BS EN IEC 60601-2-2:2018 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

BS EN IEC 60601-2-2:2018

Medical electrical equipment. Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Status : Current   Published : June 2018

Format
PDF

Format
HARDCOPY



IEC 60601-2-2:2017 is also available as

IEC 60601-2-2:2017 RLV

which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.



IEC 60601-2-2:2017 applies to the basic safety and essential performance of HF surgical equipment and HF surgical accessories.


HF surgical equipment having a rated output power not exceeding 50 W (for example for micro-coagulation, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements.


The object of this particular standard is to establish particular basic safety and essential performance requirements for HF surgical equipment and HF surgical accessories. This sixth edition cancels and replaces the fifth edition published in 2009. This edition constitutes a technical revision.


This edition includes the following significant technical changes with respect to the previous edition:


- refinement and additions to the defined terms;


- additional separation of the requirements for HF surgical equipment and HF surgical accessories;


- a new requirement for adult neutral electrodes to be contact quality monitoring neutral electrodes;


- new requirements for devices that have or use a high current mode.




Standard NumberBS EN IEC 60601-2-2:2018
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
StatusCurrent
Publication Date05 June 2018
Normative References(Required to achieve compliance to this standard)EN 60601-1-2:2015, EN 61000-4-6:2014, IEC 61000-4-3:2006, IEC 60601-1-8:2006, IEC 60601-1-2:2014, EN 61000-4-3:2006, EN 60601-1-8:2007, EN 55011:2016, CISPR 11:2015, IEC 61000-4-6:2013
Informative References(Provided for Information)ANSI/AAMI HF18:2001, CENELEC Guide 29:2007, EN 60529, IEC 60529, EN 60601-2-4:2011, EN 60601-2-18:2015, IEC 60601-2-18:2009, IEC 60601-2-4:2010, IEC 60529:1989 Cons Ed 2-1
ReplacesBS EN 60601-2-2:2009+A11:2011
International RelationshipsEN 61169-19:2011,EN IEC 60601-2-2:2018,IEC 60601-2-2:2017
Draft Superseded By16/30319034 DC
DescriptorsSafety measures, Electric current, Surgical equipment, Medical equipment, Electrical safety, Protected electrical equipment, Electrical equipment, Earthing, Electronic equipment and components, Leakage currents, Electrical medical equipment, Signal devices, Electrical testing, High frequencies
ICS11.040.30
Title in FrenchAppareils électromédicaux Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'électrochirurgie à courant haute fréquence et des accessoires d'électrochirurgie à courant haute fréquence
Title in GermanMedizinische elektrische Geräte Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten
CommitteeCH/62/4
ISBN978 0 580 89316 2
PublisherBSI
FormatA4
DeliveryYes
Pages96
File Size2.624 MB
Price£274.00


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