BS EN 60601-1-11:2015 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance

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BS EN 60601-1-11:2015

Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Status : Current   Published : June 2015

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Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment 

People are increasingly using medical equipment in their own homes, for monitoring, treatment and diagnosis - which raises the question, will the equipment work properly and safely when used by untrained operators in the uncontrolled home environment? This standard gives guidance on how to address these issues.

BS EN 60601-1-11 gives requirements and recommendations for the safety and performance of medical electrical equipment and medical electrical systems for home healthcare. Developed with contributions from clinicians, engineers and regulators, and originally published in 2010, it has now been revised to align with the current version of the general standard in this series, BS EN 60601-1:2006+-A12:2014. 

The standard applies to use by both lay operators and trained healthcare personnel. Among many other aspects of safety and performance, its scope includes:

 

  • Transport and storage 
  • Requirements for testing 
  • Operating instructions 
  • Marking and labelling
  • Usability of documents
  • Maintenance 

 

BS EN 60601-1-11:2015 will benefit manufacturers of medical electrical equipment and systems. Compliance with this standard can provide a presumption of conformity with EC Directive 93/42/EEC.




Standard NumberBS EN 60601-1-11:2015
TitleMedical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
StatusCurrent
Publication Date30 June 2015
Cross ReferencesCISPR 11:2009, IEC 60068-2-27:2008, IEC 60068-2-31:2008, IEC 60068-2-64:2008, IEC 60529:1989, IEC 60529:1989/AMD1:1999, IEC 60529:1989/AMD2:2013, IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2:2014, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1-8:2006, IEC 60601-1-8:2006/AMD1:2012, IEC 60601-1-12:2014, IEC 62366:2007, IEC 62366:2007/AMD1:2014, ISO 7000, ISO 7010:2011, ISO 7010:2011/AMD1:2012, ISO 7010:2011/AMD2:2012, ISO 7010:2011/AMD3:2012, ISO 7010:2011/AMD4:2013, ISO 7010:2011/AMD5:2014, ISO 15223-1:2012, EN 60068-2-27:2009, EN 60068-2-31:2008, EN 60068-2-64:2008, EN 60529:1991, EN 60529:1991/A1:2000, EN 60529:1991/A2:2013, EN 60601-1:2006, EN 60601-1:2006/A1:2013, EN 60601-1:2006/A12:2014, EN 60601-1-2:2014, EN 60601-1-6:2010, EN 60601-1-6:2010/A1:2015, EN 60601-1-8:2007, EN 60601-1-8:2007/A1:2013, EN 60601-1-12:2015, EN 62366:2008, EN 62366:2008/A1:2015, EN 55011:2009, EN ISO 7010:2012, EN ISO 7010:2012/A1:2014, EN ISO 7010:2012/A2:2014, EN ISO 7010:2012/A3:2014, EN ISO 7010:2012/A4:2014, EN ISO 7010:2012/A5:2015, EN ISO 15
ReplacesBS EN 60601-1-11:2010
International RelationshipsEN 60601-1-11:2015,IEC 60601-1-11:2015
Draft Superseded By14/30296572 DC
DescriptorsMedical equipment, Electrical medical equipment, Electrical equipment, Electronic equipment and components, Electrical safety, Safety measures, Domestic, Domestic facilities, Nursing homes, Instructions for use, Marking, Environment (working), Cleaning, Strength of materials
ICS11.040.01
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 utilisés dans l'environnement des soins à domicile
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale. Ergänzungsnorm: Anforderungen an medizinische elektrische Geräte und medizinische elektrische Systeme für die medizinische Versorgung in häuslicher Umgebung
CommitteeCH/62/1
ISBN978 0 580 85662 4
PublisherBSI
FormatA4
DeliveryYes
Pages70
File Size1.738 MB
Price£228.00


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