15
microorganism
microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material
3.16
noise
unwanted sound in the form of acoustic energy which can adversely affect health
3.17
personalprotective equipmentvariety of barriers including clothing and respirators used alone or in combination to protect mucousmembranes, airways,skin, and clothing from contacts with infectious or hazardous agents
3.18
physical hazard
agent, factor or circumstance that can cause harm with or without contact
Note 1 to entry: Physical hazards can be classified as occupational or environmental.
Note 2 to entry: Physical hazards include but are not limited to radiation hazards, electrical hazards, ventilationhazards,heat,noise and pressure hazards.
3.19
radionuclide
natural or synthetically produced unstable nucleus of an atom that emits ionizing radiation
3.20
record
document stating results achieved or providing evidence of activities performed
Note 1 to entry: Records can be used, for example, to formalize traceability and to provide evidence of verification,preventive action and corrective action.
Note 2 to entry: Generally records need not be under revision control
SOURCE:ISO 9000:2015,3.8.101
3.21
risk
combination of the probability of occurrence of harm and the severity of that harm
Note 1 to entry: The probability of occurrence includes the exposure to a hazardous situation, the occurrence ofahazardous event and the possibility to avoid or limit the harm.
SOURCE:ISO/IEC Guide 51:2014,3.91
3.22
risk assessment
overall process comprising a risk (3.21) analysis and a risk evaluation (3.23
[SOURCE:ISO/IEC Guide 51:2014,3.11]
3.23
risk evaluation
procedure based on the risk (3.21 analysis to determine whether tolerable risk (3,21) has beenexceeded

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