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eLibrary > BS EN IEC 80601-2-58:2024 Medical electrical equipment - Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery >

BS EN IEC 80601-2-58:2024 Medical electrical equipment - Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery, 2024

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BS EN IEC 80601-2-58:2024 Medical electrical equipment - Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery, 2024

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Annex ZA (normative)Normative references to international publicationswith their corresponding European publications [Go to Page]
English [Go to Page]
CONTENTS
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
Figure 201.101 – Test method for gravity fed irrigation
Figure 201.102 – Test method for pressurized irrigation
Figure 201.103 – Test method for aspiration pressure measurement/display accuracy
Figure 201.104 – Test method for ultrasonic velocity of tip accuracy
Figure 201.105 – Partial shadow, and camera field of view relative to tip
201.13 Hazardous situations and fault conditions for me equipment
201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.17 Electromagnetic compatibility of me equipment and me systems
202 Electromagnetic disturbances – Requirements and tests
Annexes
Annex C (informative) Guide to marking and labelling requirements for me equipment and me systems
Annex D (informative) Symbols on marking (See Clause 7)
Annex AA (informative) Particular guidance and rationale
Annex BB (informative) Reference to the general safety and performance requirements
Bibliography
Index of defined terms [Go to Page]

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BS EN IEC 80601-2-58:2024 Medical electrical equipment - Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery, 2024

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