BS EN 13060:2004+A2:2010 - Small steam sterilizers – BSI British Standards

BS EN 13060:2004+A2:2010

Small steam sterilizers

Status : Revised, Superseded, Withdrawn   Published : August 2005 Replaced By : BS EN 13060:2014+A1:2018

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BS EN 13060:2004+A2:2010 Small steam sterilizers

BS EN 13060 us a 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.

BS EN 13060 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.

BS EN 13060 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.

BS EN 13060 does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.

BS EN 13060 does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).

BS EN 13060 does not specify requirements for the validation and routine control of sterilization by moist heat.

Contents of BS EN 13060:

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General technical requirements
5 Performance requirements
6 Safety
7 Categories of tests
8 Test equipment
9 Test programme
10 Test methods
Annex A (informative) Clarification of the definition of hollow space A and hollow space B (see 3.19 and 3.20)
Annex B (informative) Process evaluation system
Annex C (informative) Suggested maximum limits of contaminants in and specification for water for steam sterilization
Annex D (informative) Example of a table to be supplied with pre-purchase documentation and with the instructions for use
Annex E (informative) Load support systems
Annex F (informative) Rationale for the tests
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC on medical devices
Bibliography

 




Standard NumberBS EN 13060:2004+A2:2010
TitleSmall steam sterilizers
StatusRevised, Superseded, Withdrawn
Publication Date03 August 2005
Withdrawn Date31 December 2014
Normative References(Required to achieve compliance to this standard)EN 867-5:2001, EN 867-1:1997, EN 285:1996, ISO 228-1:2000, EN ISO 13485:2003, EN 866-3, ISO 4126-1:2004, ISO 13485:2003, EN ISO 228-1, EN ISO 4017, EN ISO 4126-1, ISO 3746:1995, EN 475, IEC 61010-1:2001, IEC 61326:1997, EN 61010-1, ISO 4017:1999, EN 868, ISO 14937:2000, EN 61010-2-041, EN ISO 3746, EN ISO 14937, EN 61326, EN 60529, IEC 61010-2-041:1996, EN 10088-1, IEC 60529:1989
Informative References(Provided for Information)EN 556-1:2001, EN 866-1:1997, EN 764-1:2004, IEC 60751:1983, EN 554:1994, EN ISO 10993, EN 60751:1995, IEC 60584-2:1982, 97/23/EC, IEC 60073:2002, EN ISO 17664:2004, IEC 60751:1983/AMD 1:1986, ISO 17664:2004, IEC 60584-2:1982/AMD 1:1989, EN 60073:2002, EN 60584-2:1993, 93/42 EEC, ISO/DIS 14538:1997, 2006/42/EC, VIM:1993, 93/42/EEC
Replaced ByBS EN 13060:2014+A1:2018
ReplacesBS 3970-4:1990
International RelationshipsEN 13060:2004+A2:2010
Amended ByAMD 16207
Amendment, August 2010; Amendment, November 2009
DescriptorsDental equipment, Equipment safety, Sterilization (hygiene), Sterilizers, Performance, Medical equipment, Test methods, Steam sterilizers
ICS11.080.10
Title in FrenchPetits stérilisateurs à la vapeur d'eau
Title in GermanDampf-Klein-Sterilisatoren
CommitteeCH/198
ISBN978 0 580 65234 9
PublisherBSI
FormatA4
DeliveryNo
Pages72
File Size931 KB
Price£274.00


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