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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, 2009
- 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
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Standard
- Copyright information
- CONTENTS
- Glossary of equivalent standards
- Committee representation
- Background of ANSI/AAMI adoption of IEC 60601-2-21:2009
- FOREWORD
- INTRODUCTION
- 201.1 Scope, object and related standards [Go to Page]
- 201.1.1 Scope
- 201.1.2 Object
- 201.1.3 *Collateral standards
- 201.1.4 Particular standards
- 201.2 Normative references
- 201.3 Terms and definitions
- 201.4 General requirements [Go to Page]
- 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 [Go to Page]
- 201.5.3 * Ambient temperature, humidity, atmospheric pressure
- 201.5.4 Other conditions
- 201.6 Classification of ME EQUIPMENT and ME SYSTEMS
- 201.7 ME EQUIPMENT identification, marking and documents [Go to Page]
- 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
- 201.7.9.2.9 Operating instructions
- 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 [Go to Page]
- 201.9.4.2.1 Instability in transport position
- 201.9.6.2 Acoustic energy [Go to Page]
- 201.9.6.2.1.101 *Audible alarms sound level
- 201.9.8 Hazards associated with support systems [Go to Page]
- 201.9.8.101 Supports and mounting brackets for ACCESSORIES
- 201.9.8.3 Strength of PATIENT or OPERATOR support or suspension systems [Go to Page]
- 201.9.8.3.1 General
- 201.9.8.3.101 Barriers
- 201.10 Protection against unwanted and excessive radiation HAZARDS [Go to Page]
- 201.10.6 *Infrared radiation
- 201.11 Protection against excessive temperatures and other HAZARDS [Go to Page]
- 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
- 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 [Go to Page]
- 201.12.1 Accuracy of controls and instruments
- 201.12.1.101 *Accuracy of SKIN TEMPERATURE SENSOR
- 201.12.1.102 *Accuracy of distribution of irradiation to the mattress
- 201.12.1.103 *Accuracy of BABY CONTROLLED RADIANT WARMER operation
- 201.12.1.104 *Oxygen control
- 201.12.1.105 *Weighing scale
- 201.12.2 USABILITY
- 201.12.2.101 USABILITY of control
- 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
- 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
- 201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
- 201.15 Construction of ME EQUIPMENT [Go to Page]
- 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
- 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 [Go to Page]
- 202.6.2.3 Radiated RF electromagnetic fields
- 202.6.2.3.1 *Requirements
- 210 Process requirements for the development of physiologic closed-loop controllers
- Annexes [Go to Page]
- Annex AA (informative) Particular guidance and rationale [Go to Page]
- Subclause 201.1.3 – Collateral standards
- Subclause 201.3.207 – PREWARM MODE
- Subclause 201.3.212 – TEST LOAD
- Subclause 201.5.3 – Ambient temperature, humidity, atmospheric pressure
- Subclause 201.7.2.101 – Oxygen monitor
- 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
- 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
- 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
- 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
- Bibliography
- Index of defined terms used in this particular standard
- 60601-2-21_Amd1_1611.pdf [Go to Page]
- ANSI/AAMI/IEC 60601-2-21:2009/A1:2016, Medical electrical equipment— Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
- Objectives and uses of AAMI standards and recommended practices
- Title page
- AAMI Standard
- Copyright information
- Contents
- Glossary of equivalent standards
- Committee representation
- Background of ANSI/AAMI adoption of Amendment 1 to IEC 60601-2-21:2009
- Foreword
- List of amendments [Go to Page]