FprEN 17180
(Main)Sterilizers for medical purposes - Low temperature vaporized hydrogen peroxide sterilizers - Requirements and testing
Sterilizers for medical purposes - Low temperature vaporized hydrogen peroxide sterilizers - Requirements and testing
This document 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 document 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 document.
This document does not specify requirements for equipment intended to process liquids, biological waste, or human tissues.
This document does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
This document 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
Dieses Dokument legt Anforderungen und Prüfverfahren für Niedertemperatur-Wasserstoffperoxid-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.
Dieses Dokument legt Mindestanforderungen 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 Bedienelemente dieser Sterilisatoren, die für den Betrieb, die Steuerung und Überwachung erforderlich sind und welche bei der Validierung der Sterilisationsverfahren angewendet werden können;
— an die Prüfgeräte und Prüfverfahren, die zur Verifizierung der nach diesem Dokument festgelegten Leistung des Sterilisators angewendet werden.
Dieses Dokument legt keine Anforderungen an Geräte fest, die für die Aufbereitung von Flüssigkeiten, Bioabfall oder menschlichen Geweben vorgesehen sind, es sei denn sie sind Bestandteil eines Medizinprodukts.
Dieses Dokument beschreibt kein Qualitätsmanagementsystem für die Lenkung aller Stufen der Herstellung des Sterilisators.
ANMERKUNG Es wird auf die Normen zum Qualitätsmanagement verwiesen, z. B. EN ISO 13485.
Dieses Dokument legt keine Anforderungen an und Prüfungen für Dekontaminationssysteme zur Verwendung in Räumen, umschlossenen Räumen oder umgebenden Räumen fest.
Stérilisateurs à usage médical - Stérilisateurs à la vapeur de peroxyde d’hydrogène à basse température - Exigences et essais
Sterilizatorji za uporabo v medicini - Sterilizatorji s paro z nizko temperaturo in z vodikovim peroksidom - Zahteve in preskušanje
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2023
Sterilizatorji za uporabo v medicini - Sterilizatorji s paro z nizko temperaturo in z
vodikovim peroksidom - Zahteve in preskušanje
Sterilizers for medical purposes - Low temperature vapourized 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 dhydrogène 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
prEN 17180
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2023
ICS
English Version
Sterilizers for medical purposes - Low temperature
vapourized 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-Sterilisatoren mit verdampftem
¿ Exigences et essais Wasserstoffperoxid - Anforderungen und
Prüfverfahren; Deutsche und Englische Fassung PWI
EN 17180:2019
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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17180:2023 E
worldwide for CEN national Members.
prEN 17180:2023 (E)
Contents Page
European foreword . 7
Introduction . 8
1 Scope . 9
2 Normative references . 9
3 Terms and definitions . 10
4 General. 22
4.1 Sterilizer type definition . 22
4.2 Equipment development . 23
4.3 Calibration . 23
5 Equipment design and Construction . 24
5.1 Safety and security . 24
5.1.1 General. 24
5.1.2 Protective measures . 24
5.1.3 Risk control and usability . 25
5.2 Sterilizer chamber . 26
5.2.1 Materials . 26
5.2.2 Chamber dimensions . 26
5.2.3 Doors and interlocks of the sterilizer chamber . 27
5.2.4 Temperature control and insulation of the sterilizer chamber . 28
5.2.5 Test connections . 28
5.3 Further functional components . 29
5.3.1 Pipework and fittings . 29
5.3.2 H O vaporizer . 29
2 2
5.3.3 Evacuation system . 29
5.4 Framework and panelling . 30
5.5 Vibration . 30
5.6 Ancillary equipment and components . 30
5.7 Transport . 31
5.8 User interfaces . 31
6 Indicating, monitoring, controlling, and recording devices . 32
6.1 General. 32
6.1.1 Pre-set Programme . 32
6.1.2 Automatic controller . 32
6.2 Automatic control . 32
6.3 Control and monitoring system . 34
6.4 Failure . 36
6.4.1 General. 36
6.4.2 Fault . 36
6.4.3 Power failure . 37
6.4.4 Other failures . 37
6.5 Instrumentation . 38
6.5.1 General. 38
6.5.2 Temperature measuring devices . 38
6.5.3 Pressure measuring devices . 39
prEN 17180:2023 (E)
6.5.4 Time measuring devices . 40
6.5.5 Sterilizing agent control and measuring devices . 41
Indicating devices . 41
6.5.6 General . 41
6.5.7 Cycle parameter indicating devices . 41
6.5.8 Cycle parameter indications . 43
6.5.9 Status indicators and indications . 43
6.5.10 Operating cycle counter . 44
6.6 Recorders . 44
6.6.1 General . 44
6.6.2 Records . 45
Table 1 — Example for VH2O2 operating cycle and data to be recorded (for cycle profile, see
Figure 1) . 46
Figure 1 — Schematic example of a VH2O2 operating cycle profile (for programme step
numbering and related operating cycle stages, see Table 1) . 47
6.6.3 Analog presentation of records . 48
6.6.4 Digital records . 48
6.6.5 Data format for applied sterilant amount . 48
6.7 Operating cycles . 48
6.7.1 General . 48
6.7.2 Leak test . 48
6.7.3 Sterilization cycles . 49
7 Services and local environment . 49
7.1 General . 49
7.2 Sterilant and sterilizing agent . 50
7.3 Electrical supply . 50
7.4 Water . 51
7.5 Steam . 51
7.6 Vacuum . 51
7.7 Lighting . 51
7.8 Drainage and discharges . 51
7.9 Compressed air . 51
7.10 Air and inert gases. 52
7.11 Ventilation and environment . 52
8 Emissions . 52
8.1 Electromagnetic emissions . 52
8.2 Noise . 52
8.3 Exhaust emissions . 53
8.4 Heat emission . 53
9 Test instrumentation . 54
10 Performance and assessment . 54
10.1 General . 54
Table 2 — Recommended testing to demonstrate Sterilizing Agent Exposure . 55
Figure 2 — Schematic example of a VH2O2 operating cycle profile demonstrating
relationship of cycle variables . 56
10.2 Attainment conditions . 57
10.2.1 Temperature reference measurement point . 57
10.2.2 H O temperature band . 57
2 2
10.2.3 Temperature profile . 57
prEN 17180:2023 (E)
10.2.4 Pressure profile requirements . 57
10.2.5 Sterilant and sterilizing agent . 58
10.3 Microbiological performance . 59
10.3.1 General. 59
10.3.2 Reduced cycle . 59
10.3.3 Microbiological efficacy . 59
10.4 Load dryness . 59
11 Information to be supplied . 60
11.1 General. 60
11.2 Information to be available prior to purchase . 60
11.3 Information prior to installation . 60
11.4 Marking and labelling . 61
11.5 Instructions for use . 62
12 Packaging . 63
Annex A (informative) Test programme . 64
A.1 General. 64
A.2 Type test . 65
A.3 Works test . 66
A.4 Installation qualification (IQ) provisions . 66
Annex B (normative) Test instrumentation . 67
B.1 General. 67
B.2 Pressure instrumentation . 67
B.3 Pressure recording . 67
B.4 Temperature probes . 68
B.5 Temperature recording instrument . 68
B.6 Sterilant supply and concentration measurement system . 68
B.7 Penetration Type Test devices (PTTDs) . 69
B.7.1 General. 69
B.7.2 PTTD construction. 69
B.7.3 Indicator systems for PTTDs . 70
B.7.4 Other type test devices . 71
B.7.5 Biological indicators and indicator systems . 71
B.8 Sterile barrier systems . 71
B.8.1 General. 71
B.8.2 Sterile Barrier Systems for standard test loads . 72
Annex C (normative) Test loads . 73
C.1 General. 73
C.2 General. 73
C.2.1 Test load unit . 73
C.2.2 Small load . 74
prEN 17180:2023 (E)
C.3 General . 74
C.3.1 Full load . 74
Annex D (normative) Test procedures. 75
D.1 General . 75
Figure D.1 — Biological indicator and small load unit locations for conducting physical and
microbiological performance test in cylindrical chambers . 77
Figure D.2 — Biological indicator and small load unit locations for conducting physical and
microbiological performance test in rectangular chambers . 78
D.2 Test procedures . 78
D.2.1 Sterilizer chamber temperature test . 78
D.2.2 Microbiological empty chamber distribution test . 79
D.2.3 Small load physical performance test . 79
D.2.4 Small load microbiological performance test . 80
D.2.5 Full load physical performance test. 80
D.2.6 Full load microbiological performance test . 81
D.2.7 Penetration performance test with PTTD . 81
D.2.8 Air Leakage test . 82
D.2.9 Drying test . 82
Annex E (informative) Measurement of hydrogen peroxide . 83
E.1 General . 83
E.2 H O in liquids . 83
2 2
E.2.1 Selection of test method . 83
E.2.2 Spectrometric analysis of H O contents in liquids . 84
2 2
E.2.2.1 Equipment . 84
E.2.2.2 Calibration. 84
E.2.2.3 Operation . 85
E.3 H O in gaseous compositions . 85
2 2
E.3.1 Selection of measurement method . 85
E.3.2 Measurement of gaseous H2O2 using electro chemical sensors . 86
E.3.3 Calibration and operation . 86
Annex F (normative) Efficacy of H O removal . 87
2 2
F.1 H O in ambient air . 87
2 2
F.1.1 Purpose of test . 87
F.1.2 Test scope . 87
F.1.3 Instrumentation . 87
F.1.4 Acceptance criteria . 87
prEN 17180:2023 (E)
F.2 Liquid H O on load . 87
2 2
F.2.1 Purpose of test . 87
F.2.2 Test scope . 88
F.2.3 Acceptance criteria. 88
Annex G (normative) Protective measures. 89
Annex H (informative) Environmental aspects . 91
H.1 Environmental aspects regarding the life cycle of VH2O2 sterilizers - General
Environmental aspects . 91
H.2 Hydrogen peroxide . 91
H.2.1 Physico-Chemical properties . 92
H.2.2 Classification criteria and labelling requirements . 92
H.3 Environmental impact . 93
Annex I (informative) Illustrations of the interrelationship between control and recording
................................................................................................................................................................... 96
I.1 Introduction . 96
I.1.1 General. 96
I.1.2 Illustration 1 . 96
Figure I.1 — Illustration 1 of the interrelationship between control and recording [Source:
ISO/TS 22421:2021, Figure B.1] . 97
I.2 Illustration 2 . 98
Figure I.2 — Illustration 2 of the interrelationship between control and recording [Source:
ISO/TS 22421:2021, Figure B.2] . 98
I.3 Illustration 3 . 99
I.3.1 General. 99
I.3.2 Main objectives . 100
I.3.3 Control data processing system . 100
I.3.4 Independent data processing system . 100
I.3.5 Cycle control function . 100
I.3.6 Means for failure detection . 101
I.3.7 Data retention module . 101
I.3.8 Controls and indicating devices . 101
I.3.9 Recorder . 101
I.3.10 Optional printer . 101
Annex J (normative) Technical information and documentation . 102
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered . 104
Bibliography . 121
prEN 17180:2023 (E)
European foreword
This document (prEN 17180:2023) 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.
A first draft (prEN 17180:2017) was published in 2017, but the status of the project was set back to a
preliminary work item. The following changes were made to the first draft:
— the structure of the main text has been widely adapted to the structure of ISO/TS 22421:2021 and
harmonized with the current revisions of EN 14180 and EN 1422 in 2022;
— most definitions have been adapted with reference to EN ISO 11139:2018;
— a separate clause ‘Protective measures’ has been implemented for referencing to individual clauses
of EN IEC 61010-2-040 and an Annex G ‘protective measures’ has been created;
— requirements on the control and monitoring system have been merged into a clause and informative
illustrations have been provided in an Annex I;
— an Annex J ‘Technical information and documentation’ has been added to consider Annex II of the
European Medical Device Regulation (MDR).
This document has been prepared under a standardization request given to CEN by the European
Commission and the European Free Trade Association and supports essential requirements of EU
Regulation(s).
For relationship with EU Regulation(s), see informative Annex ZA, which is an integral part of this
document.
prEN 17180:2023 (E)
Introduction
This document specifies minimum requirements and test methods for sterilizers performing a low
temperature sterilization process using a composition of water and hydrogen peroxide (H O ),
2 2
vaporized, and injected into the sterilizer chamber as sterilizing agent. Vaporized hydrogen peroxide
(H O ) sterilizers process typically below 60°C and are primarily used for the sterilization of
2 2
thermolabile or moisture-sensitive medical devices in health care facilities but can also be used for
sterilization of other reusable medical devices that have been established to be compatible with VH2O2
processes. The sterilizers operate automatically using pre-set cycles. VH2O2 sterilizers can also be used
by medical device manufacturers during commercial production.
Like the other standardized low temperature sterilization processes using ethylene oxide (EN 1422 and
EN ISO 11135) or low temperature steam and formaldehyde (EN 14180 and EN ISO 25424), the VH2O2
sterilization processes are specified by physical and chemical parameters and verified using physical,
chemical, and microbiological means. The sterilizers operate automatically using pre-set cycles.
The tests described in this document are reference tests intended to demonstrate conformity with the
performance requirements specified in this document. They may be used in type tests, works tests, in
validation and re-qualification, or in periodic and routine tests carried out by the user. Validation and
routine control of sterilization processes are essential to ensure their efficacy. This document does not
cover validation and routine control of a VH2O2 sterilization process. EN ISO 14937 provides general
requirements and guidance on validation and routine control of such processes. ISO 22441 provides
specific requirements for validation and routine control of VH2O2 sterilization.
Some VH2O2 sterilizers have processes that demonstrate some level of inactivation of the causative
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 not addressed in this document, and no specific test
methods are provided.
Planning and design of products applying to this document should consider not only technical aspects
but also the environmental impact from the product during its life cycle. Environmental aspects are
addressed in Annex H of this document.
NOTE Specifications on general equipment safety are addressed in EN 61010-1, EN IEC 61010-2-040, and are
not repeated in this document. EN 60204-1 can also apply (see Annex G). Requirements on occupational safety and
health are not specified in this document. National regulations can exist.
prEN 17180:2023 (E)
1 Scope
This document specifies requirements and tests for low temperature hydrogen peroxide sterilizers, using
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 document 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
document.
This document does not specify requirements for equipment intended to process liquids, biological
waste, or human tissues unless part of a medical device.
This document does not describe a quality management system for the control of all stages of the
manufacture of the sterilizer.
NOTE Attention is drawn to the standards for quality management, e.g. EN ISO 13485.
This document does not specify requirements and tests for decontamination systems for use in rooms,
enclosures, or environmental spaces.
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 868-5:2018, Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of
porous materials and plastic film construction - Requirements and test methods
EN 868-9:2018, Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials
of polyolefines - Requirements and test methods
EN 60204-1:2018, Safety of machinery - Electrical equipment of machines - Part 1: General requirements
EN 60584-1:2013, Thermocouples - Part 1: EMF specifications and tolerances
EN 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and laboratory
use - Part 1: General requirements
EN IEC 61326-1:2021, Electrical equipment for measurement, control and laboratory use - EMC
requirements - Part 1: General requirements
EN 62366-1:2015/A1:2020, Medical devices - Part 1: Application of usability engineering to medical
devices
EN IEC 60751:2022, Industrial platinum resistance thermometers and platinum temperature sensors
prEN 17180:2023 (E)
EN IEC 61010-2-040:2021, 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
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 11607-1:2020, Packaging for terminally sterilized medical devices - Part 1: Requirements for
materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
EN ISO 11607-2:2020, Packaging for terminally sterilized medical devices - Part 2: Validation requirements
for forming, sealing and assembly processes (ISO 11607-2:2019)
EN ISO 14971:2019, Medical devices - Application of risk management to medical devices (ISO 14971:2019)
EN ISO 15223-1:2021, Medical devices - Symbols to be used with information to be supplied by the
manufacturer - Part 1: General requirements (ISO 15223-1:2021)
EN ISO 20417:2021, Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021,
Corrected version 2021-12)
ISO 2861:2020, Vacuum technology — Dimensions of clamped-type quick-release couplings
ISO 22441:2022, Sterilization of health care products — Low temperature vaporized hydrogen peroxide —
Requirements for the development, validation and routine control of a sterilization process for medical
devices
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 https://www.electropedia.org/
• ISO Online browsing platform: available at https://www.iso.org/obp
3.1
access device
means by which entry to restricted parts of equipment is achieved
Note 1 to entry: This can be by dedicated key, code, or tool.
[SOURCE: EN ISO 11139:2018, 3.4]
3.2
accompanying information
information accompanying or marked on a sterilizer and containing information for the user or those
accountable for the installation, use, maintenance, decommissioning and disposal of the sterilizer,
particularly regarding safe use
prEN 17180:2023 (E)
Note 1 to entry: The accompanying information can be regarded as part of the sterilizer.
Note 2 to entry: The accompanying information can consist of the label (see 3.29), marking, instructions for use,
technical description, installation manual, quick reference guide, etc.
Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve
auditory, visual, or tactile materials and multiple media types (e.g. CD/DVD-ROM, USB stick, website).
[SOURCE: EN ISO 20417:2021, 3.2, modified — “Medical device or accessory” has been changed to
“sterilizer”, the term “processing” has been removed, Note 1 to entry has been modified to exclude a
requirement and Note 4 to entry has been deleted.]
3.3
automatic controller
device that directs the equipment sequentially throug
...
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