EN 14180:2003/prA1

Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

Sterilisatoren für medizinische Zwecke - Niedertemperatur-Dampf-Formaldehyd-Sterilisatoren - Anforderungen und Prüfung

Stérilisateurs à usage médical - Stérilisateurs à la vapeur et au formaldéhyde à basse température - Exigences et essais

Sterilizatorji za uporabo v medicini - Sterilizatorji s paro nizke temperature in s formaldehidom - 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: 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 14180:2003/kprA1:2009 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

Relations

• Merged Into: EN 14180:2003+A1:2009 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• Effective Date: 19-Jan-2023
• Amends: EN 14180:2003 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• Effective Date: 22-Dec-2008

Overview

EN 14180:2003/prA1 is a European standard developed by CEN Technical Committee CEN/TC 102 focused on sterilizers for medical purposes, specifically those using low temperature steam and formaldehyde sterilization methods. This standard defines the essential requirements and testing procedures to ensure the safe and effective operation of sterilizing equipment utilized in healthcare settings. It supports compliance with the EU Directive 93/42/EEC on medical devices, helping manufacturers align with regulatory frameworks.

The standard provides a harmonized approach across European countries for the design, performance, and safety of low temperature sterilizers, including both steam and formaldehyde-based technologies. It also addresses essential health and safety requirements per Directive 2006/42/EC on machinery that overlap with medical device regulations.

Key Topics

• Scope of Sterilizers Covered
  The standard applies to sterilizers used at low temperatures incorporating steam and formaldehyde as sterilizing agents, suitable for medical instruments and devices sensitive to heat.

• Performance Requirements
  It specifies critical sterilization parameters, ensuring sterilizers achieve effective microbial inactivation without damaging medical instruments.

• Testing Procedures
  EN 14180 outlines mandatory tests for quality assurance during design, manufacturing, and routine use-covering mechanical safety, operational consistency, and sterilization efficacy.

• Compliance with EU Directives

  • Supports the Essential Requirements of EU Directive 93/42/EEC on medical devices.
  • Addresses relevant clauses of Directive 2006/42/EC on machinery regarding health and safety.

• Documentation and Conformity
  Establishes the documentation practices manufacturers must follow to demonstrate conformity, including performance validation data and risk assessments.

• Safety and Operational Controls
  Ensures sterilizers incorporate necessary safety features to protect users and patients from exposure to formaldehyde and steam, as well as mechanical hazards.

Applications

EN 14180:2003/prA1 is essential for:

• Medical Device Manufacturers
  Designing and validating sterilizers to meet stringent regulatory and safety standards in Europe.

• Hospitals and Healthcare Facilities
  Selecting and operating sterilizers capable of processing heat-sensitive medical instruments with assured sterilization effectiveness.

• Quality Assurance and Testing Laboratories
  Conducting compliance testing to verify sterilizer performance aligns with European requirements.

• Regulatory Bodies and Certification Organizations
  Evaluating conformity of sterilizers placed on the EU market, ensuring devices comply with medical device directives.

Utilizing standard-compliant sterilizers improves patient safety by ensuring reliable sterilization cycles, reducing the risk of infection and equipment failure.

Related Standards

• EN 13060: Small Steam Sterilizers – Addresses requirements for small-scale steam sterilizers used in medical sterilization.
• EN ISO 17665: Sterilization of Health Care Products - Moist Heat – Provides requirements for moist heat sterilization processes.
• Directive 93/42/EEC – Medical devices regulatory framework underpinning compliance with European laws.
• Directive 2006/42/EC – Machinery directive applicable to sterilizing equipment with mechanical components.

Summary

EN 14180:2003/prA1 standardizes the safety, performance, and testing of low temperature steam and formaldehyde sterilizers used in healthcare. Complying with this standard ensures sterilizers meet European regulatory requirements, safeguard patients and users, and maintain high sterilization efficacy for medical instruments. Healthcare providers and manufacturers adopting EN 14180 benefit from enhanced device reliability, regulatory confidence, and improved infection control outcomes.

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2009
Sterilizatorji za uporabo v medicini - Sterilizatorji s paro nizke temperature in s
formaldehidom - Zahteve in preskušanje
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers -
Requirements and testing
Sterilisatoren für medizinische Zwecke - Niedertemperatur-Dampf-Formaldehyd-
Sterilisatoren - Anforderungen und Prüfung
Stérilisateurs à usage médical - Stérilisateurs à la vapeur et au formaldéhyde à basse
température - Exigences et essais
Ta slovenski standard je istoveten z: EN 14180:2003/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 14180:2003
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
December 2008
ICS 11.080.10
English Version
Sterilizers for medical purposes - Low temperature steam and
formaldehyde sterilizers - Requirements and testing
Stérilisateurs à usage médical - Stérilisateurs à la vapeur et Sterilisatoren für medizinische Zwecke - Niedertemperatur-
au formaldéhyde à basse température - Exigences et Dampf-Formaldehyd-Sterilisatoren - Anforderungen und
essais Prüfung
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 14180:2003. 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 14180:2003/prA1:2008: E
worldwide for CEN national Members.

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

Foreword
This document (EN 14180:2003/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 first four paragraphs and substitute the following:
"This European Standard has been prepared under a mandate given to CEN
...