EN 867-5:2001
(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;
Systèmes non biologiques destinés à être utilisés dans des stérilisateurs - Partie 5: Spécifications des systèmes indicateurs et dispositifs d'épreuve de procédé destinés à être 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 systèmes indicateurs non biologiques, y compris les dispositifs d'épreuve de procédé au sein desquels ils sont destinés à fonctionner, qui doivent être 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 systèmes d'essai spécifiés sont destinés à être utilisés uniquement dans les petits stérilisateurs de Type B conformes au prEN 13060-2, disposant d'une chambre dont le volume utile est supérieur à 10 l, ainsi que dans les petits stérilisateurs à la vapeur de Type S conformes au prEN 13060-4, disposant également d'une chambre dont le volume utile est supérieur à 5 l.
Les systèmes 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 être enveloppées ou non, et les charges d'instruments creux, qui peuvent également être 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 à être employé lors d'essais de petites charges, dans le cas de charges poreuses contenues dans les petits stérilisateurs à la vapeur ;
- un système indicateur destiné à être employé dans le dispositif d'épreuve de procédé à charge poreuse ; l'indicateur approprié est dans ce cas un indicateur de classe B conforme à l'EN 867-1 ;
- un indicateur utilisant une variante de dispositif d'épreuve de procédé équivalente du dispositif d'épreuve de procédé à 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
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
......................................................................................................................................................
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.
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.
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 documenta
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