SIST EN 13060:2005/kprA1:2009
(Amendment)Small steam sterilizers
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
- 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
- Ref Project
EN 13060:2004/prA1 - Small steam sterilizers
Relations
- Consolidated By
SIST EN 13060:2005+A1:2009 - Small steam sterilizers - Effective Date
- 01-Oct-2009
- Effective Date
- 01-Mar-2009
Overview
EN 13060:2004/prA1 is a CEN European Standard that defines performance requirements and test methods for small steam sterilizers used for medical purposes or for materials likely to contact blood or body fluids. The amendment (prA1) updates the original EN 13060:2004 and was prepared by CEN/TC 102 “Sterilizers for medical purposes.” This standard applies to automatically controlled small steam sterilizers that either generate steam with internal electric heaters or use externally supplied steam, with chamber volumes not exceeding 60 litres and unable to accommodate a 300 × 300 × 600 mm sterilization module.
Key topics and technical requirements
- Scope and applicability: Targets small steam sterilizers for sterilizing medical devices and materials exposed to blood/body fluids; explicitly excludes sterilizers intended primarily for liquids or pharmaceutical products.
- Performance requirements: Defines the essential functional criteria that small steam sterilizers must meet (cycles, repeatability, control).
- Test methods: Specifies how to test sterilizer performance and sterilization cycles to demonstrate compliance.
- Automatic control: Applies only to sterilizers with automatic control systems (cycle programming, monitoring).
- Chamber size limit: Applies to devices with chamber volume up to 60 litres and those that cannot accept the defined sterilization module.
- Exclusions and safety scope: Does not cover safety risks from the surrounding zone (e.g., flammable gases) and does not specify validation or routine control procedures for moist heat sterilization.
- Regulatory linkage: Amendment includes modifications to Annex ZA relating to EC Directives (medical devices directive 93/42/EEC and references to Machinery Directive 2006/42/EC), clarifying which essential requirements are addressed.
Applications and users
- Intended for manufacturers of small steam sterilizers to design and certify products for medical use.
- Used by test laboratories and conformity assessment bodies to perform performance testing and verification.
- Relevant to healthcare facilities (dental clinics, outpatient clinics, small hospitals, ambulatory surgery centers) when selecting and verifying small sterilizers for instruments and devices.
- Useful for procurement, regulatory affairs, and quality managers who must ensure sterilization equipment meets European essential requirements.
Related standards
- EN 554 - validation and routine control of sterilization by moist heat (recommended reference for validation/routine control not covered by EN 13060).
- References in Annex ZA to Directive 93/42/EEC (medical devices) and Directive 2006/42/EC (Machinery) for regulatory conformity context.
EN 13060:2004/prA1 is a key reference for anyone involved in the design, testing, selection or regulation of small steam sterilizers in medical settings, ensuring consistent steam sterilization performance and safety across Europe.
Frequently Asked Questions
SIST EN 13060:2005/kprA1:2009 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Small steam sterilizers". This standard covers: 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.
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.
SIST EN 13060:2005/kprA1:2009 is classified under the following ICS (International Classification for Standards) categories: 11.080.10 - Sterilizing equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 13060:2005/kprA1:2009 has the following relationships with other standards: It is inter standard links to SIST EN 13060:2005+A1:2009, SIST EN 13060:2005. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 13060:2005/kprA1:2009 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
Foreword .3
1 Modifications to Annex ZA .4
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
...
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