EN 14180:2003+A1:2009

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

This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
This European Standard specifies minimum requirements:
-   for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;
-   for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.

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

Diese Europäische Norm legt Anforderungen und Prüfverfahren für NTDF-Sterilisatoren fest, in denen als
Sterilisiermittel ein Gemisch von Niedertemperatur-Dampf und Formaldehyd angewendet wird und die nur
unterhalb des Umgebungsdruckes arbeiten.
Diese Sterilisatoren werden in erster Linie in medizinischen Einrichtungen zur Sterilisation hitzeempfindlicher
Medizinprodukte verwendet.
Diese Europäische Norm legt Mindest-Anforderungen zu folgenden Punkten fest,
⎯ für die Leistung und Konstruktion von Sterilisatoren zur Sicherstellung, dass das Verfahren in der Lage
ist, Medizinprodukte zu sterilisieren;
⎯ an die Geräte und Kontrollmaßnahmen, die für die Validierung und Routineüberwachung des Sterilisationsverfahrens
erforderlich sind.

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

La présente Norme européenne spécifie les exigences et les essais relatifs aux stérilisateurs à la vapeur et au
formaldéhyde à basse température, utilisant comme agent de stérilisation un mélange à basse température de
vapeur d’eau et de formaldéhyde et fonctionnant uniquement à une pression inférieure à la pression atmosphérique.
Ces stérilisateurs sont utilisés en priorité pour stériliser les dispositifs médicaux thermolabiles dans les centres
de soins.
La présente Norme européenne spécifie les exigences minimales :
- de performance et de conception des stérilisateurs afin de garantir que le procédé permet de stériliser des
dispositifs médicaux ;
- pour le matériel et les systèmes nécessaires aux opérations de validation et de contrôle de routine du procédé
de stérilisation.

Sterilizatorji za uporabo v medicini - Sterilizatorji s paro nizke temperature in s formaldehidom - Zahteve in preskušanje

General Information

• Status: Withdrawn
• Publication Date: 12-May-2009
• Withdrawal Date: 14-Jul-2009
• 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: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Jul-2009
• Completion Date: 15-Jul-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+A1:2009 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

Relations

• Merged Into: EN 14180:2003+A2:2009 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• Effective Date: 18-Jan-2023
• Merged From: EN 14180:2003/prA1 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• Effective Date: 19-Jan-2023
• Merged From: EN 14180:2003 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• Effective Date: 18-Jan-2023

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilizatorji za uporabo v medicini - Sterilizatorji s paro nizke temperature in s formaldehidom - Zahteve in preskušanjeSterilisatoren für medizinische Zwecke - Niedertemperatur-Dampf-Formaldehyd-Sterilisatoren - Anforderungen und PrüfungStérilisateurs à usage médical - Stérilisateurs à la vapeur et au formaldéhyde à basse température - Exigences et essaisSterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing11.080.10Sterilizacijska opremaSterilizing equipmentICS:Ta slovenski standard je istoveten z:EN 14180:2003+A1:2009SIST EN 14180:2003+A1:2009en,fr,de01-oktober-2009SIST EN 14180:2003+A1:2009SLOVENSKI
STANDARD



SIST EN 14180:2003+A1:2009



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14180:2003+A1
May 2009 ICS 11.080.10 Replaces EN 14180:2003English Version
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Stérilisateurs à usage médical - Stérilisateurs à la vapeur et au formaldéhyde à basse température - Exigences et essais
Sterilisatoren für medizinische Zwecke - Niedertemperatur-Dampf-Formaldehyd-Sterilisatoren - Anforderungen und Prüfung This European Standard was approved by CEN on 16 May 2003 and includes Amendment 1 approved by CEN on 12 April 2009.
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. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14180:2003+A1:2009: ESIST EN 14180:2003+A1:2009



EN 14180:2003+A1:2009 (E)
2 Contents page 1Scope . 42Normative references . 43Terms and definitions . 54Technical requirements . 105Process control . 196Performance requirements . 227Sound power . 238Marking and labelling . 249Information to be supplied by the manufacturer . 2410Service and local environment . 26Annex A (normative)
Test methods . 29Annex B (normative)
Sterilizer classification and testing . 34Annex C (normative)
Test equipment . 37Annex D (normative)
Determination of formaldehyde residuals in a filter indicator . 40Annex E (informative)
Formaldehyde residues on medical devices .
...