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

BS EN 14180:2014

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

Status : Confirmed, Current   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
StatusConfirmed, Current
Publication Date31 May 2014
Confirm Date15 April 2020
Normative References(Required to achieve compliance to this standard)ISO 11138-5:2017, ISO 228-1:2000, EN 14222:2003, IEC 61010-1:2010, ISO 1874-1, EN ISO 11138-5, EN ISO 1874-1, IEC 60751:2008, EN ISO 14971:2012, EN 60751:2008, EN ISO 228-1:2003, EN ISO 15223-1, EN ISO 3746:2010, ISO 3746:2010, IEC 61326-1:2012, ISO 14971:2007, EN 867–5, EN ISO 11138-1:2006, EN 61010-2-040:2005, EN 61010–1:2010, IEC 61010-2-040:2005, ISO 15223-1, EN 764-7, EN 868–5, ISO 11138-1:2006, EN 61326-1:2013, EN 60584–2
Informative References(Provided for Information)EN ISO 9000:2005, IEC 60204-1, ISO 13485:2003, EN ISO 13732-1, 93/42/EEC, IEC 61508, EN 1041, ISO 13849-2, ISO 17665-1:2006, IEC 61508-1, EN 13445, EN ISO 4017, IEC 62061, EN 61508, IEC 62304:2006, EN ISO 534, EN ISO 13849-2, ISO 8787, EN 13445-3:2012, ISO 3781, EN 62304:2006, EN ISO 12100:2010, 2006/42/EC, EN ISO 17665-1:2006, IEC 61508-3, EN ISO 536, ISO 9000:2005, ISO 13732-1, ISO 536, EN 10027-2, EN 61508-3, 98/83/EC, ISO 12100:2010, ANSI/AAMI RD 47:1993, EN 60204-1, EN 62061, ISO 25424:2009, ISO/TS 11139:2006, 97/23/EC, EN ISO 13485:2012, EN 61508-1, EN ISO 2758, EN ISO 25424:2011, ISO 1762, ISO 4017, ISO 2758, EN 1422:1997+A1:2009, EN 285:2006+A2:2009, EN 1837:1999+A1:2009, ISO 534
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 Size1.227 MB
Price£254.00


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