EN 80601-2-58:2015
Current
The latest, up-to-date edition.
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
29-05-2015
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 of 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 for
ME EQUIPMENT
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
202 Electromagnetic compatibility - Requirements and tests
Annex C (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and ME SYSTEMS
Annex AA (informative) - Particular guidance and rationale
Bibliography
Index of defined terms
Annex ZA (normative) - Normative references to
international publications with their
corresponding European publications
Annex ZZ (informative) - Coverage of Essential
Requirements of EU Directives
IEC 80601-2-58:2014 applies to the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery and associated accessories that can be connected to this medical electrical equipment, hereafter referred to as ME equipment. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard. This second edition includes changes in order to take into account the comments submitted during the approval of the first edition as a European Medical Device Directive, as well as the comments from other National Committees during the finalization of the first edition of this standard.
| Committee |
CLC/TC 62
|
| DocumentType |
Standard
|
| ProductNote |
NEW CHILD ADDED
|
| PublisherName |
European Committee for Standards - Electrical
|
| Status |
Current
|
| Standards | Relationship |
| NF EN 80601-2-58:2015 | Identical |
| I.S. EN 80601-2-58:2015 | Identical |
| DIN EN 80601-2-58 : 2015 | Identical |
| VDE 0750-2-58 : 2015 | Identical |
| NEN EN IEC 80601-2-58 : 2015 | Identical |
| BS EN 80601-2-58:2015 | Identical |
| UNE-EN 80601-2-58:2015 | Identical |
| IEC 80601-2-58:2014+AMD1:2016 CSV | Identical |
| UNE-EN 80601-2-58:2009 | Identical |
| NBN EN 80601-2-58 : 2015 | Identical |
| CEI EN 80601-2-58 : 2016 | Identical |
| I.S. EN 80601-2-58:2015/A1:2019 | Identical |
| PN EN 80601-2-58 : 2015 | Identical |
| SN EN 80601-2-58 : 2009 AMD 11 2011 | Identical |
| PNE-FprEN 80601-2-58 | Identical |
| IEC 60950-1:2005+AMD1:2009+AMD2:2013 CSV | Information technology equipment - Safety - Part 1: General requirements |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| EN 60825-1:2014/AC:2017-06 | SAFETY OF LASER PRODUCTS - PART 1: EQUIPMENT CLASSIFICATION AND REQUIREMENTS (IEC 60825-1:2014) |
| EN 60065:2014/AC:2017-01 | AUDIO, VIDEO AND SIMILAR ELECTRONIC APPARATUS - SAFETY REQUIREMENTS (IEC 60065:2014/COR2:2016) |
| EN ISO 15004-2:2007 | Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 15004-2:2007) |
| ISO 15752:2010 | Ophthalmic instruments Endoilluminators Fundamental requirements and test methods for optical radiation safety |
| EN 60950-1:2006/A2:2013 | INFORMATION TECHNOLOGY EQUIPMENT - SAFETY - PART 1: GENERAL REQUIREMENTS (IEC 60950-1:2005/A2:2013, MODIFIED) |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| IEC 61847:1998 | Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics |
| IEC 60601-2-22:2007+AMD1:2012 CSV | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| 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 |
| EN ISO 15752:2010 | Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety (ISO 15752:2010) |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| IEC 60601-2-2:2017 | Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| ISO 15004-2:2007 | Ophthalmic instruments — Fundamental requirements and test methods — Part 2: Light hazard protection |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| EN 61847:1998 | Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics |
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