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
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, therapeutic and diagnostic laser equipment
This International Standard 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.
NOTE 1 Refer to Definition 3.49 in IEC 60825-1.
NOTE 2 Laser products for these applications classified as a CLASS 1, 1M, 2, 2M or CLASS 3R LASER PRODUCT, are covered by IEC 60825-1 and IEC 60601-1. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARD inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specifi requirements in this standard except in 7.2.13 and 8.4.1 of the General Standard. NOTE See also 4.2 of the General Standard. This standard can also be applied to surgical, cosmetic, therapeutic and diagnostic laser equipment used for compensation or alleviation of disease, injury o disability.
Medizinische elektrische Geräte - Teil 2-22: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für chirurgische, 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
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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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SLOVENSKI oSIST prEN 60601-2-22:2005
PREDSTANDARD
december 2005
Medicinska električna oprema – 2-22. del: Posebne zahteve za varnost in
bistvene lastnosti kirurške, terapevtske in diagnostične laserske opreme
Medical electrical equipment - Part 2-22: Particular requirements for the safety and
essential performance of surgical, therapeutic and diagnostic laser equipment
ICS 11.040.50; 11.040.55; 11.040.60 Referenčna številka
oSIST prEN 60601-2-22:2005(en)
© Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno
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76/314/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJET DE COMITÉ POUR VOTE (CDV)
Project number IEC 60601-2-22 Ed.3
Numéro de projet
IEC/TC or SC: Date of circulation Closing date for voting (Voting
76
Date de diffusion mandatory for P-members)
CEI/CE ou SC:
Date de clôture du vote (Vote
2005-05-20
obligatoire pour les membres (P))
2005-10-21
Title of TC/SC:
Titre du CE/SC:
OPTICAL RADIATION SAFETY AND LASER
EQUIPMENT
Secretary: Gerald Glen
Secrétaire:
Also of interest to the following committees Supersedes document
Intéresse également les comités suivants Remplace le document
76/287/CD, 76/300/CC
Functions concerned
Fonctions concernées
Safety EMC Environment Quality assurance
Sécurité
CEM Environnement Assurance qualité
CE DOCUMENT EST TOUJOURS À L'ÉTUDE ET SUSCEPTIBLE DE THIS DOCUMENT IS STILL UNDER STUDY AND SUBJECT TO CHANGE. IT
MODIFICATION. IL NE PEUT SERVIR DE RÉFÉRENCE. SHOULD NOT BE USED FOR REFERENCE PURPOSES.
LES RÉCIPIENDAIRES DU PRÉSENT DOCUMENT SONT INVITÉS À RECIPIENTS OF THIS DOCUMENT ARE INVITED TO SUBMIT, WITH THEIR
PRÉSENTER, AVEC LEURS OBSERVATIONS, LA NOTIFICATION DES COMMENTS, NOTIFICATION OF ANY RELEVANT PATENT RIGHTS OF
DROITS DE PROPRIÉTÉ DONT ILS AURAIENT ÉVENTUELLEMENT WHICH THEY ARE AWARE AND TO PROVIDE SUPPORTING
CONNAISSANCE ET À FOURNIR UNE DOCUMENTATION EXPLICATIVE. DOCUMENTATION.
Titre :
Title : IEC 60601-2-22 Ed.3: MEDICAL
ELECTRICAL EQUIPMENT –
Part 2: Particular requirements for the safety
and essential performance of surgical,
therapeutic and diagnostic laser equipment
Introductory note IEC TC76/WG4 foreword to
Note d'introduction
the CDV only.
This draft incorporates all changes due to the
comments received prior to the WG4 Valbella
meeting in October 2004 and observed at the
meeting. The document was 76/287/60601-2-
22/comments. This document was distributed by
IEC as 76/300/CC. The old numbering of
clauses and Definitions were retained in order to
facilitate reviewing. The Numbering will be
brought in an order editorially in the FDIS stage.
March 2005, The convener
The French version will be circulated later.
ATTENTION ATTENTION
CDV soumis en parallèle au vote (CEI) Parallel IEC CDV/CENELEC Enquiry
et à l’enquête (CENELEC)
FORM CDV (IEC) 2002-08-09
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– – 2
60601-2-22/CDV © IEC
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT
Part 2: Particular requirements for the safety and essential performance of
surgical, therapeutic and diagnostic laser equipment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote internation
...
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