BS EN 60601-1-8:2007+A11:2017 Medical electrical equipment. Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment.

BS EN 60601-1-8:2007+A11:2017

Medical electrical equipment. Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Status : Work in hand, Current   Published : June 2011

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What is this standard about? 

BS EN 60601-1-8 is part of a series of international standards on medical electrical equipment, covering basic safety and essential performance for both equipment and systems.It is a collateral standard – its objective is to specify requirements that are in addition to those of the general standard. BS EN 60601-1-8 covers alarm systems and signals related to medical electrical equipment. It complements BS EN 60601-1.

Who is this standard for?

  • Manufacturers, suppliers and users of medical electronic equipment and components relating to alarms and alarm systems
  • All healthcare facilities/hospitals/intensive care units
  • Health and safety professionals• Regulatory bodies and technical committees 

Why should you use this standard?

Part 1-8 of this collateral standard specifies basic safety and essential performance requirements and tests for the application of alarm systems and signals. It also provides guidance for their application.

The standard defines alarm categories (priorities) by degree of urgency and also covers consistent alarm signals and consistent control states and their marking for alarm systems.

What’s changed since the last update?

The third edition of this standard has been systematically reviewed by experts to ensure its continued market relevance. Changes include:

  • Additional technical requirements for the marking of controls and instruments are specified in this collateral standard, listed in Annex B
  • Additional requirements on accompanying documents are specified in Table B2
  • Additional requirements on instructions for use are listed in Table B3
  • There is greater definition of visual information signals and visual alarm signals 



Standard NumberBS EN 60601-1-8:2007+A11:2017
TitleMedical electrical equipment. Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
StatusWork in hand, Current
Publication Date27 June 2011
Normative References(Required to achieve compliance to this standard)IEC 60601-1:2005/AMD1:2012, EN ISO 3744:2010, EN 60601-1:2006, IEC 61672-1:2002, IEC 60417:2007 Ed 1, IEC 62366-1:2015, EN 61672-1 (IEC 61672-1:2002) AS, ISO 7000:2014, EN 60601-1:2006/A1:2013, IEC 60601-1:2005, ISO 3744:2010, EN 62366-1:2015
Informative References(Provided for Information)AAMI EC57-293, ANSI/AAMI HE48:1993, 93/42/EEC, ISO 11429:1996, ISO 14971:2000, ISO 9703-2:1994, IEC 60513:1994, ISO 11428:1996
International RelationshipsEN 60601-1-8:2007/A11:2017
Amended ByAmendment, July 2017; Corrigendum, July 2014
DescriptorsElectronic equipment and components, Medical equipment, Electrical equipment, Hospital equipment, Warning devices, Signals, Acoustic signals, Visual signals, Indicator lights, Flashing lights, Alarm systems, Legibility, Grades (quality), Colour, Harmonics, Sound intensity, Frequencies, Electrical medical equipment
ICS11.040.01
Title in FrenchAppareils électromédicaux Exigences générales pour la sécurité de base et les performances essentielles. Norme collatérale: Exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux
Title in GermanMedizinische elektrische Geräte Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale. Ergänzungsnorm: Alarmsysteme. Allgemeine Festlegungen, Prüfungen und Richtlinien für Alarmsysteme in medizinischen elektrischen Geräten und in medizinischen elektrischen Systemen
CommitteeCH/62/1
ISBN978 0 580 98362 7
PublisherBSI
FormatA4
DeliveryYes
Pages100
File Size2.378 MB
Price£274.00


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