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
Not Harmonized93/42/EEC - Medical devices
- 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
SIST EN 13060:2005/kprA1:2009 is a European Standard developed by the Slovenski inštitut za standardizacijo (SIST) that provides detailed performance requirements and test methods for small steam sterilizers. These devices play a critical role in medical and healthcare environments by ensuring the sterilization of medical instruments and other items likely to come into contact with blood or body fluids. The standard addresses sterilizers that are automatically controlled, use electrical heaters to generate steam, or utilize steam from an external source. It applies to units with a chamber volume not exceeding 60 litres and that cannot accommodate a sterilization module of 300 mm × 300 mm × 600 mm.
This standard is essential for manufacturers, suppliers, and operators of sterilization equipment, helping them ensure product conformity, efficacy, and compliance with key European directives.
Key Topics
- Performance Requirements: Outlines essential criteria for effective sterilization cycles, ensuring sufficient steam penetration and exposure times for reliable decontamination of medical devices.
- Test Methods: Specifies rigorous procedures for testing and validating the performance of small steam sterilizers, including operational consistency and load processing.
- Scope Limitations: The standard expressly excludes sterilizers intended for processing liquids or pharmaceutical products and does not specify requirements for the validation and routine control of sterilization by moist heat.
- Equipment Specifications: Applies to small steam sterilizers with automatic controls and chambers not exceeding 60 litres in volume, focusing on units primarily used for medical device sterilization.
- Exclusions: Does not cover safety requirements related to risks in the installation area (such as flammable gases) and refers users to separate standards for validation and routine control measures.
Applications
SIST EN 13060:2005/kprA1:2009 is most relevant for:
- Medical Facilities: Hospitals, clinics, dental practices, and outpatient surgery centers that require reliable sterilization of reusable medical instruments like forceps, scalpels, and other devices to prevent infection transmission.
- Laboratories: Sterilization of equipment that may come into contact with biological samples, ensuring compliance with hygiene protocols.
- Medical Device Manufacturers: Ensures their products meet European market requirements regarding sterilization and patient safety.
- Compliance and Quality Assurance: Utilized by regulatory bodies and internal auditors for conformity assessment, ensuring equipment meets both national and EU-wide regulations.
By clearly defining the performance and testing expectations, this standard supports the production and operation of reliable, validated steam sterilizers in medical settings, promoting both patient and practitioner safety.
Related Standards
- EN 554: Specifies requirements for the validation and routine control of sterilization by moist heat, which may be applied to small steam sterilizers alongside EN 13060.
- Directive 93/42/EEC: Referenced for essential requirements relating to medical devices within the European Union.
- Directive 2006/42/EC on Machinery: Relevant for sterilizers classed as machinery, aligning health and safety requirements.
- ISO/TC 198 and CEN/TC 102: Committees that develop global and European standards related to sterilization in healthcare.
- SIST EN 285: For large steam sterilizers, useful for distinguishing scope boundaries.
Keywords: small steam sterilizers, medical equipment sterilization, sterilization test methods, healthcare infection control, European Standard, compliance, medical device safety, sterilizing equipment, EN 13060, SIST.
Get Certified
Connect with accredited certification bodies for this standard
BSI Group
BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.
TÜV Rheinland
TÜV Rheinland is a leading international provider of technical services.
TÜV SÜD
TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.
Sponsored listings
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.
SIST EN 13060:2005/kprA1:2009 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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
...