BS EN 60601-2-18:2015 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of endoscopic equipment

BS EN 60601-2-18:2015

Medical electrical equipment. Particular requirements for the basic safety and essential performance of endoscopic equipment

Status : Current, Work in hand   Published : November 2015

Format
PDF

Format
HARDCOPY



IEC 60601-2-18:2009 establishes particular basic safety and essential performance requirements for endoscopic equipment. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of endoscopic equipment. IEC 60601-2-18:2009 amends and supplements IEC 60601-1:2005. This third edition cancels and replaces the second edition, published in 1996, and its Amendment 1 (2000). This edition constitutes a technical revision and has been aligned or harmonized with IEC 60601-1:2005. The main changes with respect to the previous edition include:


- alignment of requirements with IEC 60601-1:2005;


- inclusion of essential performance requirements;


- the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard;


- reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices, rather than defining different tests.




Standard NumberBS EN 60601-2-18:2015
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of endoscopic equipment
StatusCurrent, Work in hand
Publication Date30 November 2015
Normative References(Required to achieve compliance to this standard)EN 60601-2-37, IEC 60601-2-37, EN 60601-2-2:2009, EN 60601-2-2:2009+A11:2011, EN 60601-1-2:2007, EN 60601-1-2:2007/Corrigendum 1:2010, ISO 8600-1, IEC 60601-2-2:2009, IEC 60601-1-2:2007
Informative References(Provided for Information)IEC 60601-2-57, 93/42/EEC, GHTF/SG1/N41R9:2005, EN 60601-2-57
ReplacesBS EN 60601-2-18:1997, BS 5724-2.18:1997 IEC 60601-2-
International RelationshipsEN 60601-2-18:2015,EN 61935-2:2005,IEC 60601-2-18:2009
Draft Superseded By07/30166679 DC
DescriptorsSafety measures, Switchgear, Circuit-breakers, Safety engineering, Fire safety, Electrical insulation, Marking, Clinical investigation instruments, Electrical equipment, Safety, Electrical medical equipment, Instructions for use, Endoscopic apparatus, Radiation protection, Electromagnetic compatibility, Electrical safety, Temperature, Electronic equipment and components, Medical equipment
ICS11.040.50
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'endoscopie
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von endoskopischen Geräten
CommitteeCH/62/4
ISBN978 0 580 52903 0
PublisherBSI
FormatA4
DeliveryYes
Pages54
File Size1.737 MB
Price£254.00


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