IEC 60601-2-22:2007+AMD1:2012 CSV
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
Amended by
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
03-05-2022
Superseded by
Language(s)
English - French
Published date
26-10-2012
Publisher
Important note : All end users must be registered with an Account prior to user licenses being assigned.
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
IEC 60601-2-22:2007+A1:2012 applies to the 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 publication IEC 60825-1. Additionally, it addresses technical and safety issues which have arisen in the time following the previous second edition.
This consolidated version consists of the third edition (2007) and its amendment 1 (2012). Therefore, no need to order amendment in addition to this publication.
| Committee |
TC 76
|
| DevelopmentNote |
Stability Date: 2017. (09/2017)
|
| DocumentType |
Standard
|
| Pages |
53
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| NBR IEC 60601-2-22 : 2014 | Identical |
| NF EN 60601-2-22:2020 | Identical |
| DIN EN IEC 60601-2-22 : 2022-10 | Identical |
| OVE EN IEC 60601-2-22:2022 11 01 | Identical |
| OVE/ONORM EN 60601-2-22 : 2015 | Identical |
| GOST IEC 60601-2-22 : 2011 | Identical |
| NEN EN IEC 60601-2-22 : 2013 | Identical |
| PN EN 60601-2-22 : 2013 | Identical |
| AS IEC 60601.2.22:2014 | Identical |
| DIN EN 60601-2-22 : 2015 | Identical |
| SN EN 60601-2-22:2013 | Identical |
| IS 13450 : Part 2 : Sec 22 : 2019 | Identical |
| BS EN 60601-2-22:2013 | Identical |
| UNE-EN 60601-2-22:1997 | Identical |
| CEI EN 60601-2-22 : 2014 | Identical |
| EN 60601-2-22:2013 | Identical |
| NF EN 60601-2-22 : 2013 | Identical |
| PN-EN IEC 60601-2-22:2021-03 | Identical |
| NEN 10601-2-22 : 1996 | Identical |
| VDE 0750-2-22 : 2015 | Identical |
| GOST R IEC 60601-2-22 : 2008 | Identical |
| SN EN 60601-2-22 : 1996 | Identical |
| AAMI IEC TIR 60878 : 2003 | GRAPHICAL SYMBOLS FOR ELECTRICAL EQUIPMENT IN MEDICAL PRACTICE |
| DIN EN ISO 11990-2:2016-02 | LASERS AND LASER-RELATED EQUIPMENT - DETERMINATION OF LASER RESISTANCE OF TRACHEAL TUBES - PART 2: TRACHEAL TUBE CUFFS (ISO 11990-2:2010) |
| PD IEC/TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| I.S. EN ISO 11810-2:2009 | LASERS AND LASER-RELATED EQUIPMENT - TEST METHOD AND CLASSIFICATION FOR THE LASER-RESISTANCE OF SURGICAL DRAPES AND/OR PATIENT-PROTECTIVE COVERS - PART 2: SECONDARY IGNITION |
| 02/712047 DC : DRAFT OCT 2002 | ISO 11810-2 - OPTICS AND OPTICAL INSTRUMENTS - LASERS AND LASER RELATED EQUIPMENT - TEST METHODS AND CLASSIFICATION FOR LASER-RESISTANCE OF SURGICAL DRAPES AND/OR PATIENT-PROTECTIVE COVERS - SECONDARY IGNITION |
| 12/30258880 DC : 0 | BS EN 60825-1 ED.3 - SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS |
| 07/30157980 DC : 0 | BS EN 60601-2-58 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| 04/30112949 DC : DRAFT APR 2004 | IEC 60825-8 ED.2 - SAFETY OF LASER PRODUCTS - PART 8: GUIDELINES FOR THE USE OF MEDICAL LASER EQUIPMENT |
| DIN EN ISO 11990-1:2016-02 | LASERS AND LASER-RELATED EQUIPMENT - DETERMINATION OF LASER RESISTANCE OF TRACHEAL TUBES - PART 1: TRACHEAL TUBE SHAFT (ISO 11990-1:2011) |
| BS EN ISO 11990:2003 | Optics and optical instruments. Lasers and laser-related equipment. Determination of laser resistance of tracheal tube shafts |
| AAMI ES60601-1 : 2005 : INC : AMD 1 : 2012 : R201200 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| AAMI ES60601-1 : 2005 : INC : AMD 2 : 2012 : R201200 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| AAMI ES60601-1 : 2005 : R2012 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| ISO 11990-2:2010 | Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 2: Tracheal tube cuffs |
| BS EN ISO 11810-1:2009 | Lasers and laser-related equipment. Test method and classification for the laser resistance of surgical drapes and/or patient protective covers Primary ignition and penetration |
| 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 |
| PD IEC TR 60825-14:2004 | Safety of laser products A user\'s guide |
| ANSI Z80.11:2012 | OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
| 11/30193150 DC : 0 | BS EN 60601-1:2006 AMD.1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| UNI EN ISO 11810-2 : 2009 | LASERS AND LASER-RELATED EQUIPMENT - TEST METHOD AND CLASSIFICATION FOR THE LASER-RESISTANCE OF SURGICAL DRAPES AND/OR PATIENT-PROTECTIVE COVERS - PART 2: SECONDARY IGNITION |
| PD ISO/TR 20824:2007 | Ophthalmic instruments. Background for light hazard specification in ophthalmic instrument standards |
| I.S. EN 80601-2-60:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT |
| ANSI/AAMI/IEC 80601-2-58:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-58: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF LENS REMOVAL AND VITRECTOMY DEVICES FOR OPHTHALMIC SURGERY |
| AAMI ES60601-1 : 2005 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE (IEC 60601-1:2005, MOD) |
| DIN EN 1640:2010-02 | Dentistry - Medical devices for dentistry - Equipment |
| DIN EN ISO 11553-1:2009-03 | Safety of machinery - Laser processing machines - Part 1: General safety requirements (ISO 11553-1:2005) |
| ISO/IEEE 11073-10418:2014 | Health informatics — Personal health device communication — Part 10418: Device specialization — International Normalized Ratio (INR) monitor |
| BS EN 1640:2009 | Dentistry. Medical devices for dentistry. Equipment |
| ISO 11990-1:2011 | Lasers and laser-related equipment Determination of laser resistance of tracheal tubes Part 1: Tracheal tube shaft |
| BS EN 60825-1:2014 | Safety of laser products Equipment classification and requirements |
| UNI EN ISO 11553-1 : 2009 | SAFETY OF MACHINERY - LASER PROCESSING MACHINES - PART 1: GENERAL SAFETY REQUIREMENTS |
| DIN EN ISO 11810-1:2009-07 | LASERS AND LASER-RELATED EQUIPMENT - TEST METHOD AND CLASSIFICATION FOR THE LASER RESISTANCE OF SURGICAL DRAPES AND/OR PATIENT PROTECTIVE COVERS - PART 1: PRIMARY IGNITION AND PENETRATION |
| I.S. EN 1640:2009 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
| EN 60825-1:2014/AC:2017-06 | SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014) |
| DIN EN ISO 11810-2:2009-07 | LASERS AND LASER-RELATED EQUIPMENT - TEST METHOD AND CLASSIFICATION FOR THE LASER-RESISTANCE OF SURGICAL DRAPES AND/OR PATIENT-PROTECTIVE COVERS - PART 2: SECONDARY IGNITION |
| I.S. EN ISO 11810:2015 | LASERS AND LASER-RELATED EQUIPMENT - TEST METHOD AND CLASSIFICATION FOR THE LASER RESISTANCE OF SURGICAL DRAPES AND/OR PATIENT PROTECTIVE COVERS - PRIMARY IGNITION, PENETRATION, FLAME SPREAD AND SECONDARY IGNITION (ISO 11810:2015) |
| 02/712046 DC : DRAFT OCT 2002 | ISO 11810-1 - OPTICS AND OPTICAL INSTRUMENTS - LASERS AND LASER RELATED EQUIPMENT - TEST METHODS AND CLASSIFICATION FOR LASER-RESISTANCE OF SURGICAL DRAPES AND/OR PATIENT-PROTECTIVE COVERS - PRIMARY IGNITION |
| BS EN ISO 11990-2:2014 | Lasers and laser-related equipment. Determination of laser resistance of tracheal tubes Tracheal tube cuffs |
| 08/30170762 DC : DRAFT OCT 2008 | BS ISO 11990-2 - LASERS AND LASER-RELATED EQUIPMENT - DETERMINATION OF LASER RESISTANCE OF TRACHEAL TUBES - PART 2: TRACHEAL TUBE CUFFS |
| 14/30298220 DC : 0 | BS EN ISO 11810 - LASERS AND LASER-RELATED EQUIPMENT - TEST METHOD AND CLASSIFICATION FOR THE LASER RESISTANCE OF SURGICAL DRAPES AND/OR PATIENT PROTECTIVE COVERS - PRIMARY IGNITION, PENETRATION, FLAME SPREAD AND SECONDARY IGNITION |
| 17/30327513 DC : DRAFT APR 2017 | BS EN ISO 11990 - LASERS AND LASER-RELATED EQUIPMENT - DETERMINATION OF LASER RESISTANCE OF TRACHEAL TUBE SHAFT AND TRACHEAL CUFFS |
| PD IEC/TR 60825-8:2006 | Safety of laser products Guidelines for the safe use of laser beams on humans |
| NF EN 80601-2-60 : 2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT |
| BS EN ISO 11073-10418:2014 | Health informatics. Personal health device communication Device specialization. International Normalized Ratio (INR) monitor |
| CSA C22.2 No. 80601-2-60 : 2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT |
| ISO/TR 20824:2007 | Ophthalmic instruments Background for light hazard specification in ophthalmic instrument standards |
| I.S. EN 60601-1:2006&A1:2013&AC:2014&A12:2014 | MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| IEC TR 60878:2015 | Graphical symbols for electrical equipment in medical practice |
| PD IEC/TR 60601-4-3:2015 | Medical electrical equipment Guidance and interpretation. Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements |
| EN 16844:2017 | Aesthetic medicine services - Non-surgical medical treatments |
| IEC 60601-2-75:2017 | Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment |
| UNE-EN 60825-1:2015 | Safety of laser products - Part 1: Equipment classification and requirements |
| I.S. EN 60825-1:2014 | SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS |
| UNI EN 1640 : 2010 | DENTISTRY - MEDICAL DEVICES FOR DENTISTRY - EQUIPMENT |
| UNI EN ISO 11810-1 : 2009 | LASERS AND LASER-RELATED EQUIPMENT - TEST METHOD AND CLASSIFICATION FOR THE LASER RESISTANCE OF SURGICAL DRAPES AND/OR PATIENT PROTECTIVE COVERS - PART 1: PRIMARY IGNITION AND PENETRATION |
| IEC TR 60825-8:2006 | Safety of laser products - Part 8: Guidelines for the safe use of laser beams on humans |
| BS EN 80601-2-60:2015 | Medical electrical equipment Particular requirements for the basic safety and essential performance of dental equipment |
| UNE-EN ISO 11990-1:2012 | Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011) |
| CEI 76-6 : 2012 | SAFETY OF LASER PRODUCTS - PART 8: GUIDELINES FOR THE SAFE USE OF LASER BEAMS ON HUMANS |
| ANSI Z80.11 : 2012 : R2017 | OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING |
| I.S. EN 16844:2017+A2:2019 | Aesthetic medicine services - Non-surgical medical treatments |
| I.S. EN ISO 11990:2003 | OPTICS AND OPTICAL INSTRUMENTS - LASERS AND LASER-RELATED EQUIPMENT - DETERMINATION OF LASER RESISTANCE OF TRACHEAL TUBE SHAFTS |
| CEI EN 80601-2-60 : 2016 | MEDICAL ELECTRICAL EQUIPMENT - PART 2-60: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF DENTAL EQUIPMENT |
| EN ISO 11990:2003 | Optics and optical instruments - Lasers and laser-related equipment - Determination of laser resistance of tracheal tube shafts (ISO 11990:2003) |
| I.S. EN ISO 11990-2:2014 | LASERS AND LASER-RELATED EQUIPMENT - DETERMINATION OF LASER RESISTANCE OF TRACHEAL TUBES - PART 2: TRACHEAL TUBE CUFFS (ISO 11990-2:2010) |
| BS EN 60601-1 : 2006 | MEDICAL ELECTRICAL EQUIPMENT PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
| EN ISO 11553-1:2008 | Safety of machinery - Laser processing machines - Part 1: General safety requirements (ISO 11553-1:2005) |
| I.S. EN ISO 11553-1:2008 | SAFETY OF MACHINERY - LASER PROCESSING MACHINES - PART 1: GENERAL SAFETY REQUIREMENTS |
| IEC 80601-2-60:2012 | Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
| IEC 80601-2-58:2014+AMD1:2016 CSV | Medical electrical equipment - Part 2-58: Particular requirementsfor the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
| ISO 11553-1:2005 | Safety of machinery Laser processing machines Part 1: General safety requirements |
| EN 80601-2-60:2015 | Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
| ISO 11810-1:2005 | Lasers and laser-related equipment Test method and classification for the laser resistance of surgical drapes and/or patient protective covers Part 1: Primary ignition and penetration |
| ISO/IEEE 11073-10406:2012 | Health informatics — Personal health device communication — Part 10406: Device specialization — Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| ISO 11810-2:2007 | Lasers and laser-related equipment Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers Part 2: Secondary ignition |
| BS EN ISO 11810-2:2009 | Lasers and laser-related equipment. Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers Secondary ignition |
| EN ISO 11810-2:2009 | Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition (ISO 11810-2:2007) |
| EN ISO 11810:2015 | Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015) |
| EN ISO 11990-1:2014 | Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 1: Tracheal tube shaft (ISO 11990-1:2011) |
| EN 1640:2009 | Dentistry - Medical devices for dentistry - Equipment |
| EN ISO 11990-2:2014 | Lasers and laser-related equipment - Determination of laser resistance of tracheal tubes - Part 2: Tracheal tube cuffs (ISO 11990-2:2011) |
| EN ISO 11073-10406:2012 | Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) (ISO/IEEE 11073-10406:2012) |
| EN ISO 11810-1:2009 | Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (ISO 11810-1:2005) |
| I.S. EN ISO 11810-1:2009 | LASERS AND LASER-RELATED EQUIPMENT - TEST METHOD AND CLASSIFICATION FOR THE LASER RESISTANCE OF SURGICAL DRAPES AND/OR PATIENT PROTECTIVE COVERS - PART 1: PRIMARY IGNITION AND PENETRATION |
| 14/30302355 DC : 0 | BS EN ISO 11553-1 ED.2 - SAFETY OF MACHINERY - LASER PROCESSING MACHINES - PART 1: GENERAL SAFETY REQUIREMENTS |
| CEI 76-11 : 2011 | SAFETY OF LASER PRODUCTS - PART 14: A USER'S GUIDE |
| BS EN ISO 11073-10406:2012 | Health informatics. Personal health device communication Device specialization. Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| I.S. EN ISO 11073-10406:2012 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) (ISO/IEEE 11073-10406:2012) |
| 13/30271473 DC : 0 | BS EN 80601-2-58 - 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 |
| ISO 11990:2003 | Optics and optical instruments Lasers and laser-related equipment Determination of laser resistance of tracheal tube shafts |
| I.S. EN 16844:2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL PROCEDURES |
| BS IEC 60825-8:1999 | Safety of laser products Guidelines for the safe use of medical laser equipment |
| 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 |
| CSA C22.2 No. 80601-2-58 : 2010 | 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 |
| BS EN ISO 11990-1:2014 | Lasers and laser-related equipment. Determination of laser resistance of tracheal tubes Tracheal tube shaft |
| UNI EN ISO 11073-10406 : 2013 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10406: DEVICE SPECIALIZATION - BASIC ELECTROCARDIOGRAPH (ECG) (1- TO 3-LEAD ECG) |
| I.S. EN ISO 11990-1:2014 | LASERS AND LASER-RELATED EQUIPMENT - DETERMINATION OF LASER RESISTANCE OF TRACHEAL TUBES - PART 1: TRACHEAL TUBE SHAFT (ISO 11990-1:2011) |
| I.S. EN ISO 11073-10418:2014 | HEALTH INFORMATICS - PERSONAL HEALTH DEVICE COMMUNICATION - PART 10418: DEVICE SPECIALIZATION: INTERNATIONAL NORMALIZED RATIO (INR) MONITOR (ISO/IEEE 11073-10418:2014, CORRECTED VERSION 2014-05-01) |
| BS EN 16844 : 2017 | AESTHETIC MEDICINE SERVICES - NON-SURGICAL MEDICAL TREATMENTS |
| IEC TR 60825-14:2004 | Safety of laser products - Part 14: A user's guide |
| 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 |
| BS EN ISO 11810:2015 | Lasers and laser-related equipment. Test method and classification for the laser resistance of surgical drapes and/or patient protective covers. Primary ignition, penetration, flame spread and secondary ignition |
| BS EN ISO 11553-1:2008 | Safety of machinery. Laser processing machines General safety requirements |
| ISO 11810:2015 | Lasers and laser-related equipment Test method and classification for the laser resistance of surgical drapes and/or patient protective covers Primary ignition, penetration, flame spread and secondary ignition |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| DIN EN ISO 11810:2016-06 | LASERS AND LASER-RELATED EQUIPMENT - TEST METHOD AND CLASSIFICATION FOR THE LASER RESISTANCE OF SURGICAL DRAPES AND/OR PATIENT PROTECTIVE COVERS - PRIMARY IGNITION, PENETRATION, FLAME SPREAD AND SECONDARY IGNITION (ISO 11810:2015) |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| 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 |
| 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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