SIST EN 13060:2005/kprA1:2009

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

Petits stérilisateurs à la vapeur d'eau

Mali parni sterilizatorji

General Information

• Status: Not Published
• Public Enquiry End Date: 09-Mar-2009
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 98 - Abandoned project (Adopted Project)
• Start Date: 29-Jul-2011
• Due Date: 03-Aug-2011
• Completion Date: 29-Jul-2011
• 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: EN 13060:2004/prA1 - Small steam sterilizers

Relations

• Amends: SIST EN 13060:2005 - Small steam sterilizers
• Effective Date: 01-Mar-2009
• Consolidated By: SIST EN 13060:2005+A1:2009 - Small steam sterilizers
• Effective Date: 18-Jan-2023
• Consolidated By: SIST EN 13060:2005+A1:2009 - Small steam sterilizers
• Effective Date: 19-Jan-2023
• Consolidated By: SIST EN 13060:2005+A1:2009 - Small steam sterilizers
• Effective Date: 01-Oct-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 13060:2005/kprA1:2009
01-marec-2009
Mali parni sterilizatorji
Small steam sterilizers
Dampf-Klein-Sterilisatoren
Petits stérilisateurs à la vapeur d'eau
Ta slovenski standard je istoveten z: EN 13060:2004/prA1
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN 13060:2005/kprA1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 13060:2005/kprA1:2009

---------------------- Page: 2 ----------------------

SIST EN 13060:2005/kprA1:2009
EUROPEAN STANDARD
FINAL DRAFT
EN 13060:2004
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
December 2008
ICS 11.080.10

English Version
Small steam sterilizers
Petits stérilisateurs à la vapeur d'eau Dampf-Klein-Sterilisatoren
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 102.
This draft amendment A1, if approved, will modify the European Standard EN 13060:2004. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN 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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13060:2004/prA1:2008: E
worldwide for CEN national Members.

---------------------- Page: 3 ----------------------

SIST EN 13060:2005/kprA1:2009
EN 13060:2004/prA1:2008 (E)
Contents Page
Foreword .3
1 Modifications to Annex ZA .4

2

---------------------- Page: 4 ----------------------

SIST EN 13060:2005/kprA1:2009
EN 13060:2004/prA1:2008 (E)
Foreword
This document (EN 13060:2004/prA1:2008) has been prepared by Technical Committee CEN/TC 102
“Sterilizers for medical purposes”, the secretariat of which is held by DIN.
This document is currently submitted to the Unique Acceptance Procedure.
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 EC Directive(s).
For relationship with EC
...