BS EN 13060:2014+A1:2018 Small steam sterilizers

BS EN 13060:2014+A1:2018

Small steam sterilizers

Status : Current, Under review   Published : December 2014



What is this standard about?

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 with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm).

The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).

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 ISO 17665-1.

This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).

Standard NumberBS EN 13060:2014+A1:2018
TitleSmall steam sterilizers
StatusCurrent, Under review
Publication Date31 December 2014
Normative References(Required to achieve compliance to this standard)EN 285:2006+A2:2009, ISO 11138-3:2017, EN 13060:2004+A2:2010, EN 867-5:2001, ISO 4017, ISO 228-1, EN 61326-1:2013, prEN 285:2014, EN 1041, IEC 60751:2008, IEC 61326-1:2012, ISO 11140-1, EN 60751:2008, EN ISO 14971:2012, ISO 14971:2007, EN 60529, EN 10088-1, IEC 61010-1:2010, ISO 4126-1, EN ISO 11140-1, EN ISO 4017, EN ISO 17665-1:2006, EN ISO 3746, ISO 3746, EN 868, EN ISO 228-1, EN 13445, EN ISO 4126-1, IEC 61010-2-040:2005, EN 61010-1:2010, ISO 17665-1:2006, EN 61010-2-040:2005, IEC 60529, EN ISO 11138-3
Informative References(Provided for Information)IEC 62304, EN 62304, IEC 60584-2, EN 13445-5:2009, EN 764-1:2004, ISO 17664:2017, ISO 15883-1:2006, EN 61508-1, ISO 10993, IEC 60073, EN ISO 9000:2005, EN 556-1, prEN ISO 11140-6, EN ISO 11607-1, EN 62061, EN ISO 13485:2012, EN ISO 15883-1:2009, IEC 62061, TS 11139:2006, ISO 9000:2005, EN ISO 14937, EN ISO 10993, EN 60584-2, EN ISO 17664, EN ISO 15223-1, EN 61508, ISO 13485:2003, ISO 11607-2, EN ISO 11607-2, ISO 11607-1, IEC Guide 51:1999, IEC 61508-1, EN 60073, ISO 14937, EN ISO 12100
ReplacesBS EN 13060:2004+A2:2010
International RelationshipsEN 13060:2014+A1:2018
Amended ByCorrigendum, December 2018; Amendment, November 2018
DescriptorsEquipment safety, Performance, Medical equipment, Test methods, Sterilization (hygiene), Dental equipment, Steam sterilizers, Sterilizers
Title in FrenchPetits stérilisateurs à la vapeur d'eau
Title in GermanDampf-Klein-Sterilisatoren
ISBN978 0 539 03273 4
File Size1.284 MB

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