EN 1422:1997/prA1

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

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

General Information

• Status: Not Published
• ICS: 11.080 - Sterilization and disinfection
• 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: 5060 - Closure of Vote - Formal Approval
• Start Date: 11-Mar-2009
• Completion Date: 11-Mar-2009
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 1422:2000/kprA1:2009 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

Relations

• Merged Into: EN 1422:1997+A1:2009 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
• Effective Date: 23-Mar-2009
• Amends: EN 1422:1997 - Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods
• Effective Date: 22-Dec-2008

Overview

EN 1422:1997/prA1 is a European standard developed by the Committee for European Normalization (CEN), specifically by Technical Committee CEN/TC 102, focused on sterilizers for medical purposes. This amendment outlines requirements and test methods for ethylene oxide sterilizers, devices critical in healthcare for sterilizing medical instruments and equipment. The latest draft amendment aims to align this standard with essential regulatory requirements under EU Directive 93/42/EEC on medical devices and ensures compliance with safety and performance criteria.

As an authoritative benchmark, EN 1422:1997/prA1 supports manufacturers, regulatory bodies, and healthcare providers in delivering safe and effective sterilization solutions using ethylene oxide. It also refers to pertinent health and safety regulations under the Machinery Directive 2006/42/EC where applicable.

Key Topics

• Ethylene Oxide Sterilization Requirements
  This standard specifies essential design features and functional parameters for sterilizers using ethylene oxide gas, ensuring consistent sterilization efficacy while maintaining user safety.

• Test Methods
  It defines standardized test protocols to validate sterilizer performance, including sterilization cycle parameters and safety mechanisms, helping manufacturers verify device reliability.

• Regulatory Compliance
  The amendment clarifies the relationship between this standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices, providing a presumption of conformity when applied correctly.

• Health and Safety Requirements
  It addresses relevant clauses from Directive 2006/42/EC concerning machinery safety, including design safeguards and operational controls, although it notes certain requirements are only partly addressed or not covered.

• Multilingual and European Scope
  Published in official EU languages (English, French, and German), this standard applies across all CEN member countries including Austria, Germany, France, the UK, and others, ensuring harmonized requirements for ethylene oxide sterilizers throughout Europe.

Applications

• Medical Device Manufacturing
  Manufacturers designing and producing ethylene oxide sterilizers must comply with EN 1422:1997/prA1 to meet EU regulations, demonstrating that their sterilizers fulfill safety, efficacy, and performance mandates required for market access.

• Healthcare Facilities
  Hospitals and clinics utilize sterilizers meeting this standard to ensure the microbial safety of surgical instruments and medical devices sterilized using ethylene oxide, supporting infection prevention protocols.

• Regulatory Assessment and Certification
  Notified bodies and conformity assessment organizations reference this standard when evaluating ethylene oxide sterilizers for CE marking under the Medical Device Directive, facilitating regulatory approval processes.

• Quality Assurance and Testing Labs
  Laboratories conducting performance validation, routine testing, or compliance audits use the test methods prescribed to verify sterilizer function aligns with the standard’s requirements.

Related Standards

• EU Directive 93/42/EEC (Medical Devices Directive)
  EN 1422:1997/prA1 directly supports compliance with this directive’s essential health and safety requirements, streamlining regulatory conformity assessment for sterilizers in the EU market.

• Directive 2006/42/EC (Machinery Directive)
  Relevant parts of this directive on machinery safety are partially addressed within EN 1422:1997/prA1, particularly on design and operational safety features applicable when sterilizers are classified as machinery.

• Sterilizing Equipment Standards (ICS 11.080.10)
  This standard is part of a broader set of European and international standards focusing on sterilizing equipment used in medical and healthcare settings.

---

Keywords:
ethylene oxide sterilizers, medical device sterilization, EN 1422 standard, CEN standards, EU medical device compliance, sterilizer test methods, ethylene oxide sterilizer requirements, medical sterilizing equipment, sterilization safety standards, EU Directive 93/42/EEC, machinery directive compliance.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2009
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: EN 1422:1997/prA1
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
FINAL DRAFT
EN 1422:1997
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
December 2008
ICS 11.080.10
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 amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 102.
This draft amendment A1, if approved, will modify the European Standard EN 1422:1997. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment 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 Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1422:1997/prA1:2008: E
worldwide for CEN national Members.

Contents Page
Foreword .3
1 Modifications to Annex ZA .4

Foreword
This document (EN 1422:1997/prA1:2008) 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 Unique Acceptance Procedure.
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 EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document.
1 Modifications to Annex ZA
Delete the title of Annex ZA and substitute the following:
"Relationship between this European Standard and the Essential Requirements of EU Directive
93/42/EEC".
Delete the introductory text to Table ZA and substitute the following:
"This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical
...