oSIST prEN 17180:2023

Sterilizers for medical purposes - Low temperature vapourized 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

• Status: Not Published
• Public Enquiry End Date: 17-May-2023
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 09-Mar-2023
• Due Date: 27-Jul-2023
• Completion Date: 09-Jun-2023
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: prEN 17180 - Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN 17180:2023
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
oSIST prEN 17180:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 17180:2023


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.

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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
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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
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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
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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
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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 .
...