SIST EN 14180:2003
(Main)Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
This European Standard specifies minimum requirements:
3 for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;
for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.
Sterilisatoren für medizinische Zwecke - Niedertemperatur-Dampf-Formaldehyd-Sterilisatoren - Anforderungen und Prüfung
Anwendungsbereich
Dieser Europäische Norm-Entwurf legt Mindest-Leistungsanforderungen und Prüfverfahren für Sterilisatoren fest, in denen als Sterilisiermittel ein Gemisch von Niedertemperatur-Dampf und Formaldehyd angewendet wird.
Diese Sterilisatoren werden in erster Linie in medizinischen Einrichtungen zur Sterilisation hitzeempfindlicher Medizinprodukte verwendet.
Dieser Europäische Norm-Entwurf legt Mindest-Leistungsanforderungen für Sterilisatoren fest, die unterhalb des umgebenden Atmosphärendruckes arbeiten,
3 zur Sicherstellung, dass das Verfahren in der Lage ist, Medizinprodukte zu sterilisieren;
für die Geräte und Kontrollmaßnahmen, die für die Validierung und Routineüberwachung des Sterilisations-verfahrens erforderlich sind.
Stérilisateurs a usage médical - Stérilisateurs a la vapeur et au formaldéhyde a basse température - Exigences et essais
La présente Norme européenne spécifie les exigences et les essais relatifs aux stérilisateurs a la vapeur et au formaldéhyde a basse température, utilisant comme agent de stérilisation un mélange a basse température de vapeur d'eau et de formaldéhyde et fonctionnant uniquement a une pression inférieure a la pression atmosphérique.
Ces stérilisateurs sont utilisés en priorité pour stériliser les dispositifs médicaux thermolabiles dans les centres de soins.
La présente Norme européenne spécifie les exigences minimales :
3 de performance et de conception des stérilisateurs afin de garantir que le procédé permet de stériliser des dispositifs médicaux ;
3 pour le matériel et les systemes nécessaires aux opérations de validation et de contrôle de routine du procédé de stérilisation.
Sterilizatorji za uporabo v medicini – Sterilizatorji s paro nizke temperature in s formaldehidom – Zahteve in preskušanje
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 14180:2003
01-november-2003
Sterilizatorji za uporabo v medicini – Sterilizatorji s paro nizke temperature in s
formaldehidom – Zahteve in preskušanje
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers -
Requirements and testing
Sterilisatoren für medizinische Zwecke - Niedertemperatur-Dampf-Formaldehyd-
Sterilisatoren - Anforderungen und Prüfung
Stérilisateurs a usage médical - Stérilisateurs a la vapeur et au formaldéhyde a basse
température - Exigences et essais
Ta slovenski standard je istoveten z: EN 14180:2003
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN 14180:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN 14180:2003
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SIST EN 14180:2003
EUROPEAN STANDARD
EN 14180
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2003
ICS 11.080.10
English version
Sterilizers for medical purposes - Low temperature steam and
formaldehyde sterilizers - Requirements and testing
Stérilisateurs à usage médical - Stérilisateurs à la vapeur et Sterilisatoren für medizinische Zwecke - Niedertemperatur-
au formaldéhyde à basse température - Exigences et Dampf-Formaldehyd-Sterilisatoren - Anforderungen und
essais Prüfung
This European Standard was approved by CEN on 16 May 2003.
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,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, 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
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14180:2003 E
worldwide for CEN national Members.
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EN 14180:2003 (E)
Contents
page
Foreword.3
Introduction .4
1 Scope .4
2 Normative references .4
3 Terms and definitions.5
4 Technical requirements.10
4.1 Sterilizer chamber.10
4.2 Design and construction.12
4.3 Indicating, measuring, operating and recording devices.14
5 Process control.19
5.1 General.19
5.2 Sterilization cycle and automatic control.19
5.3 Override of automatic control.21
5.4 Fault.21
6 Performance requirements .22
6.1 Sterilizing performance .22
6.2 Desorption efficacy.23
6.3 Drying.23
7 Sound power .23
8 Marking and labelling .24
9 Information to be supplied by the manufacturer.24
10 Service and local environment.26
10.1 General.26
10.2 Electricity.26
10.3 Sterilant.26
10.4 Steam .27
10.5 Water .27
10.6 Compressed air.27
10.7 Drainage and discharges .27
10.8 Ventilation and environment.28
Annex A (normative) Test methods .29
Annex B (normative) Sterilizer classification and testing .34
Annex C (normative) Test equipment .37
Annex D (normative) Determination of formaldehyde residuals in a filter indicator.40
Annex E (informative) Formaldehyde residues on medical devices.43
Annex F (informative) Environmental aspects .45
Annex ZA (informative) Clauses of this European Standard addressing essential requirements or
other provisions of EU Directives .48
Bibliography .49
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Foreword
This document (EN 14180:2003) 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 January 2004, and conflicting national standards shall be withdrawn at the latest
by January 2004.
This document has been prepared under a mandate given to CEN by the European Commission and the European
Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative annex ZA which is an integral part of this document.
Annexes A, B, C and D are normative and form part of this European Standard.
Annexes E, F and ZA are for information only.
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, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,
Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
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Introduction
This European Standard specifies minimum requirements and test methods for sterilizers working below ambient
atmospheric pressure performing a low temperature steam and formaldehyde (LTSF) process.
LTSF sterilizers are primarily used for the sterilization of medical devices in health care facilities, but may also be
used during the commercial production of medical devices.
LTSF processes are specified by physical parameters and verified using physical, chemical and microbiological
means. The sterilizers operate automatically using pre-set cycles.
The test methods and test equipment given may also be applicable to validation and routine control.
Validation and routine control of sterilization processes are essential to ensure their efficacy. This standard does
not cover validation and routine control of a LTSF process. General criteria for validation and routine control of a
sterilization process, also applicable to LTSF sterilization processes, are given in EN ISO 14937.
At the present state of knowledge, LTSF sterilizers should not be assumed to deliver processes effectively
inactivating the causative agents of spongiform encephalopathies such as scrapie, Bovine Spongiform
Encephalophaty and Creutzfeld-Jakob Disease. Specific recommendations have been produced in particular
countries for the processing of materials potentially contaminated with these agents. (See also
EN ISO 14937:2000, 1.6 Note 2).
Planning and design of products applying to this standard should consider not only technical issues but also the
environmental impact from the product during its life-cycle. Environmental aspects are addressed in annex F of this
standard.
NOTE Risk analysis methods, e. g. in EN ISO 14971, pay attention to environmental aspects.
Specifications on operator safety are addressed in EN 61010–1, EN 61010–2–042 and are not repeated in this
standard. EN 60204–1 may also give valuable guidelines.
1 Scope
This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low
temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
This European Standard specifies minimum requirements:
for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical
devices;
for the equipment and controls of these sterilizers necessary for the validation and routine control of the
sterilization processes.
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 in it by amendment or revision. For undated references the latest edition of the
publication referred to applies (including amendments).
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1
EN 866–1, Biological systems for testing sterilizers and sterilization processes — Part 1: General requirements.
EN 866–5, Biological systems for testing sterilizers and sterilization processes — Part 5: Particular systems for use
2
in low temperature steam and formaldehyde sterilizers.
EN 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.
EN 868–5, Packaging materials and systems for medical devices which are to be sterilized — Parts 5: Heat and
self-sealable pouches and reels of paper and plastic film construction — Requirements and test methods.
EN 60584–2, Thermocouples — Part 2: Tolerances (IEC 60584–2:1982 + A1:1989).
EN 60751, Industrial platinum resistance thermometer sensors (IEC 60751:1983 + A1:1986).
EN 61010–1, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 1:
General requirements (IEC 61010-1:2001).
EN 61010–2–042:1997, Safety requirements for electrical equipment for measurement, control and laboratory
use — Part 2–042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of
medical materials, and for laboratory processes (IEC 61010–2–042:1997).
EN 61326:1997, Electrical equipment for measurement, control and laboratory use — EMC requirements
(IEC 61326:1997).
EN ISO 3746, Acoustics — Determination of sound power levels of noise sources using sound pressure — Survey
method using an enveloping measurement surface over a reflecting plane (ISO 3746:1995).
ISO 228–1, Pipe threads where pressure-tight joints are not made on the threads — Part 1: Dimensions, tolerances
and designation.
3 Terms and definitions
For the purposes of this European Standard, the following terms and definitions apply.
3.1
access device
means used to enable access to restricted parts of equipment
NOTE This may be a dedicated key, code or tool.
3.2
aeration
a part or parts of the sterilization process in which defined conditions are used such that formaldehyde and its
reaction products are desorbed from the medical device, and which can be performed within the sterilizer, within a
separate room or chamber, or by a combination of the two
3.3
air removal
removal of air from the sterilizer chamber and sterilization load to facilitate sterilant penetration
3.4
automatic controller
device that, in response to pre-determined cycle variables, operates the sterilizer sequentially through the required
stages of the operating cycle
1
Under revision, see new edition of ISO 11138 series which is currently being prepared by ISO/TC 198, Vienna Agreement.
2
Under revision, see new edition of ISO 11138 series which is currently being prepared by ISO/TC 198, Vienna Agreement.
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3.5
biological indicator
an inoculated carrier contained within its primary pack ready for use
[EN 866–1:1997, definition 3.1]
3.6
chamber pre-heating
the heating of inner sterilizer-chamber surfaces to achieve predetermined temperatures prior to the commencement
of a sterilization cycle
3.7
conditioning
treatment of product within the sterilization cycle, but prior to the holding time, to attain a predetermined
temperature and humidity throughout the sterilization load
3.8
cycle complete
indication that the operating cycle has been satisfactorily completed and that the sterilized load is ready for removal
from the sterilizer chamber
[EN 285:1996, definition 3.10]
3.9
cycle parameter
specified value for a cycle variable
3.10
cycle variables
the physical properties that influence the efficacy of the sterilization cycle
NOTE For LTSF-sterilizers, the cycle variables include, but may not be limited to temperature, pressure, time, sterilant
concentration.
3.11
desorption
removal of the sterilant from the chamber and the load at the end of the exposure time
3.12
double-ended sterilizer
sterilizer in which there is a door at each end of the sterilizer chamber
[EN 285:1996, definition 3.13]
3.13
equilibration time
period which elapses between the attainment of the sterilization temperature at the reference measuring point and
the attainment of the sterilization temperature at all points within the load
3.14
exposure time
time between introducing the sterilant into the chamber and the start of the desorption phase
3.15
holding time
period for which the temperature, the steam pressure and the formaldehyde concentration of the steam are held
within pre-set values and their tolerances to achieve the required inactivation efficacy in the sterilizer chamber
NOTE The holding time follows immediately after the equilibration time.
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3.16
inoculated carrier
a carrier on which a defined number of test organisms has been deposited
[EN 866-1:1997, definition 3.8]
3.17
installation qualification
IQ
obtaining and documenting evidence that equipment has been provided and installed in accordance with its
specification
[EN ISO 14937:2000, definition 3.9]
3.18
loading door
door in a double-ended sterilizer through which the sterilizer load is put into the sterilizer chamber prior to
sterilization
[EN 285:1996, definition 3.21] (See also 3.43 unloading door)
3.19
medical device
any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the
software necessary for its proper application, intended by the manufacturer to be used for human beings for the
purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of, disease,
diagnosis, monitoring, treatment, alleviation of or compensation for, an injury or handicap,
investigation, replacement or modification of the anatomy or of a physiological process,
control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
[EN ISO 13485:2000, definition 3.1]
3.20
microbicidal solution
aqueous solution containing formaldehyde to feed the vaporiser for generating sterilant in the sterilizer
3.21
operating cycle
the automatic sequence of operating stages performed in a sterilizer
[EN 1422:1997, definition 3.24]
3.22
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined limits when
used in accordance with its operational procedures
[EN ISO 14937:2000, definition 3.12]
3.23
operator
person operating equipment for its intended purpose
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3.24
override
means intended only for maintenance or safety, by which the operating cycle can be interrupted or modified
3.25
post-cycle flushing
stage after "cycle complete" indication, during which the sterilization load is left in the closed chamber and the
internal chamber atmosphere is exchanged
3.26
pressure vessel
a vessel consisting of the sterilizer chamber, door(s) and other components that form a permanent unit with the
sterilizer chamber and that are pressurised by the same pressure
3.27
process challenge device
item designed to simulate product and used to assess the penetration performance of the sterilization cycle
NOTE The device is so constituted that a biological or chemical indicator can be put in the place which is the most difficult
to reach by sterilizing agent(s).The indicator should not interfere with the function of the process challenge device.
3.28
production test
series of tests performed to demonstrate compliance of each sterilizer with its type test performance
3.29
reference measuring point
the point where the temperature sensor for the sterilization cycle control is located
3.30
requalification
repetition of part of validation for the purpose of confirming the continued acceptability of a specified process
[EN ISO 14937:2000, definition 3.20]
3.31
sterilant
microbicidal agent composed of steam containing formaldehyde
3.32
sterilant injection
single or repeated stage beginning with the introduction of sterilant into the evacuated sterilizer chamber and
ending when the set operating pressure has been attained
3.33
sterile
free from viable micro-organisms
[EN ISO 14937:2000, definition 3.23]
3.34
sterilization
validated process used to render a product free from viable micro-organisms
NOTE In a sterilization process the nature of microbial inactivation is described by an exponential function. Therefore the
presence of a viable micro-organism on any individual item can be expressed in terms of probability. This probability may be
reduced to a very low number, it can never be reduced to zero.
3.35
sterilizer
apparatus designed to achieve sterilization
[EN 285:1996, 3.36]
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3.36
sterilizer chamber
that part of the sterilizer, which receives the sterilizer load
[EN 285:1996, definition 3.37]
3.37
sterilization cycle
predetermined sequence of operating stages performed in a sterilizer for the purpose of sterilization and desorption
3.38
sterilization load
items that are to be, are being or have been sterilized simultaneously in one sterilizer chamber
3.39
sterilization process
series of actions or operations to achieve the specified requirements for sterility and for reduction of sterilant
residues to an acceptable level
NOTE This series of actions or operations includes pre-treatment (if necessary), exposure to the sterilizing agent under
defined conditions, and any necessary post-treatment. It does not include any necessary operations preceding the sterilization
process, such as cleaning, disinfection or packaging.
3.40
sterilization temperature
minimum temperature of the sterilization temperature band on which the evaluation of the sterilization efficacy is
based
3.41
sterilization temperature band
temperature tolerance range for the load and the reference measuring point, the minimum of which is the
sterilization temperature
3.42
theoretical sterilant temperature
the temperature of the sterilant, calculated from the temperature versus vapour pressure relationship of the sterilant
NOTE This value is calculated from the beginning of the exposure time until the beginning of aeration.
3.43
unloading door
door in a double-ended sterilizer through which the sterilizer load is removed from the sterilizer chamber after a
sterilization cycle
[EN 285:1996, definition 3.42] (See also 3.18 loading door)
3.44
usable space
space inside the sterilizer chamber, which is not restricted by fixed parts and which is, according to the
manufacturer’s specification, available to accept the sterilization load
3.45
validation
documented procedure for obtaining recording and interpreting the results required to establish that a process will
consistently yield product complying with predetermined specifications
[EN ISO 14937:2000, definition 3.32]
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4 Technical requirements
4.1 Sterilizer chamber
4.1.1 Materials
4.1.1.1 The surfaces of the materials for the pressure vessel (including, for example, welds) that can come into
contact with process chemicals shall be of materials which, under the designed operating conditions, are not
impaired by these chemicals. They shall not release any substances known to be toxic in such quantities that can
create a health or environmental hazard.
NOTE In the selection of materials for pressure parts and their integral attachments, due attention should be paid to the
effects of contact corrosion and differential expansion when dissimilar metals are used in contact.
4.1.1.2 Materials for sterilizer furniture including load supporting systems shall be selected to avoid corrosion
and galvanic attack.
4.1.2 Chamber size
For the usable space the following dimensions shall be specified in millimetres, as applicable:
a) For cylindrical horizontal or cylindrical vertical usable spaces: 000 x 000 in which:
the first three digits give the diameter of the usable space; and
the last three digits give the depth of the usable space.
b) For rectangular parallelepiped usable spaces: 000 x 000 x 000 in which:
the first three digits give the width of the usable space;
the next three digits give the height of the usable space; and
the final three digits give the depth of the usable space.
c) For other configurations the usable space shall be specified in analogy to a) or b).
d) If any dimension exceeds 1000 mm then four digits shall be used, without a decimal point.
4.1.3 Doors and interlocks of the sterilizer chamber
4.1.3.1 Sterilizer chambers shall be provided with one or two doors.
4.1.3.2 After closing the sterilizer door, it shall be possible to open it before a cycle has been started.
4.1.3.3 It shall not be possible to open a sterilizer door(s) during a cycle.
4.1.3.4 In case of an interrupted cycle (e. g. due to a fault), opening of the sterilizer door e. g. to gain access to
the load shall require the use of an access device.
4.1.3.5 Means shall be provided to allow access to sealing surfaces for cleaning purposes and for replacing
the door seal(s).
4.1.3.6 For double-ended sterilizers it shall not be possible to open the unloading door until a "cycle complete"
indication is obtained.
4.1.3.7 For operating cycles dedicated for test or maintenance purposes only, the cycle complete indication
shall be different from that of a normal sterilization cycle. For double-ended sterilizers such cycle complete
indications shall not permit the unloading door to be opened.
4.1.3.8 The control used to start the automatic operating cycle shall be located at the loading side of the
sterilizer.
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4.1.3.9 Except for maintenance purposes it shall not be possible to open both doors simultaneously on double-
ended sterilizers.
4.1.3.10 For double-ended sterilizers both ends of the sterilizer shall be fitted with a device to indicate whether
the door at that end can be opened.
4.1.3.11 The indication "cycle complete" shall be cancelled when a door is opened. For double-ended sterilizers
the loading door shall remain locked until the unloading door has been opened, closed and locked again.
4.1.4 Heating the sterilizer chamber
Inner sterilizer chamber surfaces shall be heated to achieve pre-set temperatures. Initiation of the sterilization cycle
shall not be possible until this condition has been fulfilled.
4.1.5 Test connections
4.1.5.1 The sterilizer chamber shall be provided with a test connection, which is used for the connection of a
test pressure measuring instrument. This connection shall be at a point of easy access, but not in a pipe for media
transport or evacuation, and shall terminate in a pipe thread ISO 228 –G1/2A. An example is given Figure 1.
The test connection shall be provided with a cap marked PT (Pressure Test) and sealed with a sterilant proof and
mechanically resistant O-ring seal or flat seal.
NOTE If national regulations require the calibration of all pressure instruments connected to the pressure vessel, test tees
and valve cocks with sealing plugs may be required to permit connection of reference instruments.
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Dimensions in millimetres
a
pipe thread ISO 228-G1/2A
Figure 1 — Example of the connection for test instruments
4.1.5.2 The sterilizer chamber shall be provided with a straight thermometry entry connection. An example is
given in Figure 2. This connection shall be at a point of easy access.
The connection shall be provided with a cap marked TT (Temperature Test) and sealed with a sterilant proof and
mechanically resistant O-ring seal or flat seal.
Dimensions in millimetres
a
pipe thread ISO 228-G1A
Figure 2 — Example of thermometry entry connection
4.2 Design and construction
4.2.1 General
A Council Directive on the approximation of the laws of the member states concerning pressure equipment was
released on 29 May 1997 (97/23/EC) and corresponding European Standards EN 13445 and EN 14222, may
apply.
4.2.2 Pipework and fittings
4.2.2.1 Pipeworks and
...
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