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 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.
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 Hohlkörper und poröse Körper sowie die chemischen Indikatoren und die biologischen 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 Dampfdurchdringungsleistung zu prüfen.
ANMERKUNG Die Hohlkörper und porösen Körper, die in diesem Dokument beschrieben sind, sind nicht als Ersatz für in Gesundheitseinrichtungen verwendete hohle und poröse Medizinprodukte vorgesehen.
a) Chemische Indikatoren, die in Verbindung mit einem in diesem Dokument beschriebenen porösen Körper verwendet werden, sind ausgelegt um zu zeigen, dass die Dampfdurchdringung eines porösen Körpers in einem Dampf Klein Sterilisator (siehe EN 13060) ausreichend ist.
Dieses Dokument legt die Anforderungen fest für:
einen als Referenzkörper verwendeten porösen Referenzkörper (RPD, en: reference porous device), mit dem gezeigt werden kann, dass alternative poröse Indikatorsysteme (APISs, en: alternative porous indicator systems) hinsichtlich ihrer Leistung entsprechend diesem Dokument gleichwertig sind, d. h. ein textiles Prüfpaket, dessen Dampfdurchdringung anhand thermometrischer Mittel bestimmt wird;
ein alternatives poröses chemisches Indikatorsystem, das hinsichtlich seiner Leistung dem porösen Referenzkörper gleichwertig ist, d. h. ein alternatives, in der Regel kommerziell hergestelltes poröses Indikatorsystem jeder Auslegung.
b) Chemische Indikatoren, die mit einem in diesem Dokument beschriebenen Beladungshohlkörper verwendet werden, sind ausgelegt um zu zeigen, dass die Dampfdurchdringung eines engen Lumens (zuvor als Hohlkörper-Beladung A bezeichnet) in einem Dampf Klein Sterilisator (siehe EN 13060) ausreichend ist.
Dieses Dokument legt die Anforderungen fest für:
einen entsprechend diesem Dokument als Referenzkörper verwendeten Referenzhohlkörper (RHD, en: reference hollow device), d. h. ein Lumenprodukt mit daran angebrachter Kapsel, anhand derer die Dampfdurchdringung durch Inaktivierung oder Überleben eines spezifizierten biologischen Indikators beurteilt wird;
einen alternativen Hohlkörper:
der mit der gleichen spezifischen Prüfbeladung verwendet wird, wie für den Referenzhohlkörper 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;
der hinsichtlich seiner Leistung dem Referenzhohlkörper gleichwertig ist, d. h. ein alternativer, in der Regel kommerziell hergestellter Hohlkörper jeder Auslegung.
WARNUNG — Die Anwendung dieses Dokuments kann den Einsatz gefährlicher Materialien, Vorgänge und Geräte bedingen. Es liegt in der Verantwortung des Anwenders dieses Dokuments, geeignete Sicherheits- und Gesundheitsvorschriften festzulegen und sich vor der Anwendung über andere geltende Einschränkungen zu informieren.
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
Overview
EN ISO 11140-6:2022 - “Sterilization of health care products - Chemical indicators - Part 6” defines Type 2 chemical indicators and process challenge devices (PCDs) used for performance testing of small steam sterilizers. The standard specifies performance requirements and test methods for both porous and hollow test devices and for the chemical and biological indicators placed inside them. It is intended specifically for small steam sterilizers (as defined by EN 13060) used in healthcare settings and supersedes EN 867-5.
Key topics and requirements
- Scope and intended use
- Applies to monitoring steam penetration in type B cycles and some type S cycles of small steam sterilizers.
- Clarifies that the described hollow and porous devices are not surrogate medical devices.
- Reference devices and alternatives
- Reference Porous Device (RPD): a textile test pack where steam penetration is judged by thermometric means; serves as the benchmark.
- Alternative Porous Indicator Systems (APISs): commercially produced porous indicator systems that must demonstrate equivalent performance to the RPD.
- Reference Hollow Device (RHD): lumened device with attached capsule where penetration is judged by inactivation/survival of a specified biological indicator.
- Alternative Hollow Indicator Systems (AHISs) and alternative hollow devices: must be validated as equivalent to the RHD.
- Performance tests and methods
- Normative test procedures for RPD/RHD and for validating APIS/AHIS are provided (annexes include detailed test methods).
- Includes requirements for leakage testing, detector specifications, and performance determination.
- Chemical indicator dry heat performance, accelerated ageing, marking and labelling requirements are addressed.
- Safety and conformity
- Contains guidance on hazards, test reproducibility and interlaboratory evaluation results.
Applications
- Validating steam penetration and air removal performance in small steam sterilizers used in:
- Dental, ambulatory surgery, and small clinic sterilization departments.
- Medical device manufacturers for type testing of small sterilizers.
- Used in routine commissioning, acceptance testing, and periodic performance checks where full-sized EN 285 test packs are impractical.
Who should use this standard
- Manufacturers of chemical indicators, process challenge devices (PCDs) and sterilizer equipment.
- Sterilization validation laboratories and test houses.
- Hospital sterile services departments (CSSD), infection control teams, and quality/regulatory professionals responsible for sterilizer validation and compliance.
Related standards
- EN 13060 - Small steam sterilizers: definitions and performance categories.
- EN 285 - Large steam sterilizers (context for differences in test methods).
- Other parts of the ISO 11140 series covering chemical indicator types and requirements.
Keywords: EN ISO 11140-6:2022, sterilization, chemical indicators, process challenge devices, small steam sterilizers, type 2 indicators, steam penetration, porous device, hollow device, EN 13060.
Frequently Asked Questions
SIST EN ISO 11140-6:2023 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "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 standard covers: 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.
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.
SIST EN ISO 11140-6:2023 is classified under the following ICS (International Classification for Standards) categories: 11.080.01 - Sterilization and disinfection in general; 11.080.20 - Disinfectants and antiseptics. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 11140-6:2023 has the following relationships with other standards: It is inter standard links to SIST EN 867-5:2002. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 11140-6:2023 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase SIST EN ISO 11140-6:2023 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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 11140-6:2022(E)
© 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 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 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 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
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.
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.]
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.
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.
ISO 11140-6:2022(E)
Dimensions in millimetres
Key
1 position of sensors
2 centre layer
Based on EN 285:2015 + A1:2021, Figur e 6.
Figure 1 — Location of temperature sensors
4.2.2.3 Place one temperature sensor at the defined reference point within the chamber to measure
the chamber reference temperature and one temperature sensor above the test pack at a height of
50 mm. Reassemble the test pack as described in 4.2.1.
4.2.2.4 As the coolest location 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 The reference temperatures and holding times shall include either 134 °C for 3,5 min or 121 °C
for 15 min, or both. The manufacturer of the chemical indicator may specify other time/temperature
combinations. All temperature sensors within the test pack shall register a minimum of either 134 °C
for 3,5 min or 121 °C for 15 min, or both, during the holding time with a pass cycle when using the
reference temperatures and holding times.
NOTE For set up of 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, can
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 (APIS)
4.2.3.1 The alternative porous indicator system (APIS) shall conform with the requirements of
ISO 11140-4 except for the purpose of demonstration of equivalent performance. The performance shall
be compared with thermometric monitoring (see 4.2.2) of the RPD given in 4.2.1 and using the steam
exposure apparatus defined in Annex A.
ISO 11140-6:2022(E)
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 an RPD
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 APIS 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 APIS shall show a fail as specified by the manufacturer indicating unsatisfactory air
removal and steam penetration when exposed to a test cycle, previously demonstrated to produce an
RPD 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 where the
temperature tolerance shall be 0/+1,5 K and the time tolerance shall be ±5 s.
4.2.4 Reference porous device (RPD) response
4.2.4.1 Reference porous device (RPD) pass response
During reference pass conditions there shall be no detectable temperature difference between the
centre of the RPD and the chamber reference temperature (within the limits of the accuracy of the
measuring equipment) during the exposure time at the sterilization temperature.
4.2.4.2 Reference porous device (RPD) fail response
During reference fault conditions, the centre of the RPD shall show a temperature 2 °C + 1/-0 °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 to 131 °C in the centre of the RPD for the first 21 s of the
plateau period).
4.3 Hollow devices
4.3.1 Reference hollow device (RHD)
4.3.1.1 This subclause describes the requirements for an RHD, including the physical specifications
and an engineering drawing (see Annex E). The manufacturer shall ensure that the internal dimensions,
the free capsule volume, the capsule mass and weight distribution around the device are all as specified.
4.3.1.2 The RHD shall consist of a single-ended capsule to contain a biological indicator, connected to
a lumen and of uniform internal dimensions throughout its length (see Annex E). The capsule shall be
of uniform cross-section over its length of the inserted indicator. Maximal angular deviations of 1° are
accepted. The RHD shall have the following specification:
a) tube wall thickness: (0,5 ± 0,05) mm;
ISO 11140-6:2022(E)
b) tube internal diameter: (2,0 ± 0,1) mm;
c) tube length: (1 500 ± 5) mm;
d) free capsule volume (280 ± 50) µl;
e) cap and receptacle material of construction: polytetrafluoroethylene (PTFE);
f) capsule mass: (14,0 ± 1,0) g;
g) lumen material of construction: fluorinated ethylene propylene (PTFE or FEP);
h) seal material of construction: heat- and steam-resistant elastomer.
NOTE The inner and outer dimension of the capsule, and the ratio of the volume of the RHD’s tube to the free
capsule volume, has an influence on the penetration and air removal characteristics. Physical properties such as
mass, heat capacity and heat transfer can also influence the test result.
4.3.1.3 The capsule shall be terminal and of uniform dimensions (cross-sections).
4.3.1.4 There shall be no bubbles visible escaping from the device, when tested according to the
method given in 4.5.2.
4.3.1.5 The following items shall be carried out to reduce the number of unnecessary variables under
test:
a) the dimension as defined in 4.3.1.2 shall be specified, measured and documented;
b) Place the hollow device on a fine mesh basket; position the terminal orifice of the hollow device at
geometric centre of test vessel; position the capsule so that it is higher than terminal orifice;
c) the RHD shall be conditioned by one of the following methods:
1) having ambient air at (50 ± 10) % RH and (25 ± 5) °C drawn through it for not less than 15 min;
or
2) drawing a vacuum (<5 kPa) for not less than 15 min at 25 ± 5 °C (e.g. in a desiccator), followed
by admission of ambient air at (50 ± 10) % RH and (25 ± 5) °C.
4.3.2 Detector for reference hollow device (RHD)
4.3.2.1 The detector to be used in the RHD shall be a carrier inoculated with Geobacillus
stearothermophilus and conforming with ISO 11138-3, modified according to Table 1.
Table 1 — Biological indicator specification
Minimum value Maximum value
D value 1,8 min 2,3 min
6 6
Population 1,0 × 10 9,9 × 10
z-value 6 °C 14 °C
NOTE Due to inherent variability in the manufacture of biological indicators, the same lot of biological
indicators can help to reduce variability in a given test series.
4.3.2.2 The carrier dimensions shall be: (38,0 + 2/-0) mm × (6,0 ± 1) mm × (0,5 ± 0,05) mm (L × W × H).
A different height may be used providing the resulting free capsule volume is maintained as specified
by 4.3.1.2 when tested according to 4.5.3.
ISO 11140-6:2022(E)
NOTE The porosity of the carrier is an important factor because the porosity volume will increase the free
capsule volume.
4.3.3 Reference hollow indicator system (RHIS)
The combination of RHD and detector for RHD shall be used as the RHIS.
4.3.4 Reference hollow indicator system (RHIS) performance determination
Three test cycles (see A.2) are defined for testing of modified air removal. These test cycles represent
test cycles adapted from ISO 11140-4. The test cycles are differentiated through particular pre-exposure
phases in which the upper pressure change points (endpoint of steam admission process step) and the
pressure change rates (during both vacuum and steam admission steps) are defined. Using the test
methods described in A.3.2 and A.3.3, characteristic vacuum pressure change points for each test cycle
shall be determined by the experimenter using the RHIS in 4.3.3. These characteristic vacuum pressure
change points are determined as shown in Figure 2 and described in the corresponding subclauses.
NOTE Numbers and frames give reference to corresponding requirements. Bars and dotted lines show
established limits for the limiting pass process (LPP), the reference pass process (RPP), the alternative pass
process (APP), the limiting fail process (LFP), the reference fail process (RFP) and the alternative fail process
(AFP). Arrows show evaluation of vacuum pressure change points. Boxes show established reaction windows.
Sizes of the reaction windows are 5 kPa or smaller.
Figure 2 — Determination of characteristic vacuum pressure change points during testing
of modified air removal
4.3.4.1 At the given vacuum set points, three RHIS tested at a time using the test cycles of A.2 shall
show no growth in three identical consecutive runs:
— Cycle 1: 17 kPa,
— Cycle 2: 23 kPa,
— Cycle 3: 21 kPa.
For each cycle the given hard limit shall correspond to the limiting pass process (LPP, see Figure 2).
4.3.4.2 Conformance shall be tested in accordance with A.3.2.
4.3.4.3 The highest pressure (vacuum) change point where the reference indicator system always
shows no growth in three identical consecutive runs shall be deemed the reference pass process (RPP,
see Figure 2). The RPP shall be used as reference for alternative hollow PCD testing (see 4.4.2).
4.3.4.4 Conformance to the RPP shall be tested in accordance with A.3.2.
ISO 11140-6:2022(E)
4.3.4.5 At the given vacuum set points, three reference indicator systems tested at a time at the test
cycles of A.2 shall always show growth in three identical consecutive runs:
— Cycle 1: 29 kPa,
— Cycle 2: 42 kPa,
— Cycle 3: 35 kPa.
For each cycle the given hard limit shall correspond to the limiting fail process (LFP), see Figure 2.
4.3.4.6 Conformance shall be tested in accordance with A.3.3.
4.3.4.7 The lowest pressure (vacuum) change point at which the RHIS always shows growth in three
identical consecutive runs shall be deemed the reference fail process (RFP) for modified air removal.
The RFP (see Figure 2) shall be used as a reference for alternative hollow PCD testing (see 4.4.4).
4.3.4.8 Conformance shall be tested in accordance with A.3.3.1.
4.3.4.9 The inner reaction window, between the highest pressure change point according to 4.3.4.3
and the lowest pressure change point according to 4.3.4.7, shall be 5 kPa or smaller.
4.3.5 Leakage test
The leakage test for cycle 1 (see Table 2 and A.2) of the RHD shall be performed in accordance with
A.3.3.
4.4 Alternative hollow indicator system (AHIS)
4.4.1 General
Alternative hollow devices may be manufactured of any alternative design but shall conform with the
requirements given in Annex C.
4.4.1.1 The chemical indicator within the alternative hollow device shall reach its chemical indicator
endpoint. This indicates satisfactory air removal and steam penetration. This shall be demonstrated
in cycles (see Table 2) previously demonstrated as capable of inactivating a population of Geobacillus
stearothermophilus spores in the RHD containing the above-specified biological indicator (see 4.3.2.1).
NOTE The chemical indicator endpoint is specified by the chemical indicator manufacturer.
4.4.1.2 Conformance shall be tested in accordance with Annex A using steam exposure apparatus
defined in A.1 and the ability to alter the rate of change of evacuation and steam admission during the
air removal stage in accordance with the standard test cycles defined in A.2.
4.4.2 The AHIS shall reach its chemical indicator endpoint at a pressure change point 10 % below the
highest pressure set point of the RPP at the test cycles in A.2 in three identical consecutive runs. This
process shall be deemed the alternative pass process (APP, see Figure 2).
4.4.3 Conformance to the APP shall be tested in accordance with C.2.
4.4.4 The lowest pressure (vacuum) change point at which the AHIS does not reach its chemical
indicator endpoint in three identical consecutive runs shall be at least 10 % below the RFP. It shall be
deemed the alternative fail process (AFP) for modified air removal (see Figure 2).
4.4.5 Conformance shall be tested in accordance with C.3.
ISO 11140-6:2022(E)
4.4.6 The inner reaction window between the highest pressure change point according to 4.4.2 and
the lowest pressure change point according to 4.4.4 shall be 5 kPa or smaller.
4.4.7 The indicator within the alternative hollow device shall show a fail result (has not reached its
chemical indicator endpoint) specified by the manufacturer indicating unsatisfactory air removal and
steam penetration when exposed to test cycles (see Table 2) previously demonstrated to produce a
fail cycle, in accordance with 4.4.4 and A.3. The chamber reference temperatures and holding times
shall include 134 °C for 3,5 min and/or 121 °C for 15 min, and/or 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.
4.4.8 Conformance shall be tested using modified test cycles described in A.2 according to the
schedule of tests shown in Table 2. The chamber reference temperatures and holding times shall include
134 °C for 3,5 min and/or 121 °C for 15 min and/or other time/temperature combination specified by
the indicator manufacturer where the temperature tolerance shall be 0/+1,5 K and the time tolerance
shall be ± 5 s.
4.4.9 Where the alternative hollow device incorporates a demountable cap, no bubbles shall be visible
escaping from the device, when tested according to the method given in 4.6.
4.5 Alternative hollow devices intended for multiple use
4.5.1 For alternative hollow devices intended for multiple use, conformance to this document shall be
demonstrated for the service life of
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.
Loading comments...