SIST EN 14180:2014

SLOVENSKI STANDARD
oSIST prEN 14180:2012
01-september-2012
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 à usage médical - Stérilisateurs à la vapeur et au formaldéhyde à basse
température - Exigences et essais
Ta slovenski standard je istoveten z: prEN 14180 rev
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
oSIST prEN 14180:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 14180:2012

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oSIST prEN 14180:2012


EUROPEAN STANDARD
DRAFT
prEN 14180 rev
NORME EUROPÉENNE

EUROPÄISCHE NORM

June 2012
ICS 11.080.10 Will supersede EN 14180:2003+A2:2009
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 draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 102.

If this draft becomes a European Standard, 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.

This draft European Standard was established by CEN 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 CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, 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, Turkey and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 14180 rev:2012: E
worldwide for CEN national Members.

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oSIST prEN 14180:2012
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Contents Page
Foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 6
4 Technical requirements . 11
5 Process control . 21
6 Performance requirements . 24
7 Sound power and vibration . 26
8 Packaging, marking and labelling . 27
9 Information to be supplied by the manufacturer . 28
10 Service and local environment . 30
Annex A (normative) Test methods . 33
Annex B (normative) Sterilizer classification and testing . 39
Annex C (normative) Test equipment . 42
Annex D (normative) Determination of formaldehyde residuals in a filter indicator . 45
Annex E (informative) Formaldehyde residues on medical devices . 48
Annex F (informative) Environmental aspects . 50
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC on medical devices . 53
Bibliography . 59

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Foreword
This document (prEN 14180:2012) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for medical
purposes”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 14180:2003+A2:2009.
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.
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
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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. Criteria for validation and routine control of LTSF
sterilization processes are given in EN ISO 25424.
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 25424:2011,
1.2.1.
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 61010–2–040 and are not repeated in this
standard. EN 60204–1 may also give valuable guidelines.

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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
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for
its application. For dated references, only the edition cited applies. For undated references, the latest edition of the
referenced document (including any amendments) applies.
EN 764-7, Pressure equipment — Part 7: Safety systems for unfired pressure equipment
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 for terminally sterilized medical devices — Part 5: Sealable pouches and reels of porous
materials and plastic film construction — Requirements and test methods
EN 980, Symbols for use in the labelling of medical devices
EN 13445 (series), Unfired pressure vessels
EN 14222, Stainless steel shell boilers
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 61010–1:2010, Safety requirements for electrical equipment for measurement, control and laboratory use —
Part 1: General requirements (IEC 61010-1:2010)
EN 61010-2-040:2005, Safety requirements for electrical equipment for measurement, control, and laboratory
use — Part 2-040: Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
(IEC 61010-2-040:2005)
EN 61326-1:2006, Electrical equipment for measurement, control and laboratory use — EMC requirement —
Part 1: General requirements (IEC 61326-1:2005)
EN 61672-1:2003, Electroacoustics — Sound level meters — Part 1: Specifications (IEC 61672-1:2002)
EN 61672-2:2003, Electroacoustics — Sound level meters — Part 2: Pattern evaluation tests (IEC 61672-2:2003)
EN ISO 228–1, Pipe threads where pressure-tight joints are not made on the threads — Part 1: Dimensions,
tolerances and designation (ISO 228-1)
EN ISO 14971:2009, Medical devices — Application of risk management to medical devices (ISO 14971:2007)
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EN ISO 3746:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
using sound pressure — Survey method using an enveloping measurement surface over a reflecting plane
(ISO 3746:2010)
EN ISO 11138-1, Sterilization of health care products — Biological indicators — Part 1: General requirements
(ISO 11138-1)
EN ISO 11138-5, Sterilization of health care products — Biological indicators — Part 5: Biological indicators for low-
temperature steam and formaldehyde sterilization processes (ISO 11138-5)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
access device
means used to enable access to restricted parts of equipment
Note 1 to entry: This may be a dedicated key, code or tool.
3.2
aeration
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
3.5
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization process
[SOURCE: ISO/TS 11139:2006, 2.3]
3.6
chamber pre-heating
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 - completed according to programme and that the sterilized load is
ready for removal from the sterilizer chamber
[SOURCE: EN 285+A2:2009, 3.9]
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3.9
cycle parameter
specified value for a cycle variable
3.10
cycle variable
physical property that influence the efficacy of the sterilization cycle
Note 1 to entry: 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
[SOURCE: EN 285+A2:2009, 3.11]
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
period 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 1 to entry: The holding time follows immediately after the equilibration time.
3.16
inoculated carrier
supporting material on or in which a defined number of viable test organisms have been deposited
[SOURCE: EN ISO 11138-1:2006, 3.10]
3.17
installation qualification
IQ
process of obtaining and documenting evidence that equipment has been provided and installed in accordance with
its specification
[SOURCE: ISO/TS 11139:2006, 2.22]
3.18
loading door
door in a double-ended sterilizer through which the sterilizer load is put into the sterilizer chamber prior to
sterilization
[SOURCE: EN 285+A2:2009, 3.17]
Note to entry: See also 3.43 unloading door.
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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
[SOURCE: EN ISO 13485:2000, 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
[SOURCE: EN 1422:1997, 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
[SOURCE: ISO/TS 11139:2006, 2.27]
3.23
operator
person operating equipment for its intended purpose
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
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
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3.27
process challenge device
PCD
item designed to constitute a defined resistance to a sterilization process and used to assess performance of the
process
Note 1 to entry: 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.
[SOURCE: ISO/TS 11139:2006, 2.33]
3.28
production test
series of tests performed to demonstrate compliance of each sterilizer with its type test performance
3.29
reference measuring point
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
[SOURCE: ISO/TS 11139:2006, 2.40]
3.31
risk assessment
overall process comprising a risk analysis and a risk evaluation
[SOURCE: EN ISO 14971:2009, 2.18]
3.32
risk control
process in which decisions and measures are implemented by which risks are reduced to, or maintaining risks
within, specified levels
[SOURCE: EN ISO 14971: 2009, 2.19]
3.33
software validation
confirmation and provision of objective evidence that the requirements for a specific intended use or specification of
the software have been fulfilled
Note 1 to entry: ISO 9000, modified.3.34.
3.34
sterilant
microbicidal agent composed of steam containing formaldehyde
3.35
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
3.36
sterile
free from viable microorganisms
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[SOURCE: ISO/TS 11139:2006, 2.43]
3.37
sterilization
validated process used to render product free from viable microorganisms
Note 1 to entry: In a sterilization process, the nature of microbial inactivation is exponential and thus the survival of a
microorganism on an individual item can be expressed in terms of probability. While this probability can be reduced to a very low
number, it can never be reduced to zero.
[SOURCE: ISO/TS 11139:2006, 2.47]
3.38
sterilizer
apparatus designed to achieve sterilization
[SOURCE: EN 285+A2:2009, 3.35]
3.39
sterilizer chamber
part of the sterilizer which receives the sterilizer load
[SOURCE: EN 285+A2:2009, 3.36]
3.40
sterilization cycle
predetermined sequence of operating stages performed in a sterilizer for the purpose of sterilization and desorption
3.41
sterilization load
product to be, or that has been, sterilized together using a given sterilization process
[SOURCE: ISO/TS 11139:2006, 2.48]:
3.42
sterilization process
series of actions or operations to achieve the specified requirements for sterility
Note 1 to entry: This series of actions includes pre-treatment of product (if necessary), exposure under defined conditions to
the sterilizing agent and any necessary post treatment. The sterilization process does not include any cleaning, disinfection or
packaging operations that precede sterilization.
3.43
sterilization temperature
minimum temperature on which the evaluation of the sterilization efficacy is based
[SOURCE: EN 285+A2:2009, 3.33]
3.44
sterilization temperature band
temperature tolerance range for the load and the reference measuring point, the minimum of which is the
sterilization temperature
Note 1 to entry: These temperatures are usually stated in whole degrees Celsius.
[SOURCE: EN 285+A2:2009, 3.34]
3.45
theoretical sterilant temperature
temperature of the sterilant, calculated from the temperature versus vapour pressure relationship of the sterilant
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Note 1 to entry: This value is calculated from the beginning of the exposure time until the beginning of aeration.
3.46
unloading door
door in a double-ended sterilizer through which the sterilizer load is removed from the sterilizer chamber after a
sterilization cycle
[SOURCE: EN 285+A2:2009, 3.41]
Note 1 to entry: See also 3.18 loading door.
3.47
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
3.48
validation
documented procedure for obtaining recording and interpreting the results required to establish that a process will
consistently yield product complying with predetermined specifications
[SOURCE: EN ISO 11139:2006, 3.35]
3.49
verification
confirmation through provision of objective evidence that specified requirements have been fulfilled
[SOURCE: EN 62304:2006, 2.55]
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 When dissimilar metals are used in contact, this can cause contact corrosion and differential expansion.
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;
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 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 The design shall allow easy and safe maintenance of the door seal(s) according to the instructions of
the manufacturer.
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.
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 and insulating the sterilizer chamber
4.1.4.1 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.
4.1.4.2 Where hot outer surfaces of the sterilizer chamber can cause a hazard and to reduce heat transmission
to the environment, these surfaces shall be isolated, except where this will interfere the intended function of the
sterilizer. This applies as well to dedicated steam supply systems, if integral part of the sterilizer.
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 EN ISO 228-1–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.
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NOTE If national regulations require the calibration of all pressure instruments connected to the pressure vessel, test tees
and valve cocks with sealing plugs can be required to permit connection of reference instruments.
Dimensions in millimetres

a
pipe thread EN ISO 228-1 -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 EN ISO 228-1 G1A
Figure 2 — Example of thermometry entry connection

4.2 Design and construction
4.2.1 Risk control and usability
4.2.1.1 Risk assessment and risk control for sterilizer design and software shall be performed following the
procedures and requirements given in EN ISO 14971. Specific requirements and results shall be established and
documented.
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For products designed and placed on the market prior to publication of this edition of EN 14180 other standards
may apply instead of EN ISO 14971.
4.2.1.2 Risk analysis shall address the specific sterilizer design and features. Measures taken for risk reduction
shall consider aspects as user knowledge, experience, training, ergonomics and usability.
NOTE EN ISO 12100 or EN 61508-1 can provide further helpful information.
4.2.2 Safety
4.2.2.1 For general design, EN 61010–1 and EN 61010–2–040 shall apply.
NOTE 1 Additional guidance is given in EN ISO 12100.
NOTE 2 For guidance regarding specific design aspects, EN 60204–1 can apply. The guidance in EN 60204–1 can reduce
testing.
4.2.2.2 If a powered chamber door is fitted, systems shall be provided to permit the removal of persons or
objects entrapped by the moving door before the pressure, force and temperature specified in IEC 61010-2-040 are
exceeded.
NOTE Reversing the direction of the door movement is a way to achieve this.
4.2.2.3 Sterilizers shall comply with EN 61326-1 regarding electromagnetic compatibility (EMC).
Sterilizers operat
...