AAMI 60601 2 21 2009 RA 2014 A1 2016
$115.49
ANSI/AAMI/IEC 60601- 2-21:2009/(R)2014 & A1:2016 – Medical Electrical Equipment-Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
| Published By | Publication Date | Number of Pages |
| AAMI | 2009 | 57 |
This standard harmonizes with the third edition of IEC 60601-1 and specifies the safety and performance requirements for infant radiant warmers.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/IEC 60601-2-21:2009, Medical Electrical Equipment —Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers |
| 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 60601-2-21:2009 |
| 10 | FOREWORD |
| 12 | INTRODUCTION |
| 13 | 201.1 Scope, object and related standards 201.1.1 Scope |
| 14 | 201.1.2 Object 201.1.3 *Collateral standards 201.1.4 Particular standards |
| 15 | 201.2 Normative references 201.3 Terms and definitions |
| 17 | 201.4 General requirements |
| 18 | 201.4.1 Conditions for application to ME EQUIPMENT OR ME SYSTEMS 201.4.3 ESSENTIAL PERFORMANCE 201.4.3.101 *Additional ESSENTIAL PERFORMANCE requirements 201.5 General requirements for testing of ME EQUIPMENT 201.5.3 * Ambient temperature, humidity, atmospheric pressure 201.5.4 Other conditions |
| 19 | 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 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 *Oxygen monitor 201.7.2.102 Distance markings 201.7.4.2 Control devices 201.7.9.2.2 Warning and safety notices |
| 20 | 201.7.9.2.9 Operating instructions |
| 21 | 201.7.9.2.13 *Maintenance 201.7.9.2.14 Accessories, supplementary equipment, used material 201.7.9.3 Technical description 201.7.9.3.1 General 201.8 Protection against electrical HAZARDS from ME EQUIPMENT 201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 201.9.4.2.1 Instability in transport position 201.9.6.2 Acoustic energy 201.9.6.2.1.101 *Audible alarms sound level |
| 22 | 201.9.8 Hazards associated with support systems 201.9.8.101 Supports and mounting brackets for ACCESSORIES 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 |
| 23 | 201.10 Protection against unwanted and excessive radiation HAZARDS 201.10.6 *Infrared radiation 201.11 Protection against excessive temperatures and other HAZARDS 201.11.1.2.2 *APPLIED PARTS not intended to supply heat to a PATIENT 201.11.1.4 Guards 201.11.2 *Fire prevention |
| 24 | 201.11.6.3 Spillage on ME EQUIPEMENT and ME SYSTEMS 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 *Accuracy of SKIN TEMPERATURE SENSOR |
| 25 | 201.12.1.102 *Accuracy of distribution of irradiation to the mattress 201.12.1.103 *Accuracy of BABY CONTROLLED RADIANT WARMER operation |
| 26 | 201.12.1.104 *Oxygen control 201.12.1.105 *Weighing scale 201.12.2 USABILITY 201.12.2.101 USABILITY of control |
| 27 | 201.12.2.102 USABILITY of mode of operation 201.12.2.103 *Time and irradiance limits in the MANUAL MODE 201.12.2.104 *Heat output level at PREWARM MODE 201.12.3 Alarm systems 201.12.3.101 Interruption of power supply 201.12.3.102 Open and short circuit of the SKIN TEMPERATURE SENSOR in BABY CONTROLLEDRADIANT WARMER operation |
| 28 | 201.12.3.103 *AUDIO PAUSED of auditory ALARM SIGNALS during MANUAL MODE 201.12.3.104 AUDIO PAUSED 201.12.3.105 Alarm function test 201.12.4.2 Indication of parameters relevant to safety 201.12.4.2.101 *CO2 concentration 201.13 HAZARDOUS SITUATIONS and fault conditions |
| 29 | 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 201.15 Construction of ME EQUIPMENT 201.15.3.5 Rough handling test 201.15.4.1 Construction of connectors 201.15.4.1.101 *Temperature sensors 201.15.4.2.1 Application |
| 30 | 201.15.4.2.2 Temperature settings 201.15.4.2.2.101 Range of CONTROL TEMPERATURE 201.16 ME SYSTEMS 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 202 Electromagnetic compatibility – Requirements and tests 202.6.2.3 Radiated RF electromagnetic fields 202.6.2.3.1 *Requirements |
| 31 | 210 Process requirements for the development of physiologic closed-loop controllers Annexes |
| 32 | Annex AA (informative) Particular guidance and rationale Subclause 201.1.3 – Collateral standards Subclause 201.3.207 – PREWARM MODE Subclause 201.3.212 – TEST LOAD |
| 33 | Subclause 201.5.3 – Ambient temperature, humidity, atmospheric pressure Subclause 201.7.2.101 – Oxygen monitor |
| 34 | Subclause 201.7.9.2.2 – Warning and safety notices Subclause 201.7.9.2.13 – Maintenance Subclause 201.9.6.2.1.101 – Audible alarms sound level Subclause 201.10.6 – Infrared radiation |
| 37 | Subclause 201.11.1.2.2 – APPLIED PARTS not intended to supply heat to a PATIENT Subclause 201.11.2 – Fire prevention Subclause 201.12.1.101 – Accuracy of SKIN TEMPERATURE SENSOR Subclause 201.12.1.102 – Accuracy of distribution of irradiation to the mattress Subclause 201.12.1.103 – Accuracy of BABY CONTROLLED RADIANT WARMER operation |
| 38 | Subclause 201.12.1.104 – Oxygen control Subclause 201.12.1.105 – Weighing scale Subclause 201.12.2.103 – Time and irradiance limits in the MANUAL MODE Subclause 201.12.2.104 – Heat output level at PREWARM MODE Subclause 201.12.3.103 – AUDIO PAUSED of auditory ALARM SIGNALS during manual control |
| 39 | Subclause 201.12.4.2.101 – CO2 concentration Subclause 201.15.4.1.101 – Temperature sensors Subclause 202.6.2.3.1 – Requirements Subclause 210.5.1 – Instructions for use Subclause 210.6.3 – PCLCS VARIABLE logging Subclause 210.8.2.2.6 – Responses of the PCLCS |
| 40 | Bibliography |
| 43 | Index of defined terms used in this particular standard |
| 45 | Title page |
| 46 | AAMI Standard Copyright information |
| 47 | Contents |
| 48 | Glossary of equivalent standards |
| 49 | Committee representation |
| 50 | Background of ANSI/AAMI adoption of Amendment 1 to IEC 60601-2-21:2009 |
| 51 | Foreword |
| 53 | List of amendments |
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