INTERNATIONAL
STANDARD

ISO
15883-7
First edition
2016-02-01

Washer-disinfectors —
Part 7:
Requirements and tests for washerdisinfectors employing chemical
disinfection for non-invasive, noncritical thermolabile medical devices
and healthcare equipment
Laveurs désinfecteurs —
Partie 7: Exigences et essais pour les laveurs désinfecteurs utilisant la
désinfection chimique pour les dispositifs médicaux et les équipements
de soins thermosensibles non invasifs et non critiques

Reference number
ISO 15883-7:2016(E)
© ISO 2016


ISO 1 5 883 -7: 2 01 6(E)

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© ISO 2016, Published in Switzerland

All rights reserved. Unless otherwise specified, no part o f this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior

written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country o f

the requester.

ISO copyright o ffice

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Tel. +41 22 749 01 11
Fax +41 22 749 09 47

www.iso.org

ii

© ISO 2016 – All rights reserved


ISO 15883-7:2016(E)

Contents

Page

Foreword .......................................................................................................................................................................................................................................... v
Introduction ................................................................................................................................................................................................................................ vi
1
2

3

4

Scope ................................................................................................................................................................................................................................. 1

Normative references ...................................................................................................................................................................................... 1

Terms and definitions ..................................................................................................................................................................................... 2
Performance requirements ....................................................................................................................................................................... 2

4.1
4.2
4.3
4.4
4.5
4.7
4. 6

5

General ........................................................................................................................................................................................................... 2
Cleaning......................................................................................................................................................................................................... 3
Disinfection ................................................................................................................................................................................................ 3
Final rinsing............................................................................................................................................................................................... 5
Self-disinfection ..................................................................................................................................................................................... 5
............................................................................................................................................................................................................. 6
Water treatment equipment........................................................................................................................................................ 6
4.7.1 General...................................................................................................................................................................................... 6
4.7.2 Disinfection of water treatment equipment............................................................................................. 6
4.7.3 Maintenance of piping................................................................................................................................................. 7
D rying


Mechanical requirements ........................................................................................................................................................................... 7

..................................................................................................... 7
............................................................................................................................................................................. 7
6
Testing for conformity .................................................................................................................................................................................... 7
6.1 General ........................................................................................................................................................................................................... 7
6.2 Test load ........................................................................................................................................................................................................ 8
6.2.1 Loading with standard goods ............................................................................................................................... 8
6.2.2 Loading with special goods .................................................................................................................................... 8
6.3 Water used for rinsing following disinfection.............................................................................................................. 8
............................................................................................................................................................................................. 8
6.4.1 General...................................................................................................................................................................................... 8
6.4.2 Procedure ............................................................................................................................................................................... 8
6.4.3 Results ....................................................................................................................................................................................... 8
6.5 Thermometric tests ............................................................................................................................................................................ 8
6.5.1 General...................................................................................................................................................................................... 8
6.5.2 Load temperature test................................................................................................................................................. 8
6.6 Chemical dosing tests ........................................................................................................................................................................ 9
6.6.1 General...................................................................................................................................................................................... 9
6.6.2 Reused process chemicals ....................................................................................................................................... 9
f
f
................................................................................................................................................................ 9
6.7.1 General...................................................................................................................................................................................... 9
6.7.2 Materials ................................................................................................................................................................................. 9
6.7.3 Procedure ............................................................................................................................................................................ 10
6.7.4 Results .................................................................................................................................................................................... 10
f

f
f
....................................................................................................................................................... 10
6.8.1 General................................................................................................................................................................................... 10
f
......................................................................................... 10
6.8.3 Self-disinfection tests ................................................................................................................................................ 11
6.8.4 Chemical disinfection of the load.................................................................................................................... 12
7
Documentation .................................................................................................................................................................................................... 12
8
Information to be provided by the manufacturer........................................................................................................... 12
9
Marking, labelling, and packaging .................................................................................................................................................. 13
10
Information to be requested from the purchaser by the manufacturer .................................................. 13
Annex A (normative) Summary of test programmes ........................................................................................................................ 14
5 .1

M aterials — D es ign, manu facture, and as s emb ly

5 .2

Pro ces s verificatio n

6.4

Lo ad drynes s

6.7


Tes ts o

6.8

Tes t o

6. 8 . 2

cleaning e ficacy

dis in ectio n e ficacy

Preliminary tes ts o n chemical dis in ectants

© ISO 2016 – All rights reserved

iii


ISO 15883-7:2016(E)
Annex B (normative) Methods for microbiological evaluation of disinfection of liquid
transport system................................................................................................................................................................................................ 16
Annex C (normative) Tests for microbiological contamination of post-disinfection rinse water ..... 21
Annex D (normative) Preparation and evaluation of indicators for microbiological testing

........................................................................................................ 22
Annex E (informative) Examples of test locations for the tests with biological indicators ...................... 26
Bibliography ............................................................................................................................................................................................................................. 30
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© ISO 2016 – All rights reserved


ISO 15883-7:2016(E)

Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work o f 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 o f
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
di fferent types o f ISO documents should be noted. This document was dra fted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some o f the elements o f this document may be the subject o f
patent rights. ISO shall not be held responsible for identi fying any or all such patent rights. Details o f

any patent rights identified during the development o f the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is in formation given for the convenience o f users and does not

constitute an endorsement.

For an explanation on the meaning o f ISO specific terms and expressions related to con formity

assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary in formation

ISO 15883-7 was prepared by the European Committee for Standardization (CEN) Technical Committee

CEN/TC 102,
, in collaboration with Technical Committee ISO/TC 198,
, in accordance with the Agreement on technical cooperation
between ISO and CEN (Vienna Agreement).
ISO 15883 consists of the following parts, under the general title Washer-disinfectors:
— Part  1:  General  requirements,  terms  and  definitions  and  tests
— Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical
Sterilizers for medical purposes
Sterilization of health care products

instruments, anaesthetic equipment, bowls, dishes, receivers, 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
thermolabile endoscopes

Part  5:  Test  soils  and  methods  for  demonstrating  cleaning  efficacy  [Technical Specification]
Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-invasive,
non-critical medical devices and healthcare equipment
Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-invasive,
non-critical thermolabile medical devices and healthcare equipment

© ISO 2016 – All rights reserved

v


ISO 15883-7:2016(E)

Introduction
I t i s i ntende d th at th i s i ntro duc tion i s to b e re ad i n conj u nc tion with the i ntro duc tion to I S O 1 5 8 8 3 -1 .
T h i s p ar t o f I S O 1 5 8 8 3 i s the s eventh o f a s erie s s p e c i fyi ng the p er formance o f wa sher- d i s i n fe c tors .
I t s p e c i fie s the p ar tic u lar re qu i rements

for

p er forma nce appl ic able to was her- d i s i n fe c tors employi ng


chemical disinfection for non-invasive, non-critical thermolabile medical devices, and healthcare
f
f
f
f
thermolabile equipment for use without further treatment in healthcare settings. Such reusable
equipment needs to be cleaned and disinfected, but processing in a washer-disinfector for surgical
instruments (see ISO 15883-2), for human waste containers (see ISO 15883-3), for endoscopes
(see ISO 15883-4), or for non-invasive, non-critical medical devices, and healthcare equipment
e qu ipment.

I ts

re qui rements

apply

to

was her- d i s i n e c tors

used

or

cle an i ng

and

d i s i n e c tion


o

emp loyi ng therma l d i s i n fe c tion (s e e I S O 1 5 8 8 3 - 6) i s i nappropri ate and/or i mprac tic a l . E xample s o f
s uch e qu ipment are b e d s te ad s and b e d s ide

fu rn itu re,

footwear, wheelchairs, or aids for the disabled.
Re qu i rements

for

wa sher- d i s i n fe c tors

for

trol leys a nd tran s p or t c a r ts , op erati ng table s ,

o ther appl ic ation s are s p e ci fie d i n o ther p ar ts o f I S O 1 5 8 8 3 .

I n re s p e c t to a ny p o tenti a l advers e e ffe c ts on the qua l ity o f water i ntende d

for

hu man con s u mp tion

cau s e d b y u s e o f the wa sher- d i s i n fe c tor, it i s no tewor thy that

a)


u nti l veri fiab le i nternationa l criteri a a re adop te d, the exi s ti ng nationa l regu lation s concern i ng

the use and/or characteristics of the washer-disinfector remain in force (e.g. the requirement of
b ackflow prevention) , a nd

b) the ISO 15883 series of standards provides no information as to whether the washer-disinfector
may b e u s e d without re s tric tion i n a ny o f the I S O memb er s tate s .

vi

© ISO 2016 – All rights reserved


INTERNATIONAL STANDARD

ISO 15883-7:2016(E)

Washer-disinfectors —
Part 7:

Requirements and tests for washer-disinfectors employing
chemical disinfection for non-invasive, non-critical
thermolabile medical devices and healthcare equipment
1 Scope
T h i s p ar t o f I S O 1 5 8 8 3 s p e c i fie s the p ar tic u l ar re qu i rements
be used

for


for

wa sher- d i s i n fe c tors ( WD) i ntende d to

the cle an i ng and chem ica l d i s i n fe c tion, i n a s i ngle op erati ng c ycle, o f reu s able item s s uch a s

the following:
a) bedframes;
b) bedside tables;
c) transport carts;
d) containers;
e) surgical tables;
f) sterilization containers;
g) surgical clogs;
h) wheelchairs, aids for the disabled.

T h i s p a r t o f I S O 1 5 8 8 3 a l s o s p e ci fie s the p er formance re qu i rements

for

the cle an i ng and d i s i n fe c tion o f

the wa sher- d i s i n fe c tor and its comp onents and acce s s orie s wh ich may b e ne ce s s a r y i n order to ach ieve

the required performance.

D evice s identi fie d with i n the s cop e s o f I S O 1 5 8 8 3 -2 , I S O 1 5 8 8 3 -3 , I S O I 5 8 8 3 - 4, a nd I S O 1 5 8 8 3 - 6 do no t

fall within the scope of this part of ISO 15883.


I n add ition, the me tho d s are s p e c i fie d , as wel l a s i n s tr umentation and i n s truc tion s re qu i re d
te s ti ng ,

works

te s ti ng ,

va l idation

(i n s ta l lation,

op eration,

a nd

p er formance

qua l i fication

for

typ e

on

fi rs t

i n s ta l lation) , routi ne control, and mon itori ng , as wel l a s re qua l i fic ation s re qu i re d to b e c arrie d out
p erio d ic a l ly a nd a fter e s s entia l rep a i rs .


NOTE

WDs corresponding to this part of ISO 15883 can also be used for cleaning and chemical disinfection

o f o ther ther mol ab i le a nd reu s ab le de vice s a s re com mende d b y the de vice m a nu fac tu rer.

T he p er formance re qu i rements s p e ci fie d i n th i s p a r t o f I S O 1 5 8 8 3 may no t en s u re the i nac tivation or

removal of the causative agent(s) (prion proteins) of Transmissible Spongiform Encephalopathies.

2 Normative references
T he

fol lowi ng

i nd i s p en s able

do c u ments , i n whole or i n p ar t, are normatively re ference d i n th i s do c u ment a nd are

for

its

appl ic ation .

For date d re ference s ,

on ly the

e d ition


cite d appl ie s .

For u ndate d

re ference s , the late s t e d ition o f the re ference d do c u ment (i nclud i ng any amend ments) appl ie s .

© ISO 2016 – All rights reserved

1


ISO 15883-7:2016(E)

ISO 15883-1:2006+A1:2014,
definitions  and  tests

Washer-disinfectors — Part 1: General requirements, terms and

ISO 15883-4, Washer-disinfectors — Part 4: Requirements and tests for washer-disinfectors employing
chemical disinfection for thermolabile endoscopes

ISO 15883-6,

Washer-disinfectors — Part 6: Requirements and tests for washer-disinfectors employing
thermal disinfection for non-invasive, non-critical medical devices and healthcare equipment

ISO/TS 15883-5:2005,
cleaning  e fficacy


Washer-disinfectors — Part 5: Test soils and methods for demonstrating

EN 10088-1, Stainless steels — Part 1: List of stainless steels
EN 10088-2, Stainless steels — Part 2: Technical delivery conditions for sheet/plate and strip of corrosion

resisting steels for general purposes

IEC 61010-2-040:2005,

Safety requirements for electrical equipment for measurement, control and
laboratory use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat
medical materials

3 Terms and definitions

For the purposes o f this document, the terms and definitions given in ISO 15883-1, ISO 15883-4, and
ISO 15883-6 apply.
4 Performance requirements
4.1 General

The WD shall conform to ISO 15883-1:2006+A1:2014 except for the following subclauses:
— 4.3.1 (which refers to thermal disinfection);

4.1.1

— 5.9 [process temperature control limits, excluding 5.9 d) and e)];
— 5.11 (process verification).
4.1.2

The WD shall be designed to clean and chemically disin fect the range o f reusable items specified.


4.1.3

When necessary, the WD shall be provided with means to facilitate the correct alignment o f the

4.1.4

The means to control the volume of the process chemical(s) admitted (see ISO 15883-

load in the washing chamber.

1:2006+A1:2014, 5.7.4 and 5.7.5) shall be adjustable by means o f a key, code, or tool. The accuracy o f the
dosing system shall be at least ±10 % or as specified and tested for con formity (see 6.6).
The automatic controller shall ensure that the final concentration o f disin fectants are within the
limits specified.

4.1.5

NOTE
Confirmation o f the concentration o f disin fectant can include the measurement o f the volume o f
disin fectant and water admitted together with a certificate o f con formity from the disin fectant supplier for the
concentration o f the disin fectant, together with data to support the shel f li fe, expiry date, etc.

2

© ISO 2016 – All rights reserved


ISO 15883-7:2016(E)


4.2

Cleaning

Cleaning shall be tested in accordance with the requirements of ISO 15883-1 using the test soils
and methods described in ISO/TS 15883-5 that are relevant to the loads to be processed.

4.2.1

During the washing stage:
a) the washing stage starts when the temperature at the control sensor of the WD is not less than the
4.2.2

s p e c i fie d was h i ng temp eratu re;

b)

the was h i ng temp eratu re b and sh a l l h ave the lower l i m it defi ne d by the wa sh i ng temp eratu re
a nd

an

upp er

l i m it

of

no t


gre ater

ISO 15883-1:2006+A1:2014, 4.2.3).

tha n

the

s p e c i fie d

wa s h i ng

temp eratu re

+10

°C

(s e e

6.7.

4.2.3

C leaning e fficacy s hall b e determined in acco rdance with

4.2.4

If the WD is designed to allow the reuse of the cleaning solution on two or more consecutive


o p erating cycles , then care s hall b e taken to ens ure that the e fficacy and s a fety (e. g. accumulatio n o f

fo reign

material, device co mp atib ility) o f the cleaning s o lutio n is no t imp aired. This s hall include at leas t

the following:
a)

s p eci fied methods which shall be used to ens ure that the cleaning solution has retained the required
cleaning e fficac y. T hes e metho ds shal l b e based on validation s tudies , which would normally be
carried out by the cleaning solution manu fac turer, to determine a s uitable p arameter, parameters

and/or indicators/markers

that may be monitored. Suitable p arameters may include the concentration

o f the ac tive ingredient and other ingredients that may also a ffec t p er formance (e. g. pH ) ;

NO TE

M i nor ch a n ge s i n

for mu l ation

o f the cle a n i ng s olution c a n h ave a s ign i fic a nt e ffe c t on its s tab i l ity,

cle a n i n g e ffic ac y, e tc .

b)


re com mendation s to the u s er

for

the ma xi mum p erio d or nu mb er o f op erati ng c ycle s

for

wh ich the

cle an i ng s olution m ay b e u s e d . T h i s sh a l l b e b as e d on va l idate d exp eri menta l data;

c)

where va l idate d u s e cond ition s (ma xi mu m p erio d or nu mb er o f op erati ng c ycle s) a re exce e de d, the

automatic controller shall
—

op erate a n aud ible a nd vi s ible a la rm and prevent the u s e o f the op erati ng c ycle u nti l the cle an i ng

solution is changed, or
— effect an automatic change of the cleaning solution in the WD.
4.3
4.3.1

Disinfection
The cycle s hall include a chemical dis in fectio n s tage, which may b e co mb ined with the cleaning


and shall be deemed to have been achieved when testing requirements in 6.8 are met.

The requirements and tests in this part of ISO 15883 are based on the use of aqueous disinfectant
These shall include the following:
a) disinfectant(s) to be used, for which in vitro f
published standards;
4.3.2

s o lutio ns . O ther sys tems b as ed o n gas eo us dis in fectants are no t excluded; equivalent tes ts are required.

e fic ac y ha s b e en demon s trate d b as e d on releva nt

© ISO 2016 – All rights reserved

3


ISO 1 5 883 -7: 2 01 6(E)

For the purpose o f e fficacy testing, a validated neutralization method shall be used. This method can be
provided by the disin fectant manu facturer.

b) when tested on surfaces for the minimum exposure time at the minimum concentration and the
minimum temperature to be used in the WD, the disinfectant demonstrates the following:
1) at least a 5 log10 inactivation of vegetative bacteria;
2) at least a 4 log10 inactivation o f yeast-like fungi;

3) at least a 4 log10 inactivation of enveloped viruses.
NOTE 2


National Regulatory Authorities can require higher inactivation values and/or e fficacy against a

NOTE 3

E fficacy tests against vegetative bacteria can exclude mycobacteria. See also 8 f).

wider range of microorganisms.

c) the compatibility o f the cleaning and disin fection solutions are indicated, including any impact on
disin fection e fficacy from carryover o f cleaning solution;
d) the experimental conditions o f tests intended to demonstrate the microbicidal e fficacy o f the
disinfectant in vitro shall reflect the conditions o f use of the disin fectant. Thus, when cleaning and

disinfection is combined, the disinfectant shall be tested in the presence of applicable interfering
substances that shall include soiling typically found in the loads to be processed.

The temperature of the disinfectant solution throughout the disinfection stage shall be monitored
temperature limits for the device(s) to be processed.
4.3 .3

to ensure that it remains within the specified limits o f the disin fectant and be compatible with the

This shall be achieved either by controlling the temperature o f the disin fectant solution or where the
temperature in the WD is not controlled that the operation o f the WD is prevented outside the specified

disinfectant temperature range.
4.3 .4

If the WD is designed to allow the reuse of the disinfectant solution on two or more consecutive


operating cycles, then care shall be taken to ensure that the e fficacy and safety (e.g. accumulation o f
foreign material, device compatibility) o f the disin fectant solution is not impaired. This shall include at

least the following:
a) the means which shall be used to ensure that the disinfectant solution has retained the required

antimicrobial disin fection e fficacy. These means shall be based on validation studies, which would
normally be carried out by the disin fectant manu facturer, to determine a suitable parameter, or
parameters and/or indicators/markers that may be monitored to indicate the antimicrobial e fficacy
o f the disin fectant. Suitable parameters may include the concentration o f the active ingredient and
other ingredients that may also a ffect per formance (e.g. pH, stability, etc.);
NOTE 1 Minor changes in formulation o f the disin fectant can have a significant e ffect on storage li fe,
antimicrobial e fficacy, etc.

b) recommendations to the user for the maximum period or number o f operating cycles for which the
disin fectant may be used. This shall be based on validated experimental data;
c) when validated use conditions (maximum period or number o f operating cycles) are exceeded, the

automatic controller shall provide an audible and/or visible indication and prevent the use of the

operating cycle until the disin fectant solution is changed (manually or automatically);

d) provide a method for the user to monitor the disinfectant using a chemical indicator or other
method specific for the disin fectant to show that the disin fectant is at or above the minimum
recommended concentration.

NOTE 2 The minimum recommended concentration is the lowest concentration of active and other ingredients
to meet the label claim of a reusable disinfectant.
4


© ISO 2016 – All rights reserved


ISO 15883-7:2016(E)

4.4 Final rinsing

The water quality used for rinsing a fter the disin fection stage shall not impair the result o f

cleaning/disinfection when tested in accordance with 6.3.
NOTE

WHO definition for potable water or National Regulatory Authorities can be considered.

4.5 Self-disinfection
4.5.1

A self-disin fection cycle shall be provided to ensure that the WD does not become a focus

for contamination of the load and to provide a means of disinfecting the WD after interventions for
maintenance, repairs, or testing (see also ISO 15883-1:2006+A1:2014, 5.3.1.2).
NOTE 1

The self-disinfection process is intended also to deal with the situation where the WD has become

contaminated. Biofilm can easily develop in the piping used to convey rinse water to the load and can contain
microorganisms in a state in which they are highly resistant to disin fection.

Thermal disinfection shall attain a minimum A 0 of 60 and shall be capable to be set to give an
A 0 -value of 600.

If the use of thermal disinfection is not possible, a chemical disinfectant different from that used for
disinfecting the loads shall be used.
NOTE 2

The use o f a disin fectant based on the same active ingredients can carry the risk o f allowing organisms

resistant to a particular disinfectant to proliferate.

Details o f the parts o f the WD subjected to the self-disin fection cycle shall be provided and
whether this cycle includes other components such as the water treatment equipment.
4.5.2
4.5.3

The WD sel f-disin fection cycle shall

a) be operated under the control of the automatic controller,
b) be a user selectable cycle,
c) provide for disin fection o f the chamber and all liquid transport systems,
d) include means to warn the user that the WD shall be operated without any load in the chamber
and, so far as may be practicable, include means to veri fy that no device is present be fore the cycle

will operate, and

e) in the case o f thermal sel f-disin fection o f the WD, ensure that all the parts o f the heating system

and the associated pipework, via which the water or the steam reach the WD tank, attain an
A 0 -value of at least 60.

The sel f-disin fection cycle shall ensure that contamination through failure o f the water treatment
equipment can be e ffectively disin fected. Compliance shall be verified by testing in accordance with 6.8.3.

4.5.4

Thermal disin fection systems shall be evaluated by thermometric monitoring o f the
system with sensors placed at those parts o f the system specified as representative o f the lowest
temperatures in the system. The entire system subjected to thermal disin fection shall attain the

4.5.5

required disinfection temperature.
4.5.6

For chemical sel f-disin fection cycles, a microbiological test shall be required. The capability o f

the WD to provide self-disinfection shall be deemed to have been established when tested in accordance
with Annex B.

© ISO 2016 – All rights reserved

5


ISO 15883-7:2016(E)
4.6 Drying
4.6.1
4.6.2

The WD s hall, unles s o therwis e s p ecified, b e p rovided with equip ment to allow drying o f the lo ad.

D rying o f the lo ad in the WD s hall b e deemed to have b een achieved when p lain s ur faces o f the


items are vis ib ly dry (s ee

6.4).

4.7 Water treatment equipment
4.7.1 General

Me an s s ha l l b e provide d to en s ure any water tre atment e quipment that i s p ar t o f the WD (s o fteners ,
de -ion i zers , fi lters , e tc .) i s op erate d with i n the l i m its (e . g. flow rate s , s upply pre s s ure s) s p e ci fie d

water treatment equipment.

for

the

4.7.2 Disinfection of water treatment equipment
4.7.2.1 When the water treatment equipment is a part of the WD, the former shall be designed and

co ns tructed to allo w

fo r

p erio dic dis in fectio n. Guidance o n the minimum

frequency

that the equip ment

is dis in fected s hall b e p rovided in acco rdance with the in fo rmatio n s up p lied by the p urchas er

quality o f the water s up p ly and the water treatment equip ment [s ee

NO TE

8

fo r

the

c) and h) ] .

T he d i s i n fe c tio n o f the water tre atment e qu ip ment c a n b e c a r rie d out du ri n g a s el f- d i s i n fe c tion c ycle .

T he ac tua l

fre quenc y

shou ld b e de cide d b y the u s er b as e d up on known, e . g. s e a s ona l, variation s i n the

qua l ity o f water s uppl ie d to the WD and the op erationa l h i s tor y o f the water tre atment e qu ipment.

T he

d i s i n fe c tion me tho d sh a l l no t c au s e a ny d amage to ,

equipment.

nor i mp ai r the e ffic ac y o f,


the tre atment

T he e ffic ac y o f the water e quipment d i s i n fe c tion pro ce du re to provide s el f- d i s i n fe c tion s ha l l b e de eme d

to have been established if, when tested in accordance with 6.3, there shall be less than 10 CFU recovered
from each of two 100 ml samples and that other control parameters (e.g. temperature, holding time)
have been achieved.

4.7.2.2 If the water treatment equipment is not part of the WD, the requirements for water supplied to

the WD s hall b e s p ecified. This s hall include s p ecificatio n o f the p ermis s ib le micro b ial co ntaminatio n o f
the water s up p ly [s ee

NO TE 1
ne ce s s a r y

8

i) ] .

To me e t the s p e c i fic ation o f the p er m i s s ib le m ic rob i a l conta m i n ation o f the water s upp l y, it c a n b e

fo r

the u s er to m a ke pro vi s ion

for

d i s i n fe c tion o f the e x ter n a l water tre atment e qu ip ment.


Final rinse water shall have less than 10 CFU/100 ml sample (see 6.3). If required, means shall be

provide d to d i s i n fe c t water u s e d

for

the fi na l ri n s e .

NOTE 2 The following methods can be suitable for control of the microbial contamination of rinse water:
— m a i nta i ne d i n a de d ic ate d re s er voi r at a temp eratu re no t le s s th a n 6 5 ° C

fo r

the ti me demon s trate d to ach ie ve

d i s i n fe c tion o f the i ncom i ng s upp l y;

— d i s i n fe c te d i m me d iatel y p rio r to u s e;

— fi ltere d to remo ve s u s p ende d p a r ticle s o f a s i z e gre ater th a n 0 , 2 μm;

— sterile, in a closed container, with a connection to the WD designed and constructed to provide aseptic transfer.

6

© ISO 2016 – All rights reserved


ISO 15883-7:2016(E)


4.7.2.3 The connection between the water supply, which has been treated to remove microbial
contamination and the circulation system for rinsing, shall be designed and constructed to provide

aseptic transfer.

Provision shall be made for disin fection o f this connection to be made periodically. The frequency and
method o f carrying out this disin fection shall be specified.
4.7.2.4

When the water treatment equipment is a part of the WD, from the time before the rinsing

stage until the end o f the processing cycle, as appropriate, the final water treatment used to fulfil the
requirements of 4.4 shall be monitored by the WD automatic controller to verify that the parameters
affecting the e fficacy o f the water treatment equipment remain within specification.
4.7.3

Maintenance of piping

The planned preventive maintenance required for the piping that is part o f the WD and is used to convey
final rinse water to the load shall be specified.
5 Mechanical requirements
5.1 Materials — Design, manufacture, and assembly

The WD should be constructed so that loading and unloading of medical equipment are possible
without the need to enter the chamber.

5.1.1

The WD design should consider the ease of access for maintenance (IEC 61010-2-040:2005,
5.4.3 and 7.5).


5.1.2

5

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The WDs shall be equipped with a level b process verification system (see ISO 15883-1:2006+A1:2014,

5.11.4.

6 Testing for conformity
6.1 General

The tests described in this subclause are in addition to the tests described in ISO 15883-1 and are

specific for WDs intended to process non-invasive, non-critical thermolabile medical devices, and
healthcare equipment. They are re ference tests intended for use in demonstrating compliance with the
specified requirements o f this part o f ISO 15883. They may be used in type tests, works tests, and in
validation and re-qualification tests, or in routine tests carried out by, or on behal f o f, the user. Other

tests and methods providing equivalent assurance may be used as the basis o f claiming compliance
with this part o f ISO 15883. In any case o f dispute, the re ference tests given in this part o f ISO 15883

shall be used.

The summary programme o f tests in addition to those given in ISO 15883-1 is shown in Annex A.
NOTE
A number o f the tests can be carried out simultaneously with each other and/or with those required
by applicable sa fety standards such as IEC 61010-2-040.

© ISO 2016 – All rights reserved

7


ISO 15883-7:2016(E)
6.2 Test load

6.2.1 Loading with standard goods

Test load shall be defined to represent typical loading o f goods to be processed such as bedsteads and

bedside tables.

6.2.2 Loading with special goods
I f non-critical, non-invasive medical devices that were not included in the type test are to be processed,
then a per formance qualification shall be carried out with representative loads.

6.3 Water used for rinsing following disinfection
Water used for final rinsing shall be collected from within the WD chamber and tested for microbial

quality in accordance with Annex C.
Where the final rinse water is collected a fter contact with the load, a neutralisation method shall be
used to eliminate any antimicrobial activity.
The test shall be carried out following installation. Testing shall be repeated weekly until it has been
established that the final rinse water is consistently within specification for at least one month. Testing
shall then be repeated annually therea fter.
NOTE

Tests for other microorganisms that can be o f clinical significance (e.g. Acinetobacter) can be performed.

6.4 Load dryness
6.4.1 General

When the WD is intended to dry the load, testing shall be carried out as described below.

6.4.2 Procedure

The WD will be loaded in accordance with manufacturer’s instructions (see 6.2) and run through

a complete cycle including the drying stage. A fter completion o f the cycle, the door (unloading) is
opened and remains open for 5 min be fore the load is removed from the chamber. The load dryness is
inspected visually.

6.4.3 Results

Report whether or not plain surfaces of the load are free visible water.

6.5 Thermometric tests
6.5.1 General


The tests shall be performed in accordance with ISO 15883-1:2006+A1:2014, 6.8.

6.5.2 Load temperature test

The load temperature test shall be carried out using reference loads made up of a full load of items that
the WD is intended to process (see 6.2). The items chosen shall be those with the greatest mass, highest
specific heat, and lowest thermal conductivity.

8

© ISO 2016 – All rights reserved


ISO 15883-7:2016(E)

6.6 Chemical dosing tests
6.6.1

General

The tests shall be performed in accordance with ISO 15883-1:2006+A1:2014, 6.9.
6.6.2

Reused process chemicals

If the WD is designed to reuse a detergent and/or disinfectant solution, before use for the last
The determination of chemical concentration is performed in accordance with a method given for the
permitted cycle the solution shall be above the minimum e ffective concentration (see 4.2.4 and 4.3.4).

process chemical(s). Record whether the requirements are fulfilled.

6

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General


The conditions of use of cleaning solutions within the WD shall be within the conditions validated and
specified as acceptable.

Tests conducted on cleaning solutions shall be carried out at the end (or simulated end) of the shelf life
after it has been stored under the worst case recommended storage conditions.
The test procedure and test loads are designed to demonstrate compliance with the requirements of
cleaning e fficacy in accordance with ISO 15883-1:2006+A1:2014, 6.10, but take into consideration the
nature of the loads and, if applicable, combination of cleaning/disinfection in a single stage.
The determination o f cleaning e fficacy shall be made on the defined cleaning stage only. To claim that

particular load(s) can be processed in the WD, data shall be required to establish that those load(s) can
be e ffectively cleaned in the WD.
6.7.2
6.7.2.1

Materials
Load carrier

The load carrier chosen for the test load shall be o f the type recommended for the devices to be

processed (see 6.2).
6.7.2.2

Test loads

The type test shall be carried out using the loads described in 6.2.
6.7.2.3

Test soils


Devices to constitute a test load shall be contaminated with one or more test soils by the method given

in ISO/TS 15883-5 that are pertinent to the load being processed.
NOTE 1

Local requirements can speci fy the use o f particular test soils and methods.

NOTE 2

The attention of manufacturers is drawn to the user’s choice of test soils(s) and method(s) for

operational testing; this can indicate a need to carry out similar testing be fore the WD is supplied.

The test soils used for the load, chamber wall, and load carriers may be the same or di fferent. Where

different test soils are used, the rationale for the choice of test soil shall be documented.

© ISO 2016 – All rights reserved

9


ISO 15883-7:2016(E)
6.7.2.4 Water quality
I f the e fficacy o f the cleaning solution is liable to be impaired by dilution with water above a certain
level o f hardness, then testing shall be carried out with a cleaning solution prepared by dilution with

water at the maximum permitted hardness.

6.7.3 Procedure

Place the test load contaminated with the test soil in the chamber. Start a normal cleaning cycle for
the load type under test. Interrupt the cycle a fter the cleaning stage and, i f applicable, just prior to the
start o f the disin fection stage. A rinse with water may be provided a fter cleaning i f defined as part o f
the cycle. I f a cycle with a combined cleaning and disin fecting stage is designed, interrupt the cycle
a fter that combined stage and any rinse. Examine the test load visually and additionally by a method

given in ISO/TS 15883-5 for the particular test soil used for the presence of residual soil. Residual soil
ISO 15883-1:2006+A1:2014, Annex C.

detection should also be confirmed by a qualitative or semi-quantitative version o f methods given in

6.7.4 Results
Record the adequacy o f the cleaning process using the criteria specified for the particular test soil
used in ISO/TS 15883-5 and additionally the detection results for the method uses in accordance with

ISO 15883-1:2006/Amd 1:2014, Annex C.

6

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6.8.1 General
The conditions o f use o f disin fectant(s) in the WD shall be within the validated and specified conditions.

Tests conducted on disinfectants shall be carried out at the end (or simulated end) of the shelf life after
the disinfectant has been stored under the worst case storage conditions.
National regulatory requirements can speci fy approval procedures prior to the use o f a disin fectant
in WDs for medical devices. Compliance with these national requirements shall be deemed necessary
within the territory where they apply.

6.8.2 Preliminary tests on chemical disinfectants
6.8.2.1 General


An initial series of tests, as set out in 4.3 , intended to veri fy the in vitro microbicidal efficacy of the
disin fectant solution under conditions identical to those which will be applied at the time o f the cycle’s
disinfection phase, shall be carried out unless adequate data under relevant conditions can be supplied
for shorter contact time(s).
For this, the microbicidal e fficacy o f the disin fectant solution shall be verified.

During these tests, experimental conditions intended to simulate the conditions within the WD
shall be used.

6.8.2.2 Concentration

The disinfectant shall be tested at the minimum concentration available during the disinfection phase
o f the cycle, based on the minimum recommended concentration (MRC).

Each disinfectant recommended for use in the WD shall be tested.

In the case where it is intended that a disin fectant solution be reused, the e fficacy o f the solution shall

be determined as a function of its minimum effective concentration (MEC) (see 4.3.4).

10

© ISO 2016 – All rights reserved


ISO 15883-7:2016(E)
6.8.2.3 Temperature

Two cases shall be considered:
a) if the disinfection stage is carried out under uncontrolled temperature conditions, the test

disinfection phase;
b) if the disinfection stage is carried out under temperature controlled conditions, the test
temperature shall correspond to the lower and upper limit disinfection temperature.
temp eratu re

s ha l l

be

the

m i ni mum

a nd

ma xi mu m

temp eratu re

p erm itte d

du ri ng

the

c ycle’s

6.8.2.4 Contact time

The contact time observed during the tests shall be the minimum duration of the disinfection stage.


6.8.2.5 Water quality
I f the e ffic ac y o f the d i s i n fe c tant i s l i able to b e i mp a i re d b y d i lution with water ab ove a cer tai n level o f
hard ne s s , then te s ti ng sha l l b e c a rrie d out with the d i s i n fe c ta nt prep a re d b y d i lution with water at the

maximum permitted hardness.

6.8.2.6 Neutralization
B e fore a n i nve s tigation o f the e ffic ac y o f the d i s i n fe c ta nt, a me tho d o f neutra l i z i ng the d i s i n fe c tant at the

end of the exposure period shall be demonstrated and documented. This shall include demonstration
that,

for

any neutra l i z i ng agent u s e d, neither the neutra l i z i ng agent nor any re ac tion pro duc ts with

the d i s i n fe c tant are m icrobic ida l or i n h ibit the grow th o f the te s t orga n i s m . When a s e condar y ho s t
s uch a s a cel l c u lture i s u s e d as the de te c tion s ys tem

for

the s u r viva l o f te s t organ i s m s , the ab s ence o f

c arr y over e ffe c ts on the cel l c u lture s ys tem and de te c tion o f low nu mb ers o f te s t organ i s m s adde d a s a
cha l lenge to the te s t s ys tem s ha l l b e demon s trate d .

6.8.2.7 Test organisms

Test organisms shall be selected on the basis of antimicrobial claims made with the WD, with

consideration of 4.3.
NOTE Guidance on choice of organisms can be obtained from relevant published method standards
f
f
f
EN 14348, EN 14476, AOAC International (2012), RKI/DVV guideline (2008).
or genera l l y accep te d n atio n a l g u idel i ne s

o n s u r ace d i s i n e c ta nt e fic ac y te s ti ng , e . g.

EN

1 3 62 4, E N

1 3 7 2 7,

6.8.2.8 Presentation of test organisms
Whi le initial potenc y tes ts may b e carried out us ing a s us p ens ion o f tes t organi s ms , the demons tration o f
e fficac y on contaminated s ur faces shall b e required. T he s ur faces o f the tes t pieces to be ino cu lated with

test organisms shall be representative of those found in the WD chamber and the devices to be processed.

6.8.2.9 Detection of test organisms

The culture method used to enumerate the number of surviving microorganisms after exposure to
the disinfectant shall be validated. The culture method shall be capable of recovering a low number
(approxi mately 10) o f the orga n i s m s

for


wh ich it i s i ntende d to b e u s e d .

6.8.3 Self-disinfection tests
6.8.3.1 Type test
T he typ e te s t i s i ntende d to veri fy that the WD “s el f- d i s i n fe c tion” mo de wi l l d i s i n fe c t tho s e p a r ts o f the
WD wh ich come i nto contac t with fluid s wh ich are i ntende d to, or c a n, contac t the lo ad .

© ISO 2016 – All rights reserved

11


ISO 15883-7:2016(E)

The test method used shall provide an estimate o f the bacterial levels in the final rinse water at the end
o f a normal operating cycle following the sel f-disin fection cycle (see Annex C).
In addition, thermometric verification o f A0 attainment shall be performed for thermal self-disinfection
cycles in accordance with ISO 15883-1:2006+A1:2014, 6.8.
6.8.3.2

Operational and routine test

The test method used shall estimate the bacterial levels in the final rinse water at the end o f a normal
operating cycle following the sel f-disin fection cycle (see Annex C).
NOTE
The test on the final rinse water can be su fficient to veri fy the sel f-disin fection cycle. The sample can
be taken from any suitable point that ensures the water is collected following circulation through the components

being disinfected.
6.8.4


Chemical disinfection of the load

6.8.4.1

Type test

The test shall be carried out in accordance with Annex D.
The test method shall use a load in accordance with 6.2 , with specific load examples given in Annex E.
A range of other microorganisms can be used in combination with a soil relevant to the load from
ISO/TS 15883-5.
NOTE

A particular test organism is suggested but others can be used at the request of the user.

Mechanical removal alone (i.e. wash-off) shall be evaluated in the absence of the disinfectant.
6

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Operational and performance tests shall establish the levels of all controlling variables that affect the
disin fection o f the load are within the limits established during type testing.
NOTE

When required by national regulation, specified test loads can be used to simulate the range o f load

items. Direct inoculation of test organisms, biological indicators, or bioburden testing (ISO 11737-1) can be used
to monitor the e fficacy o f the disin fection process. Microorganisms incorporated into test soils can be used
instead o f, or as well as, the use o f inoculated test objects (see ISO/TS 15883-5).
6.8.4.3

Routine tests

Routine tests shall establish the levels of all controlling variables that affect the disinfection of the load
are within the limits established during type testing.
7 Documentation

Documentation shall be in accordance with ISO 15883-1:2006/Amd 1:2014, Clause 7.
8 Information to be provided by the manufacturer

In addition to the in formation specified in ISO 15883-1:2006/Amd 1:2014, Clause 8, the following

information shall be provided:
a) range of load supports available and required;

b) details o f which parts o f the WD are subjected to disin fection during the disin fection stage and
sel f-disin fection cycle and which parts are not; guidance on the frequency at which any water

treatment equipment that is part of the WD shall be disinfected;


12

© ISO 2016 – All rights reserved


ISO 15883-7:2016(E)

c) locations o f temperature sensors being representative o f the lowest temperature o f the system;
d) the detergent(s) and disin fectant(s) used in the type testing;
e) recommendations to the user for the maximum period or number o f operating cycles for which the
reusable detergent(s) and/or disin fectant(s) may be used;
f

) the range o f antimicrobial activity (e.g. bactericidal, virucidal, fungicidal, mycobactericidal);

g) a method for the user to monitor the disinfectant using a chemical indicator or other method
specific for the disin fectant to show that the disin fectant is at or above the minimum e ffective
recommended concentration;
h) maximum time required for the WD to be ready for use on start-up at minimum utilities;

i) if the water treatment equipment is not part of the WD, the requirements for water supplied to the
WD including the requirement to control the microbial contamination o f the water supply (see 4.7).
9 Marking, labelling, and packaging

The WD shall be marked externally in accordance with the requirements o f IEC 61010-2-040:2005,

Clause 5.

10 Information to be requested from the purchaser by the manufacturer


The requirements o f ISO 15883-1:2006+A1:2014, Clause 10 apply.

© ISO 2016 – All rights reserved

13


ISO 15883-7:2016(E)

Annex A

(normative)

Summary of test programmes
Table A.1 — Summary of tests in addition to ISO 15883-1:2006/Amd 1:2014

Brief description of
test

Requirement
Clause

Test Clause

4.1.4

6.6

X


4.2.3
4.2.4
4.3.4
4.3

6.7
6.6.2
6.6.2
6.8.4

4.3.2
4.4
4.5.4
4.5.6

Drying

Accuracy and
repeatability

Accuracy o f the dosing
system
Cleaning e fficacy

Detergent reuse
Disinfectant reuse
Load disinfection
e fficacy

Chemical disinfectant

Final rinsing
Self-disinfection
Chemical
Self-disinfection
Water treatment
equipment
Chemical dosing

Low level indicator
Concentration
determination
Instrumentation
Legibility

Calibration

X recommended
B not recommended

Type
test

Work OQ
s test

PQ

Routine
test


X

X

B

X (Q)

X
X
X
X

B
B
B
B

B
B
B
X

X
X
X
X

X(D)
X (D)

X (D)
X (D)

6.8.2
6.3
6.8.3
Annex B

X
O
X
X

B
B
B
B

B
B
B
O

B
X
X
B

B
X (Y)

X (Y)
B

4.6
4.7

6.4
6.3

X
X

B
B

X
B

B
X

X (D)
X (Y)

in accordance
with
ISO 15883-1:2006
+A1:2014, 5.7.5
in accordance
with

ISO 15883-1:2006
+A1:2014, 5.7.6

in accordance
X
with
ISO 15883-1:2006
+A1:2014, 6.9.1
in accordance
X
with
ISO 15883-1:2006
+A1:2014, 6.9.2
X

—

—

X

—

X

X

X

—


—

X

X

—

in accordance
with
ISO 15883-1:2006
+A1:2014, 5.12.3
in accordance
with
ISO 15883-1:2006
+A1:2014, 5.11,
5.12.4, 5.13, 5.14
and 5.15

in accordance
X
with
ISO 15883-1:2006
+A1:2014, 6.6.2
in accordance
V
with
ISO 15883-1:2006
+A1:2014, 6.6.1


—

—

—

—

—

—

V

—

O optional test which can be requested by the purchaser or user
V verification o f calibration at the value(s) o f interest for the particular instrument, e.g. the disin fection temperature
Q quarterly test interval, Y yearly test interval, D daily test interval

14

© ISO 2016 – All rights reserved