BS EN 60601-1-10:2008+A1:2015 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for the development of physiologic closed-loop controllers

BS EN 60601-1-10:2008+A1:2015

Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for the development of physiologic closed-loop controllers

Status : Current, Under review   Published : August 2008

Format
PDF

Format
HARDCOPY



What is this standard about? 

BS EN 60601-1-10 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 is a collateral standard and its objective is to outline requirements that are in addition to those of the general standard. It specifically covers physiologic closed-loop controllers and complements BS EN 60601-1.

Who is this standard for?

  • Manufacturers of electrical medical equipment 
  • Suppliers of medical electronic equipment and components
  • All healthcare facilities/hospitals/intensive care units
  • Health and safety professionals
  • Regulatory bodies 

Why should you use this standard? 

This part of the BS EN 60601 series specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller (PCLC) as part of a physiologic closed-loop control system (PCLCS) in medical electrical equipment and medical electrical systems. This controls a physiologic variable, which can be a body chemistry such as blood glucose, a physical property such as a patient’s temperature or a pharmaceutical concentration. Use of PCLCs should improve patient safety and reduce healthcare costs.

What’s changed since the last update?

  • The standard has been systematically reviewed by experts to ensure its continued market relevance 
  • It takes into account the advances and on-going developments in technical equipment, to ensure performance with acceptable risks under all clinical and physiologic conditions
  • Equipment that incorporates a Programmable Electrical Medical System (PEMS) now applies to the requirements of Clause 14 of the general standard  



Standard NumberBS EN 60601-1-10:2008+A1:2015
TitleMedical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard: Requirements for the development of physiologic closed-loop controllers
StatusCurrent, Under review
Publication Date29 August 2008
Normative References(Required to achieve compliance to this standard)EN 60601-1-8:2007, IEC 60601-1:2005, EN 62304:2006, IEC 60601-1-8:2006, EN ISO 14971:2007, IEC 62304:2006, 93/42/EEC, IEC 60601-1-6:2006, ISO 14971, EN 60601-1:2006, EN 60601-1-6:2007
Informative References(Provided for Information)EN ISO 14001:2004, ISO/IEC Guide 51:1999, ISO/TR 14062:2002, ISO 9000:2005, IEC 60050-351:2006, EN ISO 14021:2001, EN ISO 9000:2005, EN ISO 14040:2006, ISO 14001:2004, ISO 14040:2006, ISO 14021:1999, IEC Guide 109:2003
International RelationshipsIEC 60601-1-10:2007/AMD1:2013,EN 60601-1-10 Amd 1 (05/15) IE
Amended ByAmendment, June 2015
Draft Superseded By12/30271196 DC
DescriptorsMedical equipment, Electrical medical equipment, Human physiology, Verification, Equipment safety, Electronic equipment and components, Controllers, Performance, Electrical safety, Electrical equipment, Feedback-control systems, Control systems
ICS11.040.01
11.040.10
Title in FrenchAppareils électromédicaux. Exigences générales pour la sécurité de base et les performances essentielles. Norme collatérale. Exigences pour le développement des régulateurs physiologiques en boucle fermée
Title in GermanMedizinische elektrische Geräte. Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale. Ergänzungsnorm. Anforderungen an die Entwicklung von physiologischen geschlossenen Regelkreisen
CommitteeCH/62/1
ISBN978 0 580 80619 3
PublisherBSI
FormatA4
DeliveryYes
Pages44
File Size1.236 MB
Price£214.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Worldwide Standards
We can source any standard from anywhere in the world


Develop a PAS

Develop a fast-track standardization document in 9-12 months


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version