AAMI 80601 2 58 2014 A1 2016
$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 | 19 |
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/A1:2016; Amendment 1 to 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 |
| 2 | Objectives and uses of AAMI standards andrecommended practices |
| 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 Amendment 1 to IEC 80601-2-58:2014 |
| 9 | Foreword |
| 11 | Introduction to the Amendment 201.1.3 Collateral standards 201.1.3 * Collateral standards 201.1.4 Particular standards 201.2 Normative references |
| 12 | 201.7 Me equipment identification, marking and documents 201.7.6.101 * Additional symbols 201.7.9.2.12 Cleaning, disinfection, and sterilization 201.11.6.7 Sterilization of me equipment and me systems 201.12.1.101.7 Accuracy of ultrasonic velocity of tip 201.12.1.101.8 Accuracy of velocity of fluid entering eye for liquefaction |
| 13 | 201.13 Hazardous situations and fault conditions for ME EQUIPMENT 201.13 Hazardous situations and fault conditions for me equipment 202 Electromagnetic compatibility – Requirements and tests 202 Electromagnetic disturbances – Requirements and tests 202.5.2.2.2 * Requirements applicable to me equipment and me systems specified for use only in a shielded location special environment 202.5.2.2.4 Requirements applicable to me equipment that includes RF transmitters 202.7 Electromagnetic emissions requirements for me equipment and me systems 202.7.1.2 Operating modes 202.8 Electromagnetic immunity requirements for me equipment and me systems 202.8.1 * General Annexes |
| 14 | Annex D (informative) Symbols on marking (See Clause 7) Table D.4 – LENS REMOVAL and VITRECTOMY symbols |
| 15 | Annex AA (informative) Particular guidance and rationale A.A.2 Rationale for particular clauses and subclauses Subclause 201.1.3 – Collateral standards Subclause 201.4.3 – Essential performance |
| 16 | Subclause 201.4.101 – Additional functions Subclause 201.7.6.101 – Additional symbols |
| 17 | Clause 201.16 – Me systems Subclause 202.5.2.2.2 – Requirements applicable to me equipment and me systems specified for use only in a shielded location special environment Subclause 202.8.1 – General |
| 18 | Bibliography |
| 19 | Index of defined terms |
