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oSIST prEN 17180:2018
01-februar-2018
Sterilizatorji za uporabo v medicini - Sterilizatorji s paro z nizko temperaturo in z
vodikovim peroksidom - Zahteve in preskušanje
Sterilizers for medical purposes - Low temperature vaporized hydrogen peroxide
sterilizers - Requirements and testing
Sterilisatoren für medizinische Zwecke - Niedertemperatur-Sterilisatoren mit
verdampftem Wasserstoffperoxid - Anforderungen und Prüfverfahren
Stérilisateurs à usage médical - Stérilisateurs à la vapeur de peroxyde d’hydrogène à
basse température - Exigences et essais
Ta slovenski standard je istoveten z: prEN 17180
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
oSIST prEN 17180:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 17180:2018
DRAFT
EUROPEAN STANDARD
prEN 17180
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2017
ICS 11.080.10
English Version
Sterilizers for medical purposes - Low temperature
vaporized hydrogen peroxide sterilizers - Requirements
and testing
Stérilisateurs à usage médical - Stérilisateurs à la Sterilisatoren für medizinische Zwecke -
vapeur de peroxyde d'hydrogène à basse température - Niedertemperatur-Wasserstoffperoxid-Sterilisatoren -
Exigences et essais Anforderungen und Prüfverfahren
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, 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
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17180:2017 E
worldwide for CEN national Members.
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Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 7
4 Mechanical components and assemblies . 14
4.1 Materials . 14
4.2 Sterilizer chamber . 14
4.2.1 Chamber size . 14
4.2.2 Doors and interlocks of the sterilizer chamber . 14
4.2.3 Heating and insulating the sterilizer chamber . 15
4.2.4 Test connections . 15
4.3 Pipework and fittings . 16
4.4 H O vaporizer . 16
2 2
4.5 Evacuation system . 17
4.6 Gas admission system . 17
4.7 Framework and panelling . 17
4.8 Accessories . 18
4.9 Transport . 18
5 Instrumentation, indicating and recording devices . 18
5.1 General. 18
5.2 Instrumentation . 18
5.3 Status indicators. 19
5.4 Measuring chains and time equipment . 20
5.4.1 Temperature probes . 20
5.4.2 Temperature measuring chains for control, independent data collection and
indication . 20
5.4.3 Pressure measuring chains for control, independent data collection and indication . 20
5.4.4 Monitoring system for hydrogen peroxide . 21
5.4.5 Time measuring chains for indication, control and recording . 21
5.4.6 Operating cycle counter . 21
5.5 Recording systems and data processing. 21
5.5.1 General. 21
5.5.2 Records . 23
5.5.3 Independent Data Collection and Processing . 25
6 Control systems . 26
6.1 General. 26
6.2 Software verification and validation . 27
6.3 Operating cycle and automatic control . 27
6.4 Override of automatic control . 30
6.5 Fault and fault indication . 30
7 Performance requirements . 31
7.1 General. 31
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7.2 Physical conditions . 32
7.2.1 Temperature reference measurement point . 32
7.2.2 Sterilization temperature band . 32
7.2.3 Temperature profile . 32
7.2.4 Temperature profile requirements . 32
7.2.5 Pressure profile . 33
7.2.6 Pressure profile requirements . 33
7.3 Sterilant . 33
7.4 Lethality (microbiological efficacy) . 34
7.4.1 General . 34
7.4.2 Reduced cycle concept . 34
7.4.3 Microbiological efficacy . 35
7.5 Efficacy of H O removal . 35
2 2
7.6 Load dryness . 36
8 Safety, Risk control and usability . 36
8.1 Risk control and usability . 36
8.2 Safety . 36
8.2.1 General . 36
8.2.2 Electromagnetic compatibility . 36
8.2.3 Protective measures . 37
8.3 Sound power and vibration . 38
9 Packaging, marking and labelling . 38
10 Information to be supplied by the manufacturer . 39
11 Services and local environment . 42
11.1 General . 42
11.2 Electricity . 42
11.3 Sterilant . 42
11.4 Water . 42
11.5 Compressed air . 43
11.6 Drainage and discharges . 43
11.7 Ventilation and environment . 43
11.8 Lighting . 43
Annex A (informative) Sterilizer classification and test programme . 44
Annex B (normative) Test equipment . 48
Annex C (normative) Test loads . 61
Annex D (normative) Test procedures. 64
Annex E (informative) Measurement of hydrogen peroxide . 73
Annex F (informative) H O residues on medical devices. 78
2 2
Annex G (normative) Protective measures . 80
Annex H (informative) Environmental aspects . 82
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 83
Bibliography . 84
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European foreword
This document (prEN 17180:2017) 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 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.
This document is a working document provided by DIN mirror group for gas sterilizer as a new work
item proposal.
The following referenced documents are indispensable for the application of this document. For
undated references, the edition of the referenced document (including any amendments) listed below
applies. For dated references, only the edition cited applies. However, for any use of this standard
within the meaning of Annex ZA, the user should always check that any referenced document has not
been superseded and that its relevant contents can still be considered the generally acknowledged
state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Correlation between normative references and dated EN and ISO standards
Equivalent dated standard
Normative references as listed
in Clause 2 of the ISO standard
EN ISO
ISO 2861 --- ISO 2861:2013
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Introduction
This European Standard specifies minimum requirements and test methods for sterilizers processing,
typically, below 80 °C, performing a low temperature sterilization process using a composition of water
O ) as sterilizing agent, vaporized and injected into the sterilizer chamber.
and hydrogen peroxide (H2 2
Vaporized hydrogen peroxide (VH O ) sterilizers are primarily used for the sterilization of thermolabile
2 2
medical devices in health care facilities, but can also be used during commercial production of medical
devices.
Like the other standardized low temperature sterilization processes using ethylene oxide (see EN 1422
and EN ISO 11135) or low temperature steam and formaldehyde (see EN 14180 and EN ISO 25424) the
VH O sterilization processes are specified by physical and chemical parameters and verified using
2 2
physical, chemical and microbiological means [ref]. The sterilizers operate automatically using pre-set
cycles.
The test methods and test equipment given could 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 VH O sterilization process. Harmonized
2 2
standards providing specific requirements for validation and routine control of VH O sterilization
2 2
processes are currently not available. EN ISO 14937 can provide general requirements and guidance on
how to perform validation and routine control of such processes.
Some VH O sterilizers have processes that demonstrate some level of inactivation of the causative
2 2
agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and
Creutzfeldt-Jakob Disease. However, this inactivation is process, cycle and test protocol specific, and not
equipment specific, therefore this inactivation is outside the scope of this European Standard, and no
specific test methods are provided [ref].
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 H of this standard.
NOTE Specifications on operators safety are addressed in EN 61010-1, EN 61010-2-040 and are not repeated
in this standard. FprEN 60204-1 can also apply (see Annex G).
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1 Scope
This European Standard specifies requirements and tests for low temperature hydrogen peroxide
sterilizers, which use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent.
These sterilizers are used for the sterilization of medical devices, particularly thermolabile medical
devices.
This European Standard specifies minimum requirements
• for the performance and design of sterilizers intended to deliver a process capable of sterilizing
medical devices;
• for the equipment and controls of these sterilizers needed for operation, control and monitoring, and
which can be used for validation of the sterilization processes;
• for the test equipment and test procedures used to verify the sterilizer performance specified by this
European Standard.
This European Standard does not specify requirements for equipment intended to process liquids,
biological waste or human tissues.
This European Standard does not describe a quality management system for the control of all stages of
the manufacture of the sterilizer.
This European Standard does not specify requirements and tests for decontamination systems for use
in rooms, enclosures or environmental spaces.
NOTE 1 Attention is drawn to the standards for quality management, e.g. EN ISO 13485.
NOTE 2 Environmental aspects of this standard are addressed in Annex H.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
EN 867-5:2001, 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 868-5:2009, Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of
porous materials and plastic film construction - Requirements and test methods
EN 868-9:2009, Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven
materials of polyolefines - Requirements and test methods
FprEN 60204-1:2016, Safety of machinery - Electrical equipment of machines - Part 1: General
requirements (IEC/FDIS 60204-1:2016)
EN 60584-1:2013, Thermocouples - Part 1: EMF specifications and tolerances (IEC 60584-1:2013)
EN 60751:2008, Industrial platinum resistance thermometers and platinum temperature sensors (IEC
60751:2008)
EN 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory
use - Part 1: General requirements IEC 61010-1:2010)
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EN 61010-2-040:2015, 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 61010-2-040:2015)
EN 61326-1:2013, Electrical equipment for measurement, control and laboratory use - EMC requirements
- Part 1: General requirements (IEC 61326-1:2012)
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 11138-1:2017, Sterilization of health care products - Biological indicators - Part 1: General
requirements (ISO 11138-1:2017)
EN ISO 11607-1:2009/A1:2014, Packaging for terminally sterilized medical devices — Part 1:
Requirements for materials, sterile barrier systems and packaging systems
(ISO 11607-1:2006/Amd 1:2014)
EN ISO 11607-2:2009/A1:2014, Packaging for terminally sterilized medical devices — Part 2: Validation
requirements for forming, sealing and assembly processes (ISO 11607-2:2006/Amd 1:2014)
EN ISO 14937:2009, Sterilization of health care products - General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices (ISO 14937:2009)
EN ISO 14971:2012, Medical devices - Application of risk management to medical devices (ISO
14971:2007, Corrected version 2007-10-01)
EN ISO 15223-1:2016, Medical devices - Symbols to be used with medical device labels, labelling and
information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)
ISO 2861:2013, Vacuum technology - Dimensions of clamped-type quick-release couplings
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1
aeration
part of the sterilization cycle during which the sterilizing agent and/or its reaction products desorb
from the medical device until predetermined levels are reached
[SOURCE: prEN ISO 11139:2017, term 3.7]
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3.2
automatic controller
device that directs the equipment sequentially through required stages of the cycle in response to
programmed cycle parameters
[SOURCE: prEN ISO 11139:2017, term 3.18]
3.3
biological indicator
test system containing viable microorganisms providing a defined resistance to a specified sterilization
process
[SOURCE: prEN ISO 11139:2017, term 3.29]
3.4
chamber
part of equipment in which a load is processed
[SOURCE: prEN ISO 11139:2017, term 3.36]
3.5
chamber pre-heating
raising the temperature of internal chamber surfaces prior to the commencement of an operating cycle
[SOURCE: prEN ISO 11139:2017, term 3.37]
3.6
conditioning
treatment of product prior to the exposure phase to attain a specified temperature, relative humidity, or
other process variable throughout the load
[SOURCE: prEN ISO 11139:2017, term 3.57]
3.7
cycle complete
message from the automatic controller that the operating cycle has ended successfully
[SOURCE: prEN ISO 11139:2017, term 3.72]
3.8
cycle parameter
value of a cycle variable including its tolerances used for control, monitoring, indication and recording
of an operating cycle
[SOURCE: prEN ISO 11139:2017, term 3.74]
3.9
cycle variable
property used to control, monitor, indicate, or record an operating cycle
Note 1 to entry: For VH2O2-sterilizers, the cycle variables include, but are not necessarily limited to
temperature, pressure, time, Sterilant concentration.
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[SOURCE: prEN ISO 11139:2017, term 3.76]
3.10
desorption
removal of the sterilizing agent from the chamber and the load at the end of the exposure phase
[SOURCE: prEN ISO 11139:2017, term 3.80]
3.11
double-ended
having separate doors for loading and unloading in separate areas
[SOURCE: prEN ISO 11139:2017, term 3.92]
3.12
fault
situation in which one or more of the process or cycle parameters is/are outside its/their specified
tolerance(s)
[SOURCE: prEN ISO 11139:2017, term 3.116]
3.13
holding time
period during which process parameters are maintained in the load, within their specified tolerances
[SOURCE: prEN ISO 11139:2017, term 3.133]
3.14
installation qualification
IQ
process of establishing by objective evidence that all key aspects of the process equipment and ancillary
system installation comply with the approved specification
[SOURCE: prEN ISO 11139:2017, term 3.223.2]
3.15
load
product, equipment or materials to be processed together within an operating cycle
[SOURCE: prEN ISO 11139:2017, term 3.155]
3.16
measuring chain
series of elements of a measuring instrument or measuring system, which constitutes the path of the
measurement signal from the input (quantity subject to measurement) to the output (the result of the
measurement)
[SOURCE: prEN ISO 11139:2017, term 3.165]
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3.17
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use or calibrator,
software, material or other similar related article, intended by the manufacturer to be used, alone or i
...