SIST EN 867-5:2002
(Main)Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
This European Standard specifies the performance requirements and test methods for non-biological indicator systems, including the process challenge devices within which they are intended to function, to be used for testing the steam penetration performance of small steam sterilizers, Type B or Type S where ap-propriate. The test systems specified are intended for use only in small steam sterilizers Type B conforming to prEN 13060-2 and having a usable chamber space greater than 10 l and for small steam sterilizers Type S conforming to prEN 13060-4 also having a usable chamber space greater than 5 l.
Non-biological indicator systems and the associate process challenge devices are specified for various types of load. The possible loads are considered in two classes: Porous loads, which can be wrapped or unwrapped, or hollow instrument loads, which also can be wrapped or unwrapped.
The relevant section of this European Standard on porous loads specifies the requirements for:
- a standard process challenge device to be used in the small load test for porous loads in small steam sterilizers;
- an indicator system for use in the porous load process challenge device. An indicator for this purpose is a Class B indicator as described in EN 867-1.
- an indicator employing an alternative process challenge device equivalent to the porous load process challenge device.
The relevant section of this European Standard on hollow instruments specifies the requirements for:
- hollow load process challenge devices to be used to simulate hollow instrument loads as defined in prEN 13060-4;
- an indicator system, for use in one of the hollow load process challenge device, for assessing steam penetration in a wrapped load of hollow instruments. An indicator for this purpose is a Class B indicator as described in EN 867-1.
The process challenge devices described in this standard are intended for use only in sterilizers of sufficient size to accommodate the proces
Nichtbiologische Systeme für den Gebrauch in Sterilisatoren - Teil 5: Festlegungen von Indikatorsystemen und Prüfkörpern für die Leistungsprüfung von Klein-Sterilisatoren vom Typ B und vom Typ S
Diese Europäische Norm legt Leistungsanforderungen an und Prüfverfahren für nichtbiologische Indikatorsysteme sowie für die Prüfkörper fest, in denen diese Systeme angewendet werden. Diese nichtbiologischen Indikatorsysteme einschließlich Prüfkörper werden zur Prüfung der Leistungsfähigkeit von Dampf-Klein-Sterilisatoren vom Typ B oder, falls zutreffend, vom Typ S hinsichtlich des Eindringens von Dampf eingesetzt. Die festgelegten Prüfsysteme dienen lediglich für den Gebrauch in Dampf-Klein-Sterilisatoren vom Typ B nach prEN 13060-2, die einen Nutzraum von mehr als 10 l besitzen, sowie in Dampf-Klein-Sterilisatoren vom Typ S nach prEN 13060-4, die einen Nutzraum von mehr als 5 l besitzen.
Nichtbiologische Indikatorsysteme und die zugehörigen Prüfkörper sind für unterschiedliche Arten von Beladungen festgelegt. Die möglichen Beladungen werden zwei Klassen zugeordnet: Poröse Beladungen oder Beladungen mit hohlen Instrumenten, die jeweils verpackt oder unverpackt vorliegen können.
Der für poröse Beladungen zutreffende Abschnitt dieser Europäischen Norm enthält Anforderungen an:
- einen normgerechten Prüfkörper, der in einer Prüfung mit Teilbeladung für poröse Beladungen in Dampf-Klein-Sterilisatoren zu verwenden ist;
- ein Indikatorsystem für den Gebrauch in einem Prüfkörper für poröse Beladungen. Ein Indikator für diesen Zweck ist ein Indikator der Klasse B nach EN 867-1;
- einen Indikator, der in einem alternativen, dem Prüfkörper für poröse Beladungen entsprechenden Prüfkörper verwendet wird. Der für hohle Instrumente zutreffende Abschnitt dieser Europäischen Norm enthält Anforderungen an:
- Prüfkörper für Hohlkörper-Beladungen, die verwendet werden, um Beladungen hohler Instrumente nach prEN 13060-4 zu simulieren;
Systemes non biologiques destinés a etre utilisés dans des stérilisateurs - Partie 5: Spécifications des systemes indicateurs et dispositifs d'épreuve de procédé destinés a etre utilisés pour les essais de performances relatifs aux petits stérilisateurs de Type B et de Type S
La présente Norme européenne définit les exigences de performances et les méthodes d'essai relatives aux systemes indicateurs non biologiques, y compris les dispositifs d'épreuve de procédé au sein desquels ils sont destinés a fonctionner, qui doivent etre suivies pour la réalisation d'essais relatifs aux performances de pénétration de la vapeur dans les petits stérilisateurs, appartenant selon les cas au Type B ou au Type S. Les systemes d'essai spécifiés sont destinés a etre utilisés uniquement dans les petits stérilisateurs de Type B conformes au prEN 13060-2, disposant d'une chambre dont le volume utile est supérieur a 10 l, ainsi que dans les petits stérilisateurs a la vapeur de Type S conformes au prEN 13060-4, disposant également d'une chambre dont le volume utile est supérieur a 5 l.
Les systemes indicateurs non biologiques, ainsi que les dispositifs d'épreuve de procédé qui leurs sont associés, sont spécifiés pour différents types de charges. Les charges possibles se répartissent en deux catégories : les charges poreuses, qui peuvent etre enveloppées ou non, et les charges d'instruments creux, qui peuvent également etre enveloppées ou non.
Le chapitre de la présente Norme européenne consacré aux charges poreuses définit les exigences concernant :
- un dispositif normalisé d'épreuve de procédé destiné a etre employé lors d'essais de petites charges, dans le cas de charges poreuses contenues dans les petits stérilisateurs a la vapeur ;
- un systeme indicateur destiné a etre employé dans le dispositif d'épreuve de procédé a charge poreuse ; l'indicateur approprié est dans ce cas un indicateur de classe B conforme a l'EN 867-1 ;
- un indicateur utilisant une variante de dispositif d'épreuve de procédé équivalente du dispositif d'épreuve de procédé a charge poreuse.
Nebiološki sistemi za uporabo v sterilizatorjih – 5. del: Specifikacija za sisteme indikatorjev in razvoj izločevalnih načrtov za preskušanje delovanja majhnih sterilizatorjev tipov B in S
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 867-5:2002
01-maj-2002
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Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems
and process challenge devices for use in performance testing for small sterilizers Type B
and Type S
Nichtbiologische Systeme für den Gebrauch in Sterilisatoren - Teil 5: Festlegungen von
Indikatorsystemen und Prüfkörpern für die Leistungsprüfung von Klein-Sterilisatoren vom
Typ B und vom Typ S
Systemes non biologiques destinés a etre utilisés dans des stérilisateurs - Partie 5:
Spécifications des systemes indicateurs et dispositifs d'épreuve de procédé destinés a
etre utilisés pour les essais de performances relatifs aux petits stérilisateurs de Type B et
de Type S
Ta slovenski standard je istoveten z: EN 867-5:2001
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN 867-5:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 867-5:2002
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SIST EN 867-5:2002
EUROPEAN STANDARD
EN 867-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2001
ICS 11.080.10
English version
Non-biological systems for use in sterilizers - Part 5:
Specification for indicator systems and process challenge
devices for use in performance testing for small sterilizers Type
B and Type S
Systèmes non biologiques destinés à être utilisés dans des Nichtbiologische Systeme für den Gebrauch in
stérilisateurs - Partie 5: Spécifications des systèmes Sterilisatoren - Teil 5: Festlegungen von Indikatorsystemen
indicateurs et dispositifs d'épreuve de procédé destinés à und Prüfkörpern für die Leistungsprüfung von Klein-
être utilisés pour les essais de performances relatifs aux Sterilisatoren vom Typ B und vom Typ S
petits stérilisateurs de Type B et de Type S
This European Standard was approved by CEN on 25 July 2001.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 867-5:2001 E
worldwide for CEN national Members.
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SIST EN 867-5:2002
EN 867-5:2001 (E)
Contents
page
Foreword 3
..............................................................................................................................................................
Introduction 4
.........................................................................................................................................................
1 Scope 4
...............................................................................................................................................................
2 Normative references 5
.....................................................................................................................................
3 Terms and definitions 5
.....................................................................................................................................
4 Requirements 6
..................................................................................................................................................
5 Test methods 12
.................................................................................................................................................
6 Marking, labelling and packaging 16
................................................................................................................
(normative)
Annex A Small steam exposure apparatus and steam for test purposes 17
................................
(normative)
Annex B Test cycles for evaluation of indicator performance in the porous load process
challenge devices 19
................................................................................................................................
Annex C (normative) Test cycles for evaluation of indicator systems for use in hollow load process
challenge devices 22
................................................................................................................................
Annex D (normative) Test cycles for evaluation of indicator systems for use in hollow load process
challenge devices 23
................................................................................................................................
Bibliography 24
......................................................................................................................................................
2
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SIST EN 867-5:2002
EN 867-5:2001 (E)
Foreword
This European Standard has been prepared by Technical Committee CEN/TC 102 "Sterilizers for medical
purposes", 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 February 2002, and conflicting national standards shall be withdrawn at the latest
by February 2002.
This European Standard has been considered by CEN/TC 102 as one of a series of European Standards concerned
with non-biological indicators used in the testing, monitoring and routine operation of sterilizers. These standards are:
EN 867-1 Non-biological systems for use in sterilizers – Part 1: General requirements
EN 867-2 Non-biological systems for use in sterilizers – Part 2: Process indicators (Class A)
EN 867-3 Non-biological systems for use in sterilizers – Part 3: Specification for Class B indicators for use in
the Bowie and Dick test
EN 867-4 Non-biological systems for use in sterilizers – Part 4: Specification for indicators as an alternative
to the Bowie and Dick test for the detection of steam penetration
prEN 867-5 Non-biological systems for use in sterilizers – Part 5: Specification for indicator systems and
process challenge devices for use in performance testing for small sterilizers Type B and Type S
In addition CEN/TC 102 Working Group 7 has prepared a series of European Standards describing biological
indicators for use in sterilizers. These European Standards are:
EN 866-1 Biological systems for testing sterilizers and sterilization processes – Part 1: General require-
ments
EN 866-2 Biological systems for testing sterilizers and sterilization processes – Part 2: Particular systems
for use in ethylene oxide sterilizers
EN 866-3 Biological systems for testing sterilizers and sterilization processes – Part 3: Particular systems
for use in moist heat sterilizers
EN 866-4 Biological systems for testing sterilizers and sterilization processes – Part 4: Particular systems
for use in irradiation sterilizers
EN 866-5 Biological systems for testing sterilizers and sterilization processes – Part 5: Particular systems
for use in low temperature steam and formaldehyde sterilizers
EN 866-6 Biological systems for testing sterilizers and sterilization processes – Part 6: Particular systems
for use in dry heat sterilizers
EN 866-7 Biological systems for testing sterilizers and sterilization processes – Part 7: Particular
requirements for self-contained biological indicator systems for use in moist heat sterilizers
EN 866-8 Biological systems for testing sterilizers and sterilization processes – Part 8: Particular require-
ments for self-contained biological indicator systems for use in ethylene oxide sterilizers
The annexes A, B, C and D are normative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,
France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden,
Switzerland and the United Kingdom.
3
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SIST EN 867-5:2002
EN 867-5:2001 (E)
Introduction
The indicators and process challenge devices described in this European Standard are intended specifically for use in
carrying out tests on small steam sterilizers, Type B or Type S.
prEN 13060 Parts 2 and 4 specify requirements and tests for small steam sterilizers Type B which are intended to
process solid products, hollow products, and porous products any of which may be wrapped in one or more layers of
sterilization grade packaging materials (see EN 868) and for small steam sterilizers Type S which may also be
specified by the manufacturer of the small steam sterilizer as intended to process hollow products and/or porous
products.
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 285:1996 for large sterilizers for wrapped goods and porous loads either because the
chamber size is unable to accommodate the standard test packs or because the efficacy of the tests is impaired when
the test pack occupies a large proportion of the chamber volume.
The indicator systems described in this European Standard are intended to be used, in conjunction with the
appropriate process challenge device, to demonstrate the rapid and complete penetration of steam into the process
challenge device. The construction of the process challenge device and the performance of the indicator are designed
to ensure that penetration of steam in the load within the sterilizer will provide adequate assurance that steam
penetration will occur in routine loads.
1 Scope
This European Standard specifies the performance requirements and test methods for non-biological indicator
systems, including the process challenge devices within which they are intended to function, to be used for testing the
steam penetration performance of small steam sterilizers, Type B or Type S where appropriate. The test systems
specified are intended for use only in small steam sterilizers Type B conforming to prEN 13060-2 and having a usable
chamber space greater than 10 l and for small steam sterilizers Type S conforming to prEN 13060-4 also having a
usable chamber space greater than 5 l.
Non-biological indicator systems and the associate process challenge devices are specified for various types of load.
The possible loads are considered in two classes: Porous loads, which can be wrapped or unwrapped, or hollow
instrument loads, which also can be wrapped or unwrapped.
The relevant section of this European Standard on porous loads specifies the requirements for:
– a standard process challenge device to be used in the small load test for porous loads in small steam sterilizers;
– an indicator system for use in the porous load process challenge device. An indicator for this purpose is a Class
B indicator as described in EN 867-1.
– an indicator employing an alternative process challenge device equivalent to the porous load process challenge
device.
The relevant section of this European Standard on hollow instruments specifies the requirements for:
– hollow load process challenge devices to be used to simulate hollow instrument loads as defined in prEN 13060-
4;
– an indicator system, for use in one of the hollow load process challenge device, for assessing steam penetration
in a wrapped load of hollow instruments. An indicator for this purpose is a Class B indicator as described in
EN 867-1.
The process challenge devices described in this standard are intended for use only in sterilizers of sufficient size to
accommodate the process challenge device with no part of the process challenge device closer than 20 mm from the
vessel wall; in the case of the porous load process challenge device the total internal volume of the vessel is not less
than 10 l.
4
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SIST EN 867-5:2002
EN 867-5:2001 (E)
2 Normative references
This European Standard incorporates, by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text, and the publications are listed hereafter. For dated
references subsequent amendments to, or revisions of, any of these publications apply to this European Standard only
when incorporated into it by amendment or revision. For undated references the latest edition of the publication
referred to applies (including amendments).
EN 285:1996
Sterilization – Steam sterilizers – Large sterilizers.
EN 866-3
Biological systems for testing sterilizers and sterilization processes – Part 3: Particular systems for use in moist
heat sterilizers.
EN 867-1
Non-biological systems for use in sterilizers – Part 1: General requirements.
EN 867-3:1997
Non-biological indicator systems for use in sterilizers – Part 3: Specification for Class B indicators for use in the
Bowie and Dick test.
EN 867-4
Non-biological systems for use in sterilizers – Part 4: Specification for indicators as an alternative to the Bowie and
Dick test for the detection of steam penetration.
prEN 13060-2
Small steam sterilizers – Part 2: Particular requirements and test methods for type B sterilizers, intended for the
sterilization of wrapped solid, hollow and porous products.
prEN 13060-4
Small steam sterilizers – Part 4: Particular requirements and test methods for type S sterilizers, intended for the
sterilization of products specified by the manufacturer of the sterilizer.
EN 20187
Paper, board and pulps – Standard atmosphere for conditioning and testing and procedure for monitoring the
atmosphere and conditioning of samples (ISO 187:1990).
EN 20534
Paper and board – Determination of thickness and apparent bulk density or apparent sheet density
(ISO 534:1988).
EN ISO 3696:1995
Water for analytical laboratory use – Specification and test methods (ISO 3696:1987).
EN ISO 5457:1999
Technical product documentation– Sizes and layout of drawing sheets (ISO 5457:1999).
ISO 10012-1
Quality assurance requirements for measuring equipment – Part 1: Metrological confirmation system for measuring
equipment.
3 Terms and definitions
For the purposes of this European Standard, the definitions given in EN 867-1 and the following definitions apply:
3.1
hollow load
devices having a minimum diameter of 2 mm or greater and no point internally at a distance greater than 1500 times
the minimum internal diameter from direct open connection with the surrounding environment
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SIST EN 867-5:2002
EN 867-5:2001 (E)
3.2
process challenge device
object which simulates the worst case of conditions for attainment of the specified sterilization conditions within the
items to be sterilized
NOTE The device is so constructed that a biological or non-biological indicator system can be placed within the device in
the position which it is most difficult for the sterilizing agent to reach. The design of the process challenge device depends on
the nature of the goods to be sterilized and the sterilization procedure.
3.3
total internal volume
volume of water at 20 °C which would be required to fill the hollow load process challenge device, including the space
which would, in use, be occupied by the indicator system
3.4
free capsule volume
capsule volume excluding the volume occupied by the indicator system
3.5
indicator system volume
volume of water at 20 °C which would fill a space bounded by the maximum external dimensions of the indicator
system
3.6
capsule volume
internal volume of that part of the hollow load process challenge device intended to accommodate the indicator system
determined as the volume of water at 20 °C which would be required to fill the capsule
4 Requirements
4.1 General
4.1.1 The requirements of EN 867-1 shall apply.
Samples of non-biological indicators shall be conditioned in accordance with EN 20187 prior to testing for
4.1.2
performance.
4.1.3 The combination of process challenge device and indicator system shall be specified as providing a test system
for either a porous load (see 4.2, 4.3 and 4.4) or a hollow instrument load (see 4.5 and 4.6).
When used in accordance with the manufacturer's instructions the indicator system, in combination with any
4.1.4
specified process challenge device, shall provide indication of failure to attain steam penetration with a sensitivity
sufficient to ensure that a satisfactory result will give confirmation that steam penetration would be attained in a
sterilizer load of the type specified.
Indicator systems intended for use with re-usable user-assembled process challenge devices shall not visibly
4.1.5
transfer indicator reagent to the material of the process challenge device during processing.
Pre-assembled process challenge devices and indicator systems intended for use with the single-use user-assembled
process challenge devices shall not transfer indicator reagent to the material of the process challenge device during
processing to an extent which impairs the utility of the product.
Compliance shall be demonstrated by visual examination after testing in accordance with the requirements of 4.3.3
and 5.3.2 as appropriate.
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SIST EN 867-5:2002
EN 867-5:2001 (E)
4.2 Process challenge device for porous load
The process challenge device for porous loads shall be a standardised test pack for assessing the performance
4.2.1
in the sterilization of porous loads in small steam sterilizers.
4.2.2 The pack shall be constructed from plain cotton sheets, bleached to a good white and each having an
approximate size of 450 mm x 300 mm. Edges other than selvage shall be oversewn, not hemmed.
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
4.2.3
shall be (27 ± 5).
-2
The mass per unit area shall be (185 ± 5) g m .
4.2.4
The sheets shall be washed when new and when soiled. During the washing process the sheets shall not be
4.2.5
subjected to any fabric conditioning agent.
After washing the sheets shall be dried and aired, but not ironed or calendered.
4.2.6
Before use the sheets shall be stored, unfolded and well separated, for at least 1 h in an environment at a
4.2.7
temperature between 20 °C and 30 °C and at a relative humidity of 40 % to 70 %.
After airing, the sheets shall be folded to approximately 110 mm x 150 mm and stacked to a height of
4.2.8
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.
NOTE 1 When forming the pack, consecutive sheets should be stacked with the folded side alternating to ensure an even
stack.
NOTE 2 Packs which are not used within 1 h of preparation can be stored until required, providing the environmental
conditions are maintained within the limits specified above.
NOTE 3 After use the sheets will become compressed. When the weight of sheets used to form a stack 120 mm high
exceeds 1000 g, the sheets should be discarded.
4.3 Indicator systems for use in the porous load process challenge device
The indicator systems are intended for use in a standard test pack of the type specified in this standard (see
4.3.1
4.2).
4.3.2 The indicator system shall comply with the requirements of EN 867-1 and, in addition, the substrate on which an
indicator reagent has been deposited shall be marked with the information "For use in small steam sterilizers".
The indicator shall comply with the requirements of EN 867-3:1997 except that:
4.3.3
a) the indicator system shall be A6 size to EN ISO 5457:1999; replacing EN 867-3:1997, 5 g);
b) the standard test pack used for evaluation of performance requirements shall be in accordance with 4.2 of this
European Standard; replacing EN 867-3:1997 annex L;
c) the steam exposure apparatus shall be as described in annex A of this European Standard;
d) the operating cycle(s) of the steam exposure apparatus shall be as described in annex B of this European
Standard.
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EN 867-5:2001 (E)
4.4 Alternative indicators equivalent to the porous load process challenge device test
The indicator shall comply with the requirements of EN 867-4 except that for the purpose of demonstration of
equivalence the performance shall be compared with thermometric monitoring of the porous load process challenge
device test pack (see 4.2) and the operational cycle(s) of the steam exposure apparatus described in annex A shall be
as described in annex B of this European Standard.
4.5 Process challenge devices for hollow instrument loads (hollow load process challenge device)
Under the conditions of use, the materials from which the hollow load process challenge device is made shall
4.5.1
not release any substances in such quantities that would constitute a health risk or which will adversely affect the
performance of indicator systems with which it is intended to be used when tested in accordance with 5.1.
NOTE For further information see EN ISO 10993-1 and ISO 14538.
The pH of a hot aqueous extract shall be within the range 6,5 to 7,5 when determined by the method given in
4.5.2
5.1.1.2.
NOTE Many non-biological indicator systems are dependent for their colour change on a change in pH, or undergo
reactions in which the reaction rate is dependent on pH. Materials which can leach acids or alkalis into indicator systems are
not suitable for general use.
The hollow load process challenge device shall be constructed of material which is neither porous nor
4.5.3
permeable to air or steam under the conditions of use (see clause 5).
4.5.4 The material(s) of which the hollow load process challenge device is constructed shall not absorb water to any
significant extent and shall not cause an increase in mass greater than 5 % when tested as described in 5.1.1.3.
Such water as can be absorbed shall:
a) not cause dimensional changes sufficient to affect adversely the compliance of the hollow load process
challenge device with the performance requirements of this European Standard or greater than a linear expansion
of 2 % when tested as described in 5.1.1.3;
b) not be released during the sterilization process to an extent which would compromise the ability of the indicator
system to demonstrate inadequate air removal when tested in accordance with 5.1.3.
The materials of which the hollow load process challenge device is constructed shall withstand exposure to the
4.5.5
sterilization process for which it is intended:
a) without distortion, melting, corrosion or other failure which would impair its utility;
b) without any change occuring in the severity of the test as a result of thermal exposure
when tested as described in 5.1.5.
When the hollow load process challenge device is also intended to be used with biological indicators (or
4.5.6
inoculated carriers) the material shall not release any substance to such an extent that it can inhibit the growth of low
numbers of surviving micro-organisms on a biological indicator or inoculated carrier when tested by the method
described in 5.1.4.
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SIST EN 867-5:2002
EN 867-5:2001 (E)
The hollow load process challenge device shall consist of a capsule to contain the indicator connected to a
4.5.7
lumen, of uniform internal dimensions throughout its length. The capsule shall be of cylindrical construction and the
internal volume shall be of uniform cross-section over its length. The process challenge device shall have the following
specification:
– Wall thickness: (0,5 ± 0,025) mm;
– Internal diameter: (2,0 ± 0,1) mm;
– Length: (1 500 ± 15) mm;
– Capsule mass: (10,0 ± 0,1) g;
– Free capsule volume: (6 ± 1) % of the total internal volume minus the capsule volume;
– Material of construction: Polytetrafluorethylene (PTFE).
NOTE Other materials of demonstrated equivalence may be used. When different materials are used, the wall thickness
and capsule mass can be varied appropriately.
The capsule for containing the indicator system shall be equipped with a demountable cap or similar device to
4.5.8
permit the positioning and removal of the indicator system and shall provide an effective seal against the passage of
air and/or steam.
The design of the capsule shall ensure that the indicator system:
4.5.9
– is retained securely in the intended position;
– does not obstruct the lumen, unless this was part of the design intent;
– can be removed easily for examination after use.
4.5.10 The free capsule volume (see 4.5.7) shall be terminal and of uniform cross-section.
NOTE The ratio of the volume of the receptacle to the free internal volume is a critical factor in determining the difficulty for
steam penetration to the indicator.
When requested by the purchaser, the process challenge device manufacturer shall make available an
4.5.11
alternative demountable cap or closure with provision for incorporating a temperature sensor (e. g. thermocouple or Pt
100 element) to sense the temperature of the free space in the capsule volume adjacent to the indicator system.
4.6 Indicator systems for use in the hollow load process challenge device
The indicator system shall be designed to be used in conjunction with a hollow load process challenge device
4.6.1
(see 4.5).
When the indicator system and hollow load process challenge device are not supplied as an assembled unit the
4.6.2
indicator supplier shall provide the purchaser/user with details of any limitations concerning the design of hollow load
process challenge device with which the indicator is intended to be used.
The indicator shall be designed and manufactured to respond to a combination of temperature and time, in the
4.6.3
presence of moisture to effect a clearly discernible colour change which shall be used to demonstrate attainment of
satisfactory conditions for sterilization.
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SIST EN 867-5:2002
EN 867-5:2001 (E)
The indicator system shall be designed and manufactured to function correctly for exposure to dry saturated
4.6.4
steam either:
– throughout the range 117,5 °C to 142,0 °C;
or,
– over a temperature range of not less than 5 C specified by the supplier within the range 117,5 °C to 142 °C.
When tested in accordance with the requirements of 5.3.3 the indicator system shall not show attainment of
4.6.5
sterilization conditions if the combination of time and temperature conditions during exposure to dry saturated steam
are equal to or less than that required to give at least an Inactivation Factor (IF) of 8 for a reference organism having a
D -value of 1,5 min and a z-value of 10 °C.
121
NOTE This corresponds to an exposure time of 12 min at 121 °C.
When tested in accordance with the requirements of 5.3.2 the indicator system always shall show attainment of
4.6.6
sterilization conditions if the combination of time and temperature conditions during exposure to dry saturated steam
are equal to or greater than that required to give at least an Inactivation Factor (IF) of 12 for a reference organism
having a D -value of 1,25 min and a z-value of 20 °C.
121
NOTE This corresponds to an exposure time of 15 min at 121 °C.
4.6.7 The response of the indicator system shall be tested at not less than four temperatures within the specified
temperature range in which the indicator system is intended to be used for exposures as the "PASS" and "FAIL" time
limits given by Table 1 or by calculation of intermediate values.
NOTE The exposure time can be calculated from the relationship:
IF D -value (as specified in 4.6.5 or 4.6.6) (1)
T
and the theoretical D-value at temperature t can be calculated from
121T
z
D D 10 (2)
T 121
and hence t = IF D (3)
T
Indicator systems intended for use over the full range of temperature 117,5 °C to 142,0 °C (see 4.6.4) shall be tested
at (121 ± 0,5) °C and at (134 ± 0,5) °C as two of the four test temperatures.
Indicator systems intended for use over a restricted range of temperature shall be tested at the two temperatures
representing the extremes of the specified range as two of the four test temperatures.
At each of the chosen test temperatures indicators shall be exposed for the minimum and maximum times
4.6.8
defining the transition zone (see Table 1).
Indicator systems exposed for the minimum time shall not show a discernible change.
Indicator systems exposed for the maximum time shall show a clear change to the colour specified by the manufac-
turer as indicative of exposure to a satisfactory sterilization cycle.
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SIST EN 867-5:2002
EN 867-5:2001 (E)
Table 1 - Limiting values for "PAS
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