SIST-TS CEN ISO/TS 11135-2:2008
(Main)Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (ISO/TS 11135-2:2008)
This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeat the requirements and is not intended to be used in isolation. The exclusions in ISO 11135-1 apply also to this Technical Specification. For ease of reference, the clause numbering in this Technical Specification corresponds to that in ISO 11135-1:2007. Further guidance for the requirements given in ISO 11135-1 is also included in Annex C of ISO 11135-1:2007 and should be used in conjunction with this Technical Specification. This guidance document is intended for people who have a basic knowledge of the principles of EO sterilization but may need help in determining how to best meet the requirements contained in ISO 11135-1. This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.
Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Teil 2: Leitfaden zur Anwendung von ISO 11135-1 (ISO/TS 11135-2:2008)
Diese Technische Spezifikation bietet einen Leitfaden für die Anforderungen in ISO 11135-1:2007. Die Anforderungen werden nicht wiederholt und es ist nicht vorgesehen, dass das Dokument alleinstehend verwendet wird.
Die Ausschließungen in ISO 11135-1 gelten auch in dieser Technischen Spezifikation.
Zum leichten Bezug entspricht die Abschnittsnummerierung in dieser Technischen Spezifikation der in ISO 11135-1:2007 verwendeten. Ein weitergehender Leitfaden für die in ISO 11135-1 enthaltenen Anforderungen ist auch in ISO 11135-1:2007, Anhang C enthalten und sollte gemeinsam mit dieser Technischen Spezifikation verwendet werden.
Das vorliegende anleitende Dokument ist für Personen gedacht, die über ein Grundwissen über die Prinzipien der EO-Sterilisation verfügen, jedoch Hilfe bei der Festlegung benötigen, wie die in ISO 11135-1 enthaltenen Anforderungen am besten erfüllt werden können. Dieses Dokument ist nicht für Personen gedacht, die über keine Grundkenntnisse der Prinzipien der EO-Sterilisation verfügen.
Stérilisation des produits de santé - Oxyde d'éthylène - Partie 2: Directives relatives à l'application de l'ISO 11135-1 (ISO/TS 11135-2:2008)
L'ISO/TS 11135-2:2008 fournit des directives pour satisfaire aux exigences de l'ISO 11135‑1. Elle ne reproduit pas ces exigences et n'est pas censée être utilisée individuellement.
Les directives données dans l'ISO/TS 11135-2:2008 peuvent être utilisées par des personnes ayant une maîtrise de base des principes de la stérilisation à l'oxyde d'éthylène mais susceptibles d'avoir besoin d'aide pour déterminer le meilleur moyen de répondre aux exigences de l'ISO 11135-1. La présente Spécification technique n'est pas destinée aux personnes n'ayant aucune connaissance des principes de la stérilisation à l'oxyde d'éthylène.
Sterilizacija izdelkov za zdravstveno nego - Etilenoksid - 2. del: Navodilo za uporabo ISO 11135-1 (ISO/TS 11135-2:2008)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 11135-2:2008
01-november-2008
Sterilizacija izdelkov za zdravstveno nego - Etilenoksid - 2. del: Navodilo za
uporabo ISO 11135-1 (ISO/TS 11135-2:2008)
Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the
application of ISO 11135-1 (ISO/TS 11135-2:2008)
Sterilisation von Produkten für die Gesundheitsfürsorge - Ethylenoxid - Teil 2: Leitfaden
zur Anwendung von ISO 11135-1 (ISO/TS 11135-2:2008)
Stérilisation des produits de santé - Oxyde d'éthylène - Partie 2: Directives relatives à
l'application de l'ISO 11135-1 (ISO/TS 11135-2:2008)
Ta slovenski standard je istoveten z: CEN ISO/TS 11135-2:2008
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST-TS CEN ISO/TS 11135-2:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TS CEN ISO/TS 11135-2:2008
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SIST-TS CEN ISO/TS 11135-2:2008
TECHNICAL SPECIFICATION
CEN ISO/TS 11135-2
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
August 2008
ICS 11.080.01
English Version
Sterilization of health care products - Ethylene oxide - Part 2:
Guidance on the application of ISO 11135-1 (ISO/TS 11135-
2:2008)
Stérilisation des produits de santé - Oxyde d'éthylène - Sterilisation von Produkten für die Gesundheitsfürsorge -
Partie 2: Directives relatives à l'application de l'ISO 11135- Ethylenoxid - Teil 2: Leitfaden zur Anwendung von ISO
1 (ISO/TS 11135-2:2008) 11135-1 (ISO/TS 11135-2:2008)
This Technical Specification (CEN/TS) was approved by CEN on 8 June 2008 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 11135-2:2008: E
worldwide for CEN national Members.
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SIST-TS CEN ISO/TS 11135-2:2008
CEN ISO/TS 11135-2:2008 (E)
Contents Page
Foreword.3
2
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SIST-TS CEN ISO/TS 11135-2:2008
CEN ISO/TS 11135-2:2008 (E)
Foreword
This document (CEN ISO/TS 11135-2:2008) has been prepared by Technical Committee CEN/TC 204
“Sterilization of medical devices", the secretariat of which is held by BSI, in collaboration with Technical
Committee ISO/TC 198 "Sterilization of health care products".
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria, 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 the United Kingdom.
Endorsement notice
The text of ISO/TS 11135-2:2008 has been approved by CEN as a CEN ISO/TS 11135-2:2008 without any
modification.
3
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SIST-TS CEN ISO/TS 11135-2:2008
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SIST-TS CEN ISO/TS 11135-2:2008
TECHNICAL ISO/TS
SPECIFICATION 11135-2
First edition
2008-08-01
Sterilization of health care products —
Ethylene oxide —
Part 2:
Guidance on the application of
ISO 11135-1
Stérilisation des produits de santé — Oxyde d'éthylène —
Partie 2: Directives relatives à l'application de l'ISO 11135-1
Reference number
ISO/TS 11135-2:2008(E)
©
ISO 2008
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SIST-TS CEN ISO/TS 11135-2:2008
ISO/TS 11135-2:2008(E)
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ii © ISO 2008 – All rights reserved
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SIST-TS CEN ISO/TS 11135-2:2008
ISO/TS 11135-2:2008(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Quality management systems . 2
4.1 Documentation. 2
4.2 Management responsibility . 2
4.3 Product realization. 3
4.4 Measurement, analysis and improvement — Control of non-conforming product . 3
5 Sterilizing agent characterization . 3
5.1 Sterilizing agent . 3
5.2 Microbicidal effectiveness . 3
5.3 Materials effects. 3
5.4 Environmental considerations . 3
6 Process and equipment characterization .4
6.1 Process characterization . 4
6.2 Equipment characterization. 4
7 Product definition . 5
7.1 General. 5
7.2 Product safety and performance. 8
7.3 Microbiological quality. 9
7.4 Documentation. 9
8 Process definition. 9
9 Validation. 12
9.1 Installation qualification. 13
9.2 Operational qualification. 14
9.3 Performance qualification. 15
9.4 Varying load configurations . 19
9.5 Review and approval of validation. 19
10 Routine monitoring and control . 20
10.1 General. 20
10.2 Parametric release. 21
11 Product release from sterilization. 22
12 Maintaining process effectiveness . 23
12.1 General. 23
12.2 Maintenance of equipment . 23
12.3 Requalification . 24
12.4 Assessment of change. 25
Annex A (informative) Guidance on ISO 11135-1:2007 Annex A Determination of process
lethality — Biological indicator/bioburden approach . 26
Annex B (informative) Guidance on ISO 11135-1:2007 Annex B Conservative determination of
lethal rate of the sterilization process — Overkill approach. 36
Bibliography . 38
© ISO 2008 – All rights reserved iii
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SIST-TS CEN ISO/TS 11135-2:2008
ISO/TS 11135-2:2008(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.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of document:
⎯ an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
⎯ an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting
a vote.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a
further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is
confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an
International Standard or be withdrawn.
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/TS 11135-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
ISO/TS 11135-2, together with ISO 11135-1, cancels and replaces ISO 11135:1994 and
ISO 11135/Cor.1:1994, which have been technically revised.
ISO/TS 11135 consists of the following parts, under the general title Sterilization of health care products —
Ethylene oxide:
⎯ Part 1: Requirements for development, validation and routine control of a sterilization process for medical
devices
⎯ Part 2: Guidance on the application of ISO 11135-1
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SIST-TS CEN ISO/TS 11135-2:2008
ISO/TS 11135-2:2008(E)
Introduction
This Technical Specification describes some of the methods that may be employed to achieve the
requirements contained in ISO 11135-1. This document is not intended as a checklist for assessing
compliance with ISO 11135-1, rather it is intended to promote a uniform understanding and implementation of
ISO 11135-1 by providing explanations and possible methods for achieving compliance with specified
requirements. It highlights important aspects and provides examples.
This Technical Specification addresses ethylene oxide (EO) sterilization in both the industrial and health care
facility settings, and it acknowledges the similarities and differences between the two applications.
Among the similarities are the common need for quality systems, staff training, and proper safety measures.
The major differences relate to the unique physical and organizational conditions in health care facilities, and
to the initial condition of re-usable devices being presented for sterilization.
Health care facilities differ from medical device manufacturers in the physical design of processing areas, in
the equipment used, and in the availability of personnel with adequate levels of training and experience. The
primary function of the health care facility is to provide patient care; medical device reprocessing is just one of
a myriad of activities that are performed to support that function.
In terms of the initial condition of medical devices, medical device manufacturers generally sterilize large
numbers of similar devices that have been produced from virgin material. Health care facilities, on the other
hand, must handle and process both new medical devices and re-usable medical devices of different
descriptions and with varying levels of bioburden. They are therefore faced with the additional challenges of
cleaning, evaluating, preparing and packaging a medical device prior to sterilization. In this document,
alternative approaches and guidance specific to health care facilities are identified as such.
In general, moist heat sterilization (also known as steam sterilization) is the method of choice for medical
devices and supplies that are sterilized in health care facilities. However, EO gas and its mixtures are effective
sterilants that are primarily used for heat- and moisture-sensitive medical devices that cannot be steam
sterilized.
For ease of reference, the numbering in this technical specification corresponds to that in ISO 11135-1.
© ISO 2008 – All rights reserved v
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SIST-TS CEN ISO/TS 11135-2:2008
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SIST-TS CEN ISO/TS 11135-2:2008
TECHNICAL SPECIFICATION ISO/TS 11135-2:2008(E)
Sterilization of health care products — Ethylene oxide —
Part 2:
Guidance on the application of ISO 11135-1
1 Scope
This Technical Specification provides guidance for the requirements in ISO 11135-1:2007. It does not repeat
the requirements and is not intended to be used in isolation.
The exclusions in ISO 11135-1 apply also to this Technical Specification.
For ease of reference, the clause numbering in this Technical Specification corresponds to that in
ISO 11135-1:2007. Further guidance for the requirements given in ISO 11135-1 is also included in Annex C of
ISO 11135-1:2007 and should be used in conjunction with this Technical Specification.
This guidance document is intended for people who have a basic knowledge of the principles of EO
sterilization but may need help in determining how to best meet the requirements contained in ISO 11135-1.
This document is not intended for people lacking a basic knowledge of the principles of EO sterilization.
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 11135-1:2007, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for
development, validation and routine control of a sterilization process for medical devices
ISO 11138-2:2006, Sterilization of health care products — Biological indicators — Part 2: Biological indicators
for ethylene oxide sterilization processes
ISO 11140-1:2005, Sterilization of health care products — Chemical indicators — Part 1: General
requirements
ISO 11737-1, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a
population of microorganisms on products
ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 17664, Sterilization of medical devices — Information to be provided by the manufacturer for the
processing of resterilizable medical devices
© ISO 2008 – All rights reserved 1
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SIST-TS CEN ISO/TS 11135-2:2008
ISO/TS 11135-2:2008(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions in ISO 11135-1 and the following apply.
3.1
dunnage
material used to mimic all or part of a sterilization load
3.2
health care facility
set of physical infrastructure elements intended to support the delivery of specific health-related services
3.3
processing group
collection of products or product families that can be sterilized in the same EO sterilization process
NOTE All products within the group have been determined to present an equal or lesser challenge to the sterilization
process than the challenge device for that group.
3.4
EO product family
collection of products that are determined to be similar or equivalent for validation purposes
3.5
re-usable medical device
medical device designated or intended by the manufacturer as suitable for reprocessing and re-use
NOTE This is not a medical device that is designated or intended by the manufacturer for single use only.
3.6
single use medical device
medical device that is designated or intended by the manufacturer for one-time use only
3.7
sterilization specialist
person with knowledge of the sterilization technology being utilized and its effects upon materials and
microorganisms
NOTE This level of knowledge has been obtained by both practical and theoretical means and the person does not
require guidance on the basic principles of the technology involved.
4 Quality management systems
4.1 Documentation
4.1.1 No guidance offered.
4.1.2 No guidance offered.
4.2 Management responsibility
4.2.1 Each organization should establish procedures for identifying training needs and ensure that all
personnel are trained to adequately perform their assigned responsibilities.
4.2.2 No guidance offered.
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SIST-TS CEN ISO/TS 11135-2:2008
ISO/TS 11135-2:2008(E)
4.3 Product realization
4.3.1 Purchasing procedures in a health care facility should ensure that re-usable medical devices are
supplied with validated instructions for cleaning, disinfection, sterilization and aeration as specified in
ISO 17664.
4.3.2 For those facilities that do not fully comply with ISO 13485, such as health care facilities, procedures
for identification of product and maintenance of traceability, should include the labelling of each item or
package prior to sterilization with a lot control identifier that includes the following information:
a) the sterilizer ID or code;
b) the date of sterilization;
c) the cycle number (i.e. the cycle run of the day or sterilizer).
It is recommended that the identity of the person who assembled the pack also be included on the identifier, to
allow for further investigation if a problem should arise.
Lot identification information enables personnel to retrieve items in the event of a recall and to trace problems
to their source.
4.3.3 No guidance offered.
4.4 Measurement, analysis and improvement — Control of non-conforming product
No guidance offered.
5 Sterilizing agent characterization
5.1 Sterilizing agent
EO is a highly penetrative gas that will permeate most packaging materials and polymeric materials. Widely
recognized compositions include 100 % EO and blends with carbon dioxide or nitrogen. The storage
conditions for EO should be in accordance with the EO manufacturer’s recommendations and all applicable
regulations.
5.2 Microbicidal effectiveness
No guidance offered.
5.3 Materials effects
No guidance offered.
5.4 Environmental considerations
5.4.1 EO is toxic, flammable and explosive; therefore, extreme caution should be used during its storage,
handling and use.
5.4.2 Effluent gas should be discharged through an EO-gas treatment system, such as a catalytic oxidiser,
wet acid scrubber or thermal oxidiser.
When choosing a diluent, its ozone depleting potential should be taken into consideration.
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ISO/TS 11135-2:2008(E)
6 Process and equipment characterization
In health care facilities, process and equipment characterization are generally the responsibility of the sterilizer
manufacturer. The management of the health care facility should have controls in place to ensure that its
equipment purchases conform to national, regional and local regulations and are suitable for the products
intended to be sterilized. The management of the health care facility should ensure the facility has the
infrastructure necessary to operate the sterilizing equipment and to achieve sterilization of medical devices.
6.1 Process characterization
No guidance offered.
6.2 Equipment characterization
6.2.1 The following factors should be considered when characterizing the equipment.
Preconditioning equipment characterization
Preconditioning may be performed in a separate preconditioning area (chamber, cell or room). The
preconditioning area (if used) should have the following performance and monitoring capabilities:
⎯ air circulation system: adequate air circulation to ensure the uniformity of temperature and humidity in
the usable space, and to ensure that uniformity is maintained in a fully loaded room or chamber;
⎯ airflow detection equipment, alarm systems or indicators monitoring the circulation system to ensure
conformance to predetermined tolerances;
⎯ means of monitoring temperature and humidity;
⎯ means of controlling temperature and humidity;
NOTE Temperature and humidity sensor control systems may utilize redundant sensors for temperature and humidity
determination in the room.
⎯ a time clock or other means of recording time of load entry into and removal from the preconditioning
area, if applicable.
Sterilization chamber equipment characterization
The sterilization chamber should have the following performance and monitoring capabilities:
⎯ means of monitoring chamber pressure, temperature and humidity (if humidity additions are
controlled by sensor readings);
⎯ means of controlling chamber pressure, temperature and humidity, if humidity additions are
controlled by sensor readings [when sensors are fixed on the equipment, ensure that a correlation is
made during installation qualification (IQ) or operational qualification (OQ) at the coldest location];
⎯ if parametric release is used, instrumentation for the direct analysis of humidity during conditioning
and EO concentration during sterilant exposure time;
⎯ a system controlling that gaseous EO was admitted to the chamber. This can be done by measuring
the temperature of the EO gas flowing from the vaporizer to the sterilizer chamber or monitoring the
pressure rise during EO injection. This system may control EO concentration during sterilant
exposure time.
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SIST-TS CEN ISO/TS 11135-2:2008
ISO/TS 11135-2:2008(E)
Aeration equipment characterization
An aeration area (chamber, cell or room) may be used to remove EO residuals from product/packaging.
Temperature uniformity, fresh air make-up and air re-circulation throughout the area are important to ensure
consistent and reproducible results. The aeration area should have the following:
⎯ airflow detection equipment, alarm systems or indicators monitoring the air handling system to
ensure that it operates within specified parameters and maintains adequate airflow in a fully loaded
room or chamber;
⎯ equipment to re-circulate air;
⎯ means of monitoring room temperature;
⎯ means of controlling room temperature.
Prior to removing product from a sterilizer, precautions should be taken to ensure that operators are not
exposed to high levels of EO due to the outgassing of the load.
The equipment specification should be reviewed to ensure that regulatory and safety requirements are met,
technical specifications are appropriate, and services and infrastructure necessary to operate the equipment
are available.
6.2.2 Humidification by steam injection is required in ISO 11135-1, because humidifiers that operate by
dispersion of unheated water as an aerosol (e.g. spinning disc humidifiers and nebulizers) can be potent
sources of microbial contamination.
6.2.3 No guidance offered.
6.2.4 If there is an undetected failure of a control or monitoring function, a sterilization load could be
released without having met its required p
...
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