AAMI 60601 2 20 2009 RA 2014 A1 2016
$131.66
ANSI/AAMI/ IEC 60601- 2-20:2009/(R)2014 & A1:2016 – Medical Electrical Equipment-Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
| Published By | Publication Date | Number of Pages |
| AAMI | 2009 | 65 |
This standard applies to the basic safety and essential performance of transport incubators. This standard does not apply to heating devices intended for physiotherapy, baby incubators, radiant warmers.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/IEC 60601-2-20:2009, Medical Electrical Equipment —Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators |
| 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 60601-2-20:2009 |
| 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 |
| 18 | 201.4 General requirements 201.4.1 Conditions for application to ME EQUIPMENT or ME SYSTEMS 201.4.3 *Essential performance 201.4.3.101 ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATORS 201.4.10 Power supply 201.4.10.101 *Ability to operate with different power supply sources |
| 19 | 201.4.10.102 Capacity of TRANSPORTABLE ELECTRICAL POWER SOURCE 201.4.10.103 Overcharge of TRANSPORTABLE ELECTRICAL POWER SOURCE 201.5 General requirements for testing ME EQUIPMENT 201.5.3 *Ambient temperature, humidity, atmospheric pressure |
| 20 | 201.5.4 Other conditions 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 Heater surface temperature 201.7.4 Marking of controls and instruments 201.7.4.2 *Control devices 201.7.9.2.2 Warning and safety notices |
| 21 | 201.7.9.2.8 *Start-up PROCEDURE 201.7.9.2.9 *Operating instructions |
| 22 | 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 201.9.2 Hazards associated with moving parts 201.9.2.1 General 201.9.4.2.1 Instability in transport position |
| 23 | 201.9.4.3 Instability from unwanted lateral movement (including sliding) 201.9.4.3.101 Tip-over force 201.9.4.3.102 *Prevention of movements 201.9.4.3.103 Prevention of infant’s movements 201.9.4.3.104 *Prevention of vibration 201.9.6.2 Acoustic energy 201.9.6.2.1 Audible acoustic energy |
| 24 | 201.9.6.2.1.101 Sound level within the compartment 201.9.6.2.1.102 * Audible alarms sound level 201.9.6.2.1.103 * Audible alarms sound level within compartment 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 |
| 25 | 201.9.8.3.101 *Barriers 201.9.8.3.102 Mattress tray 201.9.8.101 Supports and mounting brackets for accessories 201.10 Protection against unwanted and excessive radiation HAZARDS |
| 26 | 201.11 Protection against excessive temperatures and other HAZARDS 201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT 201.11.2 * Fire prevention 201.11.6.2 *Overflow in ME EQUIPMENT 201.11.6.2.101 Water level indicator 201.11.6.3 *Spillage on ME EQUIPMENT and ME SYSTEMS |
| 27 | 201.11.6.6 *Cleaning and disinfection of ME EQUIPMENT 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 * Stability of TRANSPORT INCUBATOR TEMPERATURE 201.12.1.102 * Uniformity of TRANSPORT INCUBATOR TEMPERATURE |
| 28 | 201.12.1.103 *Accuracy of SKIN TEMPERATURE SENSOR 201.12.1.104 *Accuracy between SKIN TEMPERATURE and CONTROL TEMPERATURE 201.12.1.105 *Accuracy of TRANSPORT INCUBATOR TEMPERATURE indication |
| 29 | 201.12.1.106 *Accuracy of TRANSPORT INCUBATOR TEMPERATURE control 201.12.1.107 *Warm-up time 201.12.1.108 *Overshoot of TRANSPORT INCUBATOR TEMPERATURE 201.12.1.109 *Accuracy of indication of relative humidity |
| 30 | 201.12.1.110 * Oxygen control 201.12.1.111 *Air velocity 201.12.1.113 Change in ambient temperature |
| 31 | 201.12.1.114 Provision of oxygen 201.12.1.115 Overshoot of TRANSPORT INCUBATOR TEMPERATURE 201.12.1.116 * Weighing Scale |
| 32 | 201.12.2 Usability 201.12.2.101 *Indication of SKIN TEMPERATURE 201.12.2.102 *Indication of the mode of operation 201.12.2.103 Temperature control 201.12.3 ALARM SYSTEMS |
| 33 | 201.12.3.101 *Air circulation fan 201.12.3.102 *Connector to SKIN TEMPERATURE SENSOR 201.12.3.103 Interruption of power supply |
| 34 | 201.12.3.104 AUDIO PAUSED of audible alarm 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 201.13.2.2 *Electrical SINGLE FAULT CONDITION |
| 35 | 201.13.2.6 *Leakage of liquid 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 201.15 Construction of ME EQUIPMENT 201.15.3 Mechanical strength 201.15.3.101 Access to the INFANT 201.15.3.4.2 *PORTABLE ME EQUIPMENT |
| 36 | 201.15.4.1 Construction of connectors 201.15.4.1.101 * Connection of temperature sensors 201.15.4.2 Temperature and overload control devices 201.15.4.2.1 Application 201.15.4.2.2 *Temperature settings |
| 37 | 201.15.4.6.1 Fixing, prevention of maladjustment 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 |
| 38 | 210 Requirements for the development of physiologic closed-loop controllers 210.5.1 * Instructions for use 210.5.2 Technical description 210.6.1 USABILITY 210.6.3 * PCLCS VARIABLE logging 210.8.2.2.6 *Responses of the PCLCS Annexes |
| 39 | Annex AA (informative) Particular guidance and rationale Subclause 201.1.3 – Collateral standards Subclause 201.3.208 – INFANT TRANSPORT INCUBATOR Subclause 201.4.3 – ESSENTIAL PERFORMANCE |
| 40 | Subclause 201.4.10.101 – Ability to operate with different power sources Subclause 201.5.3 – Ambient temperature, humidity, atmospheric pressure Subclause 201.7.2.101 – Oxygen monitor |
| 41 | Subclause 201.7.4.2 – Control devices Subclause 201.7.9.2.2 – Warnings and safety notices Subclause 201.7.9.2.8 – Start-up PROCEDURE Subclause 201.7.9.2.9 – Operating instructions Subclause 201.9.4.3.102 – Prevention of movements Subclause 201.9.4.3.104 – Prevention of vibration |
| 42 | Subclause 201.9.6.2.1.102 – Audible alarms sound level Subclause 201.9.6.103 – Audible alarms sound level within COMPARTMENT Subclause 201.9.8.3.101 – Barriers Subclause 201.11.2 – Fire prevention |
| 43 | Subclause 201.11.6.2 – Overflow in ME EQUIPMENT Subclause 201.11.6.3 – Spillage on ME EQUIPMENT and ME SYSTEM Subclause 201.11.6.6 – Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS Subclause 201.12.1.101 – Stability of TRANSPORT INCUBATOR TEMPERATURE Subclause 201.12.1.102 – Uniformity of TRANSPORT INCUBATOR TEMPERATURE Subclause 201.12.1.103 – Accuracy of SKIN TEMPERATURE Subclause 201.12.1.104 – Accuracy between SKIN TEMPERATURE and CONTROL TEMPERATURE Subclause 201.12.1.105 – Accuracy of TRANSPORT INCUBATOR TEMPERATURE indication |
| 44 | Subclause 201.12.1.106 – *Accuracy of TRANSPORT INCUBATOR TEMPERATURE control Subclause 201.12.1.107 – Warm-up time Subclause 201.12.1.108 – Overshoot of TRANSPORT INCUBATOR TEMPERATURE Subclause 201.12.1.109 – Accuracy of indication of relative humidity Subclause 201.12.1.110 – Oxygen control Subclause 201.12.1.111 – Air velocity Subclause 201.12.1.116 – Weighing Scale |
| 45 | Subclause 201.12.2.101 – Indication of SKIN TEMPERATURE Subclause 201.12.2.102 – Indication of the mode of operation Subclause 201.12.3.101 – Air circulation fan Subclause 201.12.3.102 – Connector to SKIN TEMPERATURE SENSOR Subclause 201.12.4.2.101 – CO2-concentration Subclause 201.13.2.2 – Electrical SINGLE FAULT CONDITION Subclause 201.13.2.6 – Leakage of liquid |
| 46 | Subclause 201.15.3.4.2 – PORTABLE ME EQUIPMENT Subclause 201.15.4.1.101 – Connection of temperature sensors Subclause 201.15.4.2.2 – Temperature settings Subclause 202.6.2.3.1 – Requirements Subclause 210.5.1 – Instructions for use Subclause 210.6.3 – PCLCS VARIABLE logging |
| 47 | Subclause 210.8.2.2.6 – * Responses of the PCLCS |
| 48 | Bibliography |
| 49 | Index of defined terms used in this particular standard |
| 51 | Title page |
| 52 | AAMI Standard Copyright information |
| 53 | Contents |
| 54 | Glossary of equivalent standards |
| 55 | Committee representation |
| 56 | Background of ANSI/AAMI adoption of Amendment 1 to IEC 60601-2-20:2009 |
| 57 | Foreword |
| 59 | List of amendments |
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