AAMI 60601 2 50 2009 RA 2014
$93.55
ANSI/AAMI/ IEC 60601- 2-50:2009/(R)2014 & A1:2016 – Medical electrical equipment-Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
| Published By | Publication Date | Number of Pages |
| AAMI | 2009 | 50 |
This standard specifies requirements for infant phototherapy equipment and can also be applied to infant phototherapy equipment used for compensation or alleviation of disease, injury or disability
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/IEC 60601-2-50:2009, Medical Electrical Equipment — Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI Standard Copyright information |
| 5 | CONTENTS |
| 6 | Glossary of equivalent standards |
| 8 | Committee representation |
| 9 | Background of ANSI/AAMI adoption of IEC 60601-2-50:2009 |
| 10 | FOREWORD |
| 13 | INTRODUCTION |
| 15 | 201.1 Scope, object and related standards 201.1.1 * Scope |
| 16 | 201.1.2 Object 201.1.3 Collateral standards 201.1.4 Particular standards |
| 17 | 201.2 Normative references 201.3 Terms and definitions |
| 19 | 201.4 General requirements |
| 20 | 201.4.3 * ESSENTIAL PERFORMANCE 201.5 General requirements for testing of ME EQUIPMENT 201.5.4 Other conditions 201.5.4.101 * Pre-ageing 201.5.4.102 Position of measurements 201.5.4.103 Stabilization period 201.5.4.104 * Arrangement in space 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 201.6.3 Protection against harmful ingress of water or particular matter |
| 21 | 201.6.3.101 INFANT PHOTOTHERAPY EQUIPMENT located under the PATIENT 201.7 ME EQUIPMENT identification, marking and documents 201.7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT PARTS 201.7.2.101 * Safety sign for PATIENT eye shield 201.7.3.1 Heating elements or lamp holders 201.7.9.2.2 Warning and safety notices |
| 22 | 201.7.9.2.5 ME EQUIPMENT description 201.7.9.2.9 Operating instructions |
| 23 | 201.7.9.2.13 Maintenance 201.7.9.2.14 ACCESSORIES, supplementary equipment, used material 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS 201.9.2.1 General |
| 24 | 201.9.5.1 Protective means 201.9.6.2 * Acoustic energy 201.9.8 HAZARDS associated with support systems 201.9.8.3 Strength of PATIENT or OPERATOR support or suspension systems 201.9.8.3.1 * General 201.9.8.3.101 Barriers |
| 25 | 201.9.8.101 Supports and mounting brackets for ACCESSORIES 201.10 Protection against unwanted and excessive radiation HAZARDS 201.10.5 * Other visible electromagnetic radiation 201.10.6 * Infrared radiation 201.10.7 * Ultraviolet radiation 201.11 Protection against excessive temperatures and other HAZARDS |
| 26 | 201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT 201.11.2 * Fire prevention 201.11.8 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT 201.12 Accuracy of controls and instruments and protection against hazardous outputs 201.12.1 Accuracy of controls and instruments 201.12.1.101 Irradiance distribution |
| 27 | 201.12.1.102 Measuring principles 201.12.1.103 * Spectral method 201.12.1.104 Integral method 201.12.1.105 * TOTAL IRRADIANCE FOR BILIRUBIN Ebi after pre-ageing |
| 28 | 201.12.1.106 * Local distribution 201.12.1.107 * Weighing Scale |
| 29 | 201.12.4 Protection against hazardous output 201.13 HAZARDOUS SITUATIONS and fault conditions 201.13.2 SINGLE FAULT CONDITIONS 201.13.2.101 Power supply fluctuation 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 201.15 Construction of ME EQUIPMENT 201.15.3.1 General 201.15.4.4 Indicators 201.15.4.4.101 Examination of the lifetime 201.16 ME SYSTEMS |
| 30 | 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 202 ELECTROMAGNETIC COMPATIBILITY 202.6.2.3 Radiated RF electromagnetic fields 202.6.2.3.1 * Requirements Annexes |
| 31 | Annex AA (informative) Particular guidance and rationale Subclause 201.1.1 – Scope Subclause 201.3.203 – INFANT PHOTOTHERAPY EQUIPMENT Subclause 201.4.3 – ESSENTIAL PERFORMANCE Subclause 201.5.4.101 – Pre-ageing |
| 32 | Subclause 201.5.4.104 – Arrangement in space Subclause 201.7.2.101 – Symbol for PATIENT eye shield Subclause 201.7.9.2.2 i) – Warning and safety notices Subclause 201.7.9.2.13 b) – Maintenance Subclause 201.9.6.2 – Acoustic energy Subclause 201.9.8.3.1 – General Subclause 201.10.5 – Other visible electromagnetic radiation |
| 33 | Subclause 201.10.6 – Infrared radiation Subclause 201.10.7 – Ultraviolet radiation |
| 35 | Subclause 201.11.1 – Excessive temperatures in ME EQUIPMENT Subclause 201.11.2 – Fire prevention Subclause 201.12.1.103 – Spectral method Subclause 201.12.1.105 – TOTAL IRRADIANCE FOR BILIRUBIN Ebi after pre-ageing Subclause 201.12.1.106 – Local distribution Subclause 201.12.1.107 – Weighing Scale |
| 36 | Subclause 202.6.2.3.1 – Requirements |
| 37 | Bibliography |
| 39 | Index of defined terms used in this particular standard |
| 41 | Title page |
| 42 | AAMI Standard Copyright information |
| 43 | Contents |
| 44 | Glossary of equivalent standards |
| 45 | Committee representation |
| 46 | Background of ANSI/AAMI adoption of Amendment 1 to IEC 60601-2-50:2009 |
| 47 | Foreword |
| 49 | List of amendments |
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