ISO/DIS 15883-1.2

Washer-disinfectors

Laveurs désinfecteurs

Standards Content (sample)

DRAFT INTERNATIONAL STANDARD ISO/DIS 15883-1.2
ISO/TC 198 Secretariat: ANSI
Voting begins on Voting terminates on
2003-01-16 2003-03-16

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION

Washer-disinfectors —
Part 1:
General requirements, definitions and tests
Laveurs désinfecteurs —
Partie 1: Exigences générales, définitions et essais
ICS 11.180.10
ISO/CEN PARALLEL ENQUIRY

This draft International Standard is a draft European Standard developed within the European

Committee for Standardization (CEN) and processed under the CEN-lead mode of collaboration as

defined in the Vienna Agreement. The document has been transmitted by CEN to ISO for circulation

for ISO member body voting in parallel with CEN enquiry. Comments received from ISO member

bodies, including those from non-CEN members, will be considered by the appropriate CEN

technical body. Accordingly, ISO member bodies who are not CEN members are requested to

send a copy of their comments on this DIS directly to CEN/TC 102 (DIN, Burggrafenstraße, 6,

D-10787 Berlin) as well as returning their vote and comments in the normal way to the ISO

Central Secretariat. Should this DIS be accepted, a final draft, established on the basis of

comments received, will be submitted to a parallel two-month FDIS vote in ISO and formal vote in

CEN.

In accordance with the provisions of Council Resolution 15/1993 this document is circulated

in the English language only.

Conformément aux dispositions de la Résolution du Conseil 15/1993, ce document est

distribué en version anglaise seulement.

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE REFERRED TO

AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.

IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT

INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO WHICH

REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
© International Organization for Standardization, 2003
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DRAFT
EUROPEAN STANDARD
prEN ISO 15883-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2003
ICS
English version
Washer-disinfectors - Part 1: General requirements, definitions
and tests (ISO/DIS 15883-1:2003)

Laveurs désinfecteurs - Partie 1: Exigences générales, Reinigungs-/Desinfektionsgeräte - Teil 1: Allgemeine

définitions et essais (ISO/DIS 15883-1:2003) Anforderungen, Definitionen und Prüfungen (ISO/DIS

15883-1:2003)

This draft European Standard is submitted to CEN members for second parallel enquiry. It has been drawn up by the Technical Committee

CEN/TC 102.

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations which

stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other language

made by translation under the responsibility of a CEN member into its own language and notified to the Management Centre has the same

status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,

Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United

Kingdom.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and

shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels

© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 15883-1:2003 E

worldwide for CEN national Members.
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prEN ISO 15883-1:2003 (E)
Contents

Foreword......................................................................................................................................................................4

Introduction .................................................................................................................................................................5

1 Scope ..............................................................................................................................................................5

2 Normative references ....................................................................................................................................6

3 Terms and definitions....................................................................................................................................6

4 Performance requirements .........................................................................................................................11

4.1 General..........................................................................................................................................................11

4.2 Cleaning........................................................................................................................................................13

4.3 Disinfection...................................................................................................................................................13

4.4 Rinsing..........................................................................................................................................................14

4.5 Drying............................................................................................................................................................14

4.6 Process chemicals.......................................................................................................................................15

5 Mechanical and process requirements .....................................................................................................15

5.1 Materials, design and manufacture/construction.....................................................................................15

5.2 Safety ............................................................................................................................................................16

5.3 Calorifiers and tanks ...................................................................................................................................17

5.4 Loading and unloading doors and their controls.....................................................................................18

5.5 Pipework and fittings...................................................................................................................................19

5.6 Spray systems..............................................................................................................................................20

5.7 Dosing systems............................................................................................................................................20

5.8 Load temperature protection......................................................................................................................21

5.9 Process temperature control limits ...........................................................................................................21

5.10 Switches, gauges and indicating devices .................................................................................................22

5.11 Process verification.....................................................................................................................................22

5.12 Instrumentation and controls .....................................................................................................................23

5.13 Temperature indicating systems................................................................................................................25

5.14 Pressure indicating systems ......................................................................................................................25

5.15 Timing equipment ........................................................................................................................................26

5.16 Operating cycle indicating equipment.......................................................................................................26

5.17 Recording instruments (if fitted) ................................................................................................................26

5.18 Control systems...........................................................................................................................................28

5.19 Override of automatic control.....................................................................................................................29

5.20 Microprocessor control systems ...............................................................................................................29

5.21 Access to software ......................................................................................................................................30

5.22 Fault indication systems.............................................................................................................................30

5.23 Water supply.................................................................................................................................................30

5.24 Venting and drainage systems...................................................................................................................31

5.25 Drainage........................................................................................................................................................31

5.26 Air filters installed within the WD...............................................................................................................32

5.27 Load handling and supports for use within the WD ................................................................................32

5.28 Trolleys .........................................................................................................................................................33

5.29 Environment .................................................................................................................................................33

5.30 Table top machines .....................................................................................................................................33

6 Testing for conformity.................................................................................................................................33

6.1 General..........................................................................................................................................................33

6.2 Test equipment ............................................................................................................................................36

6.3 Tests on doors, interlocks and fault indications......................................................................................37

6.4 Tests on water quality and water volume..................................................................................................39

6.5 Tests on pipework .......................................................................................................................................41

6.6 Tests on instrumentation fitted to the WD ................................................................................................43

6.7 Tests on load carriers..................................................................................................................................44

6.8 Thermometric tests......................................................................................................................................45

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prEN ISO 15883-1:2003 (E)

6.9 Chemical dosing tests.................................................................................................................................47

6.10 Tests of cleaning efficacy ...........................................................................................................................48

6.11 Tests of air quality .......................................................................................................................................50

6.12 Load dryness test ........................................................................................................................................50

6.13 Automatic control test.................................................................................................................................50

7 Documentation.............................................................................................................................................51

8 Information to be supplied by the manufacturer......................................................................................51

9 Marking, labelling, packaging.....................................................................................................................54

10 Information to be requested from the purchaser by the supplier of the WD.........................................54

Annex A (informative) A concept: comparative lethality of moist heat processes...........................................56

Annex B (normative) Test soils and methods for demonstrating cleaning efficacy..........................................60

Annex C (normative) Microbiological recovery medium for estimation of bacterial contamination of

water............................................................................................................................................................107

Annex D (informative) Test programme................................................................................................................108

Annex E (normative) Test methods for the detection and assessment of residual proteinaceous soiling ..112

Annex ZA (informative) Clauses of this European Standard addressing essential requirements or other

provisions of EU Directives. .....................................................................................................................115

Bibliography ............................................................................................................................................................118

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prEN ISO 15883-1:2003 (E)
Foreword

This document (prEN ISO 15883-1:2003) has been prepared by Technical Committee CEN/TC 102, "Sterilizers for

medical purposes", the secretariat of which is held by DIN, in collaboration with Technical Committee ISO/TC 198

"Sterilization of health care products".
This document is currently submitted to the second parallel Enquiry.

EN ISO 15883 consists of the following parts under the general title Washer-disinfectors:

— Part 1: General requirements, definitions and tests

— Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments,

anaesthetic equipment, hollowware, utensils, glassware, etc.

— Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste

containers

— Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermo-labile

endoscopes

Fields of application within the scope of EN ISO 15883 include laboratory, veterinary, dental and pharmaceutical

applications and other specific applications, such as washer-disinfectors for bedsteads and transport carts and the

disinfection of crockery and cutlery intended for use with immunologically compromised patients.

This document has been prepared under a mandate given to CEN by the European Commission and the European

Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document.

In respect of the potential adverse effects on the quality of water intended for human consumption caused by the

washer-disinfector:

a) this standard provides no information as to whether the washer-disinfector may be used without restriction in any

of the member states of the EU or EFTA;

b) it should be noted that, until verifiable European criteria are adopted, existing national regulations concerning the

use and/or the characteristics of the washer-disinfector remain in force.

Annexes B, C and E are normative. Annexes A, D and ZA are given for information only.

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prEN ISO 15883-1:2003 (E)
Introduction

This part of prEN ISO 15883 is the first of a series specifying the performance of washer-disinfectors and specifies

the general requirements for performance applicable to all washer-disinfectors. The requirements given in this part

apply to all washer-disinfectors specified in subsequent parts, except insofar as they may be modified or added to

by a subsequent part, in which case the requirements of that particular part will apply.

Washer-disinfectors should be used only for processing the type of loads specified by the manufacturer of the

washer-disinfector.

In selecting the appropriate washer-disinfector reference should be made both to this standard (prEN ISO 15883-1)

and to the relevant subsequent part. The choice of type of washer disinfector, operating cycle or quality of services

or process chemicals may be inappropriate for a particular load and means cannot necessarily be provided to

detect an incorrect choice or misuse.
Safety requirements for washer-disinfectors are given in IEC 61010-2-045.

This standard has been prepared on the basis that each individual washer-disinfector will be subject to validation

tests (commissioning and performance qualification on first installation) and that in use continued compliance will

be established by periodic monitoring tests carried out by, or on behalf of, the user.

NOTE Verification of cleaning efficacy is a key aspect of establishing satisfactory performance of a washer-disinfector.

The current state of knowledge has not permitted development of a single test method. As an interim measure the specification

for test methods includes methods previously used in a number of different countries. It remains the intention of the technical

committee to develop a single test method.
1 Scope

This part of prEN ISO 15883 specifies general performance requirements for washer-disinfectors (WD) and their

accessories that are intended to be used for cleaning and disinfection of re-usable medical devices and other

articles used in the context of medical, dental, pharmaceutical and veterinary practice. It specifies performance

requirements for cleaning and disinfection as well as for the accessories which may be required to achieve the

necessary performance. The methods and instrumentation required for validation, routine control and monitoring

and re-validation, periodically and after essential repairs, are also specified.

The requirements for washer-disinfectors intended to process specific loads are specified in subsequent parts of

this standard. For washer-disinfectors intended to process loads of two or more different types the requirements of

all relevant parts of this standard apply.

This standard does not specify requirements intended for machines for use for laundry or general catering

purposes.

This standard does not include requirements for machines which are intended to sterilize the load, or which are

designated as 'sterilizers'; these are specified in other standards e.g. EN 285.
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prEN ISO 15883-1:2003 (E)
2 Normative references

This European Standard incorporates by dated or undated reference, provisions from other publications. These

normative references are cited at the appropriate places in the text and the publications are listed hereafter. For

dated references, subsequent amendments to or revisions of any of these publications apply to this European

Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the

publication referred to applies (including amendments).

prEN ISO 14644-3, Cleanrooms and associated controlled environments — Part 3: Metrology and testing (in

preparation).

EN ISO 14971, Medical devices — Application of risk management to medical devices (ISO 14971:2000).

IEC 60417-1, Graphical symbols for use on equipment — Part 1: Overview and application .

IEC 60417-2, Graphical symbols for use on equipment — Part 2: Symbol originals.
IEC 60584-1, Thermocouples — Part 1: Reference tables.
IEC 60751, Industrial platinum resistance thermometer sensors.

IEC 80416-1, Basic principles for graphical symbols for use on equipment — Part 1: Creation of graphical symbols.

IEC 61010-2-045, Safety requirements for electrical equipment for measurement control and laboratory use —

Part 2-045: Particular requirements for washer-disinfectors used in medical, pharmaceutical, veterinary and

laboratory fields.

ISO 228-1, Pipe threads where pressure-tight joints are not made on the threads — Part 1: Dimensions, tolerances

and designation.
ISO 7000, Graphical symbols for use on equipment, index and synopsis.

ISO 10012-1, Quality assurance requirements for measuring equipment — Part 1: Metrological confirmation system

for measuring equipment.
European Pharmacopeia. 4 Edition, published 2001, Strasbourg, Council of Europe.
United States Pharmacopeia.
3 Terms and definitions

For the purposes of this part of prEN ISO 15883, the following terms and definitions apply:

3.1

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
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prEN ISO 15883-1:2003 (E)
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 [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 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
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prEN ISO 15883-1:2003 (E)
3.18
disinfection temperature band

range of temperatures, expressed as the disinfection temperature (see 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 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 soiling 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 value 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

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

specification
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prEN ISO 15883-1:2003 (E)
3.32
instrument washer-disinfector

washer-disinfector intended to clean and disinfect loads containing surgical instruments, anaesthetic accessories,

hollowware, 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

any instrument, apparatus, appliance material or other article, whether used alone or in combination, including the

software necessary for its proper application, intended by the manufacturer to be used for human beings for the

purpose of
- diagnosis, prevention, monitoring, treatment, or alleviation of disease;

- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap;

- investigation, replacement or modification of the anatomy or of a physiological process;

- control of conception

and which does not achieve its principal intended action in or on the human body by pharmacological,

immunological or metabolic means, but which may be assisted in its function by such means [EN 46001:1996,

definition 3.1]
3.36
microbial reduction factor

the 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 the vessel is operated during normal use
3.41
operational qualification

obtaining and documenting evidence that installed equipment operates within predetermined limits when used in

accordance with its operational procedures
3.42
override
system by which the operating cycle can be interrupted or modified as necessary
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prEN ISO 15883-1:2003 (E)
3.43
performance qualification

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 i.e. that the washer-disinfector produces items cleaned and disinfected to the required standard

3.44
routine test

periodic checking and testing carried out to establish that the operational performance of the washer-disinfector

remains within the limits establi
...