SIST EN ISO 11140-6:2023
(Main)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 11140-6:2022)
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 11140-6:2022)
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 11140-6:2022)
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 type 2 et dispositifs d'épreuve de procédé destinés à être utilisés pour les essais de performances relatifs aux petits stérilisateurs à la vapeur d'eau (ISO 11140-6:2022)
Le présent document spécifie les exigences de performance et les méthodes d'essai pour les dispositifs creux et les dispositifs poreux ainsi que les indicateurs chimiques et les indicateurs biologiques qui sont utilisés dans ces dispositifs pour la mise à l'essai d'une performance spécifique de pénétration de la vapeur pour les cycles de type B et certains cycles de type S des petits stérilisateurs à la vapeur d'eau conformes à l'EN 13060.
NOTE Les dispositifs creux et poreux décrits dans le présent document ne sont pas destinés à être utilisés comme dispositifs de substitution pour les dispositifs médicaux creux et poreux utilisés dans les établissements de soins de santé.
a) Les indicateurs chimiques utilisés avec un dispositif poreux spécifié dans le présent document sont conçus pour démontrer l'adéquation de la pénétration de la vapeur d'eau à l'intérieur d'un dispositif poreux dans les petits stérilisateurs à la vapeur d'eau (voir l'EN 13060).
Le présent document définit les exigences applicables à:
— un dispositif poreux de référence (RPD) permettant de démontrer que les systèmes indicateurs poreux alternatifs (APIS) ont des performances équivalentes à celles du présent document, c'est-à-dire un paquet d'essai textile dans lequel la pénétration de la vapeur est évaluée par des moyens thermométriques;
— un système indicateur chimique poreux alternatif dont les performances sont équivalentes à celles du RPD, c'est-à-dire un APIS, habituellement disponible dans le commerce, de n'importe quelle conception.
b) Les indicateurs chimiques utilisés avec un dispositif à charge creuse spécifié dans le présent document sont conçus pour démontrer l'adéquation de la pénétration de la vapeur dans un dispositif canulaire étroit (auparavant dénommé «charge creuse A ») dans les petits stérilisateurs à la vapeur d'eau (voir l'EN 13060).
Le présent document définit les exigences applicables à:
— un dispositif creux de référence (RHD) utilisé comme dispositif de référence dans le présent document, c'est-à-dire un dispositif canulaire avec une capsule attachée dans lequel la pénétration de la vapeur est évaluée par l'inactivation ou la survie d'un indicateur biologique spécifié;
— un dispositif creux alternatif:
— utilisant la même charge d'essai spécifique que celle définie pour le RHD et un indicateur chimique conçu spécifiquement pour être utilisé dans la charge d'essai creuse de référence, c'est-à-dire un dispositif canulaire avec une capsule attachée dans lequel la pénétration de la vapeur est évaluée par l'examen visuel d'un indicateur chimique;
— dont les performances sont équivalentes à celles du RHD, c'est-à-dire un dispositif creux alternatif, habituellement disponible dans le commerce, de n'importe quelle conception.
Sterilizacija izdelkov za zdravstveno oskrbo - Kemijski indikatorji - 6. del: Indikatorji tipa 2 in razvoj izločevalnih načrtov za preskušanje delovanja majhnih parnih sterilizatorjev (ISO 11140-6:2022)
Ta mednarodni standard določa zahteve glede delovanja in preskusne metode za kemijske indikatorje ter votle in porozne pripomočke, znotraj katerih naj bi ti delovali, ki se uporabljajo za preskušanje učinkovitosti prodiranja pare ciklov tipa B majhnih parnih sterilizatorjev; majhni parni sterilizatorji so opredeljeni v standardu EN 13060. Votli in porozni pripomočki, opisani v tem standardu, ne utemeljujejo svoje primernosti kot nadomestni pripomočki za lumenske, votle in porozne medicinske pripomočke, ki se uporabljajo v zdravstvenih ustanovah. Kemijski indikatorji, ki se uporabljajo s poroznim pripomočkom, navedenim v tem standardu, so zasnovani za prikaz ustreznosti prodiranja pare v porozni pripomoček v majhnih parnih sterilizatorjih (glej standard EN 13060). V ustreznih razdelkih tega mednarodnega standarda, ki zajemajo porozne obremenitve, so določene zahteve za: – referenčni porozni pripomoček, ki se uporablja pri preskusu z majhno obremenitvijo za porozne obremenitve v majhnih parnih sterilizatorjih in kot referenčni pripomoček, s katerim je mogoče dokazati, da je učinkovitost delovanja alternativnih poroznih pripomočkov enakovredna v skladu s tem standardom (tj. komplet za preskus tkanin, pri katerem se prodiranje pare ocenjuje s termometrično metodo); – alternativni porozni pripomoček z enako učinkovitostjo delovanja kot pri referenčnem poroznem pripomočku (tj. alternativni porozni pripomoček katere koli vrste, običajno komercialne izdelave). Kemijski indikatorji, ki se uporabljajo z votlim pripomočkom, navedenim v tem standardu, so zasnovani za prikaz ustreznosti prodiranja pare v votli pripomoček v majhnih parnih sterilizatorjih (glej standard EN 13060). V ustreznih razdelkih tega mednarodnega standarda, ki zajemajo votle obremenitve, so določene zahteve za: – referenčni votli pripomoček, ki se v tem standardu uporablja kot referenčni pripomoček (tj. lumenski pripomoček s pritrjeno kapsulo, pri katerem se prodiranje pare ocenjuje z inaktivacijo oziroma obstankom določenega biološkega indikatorja); – alternativni votli pripomoček z enako specifično preskusno obremenitvijo, kot je opredeljena za referenčni votli pripomoček, in s sistemom indikatorjev, ki je posebej namenjen za uporabo v referenčnih votlih preskusnih obremenitvah (tj. lumenski pripomoček s pritrjeno kapsulo, pri katerem se prodiranje pare ocenjuje z vizualnim pregledom sistema indikatorjev);
– alternativni votli pripomoček z enako učinkovitostjo delovanja kot pri referenčnem votlem pripomočku (tj. alternativni votli pripomoček katere koli vrste, običajno komercialne izdelave).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11140-6:2023
01-februar-2023
Nadomešča:
SIST EN 867-5:2002
Sterilizacija izdelkov za zdravstveno oskrbo - Kemijski indikatorji - 6. del:
Indikatorji tipa 2 in razvoj izločevalnih načrtov za preskušanje delovanja majhnih
parnih sterilizatorjev (ISO 11140-6:2022)
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
11140-6:2022)
Sterilisation von Produkten für die Gesundheitsfürsorge - Chemische Indikatoren - Teil 6:
Indikatoren der Klasse 2 und Prüfkörper für die Leistungsprüfung von Dampf-Klein-
Sterilisatoren (ISO 11140-6:2022)
Stérilisation des produits de santé - Indicateurs chimiques - Partie 6: Indicateurs de type
2 et dispositifs d'épreuve de procédé destinés à être utilisés pour les essais de
performances relatifs aux petits stérilisateurs à la vapeur d'eau (ISO 11140-6:2022)
Ta slovenski standard je istoveten z: EN ISO 11140-6:2022
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11140-6:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 11140-6:2023
---------------------- Page: 2 ----------------------
SIST EN ISO 11140-6:2023
EN ISO 11140-6
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2022
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN 867-5:2001
English Version
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
11140-6:2022)
Stérilisation des produits de santé - Indicateurs Sterilisation von Produkten für die
chimiques - Partie 6: Indicateurs de type 2 et Gesundheitsfürsorge - Chemische Indikatoren - Teil 6:
dispositifs d'épreuve de procédé destinés à être utilisés Indikatoren der Klasse 2 und Prüfkörper für die
pour les essais de performances relatifs aux petits Leistungsprüfung von Dampf-Klein-Sterilisatoren (ISO
stérilisateurs à la vapeur d'eau (ISO 11140-6:2022) 11140-6:2022)
This European Standard was approved by CEN on 21 November 2022.
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. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists 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 CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11140-6:2022 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 11140-6:2023
EN ISO 11140-6:2022 (E)
Contents Page
European foreword . 3
2
---------------------- Page: 4 ----------------------
SIST EN ISO 11140-6:2023
EN ISO 11140-6:2022 (E)
European foreword
This document (EN ISO 11140-6:2022) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices” the secretariat of which is held
by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2023, and conflicting national standards shall be
withdrawn at the latest by May 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN 867-5:2001.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 11140-6:2022 has been approved by CEN as EN ISO 11140-6:2022 without any
modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 11140-6:2023
---------------------- Page: 6 ----------------------
SIST EN ISO 11140-6:2023
INTERNATIONAL ISO
STANDARD 11140-6
First edition
2022-11
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
Stérilisation des produits de santé — Indicateurs chimiques —
Partie 6: Indicateurs de type 2 et dispositifs d'épreuve de procédé
destinés à être utilisés pour les essais de performances relatifs aux
petits stérilisateurs à la vapeur d'eau
Reference number
ISO 11140-6:2022(E)
© ISO 2022
---------------------- Page: 7 ----------------------
SIST EN ISO 11140-6:2023
ISO 11140-6:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11140-6:2023
ISO 11140-6:2022(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 Requirements . 3
4.1 General . 3
4.2 Porous devices . 3
4.2.1 Reference porous device (RPD) . 3
4.2.2 Detector for reference porous device (RPD) . 4
4.2.3 Alternative porous indicator system (APIS) . 5
4.2.4 Reference porous device (RPD) response . 6
4.3 Hollow devices . 6
4.3.1 Reference hollow device (RHD) . 6
4.3.2 Detector for reference hollow device (RHD) . 7
4.3.3 Reference hollow indicator system (RHIS) . 8
4.3.4 Reference hollow indicator system (RHIS) performance determination. 8
4.3.5 Leakage test . 9
4.4 Alternative hollow indicator system (AHIS) . 9
4.4.1 General . 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 (RHD) .12
5 Chemical indicator dry heat performance .13
5.1 General .13
5.2 Test 1 .13
5.3 Test 2 . 14
6 Marking and labelling .14
6.1 Device labelling . 14
6.2 Additional labelling requirements for hollow devices . 14
6.3 Chemical indicators for use in hollow devices . 15
Annex A (normative) Test method for performance of reference hollow indicator system
(RHIS) .16
Annex B (normative) Test method for performance of alternative porous indicator system
(APIS) .24
Annex C (normative) Test method for performance of alternative hollow indicator system
(AHIS) .27
Annex D (informative) Relationship between chemical indicator components .28
Annex E (normative) Reference hollow device (RHD) .30
Annex F (informative) Accelerated ageing of test samples .32
Annex G (informative) Evaluation of reference hollow devices (RHDs) — Interlaboratory
results .33
Bibliography .40
iii
© ISO 2022 – All rights reserved
---------------------- Page: 9 ----------------------
SIST EN ISO 11140-6:2023
ISO 11140-6:2022(E)
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,
in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/
TC 102, Sterilizers and associated equipment for processing of medical devices, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
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 2022 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 11140-6:2023
ISO 11140-6:2022(E)
Introduction
This document includes a description of both hollow and porous process challenge devices (PCDs) and
their performance requirements, along with methods by which an alternative PCD can be shown to
have equivalent performance to that of the reference PCD. Small sterilizers unable to accommodate a
sterilization module [rectangular parallelepiped of dimensions 300 mm (height) × 600 mm (length) ×
300 mm (width)] cannot be tested using the tests described in EN 285 for large sterilizers for wrapped
goods and porous loads because
— the chamber size of a small steam sterilizer according to EN 13060 is unable to accommodate the
standard test pack from EN 285, and
— 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 PCDs
to show penetration of steam into the PCD. 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 conforming
to EN 13060 to monitor steam penetration in type B cycles and some type S cycles.
NOTE Even though the hollow load was originally designed as a type test in EN 867-5 (withdrawn standard
replaced by this document) to test the performance of small steam sterilizers conforming with EN 13060, the
same test is also used in other standards, for example, EN 285.
v
© ISO 2022 – All rights reserved
---------------------- Page: 11 ----------------------
SIST EN ISO 11140-6:2023
---------------------- Page: 12 ----------------------
SIST EN ISO 11140-6:2023
INTERNATIONAL STANDARD ISO 11140-6:2022(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
WARNING — The use of this document can involve hazardous materials, operations and
equipment. It is the responsibility of the user of this document to establish appropriate safety
and health practices and determine the applicability of any other restrictions prior to use.
1 Scope
This document specifies the performance requirements and test methods for hollow devices and
porous devices as well as the chemical indicators and biological 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 according to EN 13060.
NOTE The hollow and porous devices described in this document are not intended for use as surrogate
devices for hollow and porous medical devices used in health care facilities.
a) 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).
This document specifies the requirements for:
— a reference porous device (RPD) as a reference device by which alternative porous indicator
systems (APISs) 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;
— an alternative porous chemical indicator system equivalent in performance to the RPD, i.e. an
APIS, usually commercially manufactured, of any design.
b) 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).
This document specifies the requirements for:
— a reference hollow device (RHD) 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;
— an alternative hollow device:
— employing the same specific test load as defined for the RHD 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;
— equivalent in performance to the RHD, i.e. an alternative hollow device, usually commercially
manufactured, of any design.
1
© ISO 2022 – All rights reserved
---------------------- Page: 13 ----------------------
SIST EN ISO 11140-6:2023
ISO 11140-6:2022(E)
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.
ISO 10012, Measurement management systems — Requirements for measurement processes and measuring
equipment
ISO 11138-3, Sterilization of health care products — Biological indicators — Part 3: Biological indicators
for moist heat sterilization processes
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, Sterilization of health care products — Biological and chemical indicators — Test equipment
EN 285:2015 +A1: 2021, Sterilization — Steam sterilizers — Large sterilizers
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 terminology 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
biological indicator
test system containing viable microorganisms providing a specified resistance to a specified
sterilization process
[SOURCE: ISO 11139:2018, 3.29]
3.2
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.]
3.3
chemical indicator endpoint
completion of a specified change after a chemical indicator (3.2) has been exposed to specified conditions
[SOURCE: ISO 11139:2018, 3.44]
3.4
chemical indicator system
combination of a chemical indicator (3.2) 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.]
2
© ISO 2022 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 11140-6:2023
ISO 11140-6:2022(E)
3.5
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 shall apply.
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 (RH) 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 reusable, user-assembled hollow devices shall not
transfer indicator reagent to the material of the hollow device during processing. Preassembled 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 process challenge device (PCD) intended to be reused shall, when used 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 reuses, as well as important information on
service, cleaning procedures, the manner of inspection and criteria, maintenance and replacement of components.
To establish conformity to the performance requirements of this document over the shelf life of the
PCD, a study shall be conducted by way of a protocol developed before study commencement. 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 reusable 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 of steam penetration shall be demonstrated by visual examination of the chemical
indicator system 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 (RPD)
4.2.1.1 The reference porous device (RPD) shall be a standardised test pack that is used to assess the
steam penetration performance of small steam sterilizers.
3
© ISO 2022 – All rights reserved
---------------------- Page: 15 ----------------------
SIST EN ISO 11140-6:2023
ISO 11140-6:2022(E)
4.2.1.2 The pack shall be constructed from plain non-coloured cotton sheets, each having an
approximate size of 450 mm × 300 mm. Edges other than selvedge shall be oversewn, not hemmed.
4.2.1.3 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).
−2
4.2.1.4 The mass per unit area shall be (185 ± 5) g ⋅ m .
4.2.1.5 The sheets shall be washed when new and when soiled. During the washing process the sheets
shall not be subjected to any fabric conditioning agent.
NOTE Washing includes adequate rinsing to remove bleach and detergent residues.
4.2.1.6 After washing, the sheets shall be dried and aired, but not ironed or calendered.
4.2.1.7 Before use, the sheets shall be equilibrated in an environment at a temperature of (25 ± 5) °C
and (50 ± 10) % RH.
4.2.1.8 After equilibration, the folded sheets shall be approximately 110 mm × 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 mass 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 mass of sheets used to form a stack approximately 120 mm high exceeds 930 g, the sheets
shall be discarded.
4.2.1.9 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) % RH 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 (RPD)
4.2.2.1 The detector for the reference porous device (RPD) shall be a thermometric recording
instrument and temperature sensors as specified in ISO 11140-4:2007, 4.6.
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.
4
© ISO 2022 – All rights reserved
---------------------- Page: 16 ----------------
...
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.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 11140-6:2021
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 11140-6:2021
ISO/DIS 11140-6:2021(E)
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
© ISO 2021 – All rights reserved iii
---------------------- Page: 5 ----------------------
oSIST prEN ISO 11140-6:2021
ISO/DIS 11140-6:2021(E)
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
---------------------- Page: 6 ----------------------
oSIST prEN ISO 11140-6:2021
ISO/DIS 11140-6:2021(E)
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.
© ISO 2021 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 11140-6:2021
---------------------- Page: 8 ----------------------
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.
© ISO 2021 – All rights reserved 1
---------------------- Page: 9 ----------------------
oSIST prEN ISO 11140-6:2021
ISO/DIS 11140-6:2021(E)
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.
2 © ISO 2021 – All rights reserved
---------------------- Page: 10 ----------------------
oSIST prEN ISO 11140-6:2021
ISO/DIS 11140-6:2021(E)
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).
-2
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.
© ISO 2021 – All rights reserved 3
---------------------- Page: 11 ----------------------
oSIST prEN ISO 11140-6:2021
ISO/DIS 11140-6:2021(E)
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
4 © ISO 2021 – All rights reserved
---------------------- Page: 12 ----------------------
oSIST prEN ISO 11140-6:2021
ISO/DIS 11140-6:2021(E)
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
© ISO 2021 – All rights reserved 5
---------------------- Page: 13 ----------------------
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
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.