EN 60601-2-22:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
09-11-2020
18-01-2013
FOREWORD
INTRODUCTION
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing ME EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME
SYSTEMS
201.7 ME EQUIPMENT identification, marking
and documents
201.8 Protection against electrical HAZARDS from
ME EQUIPMENT
201.9 Protection against MECHANICAL HAZARDS
of ME EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive
radiation HAZARDS
201.11 Protection against excessive temperatures and
other HAZARDS
201.12 Accuracy of controls and instruments and
protection against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault
conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL
SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
and ME SYSTEMS
Annexes
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and
rationale
Bibliography
Index of defined terms used in this particular standard
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Annex ZZ (informative) - Coverage of Essential
Requirements of EU Directives
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.
Committee |
CLC/TC 76
|
DevelopmentNote |
To be read in conjunction with EN 60601-1. (05/2001) Supersedes UNE EN 60601-2-22. (12/2015)
|
DocumentType |
Standard
|
PublisherName |
European Committee for Standards - Electrical
|
Status |
Superseded
|
SupersededBy | |
Supersedes |
Standards | Relationship |
OVE/ONORM EN 60601-2-22 : 2015 | Identical |
DIN EN 60601-2-22 : 2015 | Identical |
I.S. EN 60601-2-22:2013 | Identical |
SN EN 60601-2-22 : 1996 | Identical |
SS-EN 60601-2-22 : 2013 | Identical |
PN EN 60601-2-22 : 2013 | Identical |
VDE 0750-2-22 : 2015 | Identical |
CEI EN 60601-2-22 : 2014 | Identical |
NEN EN IEC 60601-2-22 : 2013 | Identical |
NEN 10601-2-22 : 1996 | Identical |
BS EN 60601-2-22:2013 | Identical |
IEC 60601-2-22:2007+AMD1:2012 CSV | Identical |
NF EN 60601-2-22 : 2013 | Identical |
NBN EN 60601 2-22 : 2013 | Identical |
SN EN 60601-2-22:2013 | Identical |
UNE-EN 60601-2-22:2013 | Identical |
NF EN 60601-2-22:2020 | Identical |
BS EN 60317-58:2010 | Identical |
PNE-EN 60601-2-22 | Identical |
I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
I.S. CLC/TR 50448:2005 | GUIDE TO LEVELS OF COMPETENCE REQUIRED IN LASER SAFETY |
EN 80601-2-58:2015 | Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
CLC/TR 50448:2005 | Guide to levels of competence required in laser safety |
DIN EN 1640:2010-02 | Dentistry - Medical devices for dentistry - Equipment |
BS EN 1640:2009 | Dentistry. Medical devices for dentistry. Equipment |
I.S. EN 1640:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
PD CLC/TR 50448:2005 | Guide to levels of competence required in laser safety |
EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
UNI EN 1640 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
02/563818 DC : DRAFT SEP 2002 | BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
BS EN 80601-2-58:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
EN 1640:2009 | Dentistry - Medical devices for dentistry - Equipment |
08/30184608 DC : DRAFT SEP 2008 | BS EN 1640 - DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
I.S. EN 80601-2-58:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL DEVICES AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
EN 60825-1:2014/AC:2017-06 | SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014) |
IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
EN 60947-3:2009/A2:2015 | LOW-VOLTAGE SWITCHGEAR AND CONTROLGEAR - PART 3: SWITCHES, DISCONNECTORS, SWITCH-DISCONNECTORS AND FUSE-COMBINATION UNITS (IEC 60947-3:2008/A2:2015) |
IEC TR 60825-14:2004 | Safety of laser products - Part 14: A user's guide |
IEC 60664-3:2016 | Insulation coordination for equipment within low-voltage systems - Part 3: Use of coating, potting or moulding for protection against pollution |
IEC 60947-3:2008+AMD1:2012+AMD2:2015 CSV | Low-voltage switchgear and controlgear - Part 3: Switches, disconnectors, switch-disconnectors and fuse-combination units |
EN 61010-1:2010 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
IEC 61010-1:2010+AMD1:2016 CSV | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
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