BS EN 80601-2-58:2015
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Medical electrical equipment Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery
Hardcopy , PDF
14-09-2019
English
30-06-2015
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/62/4
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| DevelopmentNote |
Supersedes 07/30157980 DC. (03/2009) 2009 + A11 2011 Edition remains active & will be withdrawn on 29/05/2018. Supersedes 13/30271473 DC. (06/2015)
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| DocumentType |
Standard
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| Pages |
34
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| PublisherName |
British Standards Institution
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| Status |
Withdrawn
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| SupersededBy | |
| Supersedes |
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.
| Standards | Relationship |
| IEC 80601-2-58:2014+AMD1:2016 CSV | Identical |
| EN 80601-2-58:2015 | Identical |
| IEC 80601-2-58:2014 | 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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