EN 13060:2004+A1:2009

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).
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 Medizinprodukten
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 Sterilisation
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

General Information

• Status: Withdrawn
• Publication Date: 12-May-2009
• Withdrawal Date: 16-Mar-2010
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102 - Sterilizers for medical purposes
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 17-Mar-2010
• Completion Date: 17-Mar-2010
• 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+A1:2009 - Small steam sterilizers

Relations

• Merged Into: EN 13060:2004+A2:2010 - Small steam sterilizers
• Effective Date: 16-Jan-2010
• Merged From: EN 13060:2004 - Small steam sterilizers
• Effective Date: 19-Jan-2023
• Merged From: EN 13060:2004/prA1 - Small steam sterilizers
• Effective Date: 18-Jan-2023
• Amended By: EN 13060:2004/FprA2 - Small steam sterilizers
• Effective Date: 21-Nov-2009
• Revised: EN 13060:2014 - Small steam sterilizers
• Effective Date: 04-Jul-2009

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+A1:2009SIST EN 13060:2005+A1:2009en,fr,de01-oktober-2009SIST EN 13060:2005+A1:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13060:2004+A1
May 2009 ICS 11.080.10 Supersedes EN 13060:2004English 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.
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 13060:2004+A1:2009: ESIST EN 13060:2005+A1:2009

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+A1:2009

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 764-1:2004, definition 4.5] 3.2 active drain of small steam sterilizers drain through which fluids present in the chamber are discharged during the process 3.3 air removal removal of air from the sterilizer chamber and sterilizer load sufficient to facilitate steam penetration [EN 285:1996, definition 3.2] 3.4 automatic controller device that, in response to pre-determined cycle variables, operates the sterilizer sequentially through the required stages of the cycle(s) [EN 285:1996, definition 3.3] 3.5 biological indicator inoculated carrier contained within its primary pack ready for use
Currently under revision by IEC/TC 66/WG 7. SIST EN 13060:2005+A1:2009
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