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
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

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 . 43Annex F (informative)
Environmental aspects . 45Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"""" . 48 SIST EN 14180:2003+A1:2009

3 Foreword This document (EN 14180:2003+A1:2009) has been prepared by Technical Committee CEN /TC 102, "Sterilizers for medical purposes", the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn at the latest by March 2010. This document includes Amendment 1, approved by CEN on 2009-04-12. This document supersedes EN 14180:2003. The start and finish of text introduced or altered by amendment is indicated in the text by tags !". 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 EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA which is an integral part of this document. Annexes A, B, C and D are normative and form part of this European Standard. Annexes E, F and ZA are for information only. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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.
4 Introduction This European Standard specifies minimum requirements and test methods for sterilizers working below ambient atmospheric pressure performing a low temperature steam and formaldehyde (LTSF) process. LTSF sterilizers are primarily used for the sterilization of medical devices in health care facilities, but may also be used during the commercial production of medical devices. LTSF processes are specified by physical parameters and verified using physical, chemical and microbiological means. The sterilizers operate automatically using pre-set cycles. The test methods and test equipment given may also be applicable to validation and routine control. Validation and routine control of sterilization processes are essential to ensure their efficacy. This standard does not cover validation and routine control of a LTSF process. General criteria for validation and routine control of a sterilization process, also applicable to LTSF sterilization processes, are given in EN ISO 14937. At the present state of knowledge, LTSF sterilizers should not be assumed to deliver processes effectively inactivating the causative agents of spongiform encephalopathies such as scrapie, Bovine Spongiform Encephalophaty and Creutzfeld-Jakob Disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents. (See also EN ISO 14937:2000, 1.6 Note 2). Planning and design of products applying to this standard should consider not only technical issues but also the environmental impact from the product during its life-cycle. Environmental aspects are addressed in annex F of this standard. NOTE Risk analysis methods, e. g. in EN ISO 14971, pay attention to environmental aspects. Specifications on operator safety are addressed in EN 61010–1, EN 61010–2–042 and are not repeated in this standard. EN 60204–1 may also give valuable guidelines. 1 Scope 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. 2 Normative references !The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies." SIST EN 14180:2003+A1:2009

5 EN 866–1, Biological systems for testing sterilizers and sterilization processes — Part 1: General requirements.1
EN 866–5, Biological systems for testing sterilizers and sterilization processes — Part 5: Particular systems for use in low temperature steam and formaldehyde sterilizers. 2
EN 867–5, Non-biological systems for use in sterilizers — Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S. EN 868–5, Packaging materials and systems for medical devices which are to be sterilized — Parts 5: Heat and self-sealable pouches and reels of paper and plastic film construction — Requirements and test methods. EN 60584–2, Thermocouples — Part 2: Tolerances (IEC 60584–2:1982 + A1:1989). EN 60751, Industrial platinum resistance thermometer sensors (IEC 60751:1983 + A1:1986). EN 61010–1, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 1: General requirements (IEC 61010-1:2001). EN 61010–2–042:1997, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 2–042: Particular requirements for autoclaves and sterilizers using toxic gas for the treatment of medical materials, and for laboratory processes (IEC 61010–2–042:1997). EN 61326:1997, Electrical equipment for measurement, control and laboratory use — EMC requirements (IEC 61326:1997). EN ISO 3746, Acoustics — Determination of sound power levels of noise sources using sound pressure — Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:1995). ISO 228–1, Pipe threads where pressure-tight joints are not made on the threads — Part 1: Dimensions, tolerances and designation. 3 Terms and definitions !For the purposes of this document, the following terms and definitions apply." 3.1 access device means used to enable access to restricted parts of equipment
NOTE This may be a dedicated key, code or tool. 3.2 aeration a part or parts of the sterilization process in which defined conditions are used such that formaldehyde and its reaction products are desorbed from the medical device, and which can be performed within the sterilizer, within a separate room or chamber, or by a combination of the two
3.3 air removal removal of air from the sterilizer chamber and sterilization load to facilitate sterilant penetration 3.4 automatic controller device that, in response to pre-determined cycle variables, operates the sterilizer sequentially through the required stages of the operating cycle
1 Under revision, see new edition of ISO 11138 series which is currently being prepared by ISO/TC 198, Vienna Agreement. 2 Under revision, see new edition of ISO 11138 series which is currently being prepared by ISO/TC 198, Vienna Agreement. SIST EN 14180:2003+A1:2009

6 3.5 biological indicator an inoculated carrier contained within its primary pack ready for use [EN 866–1:1997, definition 3.1] 3.6 chamber pre-heating the heating of inner sterilizer-chamber surfaces to achieve predetermined temperatures prior to the commencement of a sterilization cycle 3.7 conditioning treatment of product within the sterilization cycle, but prior to the holding time, to attain a predetermined temperature and humidity throughout the sterilization load 3.8 cycle complete indication that the operating cycle has been satisfactorily completed and that the sterilized load is ready for removal from the sterilizer chamber [EN 285:1996, definition 3.10]
3.9 cycle parameter specified value for a cycle variable
3.10 cycle variables the physical properties that influence the efficacy of the sterilization cycle NOTE For LTSF-sterilizers, the cycle variables include, but may not be limited to temperature, pressure, time, sterilant concentration. 3.11 desorption removal of the sterilant from the chamber and the load at the end of the exposure time 3.12 double-ended sterilizer sterilizer in which there is a door at each end of the sterilizer chamber [EN 285:1996, definition 3.13] 3.13 equilibration time period which elapses between the attainment of the sterilization temperature at the reference measuring point and the attainment of the sterilization temperature at all points within the load 3.14 exposure time time between introducing the sterilant into the chamber and the start of the desorption phase 3.15 holding time period for which the temperature, the steam pressure and the formaldehyde concentration of the steam are held within pre-set values and their tolerances to achieve the required inactivation efficacy in the sterilizer chamber
NOTE The holding time follows immediately after the equilibration time. SIST EN 14180:2003+A1:2009

7 3.16 inoculated carrier a carrier on which a defined number of test organisms has been deposited [EN 866-1:1997, definition 3.8] 3.17
installation qualification
IQ obtaining and documenting evidence that equipment has been provided and installed in accordance with its speci
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