SIST-TS CEN ISO/TS 17665-2:2009
(Main)Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO 17665-2:2009)
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 (ISO 17665-2:2009)
This Technical Specification provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good practice related to moist heat sterilization processes and to assist those developing and validating a moist heat sterilization process according to ISO 17665-1. NOTE 1 The structure of the main body of this ISO Technical Specification (Clauses 1 to 12) corresponds to the structure of ISO 17665-1, so that the guidance given under a particular clause or subclause of this part of ISO 17665 applies to the requirements given in the corresponding clause or subclause of ISO 17665-1. For example, guidance for subclause 5.2 of ISO 17665-1:2006 is given in 5.2. This guidance is provided in addition to the guidance given in ISO 17665-1:2006, Annex A. See also Annexe E. NOTE 2 Special considerations specific to sterilization processes performed in health care facilities are given in Annex D.
Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Teil 2: Leitfaden für die Anwendung von ISO 17665-1 (ISO 17665-2:2009)
Diese Technische Spezifikation liefert einen allgemeinen Leitfaden zur Entwicklung, Validierung und Lenkung
der Anwendung von Sterilisationsverfahren mit feuchter Hitze und ist vorgesehen, die in ISO 17665-1
dargelegten Anforderungen zu erläutern. Der in der vorliegenden Technischen Spezifikation vorgelegte
Leitfaden ist vorgesehen, bewährte Praktiken in Bezug auf Sterilisationsverfahren mit feuchter Hitze zu
fördern und diejenigen zu unterstützen, die ein Sterilisationsverfahren mit feuchter Hitze nach ISO 17665-1
entwickeln und validieren.
ANMERKUNG 1 Die Gliederung des Hauptteils der vorliegenden Technischen Spezifikation (Abschnitt 1 bis
Abschnitt 12) entspricht der Gliederung von ISO 17665-1, daher passt der unter einem bestimmten Abschnitt von diesem
Teil von ISO 17665 gegebene Leitfaden zu den im entsprechenden Abschnitt von ISO 1776-1 aufgeführten
Anforderungen. Z. B. ist ein für Abschnitt 5.2 von ISO 17665-1:2006 gegebener Leitfaden in ISO/TS 17665-2 in 5.2 zu
finden. Dieser Leitfaden wird zusätzlich zu dem in Anhang A von ISO 17665-1:2006 gegebenen Leitfaden vorgelegt.
ANMERKUNG 2 In Anhang D werden besondere Hinweise gegeben, die speziell für Sterilisationsverfahren zutreffen,
die in der Gesundheitsfürsorge durchgeführt werden.
Stérilisation des produits de santé - Chaleur humide - Partie 2: Directives relatives à l'application de l'ISO 17665-1 (ISO 17665-2:2009)
L'ISO/TS 17665-2:2009 fournit des directives générales sur le développement, la validation et le contrôle de routine de procédés de stérilisation par chaleur humide, et vise à expliquer les exigences présentées dans l'ISO 17665-1. Les directives fournies dans l'ISO/TS 17665-2:2009 sont destinées à promouvoir les bonnes pratiques relatives aux procédés de stérilisation par chaleur humide et à faciliter le développement et la validation d'un procédé de stérilisation par chaleur humide conforme à l'ISO 17665-1.
Sterilizacija izdelkov za zdravstveno nego - Vlažna toplota - 2. del: Navodilo za uporabo ISO 17665-1 (ISO 17665-2:2009)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 17665-2:2009
01-april-2009
Sterilizacija izdelkov za zdravstveno nego - Vlažna toplota - 2. del: Navodilo za
uporabo ISO 17665-1 (ISO 17665-2:2009)
Sterilization of health care products - Moist heat - Part 2: Guidance on the application of
ISO 17665-1 (ISO 17665-2:2009)
Sterilisation von Produkten für die Gesundheitsfürsorge - Feuchte Hitze - Teil 2:
Leitfaden für die Anwendung von ISO 17665-1 (ISO 17665-2:2009)
Stérilisation des produits de santé - Chaleur humide - Partie 2: Directives relatives à
l'application de l'ISO 17665-1 (ISO 17665-2:2009)
Ta slovenski standard je istoveten z: CEN ISO/TS 17665-2:2009
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST-TS CEN ISO/TS 17665-2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TS CEN ISO/TS 17665-2:2009
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SIST-TS CEN ISO/TS 17665-2:2009
TECHNICAL SPECIFICATION
CEN ISO/TS 17665-2
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
January 2009
ICS 11.080.01
English Version
Sterilization of health care products - Moist heat - Part 2:
Guidance on the application of ISO 17665-1 (ISO 17665-2:2009)
Stérilisation des produits de santé - Chaleur humide - Sterilisation von Produkten für die Gesundheitsfürsorge -
Partie 2: Directives relatives à l'application de l'ISO 17665- Feuchte Hitze - Teil 2: Leitfaden für die Anwendung von
1 (ISO 17665-2:2009) ISO 17665-1 (ISO 17665-2:2009)
This Technical Specification (CEN/TS) was approved by CEN on 23 November 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: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 17665-2:2009: E
worldwide for CEN national Members.
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SIST-TS CEN ISO/TS 17665-2:2009
CEN ISO/TS 17665-2:2009 (E)
Contents Page
Foreword .3
2
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SIST-TS CEN ISO/TS 17665-2:2009
CEN ISO/TS 17665-2:2009 (E)
Foreword
This document (CEN ISO/TS 17665-2:2009) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" of the International Organization for Standardization (ISO) and has been
taken over as CEN/TS ISO 17665-2:2009 by Technical Committee CEN/TC 204 “Sterilization of medical
devices” the secretariat of which is held by BSI.
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 17665-2:2009 has been approved by CEN as a CEN/TS ISO 17665-2:2009 without any
modification.
3
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SIST-TS CEN ISO/TS 17665-2:2009
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SIST-TS CEN ISO/TS 17665-2:2009
TECHNICAL ISO/TS
SPECIFICATION 17665-2
First edition
2009-01-15
Sterilization of health care products —
Moist heat —
Part 2:
Guidance on the application
of ISO 17665-1
Stérilisation des produits de santé — Chaleur humide —
Partie 2: Directives relatives à l'application de l'ISO 17665-1
Reference number
ISO/TS 17665-2:2009(E)
©
ISO 2009
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SIST-TS CEN ISO/TS 17665-2:2009
ISO/TS 17665-2:2009(E)
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ii © ISO 2009 – All rights reserved
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SIST-TS CEN ISO/TS 17665-2:2009
ISO/TS 17665-2:2009(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 Quality management system elements .2
5 Sterilizing agent characterization . 2
5.1 Sterilizing agent . 2
5.2 Microbicidal effectiveness . 2
5.3 Material effects. 3
5.4 Environmental considerations . 3
6 Process and equipment characterization .3
6.1 Process . 3
6.2 Equipment . 6
7 Product definition . 7
8 Process definition. 8
9 Validation. 10
9.1 General. 10
9.2 Installation qualification (IQ) . 11
9.3 Operational qualification (OQ). 11
9.4 Performance qualification (PQ) . 13
9.5 Review and approval of the validation . 14
10 Routine monitoring and control . 15
11 Product release from sterilization. 16
12 Maintaining process effectiveness . 17
12.1 Demonstration of continued effectiveness. 17
12.2 Recalibration . 17
12.3 Maintenance of equipment . 17
12.4 Requalification . 17
12.5 Assessment of change. 18
Annex A (informative) Evaluation of a sterilization process primarily based on the measurement
of physical parameters. 19
Annex B (informative) Evaluation of a sterilization process primarily based on biological
inactivation and an accompanying mechanical air removal procedure . 27
Annex C (informative) Temperature and pressure of saturated steam for use in moist heat
sterilization . 30
Annex D (informative) Special considerations for health care settings . 32
Annex E (informative) Index of normative clauses/subclauses of ISO 17665-1 and cited references
or related guidance given in ISO 17665-1 and ISO/TS 17665-2. 41
Bibliography . 44
© ISO 2009 – All rights reserved iii
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SIST-TS CEN ISO/TS 17665-2:2009
ISO/TS 17665-2:2009(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 17665-2 was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
ISO 17665 consists of the following parts, under the general title Sterilization of health care products — Moist
heat:
⎯ Part 1: Requirements for the development, validation and routine control of a sterilization process for
medical devices
⎯ Part 2: Guidance on the application of ISO 17665-1 [Technical Specification]
iv © ISO 2009 – All rights reserved
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SIST-TS CEN ISO/TS 17665-2:2009
ISO/TS 17665-2:2009(E)
Introduction
The guidance given in this Technical Specification is not intended as a checklist for assessing compliance with
ISO 17665-1. This guidance is intended to assist in obtaining a uniform understanding and implementation of
ISO 17665-1 by providing explanations and acceptable methods for achieving compliance with specified
requirements. It highlights important aspects and provides examples. Methods other than those given in this
guidance may be used. However, the use of alternative methods has to be demonstrated to be effective in
achieving compliance with ISO 17665-1.
The main body of this document is applicable to all settings where moist heat sterilization is carried out. The
annexes to this guidance document also specify detailed means of implementing the requirements of
ISO 17665-1 and represent current best practices.
The numbering of the clauses in the main body of this Technical Specification corresponds to that in
ISO 17665-1.
Medical devices reprocessed in health care facilities include a wide variety of product with varying levels of
bioburden. Appropriate and thorough cleaning and, where necessary for safe handling, decontamination
processes are essential prior to presenting product for sterilization. Mixed product loads are common in
healthcare facilities with throughput volumes dictated by historical and predicted demand for sterile product.
Health care facilities do not normally specify sterilization processes for any individual medical device. Also, it
is impractical for health care facilities to determine bioburden on a medical device. It is important that specified
instruments be disassembled before decontamination and thoroughly inspected after completion of the
sterilization process. Reassembly and assessment of functionality are also needed. Therefore, the medical
[23]
device manufacturer's instructions (see ISO 17664 ) should be followed for all aspects of cleaning,
disinfection, packaging and sterilization. Many devices can be fully immersed and can be washed and
[19-22]
disinfected in automated equipment (see ISO 15883 ). For devices that cannot be fully immersed and
that cannot tolerate thermal decontamination, alternative methods of disinfection should be used to ensure
safe handling. Such procedures and policies should be in place to ensure that medical devices undergo
appropriate reprocessing. Particular attention needs to be paid to the drying and storage of sterile medical
[8] [9]
devices. Requirements for packaging of medical devices are covered in ISO 11607-1 and ISO 11607-2 .
If multiple sterilization cycles can lead to degradation and limit the useful life of a medical device, the
manufacturer will specify the number of reprocessing cycles that can normally be tolerated.
When selecting a medical device, priority should be given to properties such as ease of cleaning and
disassembly.
Additional guidance specific to health care is offered in Annex D of this Technical Specification.
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SIST-TS CEN ISO/TS 17665-2:2009
TECHNICAL SPECIFICATION ISO/TS 17665-2:2009(E)
Sterilization of health care products — Moist heat —
Part 2:
Guidance on the application of ISO 17665-1
1 Scope
This Technical Specification provides general guidance on the development, validation and routine control of
moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The
guidance given in this Technical Specification is provided to promote good practice related to moist heat
sterilization processes and to assist those developing and validating a moist heat sterilization process
according to ISO 17665-1.
NOTE 1 The structure of the main body of this ISO Technical Specification (Clauses 1 to 12) corresponds to the
structure of ISO 17665-1, so that the guidance given under a particular clause or subclause of this part of ISO 17665
applies to the requirements given in the corresponding clause or subclause of ISO 17665-1. For example, guidance for
subclause 5.2 of ISO 17665-1:2006 is given in 5.2. This guidance is provided in addition to the guidance given in
ISO 17665-1:2006, Annex A. See also Annexe E.
NOTE 2 Special considerations specific to sterilization processes performed in health care facilities are given in
Annex D.
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 17665-1:2006, Sterilization of health care products — Moist heat — Part 1: Requirements for the
development, validation and routine control of a sterilization process for medical devices
NOTE The normative references in ISO 17665-1 refer to published standards, the content of which should be used to
assist in demonstrating compliance to the clause in which they are cited. Some are required mainly for moist heat
sterilization in industry or for manufacturers of moist heat sterilizers and could go beyond typical practice for those
performing sterilization in health care facilities.
ISO 17665-1 specifies a number of methods and procedures that can be used to monitor sterilization
processes. The equipment required will normally be commercially available. A number of the normative
references cited describe the specification and test methods used by commercial suppliers to qualify their
products. The user of such products should ensure that purchased products comply with these standards, but
will not normally need to refer to the standards.
ISO 17665-1 specifies the use of packaging complying with ISO 11607-1 and ISO 11607-2. Healthcare
facilities should purchase packaging complying with these International Standards.
One method of process validation specified in ISO 17665-1 is based on the determination of bioburden. The
[6],[7]
ISO 11737 series specifies a number of microbiological methods used during this process. Health care
facilities would not normally utilize this approach for process validation.
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SIST-TS CEN ISO/TS 17665-2:2009
ISO/TS 17665-2:2009(E)
3 Terms and definitions
For the purposes of this Technical Specification, the terms and definitions given in ISO 17665-1 and the
following apply.
3.1
tests for sterility
technical operation defined in pharmacopoeia performed on product following exposure to a sterilization
process
4 Quality management system elements
The guidance offered in Annex A of ISO 17665-1:2006 applies.
NOTE For additional considerations specific to health care facilities, see Clause D.2.
5 Sterilizing agent characterization
5.1 Sterilizing agent
5.1.1 Moist heat is water at elevated temperatures. Moist heat may be provided as saturated steam or can
be generated in situ by applying thermal energy to water already present in the product. Moisture acts as the
medium for transferring thermal energy to microorganisms.
5.1.2 Contaminants suspended in the sterilizing agent can be both toxic and corrosive and may generate a
barrier between the microorganism and the sterilizing agent. They originate from water, that is heated or
evaporated into steam or from contact between materials and the sterilizing agent during generation and
transport to the sterilizer (see Clause 6, Clause 7 and Annex A). If the level of contaminants in the sterilizing
agent can be affected by the quality of the feed water to the steam generation system, the feed water quality
should be specified.
5.2 Microbicidal effectiveness
The microbicidal activity of moist heat is based on the temperature and the duration of contact between water
molecules and microorganisms.
For the purpose of moist heat sterilization there are a number of acceptable time and temperature
combinations recognised by some pharmacopoeias. These combinations include but are not limited to those
listed in Table 1. All combinations listed are based on the concept of overkill with a safety factor that has been
established for saturated steam or water in contact with the microorganism. Superheated steam behaves
more like a dry gas and has a low microbicidal effectiveness compared with saturated steam. Superheated
steam can result from pressure reduction and/or thermodynamic compression of saturated steam. It can also
occur from the rehydration of parts of the sterilization load, particularly those parts containing natural fibres.
Superheated steam conditions can be minimized by engineering of the steam supply system, for example by:
a) having a series of pressure reduction stages from the supply pipe to the sterilizer chamber and ensuring
the pressure reduction ratio for each stage does not exceed 2:1;
b) ensuring steam velocity does not exceed 25 m/s;
c) ensuring materials made from natural fibres are pre-conditioned to a humidity greater than 40 % RH prior
to sterilization.
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SIST-TS CEN ISO/TS 17665-2:2009
ISO/TS 17665-2:2009(E)
Table 1 — Examples of minimum temperatures and times established
for adequate levels of microbial lethality in sterilization processes
Temperature Time
°C min
121 15
126 10
134 3
5.3 Material effects
Material effects are generally limited to deformation and fracture caused by the temperatures and pressures of
the sterilizing agent.
5.4 Environmental considerations
Principles of an environmental management system can be applied to a moist heat sterilization process.
[11] [12]
ISO 14001 provides a specification for an environmental management system. ISO 14040 provides
guidance on designing a life cycle assessment study. The presence of noxious substances in the exhausts
[15]
from the sterilizer should be considered. Further guidance on this clause is given in E.3 of ISO 14937:— .
6 Process and equipment characterization
NOTE The purpose of this activity is to characterize the entire sterilization process and the equipment necessary to
deliver the sterilization process safely and reproducibly.
6.1 Process
6.1.1 General
A sterilization process should be specified for each product family and/or load configuration presented for
sterilization.
Process parameters should apply to the equipment used. They should be optimised to ensure that for defined
product families specified exposure conditions will be routinely obtained throughout the sterilizer chamber, and
the maximum temperatures and rates of change of process variable (e.g. temperature and pressure) will not
cause damage or degradation to the product.
The sterilization process specification should include all the process parameters that define the exposure
profile throughout the operating cycle. It should also include the ones used to verify reproducibility. The portion
of the operating cycle over which lethality is established should be identified, and the upper and lower limits of
each process parameter that can affect both this lethality and the performance of the medical device should
be defined.
Provision should be made to record data for judging the effectiveness and suitability of a routine sterilization
process. The accuracy of measurement should be related to the tolerances of the process parameters.
If it is proposed to use an existing sterilization process to treat a new medical device, the existing sterilization
process should be detailed and contain information and data sufficient to enable process definition
(see Clause 8) to be carried out for the proposed new medical device(s) or loading configuration. The
challenge identified for the new medical device or loading condition should be less than or equal to the
challenge from the existing sterilization load(s). For some product families, assurance that defined exposure
conditions will be reproduced might only be possible if the size of the sterilization load and the load
configuration have been clearly defined.
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SIST-TS CEN ISO/TS 17665-2:2009
ISO/TS 17665-2:2009(E)
If biological indicators and chemical indicators are to be used, they should not replace routine monitoring,
measurement of process variables and any periodic tests.
Compatibility of a new medical device to the least favourable sterilization process conditions should be
assessed. Such assessment should include process parameter tolerances, uncertainties of measurement
associated with process parameters and the quality of the services (see Annex A).
Any restrictions on the size and mass of the sterilization load and its configuration should be identified and
included in the operating instructions.
The relationship between the temperature measured at the reference measuring point and the temperature
measured in the sterilization load should be known for each product family.
The performance of a medical device can be affected by contaminants on its surface. The contaminants and
maximum acceptable concentration(s) contained in each fluid coming into contact with the medical device
should be specified and included in the sterilization process specification. Some of the contaminants and their
maximum levels which need to be considered are identified in Annex A.
6.1.2 Saturated steam processes
Steam may be generated in, or admitted to a sterilizer chamber from an external source. Air in the sterilizer
chamber will be gradually removed by gravity displacement, active flow or by forced evacuation. The presence
of saturated steam will be obtained at the measurement location, e.g. the chamber discharge, when the
measured temperature is coincident with the temperature of saturated steam calculated from the pressure
(see Annex C). Both temperature and pressure are process variables, and the point of temperature
measurement is defined as the reference measuring point.
If variations in process parameters and/or the amount of non-condensable gas remaining in the
...
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