EN 14180:2014

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 Ausrüstung und Steuerung dieser Sterilisatoren, 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 stérilisant 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 performances 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 z nizko temperaturo in s formaldehidom - Zahteve in preskušanje

Standard EN 14180 določa zahteve in preskuse za sterilizatorje s paro z nizko temperaturo in s formaldehidom kot sterilizacijskim sredstvom, ki delujejo samo pri nizkem zračnem tlaku. Ti sterilizatorji se primarno uporabljajo v zdravstvenih ustanovah za sterilizacijo medicinskih pripomočkov, občutljivih na vročino. Ta evropski standard določa minimalne zahteve: – za delovanje in načrtovanje sterilizatorjev za sterilizacijo medicinskih pripomočkov; – za opremo in kontrolnike teh sterilizatorjev, potrebnih za preverjanje in rutinski nadzor med postopkom sterilizacije.

General Information

• Status: Published
• Publication Date: 20-May-2014
• 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: 9093 - Decision to confirm - Review Enquiry
• Completion Date: 15-Apr-2020
• 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 14180:2014 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing

Relations

• Replaces: EN 14180:2003+A2:2009 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• Effective Date: 08-Jun-2022
• Revised: FprEN 14180 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
• Effective Date: 19-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 z nizko temperaturo 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 14180:2014SIST EN 14180:2014en,fr,de01-oktober-2014SIST EN 14180:2014SLOVENSKI
STANDARDSIST EN 14180:2003+A2:20091DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14180
May 2014 ICS 11.080.10 Supersedes EN 14180:2003+A2:2009English 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 10 April 2014.
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-CENELEC 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-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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14180:2014 ESIST EN 14180:2014

Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references . 5 3 Terms and definitions . 6 4 Technical requirements . 11 4.1 Sterilizer chamber . 11 4.2 Design and construction . 14 4.3 Indicating, measuring, operating and recording devices . 16 5 Process control . 22 5.1 General . 22 5.2 Software verification and validation . 22 5.3 Operating cycle and automatic control . 23 5.4 Override of automatic control . 24 5.5 Fault . 24 6 Performance requirements . 25 6.1 Sterilizing performance . 25 6.2 Desorption efficacy . 27 6.3 Drying . 27 7 Sound power and vibration . 27 8 Packaging, marking and labelling . 28 9 Information to be supplied by the manufacturer . 29 10 Service and local environment . 31 10.1 General . 31 10.2 Electricity . 31 10.3 Sterilant . 31 10.4 Steam . 32 10.5 Water . 32 10.6 Compressed air . 32 10.7 Drainage and discharges . 32 10.8 Ventilation and environment . 33 10.9 Lighting . 33 Annex A (normative) Test methids . 34 Annex B (normative) Sterilizer classification and testing . 40 Annex C (normative) Test equipment . 43 Annex D (normative) Determination of formaldehyde residuals in a filter indicator . 46 Annex E (informative) Formaldehyde residues on medical devices . 49 Annex F (informative) Environmental aspects . 51 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices . 54 Bibliography . 60
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