EN 13060:2004+A2:2010

Small steam sterilizers

This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.
This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer.
This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm) and with a chamber volume not exceeding 60 litres.
This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).
The performance requirements specified in this document are not intended for the process to be effective in inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeld-Jakob disease. However, some national regulations require the use of modified steam processes as part of a general prior decontamination programme.
This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat.
NOTE   Requirements for the validation and routine control of sterilization by moist heat are given in EN 554, which may also be applied for small steam sterilizers.

Dampf-Klein-Sterilisatoren

Diese Europäische Norm legt die Leistungsanforderungen und Prüfverfahren für Dampf-Klein-Sterilisatoren und deren Sterilisationszyklen fest, die für medizinische Zwecke oder für Materialien verwendet werden, die mit Blut oder Körperflüssigkeiten in Kontakt kommen können.
Diese Europäische Norm gilt für automatisch geregelte Dampf-Klein-Sterilisatoren, die zur Dampferzeugung elektrische Heizungen verwenden oder die Dampf benutzen, der in einem System außerhalb des Sterilisators erzeugt wird.
Diese Europäische Norm gilt für Dampf-Klein-Sterilisatoren, die in erster Linie für die Sterilisation von Medizin¬produkten verwendet werden und die nicht in der Lage sind, eine Sterilisiereinheit (300 mm  300 mm  600 mm) aufzunehmen sowie deren Kammervolumen 60 Liter nicht übersteigt.
Diese Europäische Norm gilt nicht für Dampf-Klein-Sterilisatoren, die für die Sterilisation von Flüssigkeiten oder pharmazeutischen Produkten verwendet werden.
Diese Europäische Norm legt keine Sicherheitsanforderungen fest, die mit den Risiken in dem Bereich zusammenhängen, in dem der Sterilisator verwendet wird (z. B. entzündliche Gase).
Diese Europäische Norm legt keine Anforderungen für die Validierung und Routineüberwachung der Sterilisa-tion mit feuchter Hitze fest.
ANMERKUNG   Anforderungen für die Validierung und Routineüberwachung der Sterilisation mit feuchter Hitze sind in EN 554 angegeben, die auch für Dampf-Klein-Sterilisatoren angewendet werden kann.

Petits stérilisateurs à la vapeur d'eau

La présente Norme européenne spécifie les exigences en matière de performances et les méthodes d'essai relatives aux petits stérilisateurs à la vapeur d'eau et aux cycles de stérilisation utilisés à des fins médicales ou pour des matériels susceptibles d'entrer en contact avec du sang ou des liquides corporels.
La présente Norme européenne s'applique aux petits stérilisateurs à la vapeur d'eau à commande automatique qui produisent de la vapeur d'eau en utilisant des éléments chauffants électriques ou qui utilisent de la vapeur d'eau produite par un système externe au stérilisateur.
La présente Norme européenne s'applique aux petits stérilisateurs à la vapeur d'eau utilisé essentiellement pour la stérilisation des dispositifs médicaux, ne pouvant pas recevoir d'unité de stérilisation (300 mm  300 mm  600 mm) et dont le volume de la chambre n'excède pas 60 litres.
La présente Norme européenne ne s'applique pas aux petits stérilisateurs à la vapeur d'eau qui sont utilisés pour stériliser des liquides ou des produits pharmaceutiques.
La présente Norme européenne ne précise pas les exigences de sécurité relatives aux risques associés à la zone dans laquelle est utilisé le stérilisateur (par exemple gaz inflammables).
La présente Norme européenne ne spécifie pas les exigences relatives à la validation et au contrôle habituel d'une stérilisation par chaleur humide.
NOTE   Les exigences relatives à la validation et au contrôle de routine de la stérilisation par chaleur humide figurent dans l'EN 554, laquelle peut également s'appliquer aux petits stérilisateurs à la vapeur d'eau.

Mali parni sterilizatorji

Ta evropski standard določa zahteve za delovanje in preskusne metode za male parne sterilizatorje in sterilizacijske cikle, ki se uporabljajo za medicinske namene ali za materiale, ki lahko pridejo v stik s krvjo ali telesnimi tekočinami. Ta evropski standard velja za avtomatsko nadzorovane male parne sterilizatorje, ki paro proizvajajo z uporabo električnih grelcev ali uporabljajo paro, ki jo proizvaja sistem zunaj sterilizatorja. Ta evropski standard velja za male parne sterilizatorje, ki se uporabljajo predvsem za sterilizacijo medicinskih pripomočkov in se vanje ne more namestiti sterilizacijski modul (300 mm × 300 mm × 600 mm), s prostornino komore pod 60 litrov.

General Information

• Status: Withdrawn
• Publication Date: 16-Mar-2010
• Withdrawal Date: 16-Dec-2014
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 5 - Small sterilizers
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 17-Dec-2014
• 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 13060:2005+A2:2010 - Small steam sterilizers

Relations

• Merged From: EN 13060:2004/FprA2 - Small steam sterilizers
• Effective Date: 19-Jan-2023
• Merged From: EN 13060:2004+A1:2009 - Small steam sterilizers
• Effective Date: 16-Jan-2010
• Replaced By: EN 13060:2014 - Small steam sterilizers
• Effective Date: 24-Dec-2014

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Mali parni sterilizatorjiDampf-Klein-SterilisatorenPetits stérilisateurs à la vapeur d'eauSmall steam sterilizers11.080.10Sterilizacijska opremaSterilizing equipmentICS:Ta slovenski standard je istoveten z:EN 13060:2004+A2:2010SIST EN 13060:2005+A2:2010en,fr,de01-junij-2010SIST EN 13060:2005+A2:2010SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13060:2004+A2
March 2010 ICS 11.080.10 Supersedes EN 13060:2004+A1:2009English Version
Small steam sterilizers
Petits stérilisateurs à la vapeur d'eau
Dampf-Klein-Sterilisatoren This European Standard was approved by CEN on 16 April 2004 and includes Amendment 1 approved by CEN on 12 April 2009 and Amendment 2 approved by CEN on 6 February 2010.
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, Croatia, 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 © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13060:2004+A2:2010: ESIST EN 13060:2005+A2:2010

Clarification of the definition of hollow space A and hollow space B (see 3.19 and 3.20) . 57Annex B (informative)
Process evaluation system . 59Annex C (informative)
Suggested maximum limits of contaminants in and specification for water for steam sterilization. 60Annex D (informative)
Example of a table to be supplied with pre-purchase documentation and with the instructions for use . 61Annex E (informative)
Load support systems . 62Annex F (informative)
Rationale for the tests . 63Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices . 65Bibliography . 68
EN 867-1:1997, Non-biological systems for use in sterilizers — Part 1: General requirements2 EN 867-5:2001, 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 (all parts), Packaging materials and systems for medical devices which are to be sterilized3 EN 10088-1, Stainless steels — Part 1: List of stainless steels EN 60529, Degrees of protection provided by enclosures (IP code) (IEC 60529:1989) EN 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 1: General requirements (IEC 61010-1:2001)
Currently under revision by CEN/TC 102. 2
EN 867-1 is currently under revision by ISO/TC 198 and CEN/TC 102 (Vienna Agreement). 3
EN 868-1 is currently under revision by ISO/TC 198 and CEN/TC 102 (Vienna Agreement). SIST EN 13060:2005+A2:2010

EN 61326, Electrical equipment for measurement, control and laboratory use — EMC requirements (IEC 61326:1997) EN ISO 228-1, Pipe threads where pressure-tight joints are not made on the threads — Part 1: Dimensions, tolerances and designation (ISO 228-1:2000) EN ISO 3746, Acoustics — Determination of sound power levels of noise sources using sound pressure — Survey method using and enveloping measurement surface over a reflecting plane (ISO 3746:1995) EN ISO 4017, Hexagon head screws — Product grades A and B (ISO 4017:1999) EN ISO 4126-1, Safety devices for protection against excessive pressure — Part 1: Safety valves (ISO 4126-1:2004) EN ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) EN ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000) 3 Terms and definitions !For the purposes of this document, the following terms and definitions apply." NOTE Other definitions relevant to steam sterilization and its validation are given in EN 285 and EN 554. 3.1 absolute pressure pressure for which the zero value is associated with absolute vacuum [EN 764-1:20
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