BS EN 60601-1-12:2015 - Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

BS EN 60601-1-12:2015

Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

Status : Current, Under review   Published : June 2015

Format
PDF

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IEC 60601-1-12:2014 constitutes a collateral standard to IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance hereafter referred to as the general standard. Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the emergency medical services environment. The safety of medical electrical equipment in this uncontrolled, rough environment is a cause for concern. This collateral standard was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of this collateral standard are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for the development of particular standards. This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, which are intended, as indicated in the instructions for use by their manufacturer, for use in the EMS environment (Emergency Medical Services environment). The object of this collateral standard is to provide general requirements for ME equipment and ME systems carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.




Standard NumberBS EN 60601-1-12:2015
TitleMedical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
StatusCurrent, Under review
Publication Date30 June 2015
Normative References(Required to achieve compliance to this standard)EN 55011:2009, EN ISO 7010:2012, IEC 60601-1-6:2010, EN ISO 7010:2012/A5:2015, EN 60601-1:2006/A1:2013, IEC 60601-1-2:2014, EN 60529:1991, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1:2005/AMD1:2012, IEC 60601-1-8:2006/AMD1:2012, ISO 7000:2014, IEC 60068-2-64:2008, EUROCAE5 ED-14G, EN 60601-1-2:2014, EN 60601-1:2006, IEC 60601-1-8:2006, ISO 7010:2011, ISO 7010:2011/A1:2012, EN 60601-1-6:2010, EN 60529:1991/A1:2000, CISPR 11:2009, RTCA6 DO-160G, IEC 60068-2-31:2008, EN ISO 7010:2012/A4:2014, ISO 15223-1:2012, EN 60601-1-6:2010/A1:2013, EN 60068-2-31:2008, EN ISO 7010:2012/A1:2014, IEC 60601-1-11, ISO 7010:2011/A5:2014, ISO 7010:2011/A2:2012, ISO 7010:2011/A4:2013, IEC 60068-2-27:2008, EN ISO 7010:2012/A2:2014, ISO 7010:2011/A3:2012, EN 60068-2-27:2009, EN ISO 7010:2012/A3:2014, IEC 60601-1:2005, EN 60068-2-64:2008, IEC 60529:1989/AMD1:1999, EN ISO 15223-1:2012, EN 60601-1-11:2015, IEC 60529:1989
Informative References(Provided for Information)EN 13718-1:2008, IEC 61032:1997, EN 1789:2007, IEC 60335-1:2010, HD 60364, EN ISO 10651-2:2009, ASTM F1288-1990, IEC 60950-1:2005, MIL-STD-810G:2008, HD 384, IEC 60364, ISO 10651-2:2004, EN 60335-1:2012, ASTM F1339-1992, EN 60721-3-7:1995/A1:1997, EN 60065, EN 60721-3-7:1995, ASTM F2020-2002, EN 60038:2011, IEC 60038:2009, MIL-HDBK-310:1997, EN 60950-1:2006, EN 61032:1998, IEC 60721-3-7:1995/A1:1996, IEC 60721-3-7:1995, IEC 60065
International RelationshipsEN 60601-1-12:2015,IEC 60601-1-12:2014
Draft Superseded By12/30245174 DC
DescriptorsElectrical medical equipment, Environmental testing, Emergency services, Electrical equipment, Performance, Health and safety requirements
ICS11.040.01
11.040.50
Title in FrenchAppareils électromédicaux. Exigences générales pour la sécurité de base et les performances essentielles. Norme collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être utilisés dans l'environnement des services médicaux d'urgence
Title in GermanMedizinische elektrische Geräte. Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale. Ergänzungsnorm: Anforderungen an medizinische elektrische Geräte und medizinische elektrische Systeme in der Umgebung für den Notfalleinsatz
CommitteeCH/62/1
ISBN978 0 580 75144 8
PublisherBSI
FormatA4
DeliveryYes
Pages58
File Size1.507 MB
Price£254.00


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