{"id":198180,"date":"2024-10-19T12:36:58","date_gmt":"2024-10-19T12:36:58","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-60601-2-20-2009-ra-2014-a1-2016\/"},"modified":"2024-10-25T05:10:09","modified_gmt":"2024-10-25T05:10:09","slug":"aami-60601-2-20-2009-ra-2014-a1-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-60601-2-20-2009-ra-2014-a1-2016\/","title":{"rendered":"AAMI 60601 2 20 2009 RA 2014 A1 2016"},"content":{"rendered":"

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.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/IEC 60601-2-20:2009, Medical Electrical Equipment \u2014Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators <\/td>\n<\/tr>\n
2<\/td>\nObjectives and uses of AAMI standards and recommended practices <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nCONTENTS <\/td>\n<\/tr>\n
6<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
8<\/td>\nCommittee representation <\/td>\n<\/tr>\n
9<\/td>\nBackground of ANSI\/AAMI adoption of IEC 60601-2-20:2009 <\/td>\n<\/tr>\n
10<\/td>\nFOREWORD <\/td>\n<\/tr>\n
12<\/td>\nINTRODUCTION <\/td>\n<\/tr>\n
13<\/td>\n201.1 Scope, object and related standards
201.1. 1 Scope <\/td>\n<\/tr>\n
14<\/td>\n201.1. 2 Object
201.1.3 *Collateral standards
201.1. 4 Particular standards <\/td>\n<\/tr>\n
15<\/td>\n201.2 Normative references
201.3 Terms and definitions <\/td>\n<\/tr>\n
18<\/td>\n201.4 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 <\/td>\n<\/tr>\n
19<\/td>\n201.4.10.102 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 <\/td>\n<\/tr>\n
20<\/td>\n201.5.4 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 <\/td>\n<\/tr>\n
21<\/td>\n201.7.9.2.8 *Start-up PROCEDURE
201.7.9.2.9 *Operating instructions <\/td>\n<\/tr>\n
22<\/td>\n201.7.9.3 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
\n
201.9.2 Hazards associated with moving parts
201.9.2.1 General
201.9.4.2.1 Instability in transport position <\/td>\n<\/tr>\n
23<\/td>\n201.9.4.3 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\u2019s movements
201.9.4.3.104 *Prevention of vibration
201.9.6.2 Acoustic energy
201.9.6.2.1 Audible acoustic energy <\/td>\n<\/tr>\n
24<\/td>\n201.9.6.2.1.101 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 <\/td>\n<\/tr>\n
25<\/td>\n201.9.8.3.101 *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 <\/td>\n<\/tr>\n
26<\/td>\n201.11 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 <\/td>\n<\/tr>\n
27<\/td>\n201.11.6.6 *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 <\/td>\n<\/tr>\n
28<\/td>\n201.12.1.103 *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 <\/td>\n<\/tr>\n
29<\/td>\n201.12.1.106 *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 <\/td>\n<\/tr>\n
30<\/td>\n201.12.1.110 * Oxygen control
201.12.1.111 *Air velocity
201.12.1.113 Change in ambient temperature <\/td>\n<\/tr>\n
31<\/td>\n201.12.1.114 Provision of oxygen
201.12.1.115 Overshoot of TRANSPORT INCUBATOR TEMPERATURE
201.12.1.116 * Weighing Scale <\/td>\n<\/tr>\n
32<\/td>\n201.12.2 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 <\/td>\n<\/tr>\n
33<\/td>\n201.12.3.101 *Air circulation fan
201.12.3.102 *Connector to SKIN TEMPERATURE SENSOR
201.12.3.103 Interruption of power supply <\/td>\n<\/tr>\n
34<\/td>\n201.12.3.104 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 <\/td>\n<\/tr>\n
35<\/td>\n201.13.2.6 *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 <\/td>\n<\/tr>\n
36<\/td>\n201.15.4.1 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 <\/td>\n<\/tr>\n
37<\/td>\n201.15.4.6.1 Fixing, prevention of maladjustment
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
202 Electromagnetic compatibility \u2013 Requirements and tests
202.6.2.3 Radiated RF electromagnetic fields
202.6.2.3.1 *Requirements <\/td>\n<\/tr>\n
38<\/td>\n210 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 <\/td>\n<\/tr>\n
39<\/td>\nAnnex AA (informative) Particular guidance and rationale
Subclause 201.1.3 \u2013 Collateral standards
Subclause 201.3.208 \u2013 INFANT TRANSPORT INCUBATOR
Subclause 201.4.3 \u2013 ESSENTIAL PERFORMANCE <\/td>\n<\/tr>\n
40<\/td>\nSubclause 201.4.10.101 \u2013 Ability to operate with different power sources
Subclause 201.5.3 \u2013 Ambient temperature, humidity, atmospheric pressure
Subclause 201.7.2.101 \u2013 Oxygen monitor <\/td>\n<\/tr>\n
41<\/td>\nSubclause 201.7.4.2 \u2013 Control devices
Subclause 201.7.9.2.2 \u2013 Warnings and safety notices
Subclause 201.7.9.2.8 \u2013 Start-up PROCEDURE
Subclause 201.7.9.2.9 \u2013 Operating instructions
Subclause 201.9.4.3.102 \u2013 Prevention of movements
Subclause 201.9.4.3.104 \u2013 Prevention of vibration <\/td>\n<\/tr>\n
42<\/td>\nSubclause 201.9.6.2.1.102 \u2013 Audible alarms sound level
Subclause 201.9.6.103 \u2013 Audible alarms sound level within COMPARTMENT
Subclause 201.9.8.3.101 \u2013 Barriers
Subclause 201.11.2 \u2013 Fire prevention <\/td>\n<\/tr>\n
43<\/td>\nSubclause 201.11.6.2 \u2013 Overflow in ME EQUIPMENT
Subclause 201.11.6.3 \u2013 Spillage on ME EQUIPMENT and ME SYSTEM
Subclause 201.11.6.6 \u2013 Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS
Subclause 201.12.1.101 \u2013 Stability of TRANSPORT INCUBATOR TEMPERATURE
Subclause 201.12.1.102 \u2013 Uniformity of TRANSPORT INCUBATOR TEMPERATURE
Subclause 201.12.1.103 \u2013 Accuracy of SKIN TEMPERATURE
Subclause 201.12.1.104 \u2013 Accuracy between SKIN TEMPERATURE and CONTROL TEMPERATURE
Subclause 201.12.1.105 \u2013 Accuracy of TRANSPORT INCUBATOR TEMPERATURE indication <\/td>\n<\/tr>\n
44<\/td>\nSubclause 201.12.1.106 \u2013 *Accuracy of TRANSPORT INCUBATOR TEMPERATURE control
Subclause 201.12.1.107 \u2013 Warm-up time
Subclause 201.12.1.108 \u2013 Overshoot of TRANSPORT INCUBATOR TEMPERATURE
Subclause 201.12.1.109 \u2013 Accuracy of indication of relative humidity
Subclause 201.12.1.110 \u2013 Oxygen control
Subclause 201.12.1.111 \u2013 Air velocity
Subclause 201.12.1.116 \u2013 Weighing Scale <\/td>\n<\/tr>\n
45<\/td>\nSubclause 201.12.2.101 \u2013 Indication of SKIN TEMPERATURE
Subclause 201.12.2.102 \u2013 Indication of the mode of operation
Subclause 201.12.3.101 \u2013 Air circulation fan
Subclause 201.12.3.102 \u2013 Connector to SKIN TEMPERATURE SENSOR
Subclause 201.12.4.2.101 \u2013 CO2-concentration
Subclause 201.13.2.2 \u2013 Electrical SINGLE FAULT CONDITION
Subclause 201.13.2.6 \u2013 Leakage of liquid <\/td>\n<\/tr>\n
46<\/td>\nSubclause 201.15.3.4.2 \u2013 PORTABLE ME EQUIPMENT
Subclause 201.15.4.1.101 \u2013 Connection of temperature sensors
Subclause 201.15.4.2.2 \u2013 Temperature settings
Subclause 202.6.2.3.1 \u2013 Requirements
Subclause 210.5.1 \u2013 Instructions for use
Subclause 210.6.3 \u2013 PCLCS VARIABLE logging <\/td>\n<\/tr>\n
47<\/td>\nSubclause 210.8.2.2.6 \u2013 * Responses of the PCLCS <\/td>\n<\/tr>\n
48<\/td>\nBibliography <\/td>\n<\/tr>\n
49<\/td>\nIndex of defined terms used in this particular standard <\/td>\n<\/tr>\n
51<\/td>\nTitle page <\/td>\n<\/tr>\n
52<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
53<\/td>\nContents <\/td>\n<\/tr>\n
54<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
55<\/td>\nCommittee representation <\/td>\n<\/tr>\n
56<\/td>\nBackground of ANSI\/AAMI adoption of Amendment 1 to IEC 60601-2-20:2009 <\/td>\n<\/tr>\n
57<\/td>\nForeword <\/td>\n<\/tr>\n
59<\/td>\nList of amendments <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

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<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2009<\/td>\n65<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198184,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198180","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198180","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/198184"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198180"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198180"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198180"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}