ISO 15883-1:2006 ウォッシャーディスインフェクター—パート1：一般的な要件、用語、定義、およびテスト | ページ 6

3.1

A₀

equivalent time in seconds at 80 °C, delivered by the disinfection process, with reference to a microorganism with a z value of 10 K

3.2

automatic controller

device that, in response to pre-determined cycle variables, operates the apparatus sequentially through the required stages of the process or processes

3.3

bedpan washer-disinfector

washer-disinfector intended to be used for the emptying, flushing, cleaning and thermal disinfecting of human waste containers

3.4

bioburden

population of viable microorganisms on a product and/or its container

3.5

calibration

set of operations that establish, under specified conditions, the relationship between values of a quantity indicated by a measuring instrument or measuring system, or values represented by a material measure or a reference material, and the corresponding values realized by standard

[SOURCE:EN 285:1996, definition 3.5]

3.6

calorifier

closed vessel, in which water is indirectly heated, by the flow of heated fluid through a heat exchanger, under a pressure greater than atmospheric

3.7

chamber

that part of the washer-disinfector in which the load is processed

Note 1 to entry: The chamber does not include steam generators, pipework, e.g. drain and fittings from which it can be isolated.

3.8

chemical disinfection

disinfection achieved by the action of one or more chemicals the primary purpose of which is to be microbicidal

3.9

cleaning

removal of contamination from an item to the extent necessary for its further processing and its intended subsequent use

3.10

continuous process machine

machine which automatically transports the load through each stage of the operating cycle

3.11

critical process variables

those process variables for which the values during an operating cycle have been identified by the manufacturer as sufficient to ensure that the cycle meets the performance defined during validation

3.12

cycle complete

indication that the washing and disinfection cycle has been satisfactorily completed and that the disinfected load is ready for removal from the chamber

3.13

cycle control recorder

a device which records the values of one or more control variables as seen by the automatic controller

3.14

D value

exposure time required under a defined set of conditions to cause a 1-logarithm or 90 % reduction in the population of a particular microorganism

3.15

dead volume

volume of pipework which is not purged by the usual flow of liquids during the operating cycle

3.16

disinfection

reduction of the number of viable microorganisms on a product to a level previously specified as appropriate for its intended further handling or use

3.17

disinfection temperature

minimum temperature of the disinfection temperature band

3.18

disinfection temperature band

range of temperatures, expressed as the disinfection temperature (3.17) and the maximum allowable temperature which may prevail throughout the load during the disinfection time

3.19

disinfection time

period for which the critical process variable(s) (e.g. temperature of the load, disinfectant concentration in the chamber) are maintained at or above that specified for disinfection

3.20

door

device provided as a means of closing and sealing the chamber

3.21

double-ended washer-disinfector

washer-disinfector with separate doors for loading and unloading

3.22

endoscope washer-disinfector

washer-disinfector intended to clean and disinfect loads containing flexible endoscopes

3.23

fail safe

attribute of washer-disinfector design, or its associated services, that ensures that a single fault condition will not give rise to a safety hazard

3.24

fault

recognition by the automatic controller that at least one of the pre-set process variables for the washer-disinfector cycle have not been attained

3.25

fluid

liquid, gas or vapour

3.26

flushing

removal of gross contamination and/or the contents of a load item, but not necessarily contamination adhering to the surface of the load item, by displacement with water

3.27

free draining

allowing the unimpeded flow of liquids under the influence of gravity towards the discharge point

3.28

holding time

period during which the critical process variables are maintained at or above the values specified

3.29

human waste

excretions and body fluids including faeces, urine, blood, pus, vomit and mucus

3.30

human waste container

re-usable vessel for holding and transporting human waste

3.31

installation qualification

IQ

process of obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification

[SOURCE:ISO/TS 11139:2001, definition 2.20]

3.32

instrument washer-disinfector

washer-disinfector intended to clean and disinfect loads containing surgical instruments, anaesthetic accessories, bowls, dishes, receivers, utensils, glassware and similar items

3.33

load

collective term used to describe all the goods, equipment and materials that are put into a washer-disinfector at any one time for the purpose of cleaning and disinfecting it by an operating cycle

3.34

loading door

door in a double-ended washer-disinfector through which the load is put into the washer-disinfector prior to processing

3.35

medical device

[SOURCE:ISO 13485:2003, definition 3.7]

3.36

microbial reduction factor

extent to which the bioburden is reduced in tenfold increments expressed as logarithms (base 10)

3.37

monitoring

measurement of physical variables and comparison of the values obtained with the values specified for the process

3.38

normal operation

operation of the washer-disinfector in accordance with the manufacturer’s instructions and with all process parameters within the limits specified by the manufacturer

3.39

operating cycle

complete set of stages that is carried out in the sequence as regulated by the automatic controller

3.40

operating pressure

gauge pressure at which a vessel is operated during normal use

3.41

operational qualification

OQ

process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures

[SOURCE:ISO/TS 11139:2001, definition 2.24]

3.42

override

system by which the operating cycle can be interrupted or modified as necessary

3.43

performance qualification

PQ

process of obtaining and documenting evidence that the equipment, as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification

[SOURCE:ISO/TS 11139:2001, definition 2.26]

Note 1 to entry: The performance qualification for washer-disinfectors would concern the number of items cleaned and disinfected to the required standard.

3.44

process chemical

formulation of chemical compounds intended for use in a washer-disinfector

Note 1 to entry: Process chemicals include for example detergents, surfactants, rinse aids, disinfectants, enzymatic cleaners.

3.45

process variable

physical and chemical properties that influence the efficacy of all stages of the process

3.46

process verification recorder

device that, independently of the automatic controller, records values obtained for some, or all, of the control variables

3.47

recorder

system fitted to the washer-disinfector, or connected to the washer-disinfector, producing a permanent record of information graphically, digitally or electronically

3.48

re-qualification

repeat of part or all of the validation test requirements for the purpose of confirming process reliability

3.49

rinsing

removal of process residues by displacement and dilution with water

3.50

routine test

periodic checking and testing carried out to establish that the operational performance of the washer-disinfector remains within the limits established during validation

3.51

steam generator

vessel designed to contain water and a heating system (e.g. a steam coil or a fully immersed electric element) which is used to heat water to its vapour state

3.52

tank

process vessel, integral to the washer-disinfector, designed to hold fluids that are used during processing

3.53

test microorganism

microbial strain from a recognised culture collection used in microbiological testing of the performance of a washer-disinfector

Note 1 to entry: A recognized culture collection is an international depository under the Budapest Treaty on “The International Recognition of the Deposit of Microorganisms for the Purpose of Patent and Regulation".

3.54

test soil

formulation used to test the efficacy of cleaning in a washer-disinfector

3.55

thermal disinfection

disinfection achieved by the action of moist heat

3.56

type test

test programme to verify conformity of a washer-disinfector type to this standard and establish data for reference in subsequent tests

3.57

unloading door

door in a double-ended (3.21) washer-disinfector through which the load is removed after an operating cycle

3.58

validation

documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications

[SOURCE:ISO/TS 11139:2001, definition 2.50]

3.59

verification

confirmation through the provision of objective evidence, that specified requirements have been fulfilled

[SOURCE:ISO 9000:2005, definition 3.8.4]

3.60

viable microorganism

microorganisms, including viruses, which are capable of multiplication under specified culture conditions

3.61

warning pipe

secondary overflow pipe so fitted that its outlet, whether inside or outside the machine, is in a conspicuous position to indicate an overflow condition

3.62

washer-disinfector

WD

machine intended to clean and disinfect medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practice

3.63

washing

removal of adherent contamination from surfaces to be cleaned by means of an aqueous medium, with or without process chemicals, as necessary

3.64

works test

series of tests performed prior to delivery to demonstrate compliance of each washer-disinfector with its specification

3.65

z value

change in temperature in kelvins (K) required to achieve a tenfold change in the rate of microbial inactivation by a moist heat disinfection process