13/30271473 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
Hardcopy , PDF
06-30-2015
English
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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
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
Annexes
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
BS EN 80601-2-58
| Committee |
CH/62/4
|
| DocumentType |
Draft
|
| Pages |
31
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| 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 |
| ISO 15752:2010 | Ophthalmic instruments Endoilluminators Fundamental requirements and test methods for optical radiation safety |
| 2001/104/EC : 2001 COR 1 2002 | DIRECTIVE 2001/104/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 7 DECEMBER 2001 AMENDING COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES (TEXT WITH EEA RELEVANCE) |
| 2007/47/EC : 2007 COR 1 2015 | DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE) |
| 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 |
| 2000/70/EC : 2000 | DIRECTIVE 2000/70/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 16 NOVEMBER 2000 AMENDING COUNCIL DIRECTIVE 93/42/EC AS REGARDS MEDICAL DEVICES INCORPORATING STABLE DERIVATES OF HUMAN BLOOD OR HUMAN PLASMA |
| 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 |
| 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 |
| 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 |
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