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

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, Under review   Published : June 2015

Format
PDF

Format
HARDCOPY



What is this standard about? 

BS EN 60601-1-11:2015 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems.This part covers medical equipment used in the home. It is a collateral standard which means its objective is to specify requirements that are in addition to those of the general standard. It also complements BS EN 60601-1.

Who is this standard for?

  • Those working in the home healthcare industry
  • Users of medical equipment in the home
  • Manufacturers of electrical medical equipment 
  • Suppliers of medical electronic equipment and components
  • Health and safety professionals
  • Regulatory bodies

Why should you use this standard? 

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 an uncontrolled home environment? This standard gives guidance on how to address these issues and includes recommendations on testing, marking and labelling, maintenance, operating instructions and transport, and storage. 

What’s changed since the last update?

This part of the collateral standard has been systematically reviewed by experts to ensure its continued market relevance.  Significant changes include:

  • Closer alignment with the current version of the general standard in this series, BS EN 60601-1:2006+A12:2014
  • Redrafting of sub clauses 
  • Correction of test method for relative humidity control at temperatures above 35 °C



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, Under review
Publication Date30 June 2015
Normative References(Required to achieve compliance to this standard)IEC 60068-2-64:2008, ISO 7010:2011/AMD1:2012, EN 60068-2-64:2008, EN 60601-1-8:2007/A1:2013, ISO 7010:2011/AMD3:2012, EN 60601-1:2006/A1:2013, EN ISO 7010:2012/A2:2014, EN 60529:1991/A1:2000, CISPR 11:2009, IEC 60601-1-2:2014, EN 55011:2009, EN 60601-1:2006/A12:2014, IEC 60601-1-6:2010, EN 62366:2008, IEC 60601-1:2005, EN ISO 7010:2012/A5:2015, IEC 60601-1-8:2006, EN 60601-1-2:2014, EN 60068-2-31:2008, EN 62366:2008/A1:2015, IEC 60068-2-31:2008, EN 60529:1991, IEC 60601-1-8:2006/AMD1:2012, ISO 7000, IEC 60601-1:2005/AMD1:2012, IEC 60601-1-6:2010/AMD1:2013, IEC 60529:1989/AMD2:2013, EN 60601-1-8:2007, IEC 60529:1989/AMD1:1999, EN 60068-2-27:2009, IEC 60068-2-27:2008, EN ISO 7010:2012/A3:2014, ISO 7010:2011/AMD2:2012, EN ISO 7010:2012/A4:2014, ISO 7010:2011, EN ISO 7010:2012/A1:2014, EN ISO 15223-1:2012, IEC 60529:1989, EN 60601-1-6:2010/A1:2015, EN 60601-1:2006, EN 60529:1991/A2:2013, IEC 60601-1-12:2014, EN ISO 7010:2012, ISO 15223-1:2012, ISO 7010:2011/AMD5:2014, IEC 62366:2007/AMD1:2014, IEC 62366:2007, EN 60601-1-12:2015, ISO 7010:2011/AMD4:2013, EN 6060
Informative References(Provided for Information)EN 60950-1:2006/A1:2010, ASTM F2020-02, IEC 60601-1-9, EN 61032:1998, EN ISO 10651-2:2009, HD 60364, EN 60335-1:2012, EN 60038:2011, IEC 60721-3-7:1995, IEC 60950-1:2005, IEC 60950-1:2005/A1:2009, ISO 10651-2:2004, IEC 60950-1:2005/A2:2013, EN 60601-1-9, 93/42/EEC, EN 60065:2014, EN 60721-3-7:1995, HD 384, IEC 60364, IEC 60335-1:2010, IEC 61032:1997, IEC 60065:2014, EN 13718-1:2008, MIL-HDBK-310, IEC 60038:2009, EN 60950-1:2006, EN 60950-1:2006/A2:2013, MIL-STD-810F(3):2003
ReplacesBS EN 60601-1-11:2010
International RelationshipsEN 60601-1-11:2015,EN 61158-4-17:2008,IEC 60601-1-11:2015
Draft Superseded By14/30296572 DC
DescriptorsMarking, Electrical safety, Electronic equipment and components, Domestic, Safety measures, Strength of materials, Nursing homes, Medical equipment, Instructions for use, Electrical medical equipment, Environment (working), Domestic facilities, Electrical equipment, Cleaning
ICS11.020.10
11.040.01
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 Size1.737 MB
Price£254.00


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