SIST EN ISO 11138-1:2006
(Main)Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)
Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006)
This part of ISO 11138 provides general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes. This part of ISO 11138 specifies basic and common requirements that are applicable to all subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 1: Allgemeine Anforderungen (ISO 11138-1:2006)
1.1 Allgemeines
1.1.1 Dieser Teil von ISO 11138 enthält allgemeine Anforderungen an die Herstellung, Kennzeichnung, Prüfverfahren und Leistungsmerkmale bei biologischen Indikatoren, einschließlich beimpfter Keimträger und Suspensionen und deren Bestandteilen, die bei der Validierung und Routineüberwachung von Sterilisations¬verfahren verwendet werden sollen.
1.1.2 Dieser Teil von ISO 11138 legt grundlegende und allgemeine Anforderungen fest, die für alle Folgeteile der ISO 11138 gelten. Anforderungen an biologische Indikatoren für besonders festgelegte Verfahren sind in den Folgeteilen der ISO 11138 enthalten. Wenn kein spezifischer Folgeteil erarbeitet wird, gilt dieser Teil.
ANMERKUNG Nationale oder regionale Bestimmungen können gelten.
1.2 Nicht erfasste Gebiete
Dieser Teil der ISO 11138 gilt nicht für mikrobiologische Prüfsysteme für Verfahren, die auf der physikalischen Beseitigung von Mikroorganismen beruhen, z. B. Filtrationsverfahren oder Verfahren, bei denen die physikalische und/oder mechanische Keimentfernung mit einer mikrobiologischen Inaktivierung verbunden wird, wie bei der Anwendung von Wasch-Desinfektionsgeräten oder dem Durchspülen und Bedampfen von Leitungen. Dieser Teil der ISO 11138 könnte jedoch Elemente enthalten, die für solche mikrobiologischen Prüfsysteme von Bedeutung sind.
Stérilisation des produits de santé - Indicateurs biologiques - Partie 1: Exigences générales (ISO 11138-1:2006)
L'ISO 11138-1:2006 fournit les exigences générales relatives à la production, à l'étiquetage, aux méthodes d'essai et fournit les caractéristiques de performance des indicateurs biologiques, notamment les porte-germes inoculés et les suspensions et leurs composants, à utiliser dans la validation et la surveillance de routine des procédés de stérilisation.
L'ISO 11138-1:2006 spécifie les exigences fondamentales et communes applicables à toutes les autres parties de l'ISO 11138. Les exigences relatives aux indicateurs biologiques pour des procédés particuliers spécifiés sont précisées dans les autres parties de l'ISO 11138. En l'absence d'autre partie spécifique, la présente partie s'applique.
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 1. del: Splošne zahteve (ISO 11138-1:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11138-1:2006
01-september-2006
1DGRPHãþD
SIST EN 866-1:2000
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 1. del: Splošne
zahteve (ISO 11138-1:2006)
Sterilization of health care products - Biological indicators - Part 1: General requirements
(ISO 11138-1:2006)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 1:
Allgemeine Anforderungen (ISO 11138-1:2006)
Stérilisation des produits de santé - Indicateurs biologiques - Partie 1: Exigences
générales (ISO 11138-1:2006)
Ta slovenski standard je istoveten z: EN ISO 11138-1:2006
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11138-1:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11138-1:2006
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SIST EN ISO 11138-1:2006
EUROPEAN STANDARD
EN ISO 11138-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2006
ICS 11.080.01 Supersedes EN 866-1:1997
English Version
Sterilization of health care products - Biological indicators - Part
1: General requirements (ISO 11138-1:2006)
Stérilisation des produits de santé - Indicateurs biologiques Sterilisation von Produkten für die Gesundheitsfürsorge -
- Partie 1: Exigences générales (ISO 11138-1:2006) Biologische Indikatoren - Teil 1: Allgemeine Anforderungen
(ISO 11138-1:2006)
This European Standard was approved by CEN on 7 June 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, 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
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-1:2006: E
worldwide for CEN national Members.
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SIST EN ISO 11138-1:2006
EN ISO 11138-1:2006 (E)
Foreword
This document (EN ISO 11138-1:2006) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with 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 January 2007, and conflicting national
standards shall be withdrawn at the latest by January 2007.
This document supersedes EN 866-1:1997.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 11138-1:2006 has been approved by CEN as EN ISO 11138-1:2006 without any
modifications.
2
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SIST EN ISO 11138-1:2006
INTERNATIONAL ISO
STANDARD 11138-1
Second edition
2006-07-01
Sterilization of health care products —
Biological indicators —
Part 1:
General requirements
Stérilisation des produits de santé — Indicateurs biologiques —
Partie 1: Exigences générales
Reference number
ISO 11138-1:2006(E)
©
ISO 2006
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SIST EN ISO 11138-1:2006
ISO 11138-1:2006(E)
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ii © ISO 2006 – All rights reserved
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SIST EN ISO 11138-1:2006
ISO 11138-1:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
1.1 General. 1
1.2 Exclusions . 1
2 Normative references . 1
3 Terms and definitions. 2
4 General manufacturing requirements. 4
4.1 Manufacturing controls. 4
4.2 Test organism . 5
4.3 Information supplied by manufacturer (labelling). 6
4.4 Storage and transport . 6
5 Specific manufacturing requirements . 7
5.1 Suspensions. 7
5.2 Carrier, primary and secondary packaging . 7
5.3 Inoculated carrier. 8
5.4 Biological indicators. 8
5.5 Self-contained biological indicators. 8
6 Determination of resistance . 8
6.1 General resistance requirements. 8
6.2 Test organism . 9
6.3 Population of test organisms . 9
6.4 Resistance characteristics . 9
6.5 Test conditions . 10
7 Culture conditions . 10
7.1 Incubator. 10
7.2 Growth medium. 10
7.3 Incubation. 10
Annex A (normative) Determination of viable count . 11
Annex B (normative) Determination of growth inhibition by carriers and primary packaging
materials exposed to sterilization processes . 13
Annex C (normative) D value determination by survivor curve method . 15
Annex D (normative) D value determination by fraction negative method. 19
Annex E (normative) Survival-kill response characteristics . 35
Annex F (informative) Relationship between components of biological indicators . 36
Bibliography . 37
© ISO 2006 – All rights reserved iii
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SIST EN ISO 11138-1:2006
ISO 11138-1:2006(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 11138-1 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11138-1:1994), which has been technically
revised.
ISO 11138 consists of the following parts, under the general title Sterilization of health care products —
Biological indicators:
⎯ Part 1: General requirements
⎯ Part 2: Biological indicators for ethylene oxide sterilization processes
⎯ Part 3: Biological indicators for moist heat sterilization processes
⎯ Part 4: Biological indicators for dry heat sterilization processes
⎯ Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
iv © ISO 2006 – All rights reserved
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SIST EN ISO 11138-1:2006
ISO 11138-1:2006(E)
Introduction
This part of ISO 11138 specifies general requirements for production, labelling, test methods and performance
requirements for the manufacture of biological indicators including inoculated carriers and suspensions
intended for use in validation and monitoring of sterilization processes. Subsequent parts of ISO 11138
provide additional specific requirements for biological indicators for defined sterilization processes.
A graphic description of a biological indicator and its components is presented in Annex F. The presentation
includes the two types of biological indicator which are covered by ISO 11138. This shows that inoculated
carriers can be presented directly to the sterilizing agent without prior packaging, or included in a primary
package that permits access by the sterilizing agent.
The resistance characteristics depend on the type of test organism, its numbers, the method of preparation
and the effects of the primary package. Advice on selection, use and interpretation of results of biological
[7]
indicators can be found in ISO 14161 .
For any individual sterilization process, including those covered in subsequent parts of ISO 11138, the
resistance of the biological indicator will also depend on its microenvironment during testing. In theory, this
could lead to an infinite variation in the preparation of biological indicators. Moreover, a sterilization process
could be manipulated in infinite variety to suit each possible set of conditions to which products could be
exposed. It has therefore been routine practice to manufacture biological indicators that, when exposed to a
set of conditions in a defined sterilization process, provide resistance characteristics expressed as D values
and, where relevant, z values. Such values are set out in the subsequent parts of ISO 11138.
ISO 11138, parts 1 to 5 represent the current “state-of-the-art” according to the experts representing
manufacturers, users and regulatory authorities involved in developing this International Standard.
Biological indicators for specific sterilization processes not covered by reference test conditions in subsequent
parts of ISO 11138 should comply with the general requirements in this part, including the resistance testing
procedures. Such biological indicators might not be well enough described, or might be used for novel
sterilization processes, or might be represented by isolated bioburden microorganisms. If microorganisms
[27]
other than risk group 1 (WHO,1993 ) are included in these biological indicators, the appropriate containment
and safety levels must be met.
Standards exist providing requirements for the validation and control of sterilization processes
(see Bibliography).
NOTE Some countries or regions might have published other standards covering requirements for sterilization or
biological indicators (see Bibliography).
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SIST EN ISO 11138-1:2006
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SIST EN ISO 11138-1:2006
INTERNATIONAL STANDARD ISO 11138-1:2006(E)
Sterilization of health care products — Biological indicators —
Part 1:
General requirements
1 Scope
1.1 General
1.1.1 This part of ISO 11138 provides general requirements for production, labelling, test methods and
performance characteristics of biological indicators, including inoculated carriers and suspensions, and their
components, to be used in the validation and routine monitoring of sterilization processes.
1.1.2 This part of ISO 11138 specifies basic and common requirements that are applicable to all
subsequent parts of ISO 11138. Requirements for biological indicators for particular specified processes are
provided in the subsequent parts of ISO 11138. If no specific subsequent part is provided, this part applies.
NOTE National or regional regulations may apply.
1.2 Exclusions
This part of ISO 11138 does not apply to microbiological test systems for processes that rely on physical
removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical
removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of
pipelines. This part of ISO 11138, however, could contain elements relevant to such microbiological test
systems.
2 Normative references
The following referenced documents are indispensable for the application 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 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
ISO 11135:1994, Medical devices — Validation and routine control of ethylene oxide sterilization
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
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SIST EN ISO 11138-1:2006
ISO 11138-1:2006(E)
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
ISO 11737-1, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a
population of microorganisms on products
ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 15223, Symbols to be used with medical device labels, labelling and information to be supplied
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 18472, Sterilization of health care products — Biological and chemical indicators — Test equipment
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization
process
[ISO/TS 11139, definition 2.3]
3.2
carrier
supporting material on or in which test microorganisms are deposited
3.3
colony forming unit
CFU
individual visible units of growth of microorganisms arising from a single cell or multiple cells
3.4
culture collection number
unique identification of the test organism allocated by a scientifically recognised service culture collection
3.5
culture conditions
combination of growth media and manner of incubation used to promote germination, growth and/or
multiplication of microorganisms
NOTE The manner of incubation may include the temperature, time and any other conditions specified for incubation.
[ISO/TS 11139, definition 2.10]
3.6
D value
D value
10
time or dose required to achieve inactivation of 90 % of a population of the test microorganism under stated
dose conditions
[ISO/TS 11139, definition 2.11]
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SIST EN ISO 11138-1:2006
ISO 11138-1:2006(E)
3.7
F value
BIO
product of the logarithm of the population and the D value where the F value is an expression of the
BIO
resistance of the biological indicator
3.8
inactivation
loss of ability of microorganisms to grow and/or multiply
[ISO/TS 11139, definition 2.21]
3.9
inactivation curve
graphical representation of inactivation of test organism against increasing exposure to the sterilizing agent at
stated conditions
3.10
inoculated carrier
supporting material on or in which a defined number of viable test organisms have been deposited
NOTE See Annex F.
3.11
nominal population
manufacturer’s stated number of viable microorganisms
6
NOTE This is generally expressed in log function (e.g., 10 ).
10
3.12
packaging system
combination of the sterile barrier system and protective packaging
[ISO/TS 11139, definition 2.28]
3.13
primary package
element of the packaging system which maintains the integrity of the product
NOTE The packaging system protects the inoculated carrier from damage and contamination without preventing
penetration of the sterilizing agent.
3.14
process challenge device
PCD
item designed to constitute a defined resistance to a sterilization process and used to assess performance of
the process
[ISO/TS 11139, definition 2.33]
3.15
resistometer
test equipment designed to create defined reference combinations of the physical and/or chemical variables of
a sterilization process
3.16
secondary package
container in which biological indicators are packed for transport and storage
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SIST EN ISO 11138-1:2006
ISO 11138-1:2006(E)
3.17
self-contained biological indicator
biological indicator presented in such a way that the primary package, intended for incubation, contains the
incubation medium required for recovery of the test organism
3.18
survival-kill window
extent of exposure to a sterilization process under defined conditions where there is a transition from all
biological indicators showing growth (survival time) to all biological indicators showing no growth (kill time)
3.19
suspension
viable test organisms suspended in a fluid
NOTE Suspension can be a biological indicator if ready to use in a sealed glass ampoule, or may be an intermediate
component used to produce an inoculated carrier or biological indicator.
3.20
viable count
actual number of recoverable colony-forming units or other appropriate units
NOTE See Annex A.
3.21
z value
change in exposure temperature of a thermal sterilization process, which corresponds to a tenfold change in D
value
NOTE See ISO 11138-3 and ISO 11138-4.
4 General manufacturing requirements
4.1 Manufacturing controls
4.1.1 Quality systems
The manufacturer shall establish, document and maintain a formal quality system (e.g. ISO 13485, GMPs or
other national or regional requirements) to cover all operations required by this part of ISO 11138. In particular,
the manufacturer shall take precautions at all stages of production to minimize contamination that would
adversely affect the performance of the biological indicator.
4.1.2 Traceability
4.1.2.1 Traceability of manufacturing components shall be maintained.
4.1.2.2 Manufacturing components shall include all materials incorporated in, or coming into direct
contact with, the test organism suspension, the inoculated carrier or its primary package.
4.1.3 End product requirements
The finished product shall comply with the requirements set out in this part of ISO 11138, see:
a) manufacturing (Clause 5);
b) labelling (4.3);
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SIST EN ISO 11138-1:2006
ISO 11138-1:2006(E)
c) resistance characteristics (6.4);
d) storage and transport (4.4).
NOTE 1 Advice on methods for the use of biological indicators is provided in ISO 14161.
NOTE 2 National and/or regional requirements might exist, for example in the various national or regional
pharmacopoeias.
4.1.4 Personnel
The procedures and methods in this part of ISO 11138 shall be carried out by suitably trained and
experienced laboratory personnel (see 4.1.1).
4.2 Test organism
4.2.1 Strain
4.2.1.1 Test organisms shall be of a defined strain, available through a recognised culture collection, and
shall be identified by appropriate test methods.
4.2.1.2 The test organism should be a strain that is:
a) suitable for handling without special containment facilities, does not need specific containment
procedures for handling and does not have specific transport or mailing requirements (e.g. Risk Group 1,
WHO 1993);
b) sufficiently stable to maintain its resistance characteristics for the duration of the stated shelf-life when
transported and stored in accordance with label directions.
NOTE Traditionally, the test organisms of biological indicators have been bacterial spores, usually derived from
Bacillus or Geobacillus species.
4.2.1.3 Test organisms other than bacterial spores may be used if they have been shown to provide
appropriate resistance to the sterilization process.
4.2.2 Originating inoculum for suspension
4.2.2.1 The initial inoculum for each batch of test organism suspension shall be:
a) traceable to the reference culture and available through a recognized culture collection;
b) verified as to its identity and purity.
4.2.2.2 The methods used for maintaining test organism cultures shall be designed to protect them from
contamination and to minimize any induced changes in the inherent properties of the test organisms.
4.2.2.3 Verification tests are specific for each strain of test organism and shall be documented and
validated by the manufacturer.
4.2.3 Test organism count
4.2.3.1 The viable test organism count of the suspension shall be determined in accordance
with Annex A.
4.2.3.2 If the user requires information on the growth index of the test organism, this shall be provided by
expressing the viable test organism count as a percentage of the total direct microscopic count.
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SIST EN ISO 11138-1:2006
ISO 11138-1:2006(E)
4.3 Information supplied by manufacturer (labelling)
4.3.1 The following information shall be provided on the label of each individual unit of suspension,
inoculated carrier packaging and biological indicator:
⎯ a unique code by which the manufacturing history can be traced;
⎯ the name of the test organism;
⎯ an indication of the sterilization process for which the suspension, inoculated carriers or biological
indicators are suitable;
⎯ the expiry date, expressed according to ISO 8601, e.g. YYYY-MM-DD;
⎯ the manufacturer’s name, trademark, address or other means of identification.
Internationally recognized symbols may be used where appropriate (see 4.1.3 and ISO 15223).
4.3.2 The information given in Table 1 shall be provided within the secondary packaging of each batch of
product.
4.3.3 Requirements for labelling may be achieved by the use of appropriate symbols (ISO 15223).
Table 1 — Information to be provided by the manufacturer
Inoculated Biological
Information requirement Suspension
carrier indicator
The name or abbreviation of the culture collection from
which the test organism has been obtained and the Required Required Required
reference number of the strain
The nominal volume of suspension, in ml Required — —
The process for which the product is suitable for use, the
resistance and the procedure and carrier used to determine Required Required Required
a
the resistance
The specified storage conditions Required Required Required
Disposal instructions Required Required Required
Directions for use, especially data about the medium,
incubation and other conditions to be used for recovery of test Required Required Required
organisms after exposure to the sterilization process
The number of test organisms per ml (suspension), or per
Required Required Required
a
unit (inoculated carrier or biological indicator)
The number of product units in the secondary pack — Required Required
A reference to this part of ISO 11138 Required Required Required
a
Test methodology used to determine resistance and population should be supplied by the manufacturer upon request.
4.4 Storage and transport
4.4.1 Storage and transport conditions for the test organism suspension shall be maintained such that the
test organism suspension complies with the requi
...
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