prEN 1422

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

1.1 This document specifies the requirements and the relevant tests for automatically controlled sterilizers employing ethylene oxide (EO) gas as the sterilant, either as a pure gas or a mixture with other gases, being used for the sterilization of medical devices and their accessories.
1.2 This document specifies requirements for ethylene oxide sterilizers (EO sterilizers) for:
-   the performance and design of sterilizers intended to deliver a process capable of sterilizing medical devices;
-   the equipment and controls of these sterilizers, needed for operation, control and monitoring of the sterilization processes;
-   the test equipment and test procedures used to verify the sterilizer performance specified by this document.
1.3 This document does not cover sterilizers which employ the injection of EO or mixtures containing EO directly into packages or into a flexible chamber.

Sterilisatoren für medizinische Zwecke - Ethylenoxid-Sterilisatoren - Anforderungen und Prüfverfahren

1.1   Dieses Dokument legt die Anforderungen und entsprechenden Prüfverfahren für automatisch gesteuerte Sterilisatoren fest, die Ethylenoxid (EO) entweder als reines Gas oder als Gas im Gemisch mit anderen Gasen als Sterilisiermittel zur Sterilisation von Medizinprodukten und Zubehör verwenden.
1.2   Dieses Dokument legt die Anforderungen an Ethylenoxid-Sterilisatoren (EO-Sterilisatoren) 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 der Sterilisationsverfahren erforderlich sind;
-   an die Prüfgeräte und Prüfverfahren, die zur Verifizierung der nach diesem Dokument festgelegten Leistung des Sterilisators angewendet werden.
1.3   Dieses Dokument behandelt keine Sterilisatoren, bei denen die Sterilisation durch die Einleitung von EO oder Gemischen mit EO direkt in die Produktverpackungen oder eine flexible Kammer erfolgt.

Stérilisateurs à usage médical - Stérilisateurs à l'oxyde d'éthylène - Exigences et méthodes d'essai

1.1   Le présent document énonce les exigences et essais relatifs aux stérilisateurs à commande automatisée employant de l’oxyde d’éthylène (OÉ) gazeux comme agent stérilisant (pur ou mélangé avec d’autres gaz) utilisés pour la stérilisation des dispositifs médicaux et de leurs accessoires.
1.2   Le présent document spécifie les exigences relatives aux stérilisateurs à l’oxyde d’éthylène (stérilisateurs à l’OÉ) concernant :
-   la performance et la conception des stérilisateurs destinés à fournir un procédé capable de stériliser des dispositifs médicaux ;
-   l’équipement et les contrôles de ces stérilisateurs nécessaires au fonctionnement, au pilotage et à la surveillance des procédés de stérilisation ;
-   l’équipement d’essai et les modes opératoires d’essai utilisés pour vérifier les performances du stérilisateur spécifiées par le présent document.
1.3   Le présent document ne couvre pas les stérilisateurs utilisant l’injection d’OÉ ou de ses mélanges directement dans les emballages ou dans une chambre flexible.

Sterilizatorji za uporabo v medicini - Sterilizatorji z etilenoksidom - Zahteve in preskusne metode

General Information

• Status: Not Published
• Publication Date: 21-Jun-2026
• 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: 4020 - Submission to enquiry - Enquiry
• Start Date: 24-Apr-2025
• Due Date: 02-May-2024
• Completion Date: 24-Apr-2025
• 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: oSIST prEN 1422:2025 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

Relations

• Revises: EN 1422:2014 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
• Effective Date: 30-Aug-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2025
Sterilizatorji za uporabo v medicini - Sterilizatorji z etilenoksidom - Zahteve in
preskusne metode
Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test
methods
Sterilisatoren für medizinische Zwecke - Ethylenoxid-Sterilisatoren - Anforderungen und
Prüfverfahren
Stérilisateurs à usage médical - Stérilisateurs à l'oxyde d'éthylène - Exigences et
méthodes d'essai
Ta slovenski standard je istoveten z: prEN 1422
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
April 2025
ICS 11.080.10 Will supersede EN 1422:2014
English Version
Sterilizers for medical purposes - Ethylene oxide
sterilizers - Requirements and test methods
Stérilisateurs à usage médical - Stérilisateurs à l'oxyde Sterilisatoren für medizinische Zwecke - Ethylenoxid-
d'éthylène - Exigences et méthodes d'essai Sterilisatoren - 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, 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 1422:2025 E
worldwide for CEN national Members.

Contents Page
European foreword . 6
Introduction . 7
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 10
4 General. 17
4.1 Product definition. 17
4.2 Equipment development . 17
4.3 Calibration . 18
5 Equipment design and construction . 18
5.1 Safety and security . 18
5.1.1 General. 18
5.1.2 Protective measures . 19
5.1.3 Risk control and usability . 21
5.2 Sterilizer chamber . 21
5.2.1 Dimensions. 21
5.2.2 Doors and interlocks of the sterilizer chamber . 22
5.2.3 Chamber integrity . 23
5.2.4 Pressure vessels . 24
5.2.5 Uniformity of conditions, temperature control and insulating the sterilizer chamber . 24
5.3 Further functional components . 24
5.3.1 Pipework and fittings . 24
5.3.2 Vaporizers . 25
5.3.3 Evacuation system . 25
5.3.4 Framework and panelling . 26
5.3.5 Loading Equipment . 27
5.4 Materials . 27
5.4.1 Chamber materials . 27
5.4.2 Other materials used in the construction of the sterilizer . 27
5.5 Test connections . 28
5.6 Vibration . 29
5.7 User interfaces . 29
5.8 Transport . 30
6 Indicating, monitoring, controlling and recording devices . 31
6.1 General. 31
6.1.1 General. 31
6.1.2 Pre-set programme . 31
6.1.3 Automatic controller . 31
6.2 Automatic control . 31
6.3 Control and monitoring system . 33
6.4 Failure . 34
6.4.1 General. 34
6.4.2 Fault . 35
6.4.3 Power failure . 36
6.4.4 Other failures . 36
6.5 Instrumentation . 36
6.5.1 General . 36
6.5.2 Temperature measuring devices . 37
6.5.3 Pressure measuring devices . 39
6.5.4 Time measuring devices . 40
6.5.5 Sterilizing agent control and measuring devices . 40
6.5.6 Relative humidity (RH) sensors . 41
6.6 Indicating devices . 41
6.6.1 General . 41
6.6.2 Cycle parameter indicating devices . 41
6.6.3 Cycle parameter indications . 43
6.6.4 Status indicators and indications . 43
6.6.5 Operating cycle counter . 44
6.7 Recorders . 45
6.7.1 General . 45
6.7.2 Records . 46
6.7.3 Analogue presentation of records . 47
6.7.4 Digital records . 47
6.8 Operating cycles . 48
6.8.1 General . 48
6.8.2 Maintenance leak test . 48
6.8.3 Sterilization cycles . 49
7 Services and local environment . 51
7.1 General . 51
7.2 Sterilizing agent and sterilant . 52
7.3 Electrical supply . 53
7.4 Water .
...