oSIST prEN ISO 11140-6:2021

Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO/DIS 11140-6:2021)

This International Standard specifies the performance requirements and test methods for chemical indicators and hollow devices and porous devices within which they are intended to function, to be used for testing the steam penetration performance of type B cycles of small steam sterilizers; small steam sterilizers are defined in EN 13060. The hollow and porous devices described in this standard do not substantiate their suitability as surrogate devices for lumened, hollow and porous medical devices used in health care facilities.
Chemical indicators used with a porous device specified in this standard are designed to demonstrate the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060).
The relevant sections of this International Standard covering porous loads specify the requirements for
— a reference porous device to be used in the small load test for porous loads in small steam sterilizers and as a reference device by which alternative porous devices can be shown to be equivalent in performance according to this standard; ie, a textile test pack in which steam penetration is judged by thermometric means;
— an alternative porous device equivalent in performance to the reference porous device; ie, an alternative porous device, usually commercially manufactured, of any design.
Chemical indicator systems used with a hollow load device specified in this standard are designed to demonstrate the adequacy of steam penetration into a hollow device in small steam sterilizers (see EN 13060).
The relevant sections of this International Standard covering hollow loads specify the requirements for
— a reference hollow device used as a reference device in this standard; ie, a lumened device with attached capsule in which steam penetration is judged by inactivation or survival of a specified biological indicator;
— an alternative hollow device employing the same specific test load as defined for the reference hollow device and an indicator system designed specifically for use in the reference hollow test load; ie, a lumened device with an attached capsule in which steam penetration is judged by visual examination of an indicator system;
— an alternative hollow device equivalent in performance to the reference hollow device; ie, an alternative hollow device, usually commercially manufactured, of any design.

Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 6: Indikatoren der Klasse 2 und Prüfkörper für die Leistungsprüfung von Dampf-Klein-Sterilisatoren (ISO/DIS 11140-6:2021)

Dieses Dokument legt die Leistungsanforderungen und Prüfverfahren für hohle und poröse Körper sowie die Indikatoren fest, die in diesen Körpern eingesetzt werden, um Dampf‑Klein‑Sterilisatoren nach EN 13060 bei Typ-B-Zyklen und einigen Typ-S-Zyklen auf eine spezifizierte Dampf-Durchdringungsleistung zu prüfen. Die Eignung der hohlen und porösen Körper, die in diesem Dokument als Ersatz für in Gesundheitseinrichtungen verwendete hohle und poröse Medizinprodukte beschrieben sind, ist nicht belegt.
Mit einem in diesem Dokument spezifizierten porösen Körper verwendete chemische Indikatoren sind ausgelegt zu zeigen, dass die Dampfdurchdringung eines porösen Körpers in einem Dampf‑Klein‑Sterilisator (siehe EN 13060) ausreichend ist.
Die für poröse Beladungen zutreffenden Abschnitte dieses Dokuments enthalten Anforderungen an:
a) einen als Referenzkörper verwendeten porösen Referenzkörper, mit dem gezeigt werden kann, dass alternative poröse Indikatorsysteme hinsichtlich ihrer Leistung entsprechend diesem Dokument gleichwertig sind, d. h. ein textiles Prüfpaket, dessen Dampfdurchdringung anhand thermometrischer Mittel bestimmt wird;
b) ein alternatives poröses Indikatorsystem, das hinsichtlich seiner Leistung dem porösen Referenzkörper gleichwertig ist, d. h. ein alternatives, in der Regel kommerziell hergestelltes poröses Indikatorsystem jeder Auslegung.
Mit einem in diesem Dokument spezifizierten hohlen Beladungsgerät verwendete chemische Indikatoren sind ausgelegt zu zeigen, dass die Dampfdurchdringung eines engen Lumens (zuvor als Hohlkörper-Beladung A bezeichnet) in einem Dampf‑Klein‑Sterilisator (siehe EN 13060) ausreichend ist.
Die für hohle Beladungen zutreffenden Abschnitte dieses Dokuments enthalten Anforderungen an:
a) einen entsprechend diesem Dokument als Referenzkörper verwendeten hohlen Referenzkörper, d. h. ein Lumenprodukt mit daran angebrachter Kapsel, anhand derer die Dampfdurchdringung durch Inaktivierung oder Überleben eines spezifizierten biologischen Indikators beurteilt wird;
b) einen alternativer Hohlkörper:
i) der mit der gleichen spezifischen Prüfbeladung verwendet wird, wie für den hohlen Referenzkörper angegeben, sowie einen chemischen Indikator, der speziell für die Verwendung in der hohlen Referenzprüfbeladung ausgelegt ist, d. h. ein Lumenprodukt mit daran angebrachter Kapsel, anhand derer die Dampfdurchdringung durch visuelle Untersuchung eines chemischen Indikators beurteilt wird;
ii) der hinsichtlich seiner Leistung dem hohlen Referenzkörper gleichwertig ist, d. h. ein alternativer, in der Regel kommerziell hergestellter hohler Körper jeder Auslegung.

Stérilisation des produits de santé - Indicateurs chimiques - Partie 6: Indicateurs de classe 2 et dispositifs de processus d'essai pour le test de performances des petits stérilisateurs à la vapeur d'eau (ISO/DIS 11140-6:2021)

Sterilizacija izdelkov za zdravstveno oskrbo - Kemijski indikatorji - 6. del: Indikatorji tipa 2 in razvoj izločevalnih načrtov za preskušanje delovanja majhnih parnih sterilizatorjev (ISO/DIS 11140-6:2021)

General Information

• Status: Not Published
• Public Enquiry End Date: 25-Sep-2021
• ICS: 11.080.01 - Sterilization and disinfection in general
• ICS: 11.080.20 - Disinfectants and antiseptics
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 19-Jul-2021
• Due Date: 06-Dec-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: prEN ISO 11140-6 - Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing of small steam sterilizers (ISO/DIS 11140-6:2021)

RELATIONS

• Revised: SIST EN 867-5:2002 - Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
• Effective Date: 01-Jul-2015

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 11140-6:2021
01-september-2021
Sterilizacija izdelkov za zdravstveno oskrbo - Kemijski indikatorji - 6. del:

Indikatorji tipa 2 in razvoj izločevalnih načrtov za preskušanje delovanja majhnih

parnih sterilizatorjev (ISO/DIS 11140-6:2021)

Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and

process challenge devices for use in performance testing of small steam sterilizers

(ISO/DIS 11140-6:2021)

Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 6:

Indikatoren der Klasse 2 und Prüfkörper für die Leistungsprüfung von Dampf-Klein-

Sterilisatoren (ISO/DIS 11140-6:2021)

Stérilisation des produits de santé - Indicateurs chimiques - Partie 6: Indicateurs de

classe 2 et dispositifs de processus d'essai pour le test de performances des petits

stérilisateurs à la vapeur d'eau (ISO/DIS 11140-6:2021)
Ta slovenski standard je istoveten z: prEN ISO 11140-6
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
oSIST prEN ISO 11140-6:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 11140-6:2021
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oSIST prEN ISO 11140-6:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11140-6
ISO/TC 198 Secretariat: ANSI
Voting begins on: Voting terminates on:
2021-07-07 2021-09-29
Sterilization of health care products — Chemical
indicators —
Part 6:
Type 2 indicators and process challenge devices for use in
performance testing of small steam sterilizers
ICS: 11.080.01
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
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
ISO/CEN PARALLEL PROCESSING
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
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11140-6:2021(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. ISO 2021
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oSIST prEN ISO 11140-6:2021
ISO/DIS 11140-6:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of 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 of the requester.
ISO copyright office
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Phone: [phone]
Email: [e-mail]
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Published in Switzerland
ii © ISO 2021 – All rights reserved
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Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

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

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

3 Terms and definitions ..................................................................................................................................................................................... 2

4 Requirements .......................................................................................................................................................................................................... 2

4.1 General ........................................................................................................................................................................................................... 2

4.2 Porous devices ......................................................................................................................................................................................... 3

4.2.1 Reference porous device ........................................................................................................................................... 3

4.2.2 Detector for reference porous device ............................................................................................................ 4

4.2.3 Alternative porous indicator system .............................................................................................................. 5

4.2.4 Reference porous device ........................................................................................................................................... 5

4.3 Hollow devices ........................................................................................................................................................................................ 6

4.3.1 Reference hollow device ........................................................................................................................................... 6

4.3.2 Detector for reference hollow device ............................................................................................................. 7

4.3.3 Reference hollow indicator system .................................................................................................................. 7

4.3.4 Reference indicator system performance determination ............................................................ 7

4.3.5 Leakage test ...................................................................... .................................................................................................... 9

4.4 Alternative hollow indicator system .................................................................................................................................... 9

4.5 Alternative hollow devices intended for multiple use .......................................................................................10

4.6 Test procedure for validation of conformance of the alternative hollow device

to the reference hollow device ...............................................................................................................................................11

5 Chemical indicator dry heat performance .............................................................................................................................13

5.1 General ........................................................................................................................................................................................................13

5.2 Test 1.............................................................................................................................................................................................................13

5.3 Test 2.............................................................................................................................................................................................................13

6 Marking and labelling ..................................................................................................................................................................................14

6.1 Alternative porous indicator system .................................................................................................................................14

6.2 Reference hollow device ..............................................................................................................................................................14

6.3 Alternative hollow device ...........................................................................................................................................................14

6.4 Chemical indicators for use in hollow devices .........................................................................................................14

Annex A (normative) Test method for performance of reference hollow indicator system ....................16

Annex B (normative) Test method for performance of alternative porous indicator system ...............25

Annex C (normative) Test method for performance of alternative hollow indicator system.................28

Annex D (informative) Relationship of chemical indicator components ....................................................................29

Annex E (normative) Reference hollow device .......................................................................................................................................31

Annex F (informative) Accelerated ageing of test samples.........................................................................................................33

Annex G (informative) Evaluation of reference hollow devices – results ....................................................................34

Bibliography .............................................................................................................................................................................................................................42

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Foreword

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

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

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

different types of ISO documents should be noted. This document was drafted 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 of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of 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 information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.

A list of all parts in the ISO 11140 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
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Introduction

This document is intended for manufacturers and specifies the requirements for chemical indicators

and process challenge devices used as steam penetration tests to monitor type B cycles and some type

S cycles of small steam sterilizers conforming to EN 13060.

This part of ISO 11140 includes a description of both hollow and porous devices and their performance

requirements along with methods by which alternative device can be shown to have equivalent

performance to that of the references. Small sterilizers unable to accommodate a sterilization module

(600 mm x 300 mm x 300 mm) cannot be tested using the tests described in EN 285 for large sterilizers

for wrapped goods and porous loads. The chamber size is unable to accommodate the standard test

pack and because the efficacy of the tests is impaired when the test pack occupies a large proportion of

the chamber volume (>20 % chamber volume).

Indicators described in this document are intended to be used in conjunction with appropriate process

challenge devices to show penetration of steam into the process challenge device. The reference

indicator systems and alternative indicator systems pose specified challenges to air removal and steam

penetration.

The devices described in this document are intended for use only in small steam sterilizers (that are

unable to accommodate a sterilization module as defined in EN 285) to monitor steam penetration in

type B cycles and some type S cycles.

NOTE The use of this document can involve hazardous materials, operations and equipment. This document

does not purport to address to all the safety problems associated with its use. It is the responsibility of the user of

this document to establish appropriate safety and health practices and determine the applicability of regulatory

limitations prior to use.
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oSIST prEN ISO 11140-6:2021
DRAFT INTERNATIONAL STANDARD ISO/DIS 11140-6:2021(E)
Sterilization of health care products — Chemical
indicators —
Part 6:
Type 2 indicators and process challenge devices for use in
performance testing of small steam sterilizers
1 Scope

This document specifies the performance requirements and test methods for hollow devices and porous

devices as well as the indicators that are utilized within these devices for testing a specific steam

penetration performance of type B cycles and some type S cycles of small steam sterilizers that comply

with EN 13060. The suitability of the hollow and porous devices described in this document as surrogate

devices for hollow and porous medical devices used in health care facilities is not substantiated.

Chemical indicators used with a porous device specified in this document are designed to demonstrate

the adequacy of steam penetration into a porous device in small steam sterilizers (see EN 13060).

The relevant sections of this document covering porous loads specify the requirements for:

a) a reference porous device as a reference device by which alternative porous indicator systems can

be shown to be equivalent in performance according to this document, i.e. a textile test pack in

which steam penetration is judged by thermometric means;

b) an alternative porous indicator system equivalent in performance to the reference porous device,

i.e. an alternative porous indicator system, usually commercially manufactured, of any design.

Chemical indicators used with a hollow load device specified in this document are designed to

demonstrate the adequacy of steam penetration into a narrow lumen (previously known as hollow

load A) in small steam sterilizers (see EN 13060).

The relevant sections of this document covering hollow loads specify the requirements for:

a) a reference hollow device used as a reference device in this document, i.e. a lumened device with

attached capsule in which steam penetration is judged by inactivation or survival of a specified

biological indicator;
b) an alternative hollow device:

i. employing the same specific test load as defined for the reference hollow device and a chemical

indicator designed specifically for use in the reference hollow test load, i.e. a lumened device

with an attached capsule in which steam penetration is judged by visual examination of a

chemical indicator;

ii. equivalent in performance to the reference hollow device, i.e. an alternative hollow device,

usually commercially manufactured, of any design.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

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ISO 10012:2003, Measurement management systems — Requirements for measurement processes and

measuring equipment

ISO 11140-1:2014, Sterilization of health care products — Chemical indicators — Part 1: General

requirements

ISO 11140-4:2007, Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators

as an alternative to the Bowie and Dick-type test for detection of steam penetration

ISO 18472:2018, Sterilization of health care products — Biological and chemical indicators — Test

equipment
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 11140-1 and the following

apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
chemical indicator

test system that reveals change in one or more pre-specified process variables based on a chemical or

physical change resulting from exposure to a process
Note 1 to entry: See Annex D.
[SOURCE: ISO 11139:2018, 3.43, modified – Note 1 to entry has been added]
3.2
chemical indicator endpoint

completion of a specified change after a chemical indicator has been exposed to specified conditions

[SOURCE: ISO 11139:2018, 3.44]
3.3
chemical indicator system
combination of a chemical indicator and a specific test load
Note 1 to entry: See Annex D.
[SOURCE: ISO 11139:2018, 3.43.1, modified – Note 1 to entry has been added]
3.4
process challenge device
PCD

item providing a defined resistance to a cleaning, disinfection, or sterilization process and used to

assess performance of the process
[SOURCE: ISO 11139:2018, 3.205]
4 Requirements
4.1 General

4.1.1 Unless specified otherwise in this document, the requirements of ISO 11140-1:2014 shall apply.

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4.1.2 The chemical indicator, the biological indicator, the hollow device and porous device shall be

conditioned in an environment of (50 ± 10) % relative humidity and (25 ± 5) °C. Means shall be used to

ensure the internal volume of the hollow device is conditioned similarly.

4.1.3 Chemical indicators intended for use with re-usable user-assembled hollow devices shall not

transfer indicator reagent to the material of the hollow device during processing. Pre-assembled hollow

devices and porous devices, and indicators for single-use or user-assembled devices shall not transfer

indicator reagent to the material of the device during processing to an extent which impairs the utility of

the device.

4.1.4 A PCD intended to be re-used shall, when processed in accordance with the provided instructions

for use, meet the relevant requirements of this document, during its specified shelf life.

NOTE 1 Instruction can include restriction on the number of re-uses, as well as important information on

service, cleaning procedures, the manner of inspection and criteria, maintenance and replacement of components.

For demonstration of conformance, a study shall be conducted by way of a protocol developed before

study commencement, to show conformity to the performance requirements of this document over

the shelf life of the product. This may be either a real-time study, or be accelerated. An example of an

accelerated study is given in Annex F.
NOTE 2 Some regulatory authorities will only accept data from real-time studies.

4.1.5 For chemical indicator systems with re-usable user-assembled hollow devices, conformance to

this document shall be demonstrated for the whole of the usable life of the chemical indicator system as

specified by the manufacturer.

4.1.6 Conformance shall be demonstrated by visual examination before and after testing in accordance

with the requirements of 4.2.3, 4.4 and 4.5, as appropriate.

4.1.7 The designs of alternative hollow and porous devices are not restricted provided they meet the

requirements of 4.2.3, 4.4 and 4.5.
4.2 Porous devices
4.2.1 Reference porous device

The reference porous device shall be a standardised test pack that is used to assess the steam

penetration performance of small steam sterilizers.

4.2.1.1 The pack shall be constructed from plain non-coloured cotton sheets, each having an

approximate size of 450 mm x 300 mm. Edges other than selvage shall be oversewn, not hemmed.

4.2.1.2 The number of threads per 10 mm in the warp shall be (30 ± 6) and the number of threads per

10 mm in the weft shall be (27 ± 5).
4.2.1.3 The mass per unit area shall be (185 ± 5) g ⋅ m .

4.2.1.4 The sheets shall be machine-washed when new and when soiled. During the machine-washing

process the sheets shall not be subjected to any fabric conditioning agent.
NOTE Washing includes adequate rinsing to remove bleach and detergent residues.

4.2.1.5 After washing, the sheets shall be dried and aired, but not ironed or calendered.

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4.2.1.6 Before use, the sheets shall be equilibrated in an environment at a temperature of (25 ± 5) °C

and a relative humidity of (50 ± 10) %.

4.2.1.7 After equilibration, the folded sheets shall be approximately 110 mm x 150 mm and stacked

to a height of approximately 120 mm after compressing by hand. The pack shall be wrapped in a single

sheet of the same fabric and secured with tape not exceeding 19 mm in width. The total weight of the

pack shall be (900 ± 30) g.

When forming the pack, consecutive sheets should be stacked with the folded side alternating to ensure

an even stack.

When the weight of sheets used to form a stack approximately 120 mm high exceeds 930 g, the sheets

should be discarded.

4.2.1.8 Prior to use the temperature and humidity of the pack shall be measured using a suitable

calibrated temperature and humidity probe. The conditions within the pack shall be between (50 ± 10) %

relative humidity and (25 ± 5) °C before it is used for test purposes.
NOTE Pack temperature and humidity can be measured using a sword hygrometer.
4.2.2 Detector for reference porous device

4.2.2.1 The detector for the reference porous device shall be a thermometric recording instrument and

temperature sensors as specified in 4.6 of ISO 11140-4:2007.

4.2.2.2 Remove the wrapping from the standard test pack and place five, temperature sensors within

the test pack at locations as indicated in Figure 1, of which one shall be placed at the geometric centre of

the test pack. The others shall be arranged in a pattern around the geometric centre of the test pack to

detect a temperature depression occurring within a radius of 30 mm of the geometric centre.

Dimensions in millimetres
Key
1 position of sensor
2 centre layer
Figure 1 — Location of temperature probes
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4.2.2.3 Place one temperature sensor at the defined reference point within the chamber to measure

the chamber reference temperature. Reassemble the test pack as described in 4.2.1.

4.2.2.4 As the coolest spot within the standard test pack will not be predictably at the exact

geometric centre, the additional temperature sensors in the standard test pack are used to improve the

reproducibility of the test results.

4.2.2.5 If it is ensured that saturated steam is present in the chamber, the reference temperatures and

holding times shall include 134 °C for 3,5 min and/or 121 °C for 15 min. All temperature sensors within

the test pack shall register 134 °C for 3,5 min and/or 121 °C for 15 min in a pass cycle.

NOTE In setting up the standard test pack, the use of a chemical indicator test sheet conforming with

ISO 11140-3, cut to the size of the horizontal dimensions of the standard test pack, and placed within the pack,

might be helpful in visualizing the position of the air pocket and determining the optimum position for the

temperature sensors.
4.2.3 Alternative porous indicator system

4.2.3.1 The alternative porous indicator system shall conform with the requirements of

ISO 11140-4:2007 except for the purpose of demonstration of equivalent performance. The performance

shall be compared with thermometric monitoring (see 4.2.2) of the reference porous device given in

4.2.1 and using the steam exposure apparatus defined in Annex A.

4.2.3.2 Carry out the test on three samples for each of three production batches using operating

cycles with a sub-atmospheric air removal stage, and on further sets of samples with operating cycles

employing a super-atmospheric air removal stage defined in Annex B.

4.2.3.3 Before and after each series of three tests, run an operating cycle containing a reference porous

device monitored with temperature sensors, to verify the operating cycle is performing within the

required limits as shown in 4.2.4.

4.2.3.4 The alternative porous indicator system shall show a uniform colour change after exposure

to saturated steam at 134 °C for 3.5 min, or at 121 °C for 15 min or at any other time/temperature

combination specified by the manufacturer, where the temperature tolerance shall be -0/+1,5 K and the

time tolerance shall be ± 5 s, indicating satisfactory air removal and steam penetration.

4.2.3.5 The alternative porous indicator system shall show a fail as specified by the manufacturer

indicating unsatisfactory air removal and steam penetration when exposed to a test cycles, previously

demonstrated to produce a reference porous device fault response.

Exposure to a reference fault condition shall produce a fault response regardless of the means of

creating the reference fault condition, i.e. the system used to produce the fault may use air retention or

air injection. The test cycles used to generate the reference fault conditions shall be as shown in B.4, B.5

and B.6.

The chamber reference temperatures and holding times shall include 134 °C for 3,5 min, or 121 °C for

15 min or another time/temperature combination specified by the manufacturer when the temperature

tolerance shall be -0/+1,5 K and the time tolerance shall be ± 5 s.
4.2.4 Reference porous device
4.2.4.1 Reference porous device pass response

During reference pass conditions there shall be no detectable temperature difference between the

centre of the reference porous device and the chamber reference temperature (within the limits of

the accuracy of the measuring equipment) by the end of the first 10 % of the exposure time for the

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oSIST prEN ISO 11140-6:2021
ISO/DIS 11140-6:2021(E)

sterilization temperature. (e. g. for sterilization at 134 °C for 3,5 min after first 18 s of the plateau

period).
4.2.4.2 Reference porous device fail response

During reference fault conditions the centre of the reference porous device shows a temperature 2 °C

lower than the chamber reference temperature (within the limits of the accuracy of the measuring

equipment) during the first 10 % of the exposure time for the sterilization temperature. (e.g. for

sterilization at 134 °C for 3,5 min a temperature of 132 °C or less in the centre of the reference porous

device for the first 18 s of the plateau period).
Table 1 — Schedule of test cycles to be used
Standard test cycle of ISO 11140-4:2007, Annex B
B.1 B.2 B.3
Test condition
Sub- Trans- Super-
atmospheric atmospheric atmospheric
pulsing pulsing pulsing
“Pass” cycle (see 6.1) √ √ √
“Fail” cycle – modified air removal stage (see 6.2) √ √ x
“Fail” cycle – induced leak (see 6.2) √ x x
“Fail” cycle – air injection (see 6.2) √ x √
√ = test required
x = test not required
4.3 Hollow devices
4.3.1 Reference hollow device
This section describes the requirements for a r
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