BS EN 14180:2014 - Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing

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BS EN 14180:2014

Sterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing

Status : Current, Under review   Published : May 2014

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This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. This European Standard specifies minimum requirements: - for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.




Standard NumberBS EN 14180:2014
TitleSterilizers for medical purposes. Low temperature steam and formaldehyde sterilizers. Requirements and testing
StatusCurrent, Under review
Publication Date31 May 2014
Cross ReferencesEN 764-7, EN 867–5, EN 868–5, EN 14222:2003, EN 60584–2, EN 60751:2008, IEC 60751:2008, EN 61010–1:2010, IEC 61010-1:2010, EN 61010-2-040:2005, IEC 61010-2-040:2005, EN 61326-1:2013, IEC 61326-1:2012, EN ISO 228-1:2003, ISO 228-1:2000, EN ISO 1874-1, ISO 1874-1, EN ISO 3746:2010, ISO 3746:2010, EN ISO 11138-1:2006, ISO 11138-1:2006, EN ISO 11138-5, ISO 11138-5, EN ISO 14971:2012, ISO 14971:2007, EN ISO 15223-1, ISO 15223-1, 93/42/EEC, EN 285:2006+A2:2009, EN 1041, EN 1422:1997+A1:2009, EN 1837:1999+A1:2009, EN 10027-2, EN 13445, EN 13445-3:2012, EN 60204-1, IEC 60204-1, EN 61508, IEC 61508, EN 61508-1, IEC 61508-1, EN 61508-3, IEC 61508-3, EN 62061, IEC 62061, EN 62304:2006, IEC 62304:2006, EN ISO 534, ISO 534, EN ISO 536, ISO 536, EN ISO 2758, ISO 2758, EN ISO 4017, ISO 4017, EN ISO 9000:2005, ISO 9000:2005, EN ISO 12100:2010, ISO 12100:2010, EN ISO 13485:2012, ISO 13485:2003, EN ISO 13732-1, ISO 13732-1, EN ISO 13849-2, ISO 13849-2, EN ISO 17665-1:2006, ISO 17665-1:2006, EN ISO 25424:2011, ISO 25424:2009, ISO 1762, ISO 3781, ISO 8787, ISO/TS 11139:2006, ANSI/AAMI RD 47:1993, 93/4
ReplacesBS EN 14180:2003+A2:2009
International RelationshipsEN 14180:2014
Draft Superseded By12/30262894 DC
DescriptorsMedical equipment, Formaldehyde, Testing, Steam, Steam sterilizers, Sterilizers, Sterilization (hygiene), Low temperatures
ICS11.080.10
Title in FrenchStérilisateurs à usage médical. Stérilisateurs à la vapeur et au formaldéhyde à basse température. Exigences et essais
Title in GermanSterilisatoren für medizinische Zwecke. Niedertemperatur- Dampf-Formaldehyd-Sterilisatoren. Anforderungen und Prüfung
CommitteeCH/198
ISBN978 0 580 78885 7
PublisherBSI
FormatA4
DeliveryYes
Pages66
File Size609 KB
Price£246.00


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