prEN 17180

Sterilizers for medical purposes - Low temperature vaporized hydrogen peroxide sterilizers - Requirements and testing

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.

Sterilisatoren für medizinische Zwecke - Niedertemperatur-Sterilisatoren mit verdampftem Wasserstoffperoxid - Anforderungen und Prüfverfahren

Diese Europäische Norm legt Anforderungen an und Prüfverfahren für Niedertemperatur Wasserstoff-peroxid Sterilisatoren fest, in denen als sterilisierendes Agens eine verdampfte wässrige Lösung von Wasserstoffperoxid verwendet wird.
Diese Sterilisatoren werden zur Sterilisation von Medizinprodukten, insbesondere von thermolabilen Medizinprodukten, verwendet.
Diese Europäische Norm legt Mindest Anforderungen zu folgenden Punkten fest,
-   an die Leistung und Konstruktion von Sterilisatoren, um ein Verfahren bereitzustellen, das in der Lage ist, Medizinprodukte zu sterilisieren;
-   an die Ausrüstung und Regel  und Steuergeräte (RS) dieser Sterilisatoren, die für den Betrieb, die Steuerung und Überwachung erforderlich sind und die bei der Validierung der Sterilisationsverfahren angewendet werden können;
-   an die Prüfgeräte und Prüfverfahren, die zur Verifizierung der nach dieser Europäischen Norm festgelegten Leistung des Sterilisators angewendet werden.
Diese Europäische Norm legt keine Anforderungen an Geräte fest, die für die Aufbereitung von Flüssigkeiten, Bioabfall oder menschlichen Geweben vorgesehen sind.
Diese Europäische Norm beschreibt kein Qualitätsmanagementsystem für die Lenkung aller Stufen der Herstellung des Sterilisators.
Diese Europäische Norm legt keine Anforderungen an und Prüfungen für Dekontaminationssysteme zur Verwendung in Räumen, umschlossenen Räumen oder umgebenden Räumen fest.
ANMERKUNG 1   Es wird auf die Normen zum Qualitätsmanagement verwiesen, z. B. EN ISO 13485.
ANMERKUNG 2   Umweltaspekte dieser Norm werden in Anhang H behandelt.

Stérilisateurs à usage médical - Stérilisateurs à la vapeur de peroxyde d’hydrogène à basse température - Exigences et essais

La présente Norme européenne spécifie des exigences et des essais pour les stérilisateurs au peroxyde d’hydrogène à basse température qui utilisent une solution aqueuse vaporisée de peroxyde d’hydrogène comme agent stérilisant.
Ces stérilisateurs sont utilisés pour la stérilisation de dispositifs médicaux, notamment des dispositifs médicaux thermosensibles.
La présente Norme européenne spécifie les exigences minimales :
-   de performances et de conception des stérilisateurs destinés à fournir un procédé capable de stériliser des dispositifs médicaux ;
-   pour les équipements et commandes de ces stérilisateurs nécessaires à leur fonctionnement, leur pilotage et leur surveillance et qui peuvent être utilisés pour la validation des procédés de stérilisation ;
-   pour l’équipement d’essai et les modes opératoires d’essai utilisés pour vérifier les performances du stérilisateur spécifiées par la présente Norme européenne.
La présente Norme européenne ne spécifie par d’exigences pour les équipements destinés à traiter des liquides, des déchets biologiques ou des tissus humains.
La présente Norme européenne ne décrit pas de système de management de la qualité pour le pilotage de toutes les étapes de la fabrication des stérilisateurs.
La présente Norme européenne ne spécifie par d’exigences ni d’essais concernant les systèmes de décontamination destinés à être utilisés dans des salles, des enceintes ou des espaces environnementaux.
NOTE 1   L’attention est attirée sur les normes relatives au management de la qualité, par exemple l’EN ISO 13485.
NOTE 2   Les aspects environnementaux de la présente norme sont abordés dans l’Annexe H.

Sterilizatorji za uporabo v medicini - Sterilizatorji s paro z nizko temperaturo in z vodikovim peroksidom - Zahteve in preskušanje

General Information

• Status: Not Published
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 6 - Gas sterilizers
• Current Stage: 4098 - Decision to abandon - Enquiry
• Completion Date: 29-Mar-2019
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: oSIST prEN 17180:2018 - Sterilizers for medical purposes - Low temperature vaporized hydrogen peroxide sterilizers - Requirements and testing

Overview

prEN 17180 - Sterilizers for medical purposes: Low temperature vaporized hydrogen peroxide (VHP) sterilizers - Requirements and testing is a CEN draft European Standard that specifies minimum requirements, performance criteria and test methods for sterilizers that use a vaporized aqueous solution of hydrogen peroxide as the sterilizing agent. It covers machines typically operating below 80 °C for sterilizing medical devices, especially thermolabile items, and defines what is needed to verify sterilization performance through physical, chemical and microbiological means.

Key topics and requirements

The standard addresses the full technical scope needed to design, operate and verify VHP sterilizers, including:

• Performance and design: chamber construction, door/interlocks, heating and insulation, pipework and fittings, vaporizers and evacuation systems.
• Instrumentation & monitoring: temperature and pressure probes, H2O2 monitoring systems, status indicators, recording systems and independent data collection.
• Control systems and software: automatic cycle controls, software verification/validation, overrides, fault detection and user interfaces.
• Sterilization process requirements: physical conditions (temperature/pressure profiles), sterilant specification, lethality/microbiological efficacy concepts (including reduced-cycle considerations) and H2O2 removal/efficacy checks.
• Testing and validation: normative annexes provide test equipment lists, defined test loads and prescriptive test procedures for performance verification and routine control.
• Safety, risk control and usability: protective measures, EMC, sound/vibration and operator safety requirements.
• Labelling, documentation and services: manufacturer information, packaging, electrical/water/air requirements, drainage and ventilation.
• Environmental aspects: informative Annex H addresses environmental considerations and emissions.

The standard explicitly excludes equipment for processing liquids, biological waste or human tissues and does not replace a manufacturer’s comprehensive quality management system.

Practical applications and users

prEN 17180 is targeted at:

• Medical device sterilizer manufacturers - design, testing and type-approval of VHP sterilizers.
• Sterile processing departments in hospitals and clinics - selecting, validating and operating low-temperature VHP sterilizers for thermolabile instruments.
• Validation engineers and QA/QC laboratories - developing validation protocols, routine monitoring and performance testing.
• Regulatory and procurement teams - assessing conformity with European requirements and specifying procurement criteria.

Using the standard supports safe, reproducible low-temperature sterilization, compliance with regulatory expectations and robust validation/routine control practices.

Related standards

• EN ISO 13485 (quality management for medical devices) - referenced for quality aspects.
• Other low-temperature sterilization standards (for context): EN 1422, EN ISO 11135 (ethylene oxide), EN 14180, EN ISO 25424 (steam/formaldehyde processes).

Keywords: low temperature vaporized hydrogen peroxide sterilizers, VHP sterilizers, prEN 17180, sterilization validation, sterilizer performance testing, thermolabile medical devices.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
EUROPEAN STANDARD
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.

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
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

prEN17180:2017 (E)
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
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).
prEN17180:2017 (E)
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)
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]
prEN17180:2017 (E)
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.
[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]
prEN17180:2017 (E)
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 in
combination, for human beings for one or more of the specific medical purpose(s) of:
• diagnosis, prevention, monitoring, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
• investigation, replacement, modification or support of the anatomy or of a physiological process;
• supporting or sustaining life;
• control of conception;
• disinfection of medical devices;
• providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic
means, but which may be assisted in its intended function by such means
Note 1 to entry: Products which may be considered to be medical devices in some jurisdictions but not in others
include:
• items specifically intended for cleaning or sterilization of medical devices;
• pouches, reel goods, sterilization wrap, and reusable containers for packaging of medical devices for
sterilization;
• disinfection substances;
• aids for persons with disabilities;
• devices incorporating animal and/or human tissues;
• devices for in vitro fertilization or assisted reproduction technologies.
[SOURCE: prEN ISO 11139:2017, term 3.166]
3.18
monitoring
continual checking, supervising, critically observing or determining the status in order to identify
change from the performance level required or expected
[SOURCE: prEN ISO 11139:2017, term 3.180]
3.19
operating cycle
complete set of stages of a process, carried out in a specified sequence
[SOURCE: prEN ISO 11139:2017, term 3.188]
3.20
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: prEN ISO 11139:2017, term 3.223.3]
3.21
override
system by which an operating cycle can be interrupted or modified as necessary
[SOURCE: prEN ISO 11139:2017, term 3.191]
3.22
process challenge device
PCD
item providing a defined resistance to a cleaning, disinfection, or 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) and does not interfere with the function of the process
challenge device.
[SOURCE: prEN ISO 11139:2017, term 3.205]
3.23
process variable
chemical or physical attribute within a cleaning, disinfection, packaging, or sterilization process,
changes in which can alter its effectiveness
EXAMPLES Time, temperature, pressure, concentration, humidity, wavelength.
[SOURCE: prEN ISO 11139:2017, term 3.214]
3.24
reference measurement point
location of the sensor controlling the operating cycle
[SOURCE: prEN ISO 11139:2017, term 3.230]
3.25
services
supplies from an external source needed for the function of equipment
[SOURCE: prEN ISO 11139:2017, term 3.256]
EXAMPLES Electricity, sterilant, compressed air, drainage.
3.26
stage
part of an operating cycle with a specified function
prEN17180:2017 (E)
EXAMPLES Air removal stage, plateau period, drying stage and final air admission stage.
[SOURCE: prEN ISO 11139:2017, term 3.266]
3.27
sterilant
chemical or combination of chemicals used to generate a sterilizing agent
[SOURCE: prEN ISO 11139:2017, term 3.272]
3.28
sterilant injection
introduction of sterilant into the evacuated chamber until the set operating pressure has been attained
or the specified quantity of sterilizing agent has been delivered
[SOURCE: prEN ISO 11139:2017, term 3.273]
3.29
sterile
free from viable microorganisms
[SOURCE: prEN ISO 11139:2017, term 3.275]
Note 1 to entry For “free from viable microorganisms” see EN 556-1.
3.30
sterile barrier system
minimum package that minimizes the risk of ingress of microorganisms and allows aseptic presentation
of the sterile product at the point of use
[SOURCE: prEN ISO 11139:2017, term 3.276]
3.31
sterilization
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: prEN ISO 11139:2017, term 3.282]
Note 2 to entry For “free from viable microorganisms” see EN 556-1.
3.32
sterilization cycle
predetermined sequence of stages performed in a sterilizer to achieve product free of viable
microorganisms
[SOURCE: prEN ISO 11139:2017, term 3.284]
3.33
sterilization process
series of actions or operations needed 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.
[SOURCE: prEN ISO 11139:2017, term 3.289]
3.34
sterilization temperature
minimum temperature on which the evaluation of the sterilization efficacy is based
[SOURCE: prEN ISO 11139:2017, term 3.291]
3.35
sterilizer
equipment designed to achieve sterilization
[SOURCE: prEN ISO 11139:2017, term 3.292]
3.36
temperature band
range of temperatures expressed as the minimum and the maximum temperatures which prevail
throughout the load during the defined period of a cycle
[SOURCE prEN ISO 11139:2017, term 3.298]
3.37
sterilizing agent
physical or chemical entity, or combination of entities, having sufficient microbicidal activity to achieve
sterility under defined conditions
[SOURCE: prEN ISO 11139:2017, term 3.293]
3.38
usable chamber volume
defined space within the chamber that is available to accept the load
[SOURCE: prEN ISO 11139:2017, term 3.324]
3.39
validation
confirmation process, through the provision of objective evidence that the requirements for a specific
intended use or application have been fulfilled
[SOURCE: prEN ISO 11139:2017, term 3.319]
3.40
verification
provision of objective evidence, that the specified requirements have been fulfilled
Note 1 to entry The objective evidence needed for a verification can be the result of an inspection or of other
forms of determination such as performing alternative calculations or reviewing documents.
prEN17180:2017 (E)
Note 2 to entry The word “verified” is used to designate the corresponding status.
[SOURCE: prEN ISO 11139:2017, term 3.320]
3.41
works test
series of tests performed prior to delivery to demonstrate compliance of a piece of equipment with its
specification
[SOURCE: prEN ISO 11139:2017, term 3.331]
4 Mechanical components and assemblies
4.1 Materials
4.1.1 The surfaces of the materials for the sterilizer components (including, for example, sterilizer
chamber, connected piping, 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 and do
not react with these chemicals creating a hazard.
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.
4.1.2 Materials for sterilizer furniture including load supporting systems shall be selected to avoid
corrosion and galvanic attack.
4.2 Sterilizer chamber
4.2.1 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 × 000 in which:
1) the first three digits give the diameter of the usable space; and
2) the last three digits give the depth of the usable space;
b) for rectangular parallelepiped usable spaces: 000 × 000 × 000 in which:
1) the first three digits give the width of the usable space;
2) the next three digits give the height of the usable space; and
3) 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 1 000 mm then four digits shall be used, without a decimal point.
4.2.2 Doors and interlocks of the sterilizer chamber
4.2.2.1 Sterilizer chambers shall be provided with one or two doors.
4.2.2.2 After closing the sterilizer door, it shall be possible to open it before a cycle has been
started.
4.2.2.3 It shall not be possible to open a sterilizer door(s) during a cycle.
4.2.2.4 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 a key, code or tool, see also 6.5.3.
4.2.2.5 The design shall allow easy and safe maintenance of the door seal(s) according to the
instructions of the manufacturer.
4.2.2.6 For double-ended sterilizers it shall not be possible to open the unloading door until a “cycle
complete” is obtained.
4.2.2.7 For operating cycles dedicated for test or user 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.
4.2.2.8 The control used to start the automatic operating cycle shall be located at the loading side of
the sterilizer.
4.2.2.9 Except for maintenance purposes it shall not be possible on double-ended sterilizers to
open both sterilizer doors at the same time.
4.2.2.10 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.
4.2.2.11 “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.
4.2.3 Heating and insulating the sterilizer chamber
4.2.3.1 Sterilizer chamber surfaces shall be heated to achieve pre-set temperatures prior to cycle
commencement [see 10.3 e)].
NOTE The chamber doors are part of the chamber.
All measured sterilizer chamber surface temperatures shall be within a range of 10 K during defined
cycle stages, when tested as described in D.2.1.1.
4.2.3.2 Initiation of the sterilization cycle shall not be possible until these conditions have been
fulfilled.
4.2.3.3 Where hot outer surfaces of the sterilizer chamber can cause a burn hazard and to reduce
heat transmission to the environment, these surfaces shall be insulated, except where this will interfere
with the intended function of the sterilizer. This applies as well to the vaporization system.
4.2.4 Test connections
4.2.4.1 The sterilizer chamber shall be provided with at least one test connection, which is used for
the connection of test measuring instruments. This connection shall be at a point of easy access, but not
in a pipe for fluid transport, and shall terminate in a DN25KF flange connection according to
ISO 2861:2013 (see Figure 1). The test connection(s) shall be connected to the chamber with a
minimum internal diameter of 26 mm.
prEN17180:2017 (E)
4.2.4.2 The test connection shall be sealed with a sterilant proof and mechanically resistant O-ring
seal.
NOTE If national regulations require the calibration of all pressure instruments connected to the sterilizer
chamber, test tees and valve cocks with sealing plugs can be required to permit connection of reference
instruments.
Dimensions in millimetres
a DN25KF flange connection according to ISO 2861:2013
Figure 1 — Test instrument connection port
4.3 Pipework and fittings
4.3.1 Means shall be provided to prevent the ingress of contaminants from external sources that
could affect the performance of the sterilizer.
NOTE For connections to potable water supply and draining, national or local regulations could apply.
4.3.2 Pipework shall be designed to prevent unintended accumulation of condensate.
NOTE 1 Accumulation of H2O2 can create a hazard.
NOTE 2 Insulation is a way to avoid heat loss or condensation for all pipework carrying fluids, except where
this will interfere with the function of the sterilizer.
4.3.3 All control valves in the pipework and test connections shall be marked with permanent
identification (see 9.4).
4.4 H2O2 vaporizer
4.4.1 If a vaporizer is used, which can be disconnected from the feed to the chamber, means shall be
provided to protect from accidental hazardous effluent of fluids to the environment.
4.4.2 Means shall be provided to prevent excessive temperatures which can create hazards, e.g.
explosion.
NOTE Pressure devices are regulated by the Pressure Equipment Directive 2014/68/EU [5].
4.4.3 The variables affecting vaporization of H O shall be controlled within their tolerances.
2 2
4.5 Evacuation system
4.5.1 Sterilizers shall be provided with a vacuum system to remove air, humidity and H O . The
2 2
lowest absolute pressure needed for fulfilling the requirements of clause 7 when tested according to D.2
shall be specified.
4.5.2 Means shall be specified and provided with the vacuum system to reduce the H O and its
2 2
possible reaction products into concentrations harmless to the operator and the environment (see also
Annex H).
NOTE A catalyst or gas plasma can be used to break down H O into oxygen and water.
2 2
4.5.3 The sterilizer shall be provided with means for leak testing which shall include the sterilizer
chamber and all relevant connected pipework and fittings.
At leak testing the chamber and relevant pipework shall be evacuated to or below the lowest set-point
applied during the cycle(s) available to the operator, see 6.3.2.
4.6 Gas admission system
4.6.1 Where the operating cycle requires the intended admission of air or other gases, with the
exception of sterilant, into the sterilizer chamber, microbial recontamination of the sterilization load
shall be prevented.
4.6.2 I
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