| Standard Number | BS EN 80601-2-58:2015+A1:2019 |
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| Title | Medical electrical equipment. Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery |
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| Status | Current |
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| Publication Date | 30 June 2015 |
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| Normative References(Required to achieve compliance to this standard) | EN ISO 11607-1:2009/A1:2014, ISO 11607-1:2006/Amd 1:2014, ISO 11607-2:2006/Amd 1:2014, EN 55011, CISPR 11, IEC 60601-1-2:2014, EN 60601-1-2:2015, EN ISO 11607-2:2006/A1:2014 |
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| Informative References(Provided for Information) | EN 61847, IEC 60825-1, EN 60950-1, IEC 61847, EN 60065, EN 60825-1, IEC 60950-1, IEC 60065 |
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| Replaces | BS EN 80601-2-58:2009+A11:2011 |
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| International Relationships | EN 80601-2-58:2015/A1:2019,IEC 80601-2-58:2014/AMD1:2016 |
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| Amended By | Amendment, September 2019 |
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| Descriptors | Electrical safety, Ophthalmology, Electrical medical equipment, Performance, Ophthalmic equipment, Eyes, Hazards, Instructions for use, Performance testing, Medical equipment, Accuracy, Safety measures, Surgical instruments |
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| ICS | 11.040.70
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| Title in French | Appareils électromédicaux Exigences particulières pour la sécurité de base et les performances essentielles des dispositifs de retrait du cristallin et des dispositifs de vitrectomie pour la chirurgie ophtalmique |
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| Title in German | Medizinische elektrische Geräte Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale für Geräte zur Linsenentfernung und Geräte zur Glaskörperentfernung in der Augenchirurgie |
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| Committee | CH/62/4 |
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| ISBN | 978 0 580 90617 6 |
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| Publisher | BSI |
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| Format | A4 |
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| Delivery | Yes |
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| Pages | 40 |
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| File Size | 2.002 MB |
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| Price | £214.00 |
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