EN 60601-2-22:2013

Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment

Applies to the basic safety and essential performance of laser equipment for either surgical, therapeutic, medical diagnostic, cosmetic, or veterinary applications, intended for its use on humans or animals, classified as a class 3B or class 4 laser product as defined by 3.22 and 3.23 in IEC 60825-1, hereafter referred to as laser equipment. Throughout this International Standard, light emitting diodes (LED) are included whenever the word 'laser' is used. This standard can also be applied to surgical, cosmetic, therapeutic and diagnostic laser equipment used for compensation or alleviation of disease, injury or disability. This third edition cancels and replaces the second edition of IEC 60601-2-22, published in 1995. This edition constitutes a technical revision. This third edition takes account of the recently published new editions of the General Standard IEC 60601-1 and Group safety publication IEC 60825-1. Additionally, it addresses technical and safety issues which have arisen in the time following the previous second edition.

Medizinische elektrische Geräte - Teil 2-22: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für chirurgische, kosmetische, therapeutische und diagnostische Lasergeräte

Appareils électromédicaux - Partie 2-22: Règles particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux, esthétiques, thérapeutiques et de diagnostic à laser

S'applique à la sécurité de base et aux performances essentielles des appareils à laser pour applications chirurgicales, thérapeutiques, de diagnostic médical, esthétiques ou vétérinaires destinés à être utilisés sur les êtres humains ou les animaux, qui sont classés comme appareils a laser de classe 3B ou de classe 4 définis en 3.22 et 3.23 de la CEI 60825-1, appelés ci-après appareils à laser. Dans la présente Norme internationale, la référence au terme 'laser' inclut systématiquement les diodes électroluminescentes (DEL). La présente norme peut également être appliquée aux appareils à laser pour applications chirurgicales, esthétiques, thérapeutiques et de diagnostic médical utilisés pour le traitement ou le soulagement des maladies, des blessures ou des incapacités. Cette troisième édition annule et remplace la deuxième édition de la CEI 60601-2-22, publiée en 1995. Cette édition constitue une révision technique. Cette troisième édition prend en compte les nouvelles éditions récemment publiées de la Norme générale CEI 60601-1 et la Publication groupée de sécurité CEI 60825-1. De plus, elle traite des questions techniques et de sécurité surgies depuis la précédente deuxième édition.

Medicinska električna oprema - 2-22. del: Posebne varnostne zahteve ter bistvene lastnosti kirurške, terapevtske in diagnostične laserske opreme

Ta mednarodni standard velja za OSNOVNO VARNOST in BISTVENE LASTNOSTI laserske opreme za kirurško, terapevtsko, medicinsko diagnostično, kozmetično ali veterinarsko uporabo, ki je namenjena za uporabo na ljudeh ali živalih, razvrščeni kot LASERSKI IZDELEK RAZREDA 3B ali 4, kot je določeno v točkah 3.22 in 3.23 standarda IEC 60825-1, in se v nadaljevanju navaja kot LASERSKA OPREMA. V besedilu tega mednarodnega standarda so pri uporabi besede »laser« vključene svetleče diode (LED).
OPOMBA 1: Glej točko 3.49 v standardu IEC 60825-1.
OPOMBA 2: Laserske izdelke za te namene, ki so razvrščeni v RAZRED 1, 1M, 2, 2M ali 3R, obravnavata standarda IEC 60825-1 in IEC 60601-1. Če je poglavje ali podpoglavje namenjeno samo obravnavi ELEKTROMEDICINSKE OPREME ali ELEKTROMEDICINSKIH SISTEMOV, bo to zapisano v naslovu in vsebini poglavja ali podpoglavja. Če ni zapisano, poglavje ali podpoglavje obravnava ELEKTROMEDICINSKO OPREMO in ELEKTROMEDICINSKE SISTEME. Posebne zahteve tega standarda ne vključujejo temeljnih TVEGANJ pri nameravani fiziološki funkciji ELEKTROMEDICINSKE OPREME in SISTEMOV, ki spadajo na področje tega standarda, razen v točkah 7.2.13 in 8.4.1 splošnega standarda. OPOMBA: Glejte tudi točko 4.2 splošnega standarda. Ta standard lahko velja tudi za kirurško, kozmetično, terapevtsko in diagnostično lasersko opremo, ki se uporablja za lajšanje bolezni, poškodb ali invalidnosti.

General Information

• Status: Withdrawn
• Publication Date: 17-Jan-2013
• Withdrawal Date: 28-Nov-2015
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.040.50 - Radiographic equipment
• ICS: 11.040.60 - Therapy equipment
• ICS: 31.260 - Optoelectronics. Laser equipment
• Technical Committee: CLC/TC 76 - Optical radiation safety and laser equipment
• Drafting Committee: IEC/TC 76 - IEC_TC_76
• Parallel Committee: IEC/TC 76 - IEC_TC_76
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 30-Oct-2023
• Completion Date: 30-Oct-2023
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN 60601-2-22:2013 - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, therapeutic and diagnostic laser equipment

Relations

• Replaces: EN 60601-2-22:1996 - Medical electrical equipment - Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
• Effective Date: 28-Jan-2023
• Replaced By: EN IEC 60601-2-22:2020 - Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
• Effective Date: 03-Nov-2020

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Medizinische elektrische Geräte - Teil 2-22: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für chirurgische, therapeutische und diagnostische LasergeräteAppareils électromédicaux - Partie 2-22: Règles particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux, esthétiques, thérapeutiques et de diagnostic à laserMedical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, therapeutic and diagnostic laser equipment31.260Optoelektronika, laserska opremaOptoelectronics. Laser equipment11.040.60Terapevtska opremaTherapy equipment11.040.55Diagnostic equipmentICS:Ta slovenski standard je istoveten z:EN 60601-2-22:2013SIST EN 60601-2-22:2013en01-marec-2013SIST EN 60601-2-22:2013SLOVENSKI
STANDARD



SIST EN 60601-2-22:2013



EUROPEAN STANDARD EN 60601-2-22 NORME EUROPÉENNE
EUROPÄISCHE NORM January 2013
CENELEC European Committee for Electrotechnical Standardization Comité Européen de Normalisation Electrotechnique Europäisches Komitee für Elektrotechnische Normung
Management Centre: Avenue Marnix 17, B - 1000 Brussels
© 2013 CENELEC -
All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-22:2013 E
ICS 11.040.01; 31.260 Supersedes EN 60601-2-22:1996
English version
Medical electrical equipment -
Part 2-22: Particular requirements for basic safety
and essential performance of surgical, cosmetic, therapeutic
and diagnostic laser equipment (IEC 60601-2-22:2007 + A1:2012)
Appareils électromédicaux -
Partie 2-22: Règles particulières pour la sécurité de base et les performances essentielles des appareils chirurgicaux, esthétiques, thérapeutiques
et de diagnostic à laser (CEI 60601-2-22:2007 + A1:2012)
Medizinische elektrische Geräte -
Teil 2-22: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für chirurgische, kosmetische, therapeutische
und diagnostische Lasergeräte (IEC 60601-2-22:2007 + A1:2012)
This European Standard was approved by CENELEC on 2012-11-29. CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
SIST EN 60601-2-22:2013



EN 60601-2-22:2013 - 2 -
Foreword The texts of document 76/359/FDIS, future edition 3 of IEC 60601-2-22, and document 76/444/CDV, future amendment 1 to edition 3 of IEC 60601-2-22, prepared by IEC/TC 76 "Optical radiation safety and laser equipment" were submitted to the IEC-CENELEC parallel vote and approved by CENELEC as EN 60601-2-22:2013, based on IEC 60601-2-22:2007 + A1:2012.
The following dates are fixed: • latest date by which the document has to be implemented at national level by publication of an identical national standard or by endorsement (dop) 2013-08-29 • latest date by which the national standards conflicting with the document have to be withdrawn (dow) 2015-11-29
This document supersedes EN 60601-2-22:1996.
EN 60601-2-22:2013 includes the following significant technical changes with respect to EN 60601-2-22:1996: This third edition takes account of the recently published new editions of the General Standard EN 60601-1 and Group safety publication EN 60825-1. Additionally, it addresses technical and safety issues which have arisen in the time following the previous second edition.
This standard is to be read in conjunction with EN 60601-1:2006.
In this standard, the following print types are used: - requirements and definitions: roman type. - test specifications: italic type. - informative material appearing outside of tables, such as notes, examples and references: in smaller type. Normative text of tables is also in a smaller type. - TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS NOTED: SMALL CAPITALS.
In referring to the structure of this standard, t
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