AAMI 60601 2 19 2009 RA 2014 A1 2016
$115.49
ANSI/AAMI/IEC 60601-2-19:2009/(R)2014 & A1:2016 – Medical Electrical Equipment-Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
| Published By | Publication Date | Number of Pages |
| AAMI | 2009 | 58 |
This standard applies to the basic safety and essential performance of baby incubators. This standard can also be applied to baby incubators used for compensation or alleviation of disease, injury or disability. This standard does not apply to heating devices intended for physiotherapy, radiant warmers, and transport incubators.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI/IEC 60601-2-19:2009, Medical Electrical Equipment — Part 2-19: Particular requirements for the basic safety and essential performance of infant 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 60601-2-19:2009 |
| 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 ESSENTIAL PERFORMANCE of INFANT INCUBATORS 201.5 General requirements for testing ME EQUIPMENT |
| 19 | 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 201.7 ME EQUIPMENT identification, marking and documents 201.7.2.101 * Oxygen monitor 201.7.2.102 Heater surface temperature 201.7.4 Markings of controls and instruments (see also Table C.3 of the general standard) 201.7.4.2 * Control devices |
| 20 | 201.7.9.2.2 * Warning and safety notices 201.7.9.2.8 * Start-up PROCEDURE 201.7.9.2.9 * Operating instructions |
| 21 | 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 201.9.6.2 Acoustic energy 201.9.6.2.1 Audible acoustic energy 201.9.6.2.1.101 * Sound level within the COMPARTMENT 201.9.6.2.1.102 * Audible alarm sound level |
| 22 | 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 system 201.9.8.3.1 General 201.9.8.3.101 * Barriers 201.9.8.3.102 MATTRESS tray |
| 23 | 201.9.8.101 Supports and mounting brackets for ACCESSORIES 201.10 Protection against unwanted and excessive radiation HAZARDS 201.11 Protection against excessive temperatures and other hazards 201.11.1 Excessive temperature in ME EQUIPMENT 201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT |
| 24 | 201.11.2 * Fire prevention 201.11.6.2 * Overflow in ME EQUIPMENT 201.11.6.3 Spillage on ME EQUIPMENT and ME SYSTEMS 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 |
| 25 | 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 INCUBATOR TEMPERATURE 201.12.1.102 * Uniformity of INCUBATOR TEMPERATURE 201.12.1.103 * Accuracy of SKIN TEMPERATURE SENSOR |
| 26 | 201.12.1.104 * Accuracy between SKIN TEMPERATURE and CONTROL TEMPERATURE 201.12.1.105 * Accuracy of INCUBATOR TEMPERATURE indication 201.12.1.106 * Accuracy of INCUBATOR TEMPERATURE control 201.12.1.107 * Warm-up time |
| 27 | 201.12.1.108 * Overshoot of INCUBATOR TEMPERATURE 201.12.1.109 * Accuracy of indication of relative humidity 201.12.1.110 * Oxygen control 201.12.1.111 * Air velocity |
| 28 | 201.12.1.112 * Weighing scale 201.12.2 Usability 201.12.2.101 * Indication of SKIN TEMPERATURE |
| 29 | 201.12.2.102 * Indication of the mode of operation 201.12.2.103 Temperature control 201.12.3 Alarm systems 201.12.3.101 * Air circulation fan 201.12.3.102 * Connector to SKIN TEMPERATURE SENSOR |
| 30 | 201.12.3.103 Alarm for interruption of power supply 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 |
| 31 | 201.13 HAZARDOUS SITUATIONS and fault conditions 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 201.15.3.5 Rough handling test |
| 32 | 201.15.3.101 Access to INFANT 201.15.4.1 Construction of connectors 201.15.4.1.101 * Temperature sensors 201.15.4.2 Temperature and overload control devices 201.15.4.2.1 Application |
| 34 | 201.15.4.2.2 Temperature settings 201.15.4.2.2.101 * AIR CONTROLLED INCUBATOR range 201.15.4.2.2.102 * BABY CONTROLLED INCUBATOR range 201.16 ME SYSTEMS 201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 202 Electromagnetic compatibility – Requirements and test 202.6.2.3 Radiated RF electromagnetic fields 202.6.2.3.1 Requirements |
| 35 | 210 Requirements for the development of physiologic closed-loop controllers Annexes |
| 36 | Annex AA (informative) Particular guidance and rationale Subclause 201.1.3 – Collateral standards Subclause 201.4.3 – ESSENTIAL PERFORMANCE |
| 37 | Subclause 201.5.3 a) – Ambient temperature, humidity, atmospheric pressure Subclause 201.7.2.101 – Oxygen monitor 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 |
| 38 | Subclause 201.7.9.2.9 – Operating instructions Subclause 201.9.6.2.1.101 – Sound level within the COMPARTMENT Subclause 201.9.6.2.1.102 – Audible alarm sound level |
| 39 | Subclause 201.9.6.2.103 – Audible alarms sound level within COMPARTMENT Subclause 201.9.8.3.101 – Barriers Subclause 201.11.2 – Fire prevention Subclause 201.11.6.2 – Overflow in ME EQUIPMENT Subclause 201.11.6.6 – Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS Subclause 201.12.1.101 – Stability of INCUBATOR TEMPERATURE |
| 40 | Subclause 201.12.1.102 – Uniformity of INCUBATOR TEMPERATURE Subclause 201.12.1.103 – Accuracy of SKIN TEMPERATURE SENSOR Subclause 201.12.1.104 – Accuracy between SKIN TEMPERATURE and CONTROL TEMPERATURE Subclause 201.12.1.105 – Accuracy of INCUBATOR TEMPERATURE indication Subclause 201.12.1.106 – *Accuracy of INCUBATOR TEMPERATURE control Subclause 201.12.1.107 – Warm-up time Subclause 201.12.1.108 – Overshoot of INCUBATOR TEMPERATURE |
| 41 | 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 201.12.1.112 – Weighing Scale Subclause 201.12.2.101 – Indication of SKIN TEMPERATURE indication Subclause 201.12.2.102 – Indication of the mode of operation |
| 42 | 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 201.13.2.6 – Leakage of liquid Subclause 201.15.4.1.101 – Temperature sensors Subclause 201.15.4.2.1 aa) Subclause 201.15.4.2.1 dd) and ee) |
| 43 | Subclause 201.15.4.2.2.101 – AIR CONTROLLED INCUBATOR range Subclause 201.15.4.2.2.102 – BABY CONTROLLED INCUBATOR range Subclause 210.5.1 – Instructions for use Subclause 210.6.3 – PCLCS VARIABLE logging Subclause 210.8.2.2.6 – * Responses of the PCLCS |
| 44 | Bibliography |
| 45 | Index of defined terms used in this particular standard |
| 47 | Title page |
| 48 | AAMI Standard Copyright information |
| 49 | Contents |
| 50 | Glossary of equivalent standards |
| 51 | Committee representation |
| 52 | Background of ANSI/AAMI adoption of Amendment 1 to IEC 60601-2-19:2009 |
| 53 | Foreword |
| 55 | List of amendments |
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