AAMI 80601 2 58 2014
$93.55
ANSI/AAMI/IEC 80601-2-58:2014 – Medical electrical equipment – Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery
| Published By | Publication Date | Number of Pages |
| AAMI | 2014 | 34 |
The purpose of this standard is to set appropriate requirements for the safety and performance of lens removal and vitrectomy devices for ophthalmic surgery to reduce the risk of detrimental impact on the medical treatment to an acceptable level for their intended use. The benefit of this standard is to the medical industry, manufacturers, medical regulators, hospitals, clinics, medical users and finally to the patient
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/ IEC 80601-2-58:2014, Medical electrical equipment – Part 2-58: Particular requirements for basic safety and essential performance of lens removal and vitrectomy devices for ophthalmic surgery |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 8 | Background of ANSI/AAMI adoption of IEC 80601-2-58:2014 |
| 9 | FOREWORD |
| 11 | INTRODUCTION |
| 13 | 201.1 Scope, object and related standards 201.1.1 * Scope 201.1.2 Object 201.1.3 Collateral standards 201.1.4 Particular standards |
| 14 | 201.2 Normative references |
| 15 | 201.3 Terms and definitions |
| 17 | 201.4 General requirements 201.4.3 * Essential performance 201.4.3.101 General 201.4.101 * Additional functions 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 |
| 18 | 201.7.9.2.2 Warning and safety notices 201.7.9.2.8 Start-up procedure 201.7.9.2.9 Operating instructions 201.7.9.2.12 Cleaning, disinfection, and sterilization |
| 19 | 201.7.9.2.13 Maintenance 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 201.11.1.2 Temperature of applied parts 201.11.1.2.1 Applied parts intended to supply heat to a patient 201.11.6.7 Sterilization of me equipment and me systems 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.12.1 Accuracy of controls and instruments |
| 20 | 201.12.1.101 Additional accuracy of controls and instruments requirements 201.12.1.101.1 Accuracy of static irrigation pressure |
| 21 | 201.12.1.101.2 Accuracy of aspiration pressure |
| 23 | 201.12.1.101.3 Accuracy of diathermy power 201.12.1.101.4 Accuracy of diathermy frequency 201.12.1.101.5 Accuracy of illumination output 201.12.1.101.6 * Fragmentation 201.12.1.101.7 Accuracy of ultrasonic velocity of tip |
| 25 | 201.12.1.101.8 Accuracy of velocity of fluid entering eye for liquefaction |
| 26 | 201.12.1.101.9 Accuracy of vitrectomy probe cut rate 201.12.4 Protection against hazardous output |
| 27 | 201.12.4.101.1 Hazardous output for static irrigation pressure 201.12.4.101.2 Hazardous output for aspiration 201.12.4.101.3 Hazardous output for diathermy power 201.12.4.101.4 Hazardous output for diathermy frequency 201.12.4.101.5 * Hazardous output for Illumination |
| 28 | 201.12.4.101.6 Fragmentation 201.12.4.101.7 Hazardous output for ultrasonic velocity of tip 201.12.4.101.8 Hazardous output for velocity of fluid entering eye for liquefaction 201.12.4.101.9 Hazardous output for vitrectomy probe cut rate 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 |
| 29 | 202.5.2.2.2 Requirements applicable to ME equipment and ME systems other than those specified for use only in a shielded location 202.5.2.2.3 * Requirements applicable to ME equipment and ME systems for use only in a shielded location |
| 30 | Annex C: Guide to marking and labelling requirements for me equipment and me systems 201.C.5 Accompanying documents, instructions for use |
| 31 | Annex AA: Particular guidance and rationale A.A.1 General guidance A.A.2 Rationale for particular clauses and subclauses |
| 33 | Bibliography |
| 34 | Index of defined terms |
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ANSI/AAMI/IEC 80601-2-58:2014 – Medical electrical equipment-Part 2-58: Particular requirements for basic safety and essential performance…
