{"id":198124,"date":"2024-10-19T12:36:46","date_gmt":"2024-10-19T12:36:46","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-60601-2-21-2009-ra-2014-a1-2016\/"},"modified":"2024-10-25T05:09:58","modified_gmt":"2024-10-25T05:09:58","slug":"aami-60601-2-21-2009-ra-2014-a1-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-60601-2-21-2009-ra-2014-a1-2016\/","title":{"rendered":"AAMI 60601 2 21 2009 RA 2014 A1 2016"},"content":{"rendered":"

This standard harmonizes with the third edition of IEC 60601-1 and specifies the safety and performance requirements for infant radiant warmers.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/IEC 60601-2-21:2009, Medical Electrical Equipment \u2014Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers <\/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 60601-2-21:2009 <\/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
17<\/td>\n201.4 General requirements <\/td>\n<\/tr>\n
18<\/td>\n201.4.1 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 <\/td>\n<\/tr>\n
19<\/td>\n201.6 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 <\/td>\n<\/tr>\n
20<\/td>\n201.7.9.2.9 Operating instructions <\/td>\n<\/tr>\n
21<\/td>\n201.7.9.2.13 *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 <\/td>\n<\/tr>\n
22<\/td>\n201.9.8 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 <\/td>\n<\/tr>\n
23<\/td>\n201.10 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 <\/td>\n<\/tr>\n
24<\/td>\n201.11.6.3 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 <\/td>\n<\/tr>\n
25<\/td>\n201.12.1.102 *Accuracy of distribution of irradiation to the mattress
201.12.1.103 *Accuracy of BABY CONTROLLED RADIANT WARMER operation <\/td>\n<\/tr>\n
26<\/td>\n201.12.1.104 *Oxygen control
201.12.1.105 *Weighing scale
201.12.2 USABILITY
201.12.2.101 USABILITY of control <\/td>\n<\/tr>\n
27<\/td>\n201.12.2.102 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 <\/td>\n<\/tr>\n
28<\/td>\n201.12.3.103 *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 <\/td>\n<\/tr>\n
29<\/td>\n201.14 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 <\/td>\n<\/tr>\n
30<\/td>\n201.15.4.2.2 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 \u2013 Requirements and tests
202.6.2.3 Radiated RF electromagnetic fields
202.6.2.3.1 *Requirements <\/td>\n<\/tr>\n
31<\/td>\n210 Process requirements for the development of physiologic closed-loop controllers
Annexes <\/td>\n<\/tr>\n
32<\/td>\nAnnex AA (informative) Particular guidance and rationale
Subclause 201.1.3 \u2013 Collateral standards
Subclause 201.3.207 \u2013 PREWARM MODE
Subclause 201.3.212 \u2013 TEST LOAD <\/td>\n<\/tr>\n
33<\/td>\nSubclause 201.5.3 \u2013 Ambient temperature, humidity, atmospheric pressure
Subclause 201.7.2.101 \u2013 Oxygen monitor <\/td>\n<\/tr>\n
34<\/td>\nSubclause 201.7.9.2.2 \u2013 Warning and safety notices
Subclause 201.7.9.2.13 \u2013 Maintenance
Subclause 201.9.6.2.1.101 \u2013 Audible alarms sound level
Subclause 201.10.6 \u2013 Infrared radiation <\/td>\n<\/tr>\n
37<\/td>\nSubclause 201.11.1.2.2 \u2013 APPLIED PARTS not intended to supply heat to a PATIENT
Subclause 201.11.2 \u2013 Fire prevention
Subclause 201.12.1.101 \u2013 Accuracy of SKIN TEMPERATURE SENSOR
Subclause 201.12.1.102 \u2013 Accuracy of distribution of irradiation to the mattress
Subclause 201.12.1.103 \u2013 Accuracy of BABY CONTROLLED RADIANT WARMER operation <\/td>\n<\/tr>\n
38<\/td>\nSubclause 201.12.1.104 \u2013 Oxygen control
Subclause 201.12.1.105 \u2013 Weighing scale
Subclause 201.12.2.103 \u2013 Time and irradiance limits in the MANUAL MODE
Subclause 201.12.2.104 \u2013 Heat output level at PREWARM MODE
Subclause 201.12.3.103 \u2013 AUDIO PAUSED of auditory ALARM SIGNALS during manual control <\/td>\n<\/tr>\n
39<\/td>\nSubclause 201.12.4.2.101 \u2013 CO2 concentration
Subclause 201.15.4.1.101 \u2013 Temperature sensors
Subclause 202.6.2.3.1 \u2013 Requirements
Subclause 210.5.1 \u2013 Instructions for use
Subclause 210.6.3 \u2013 PCLCS VARIABLE logging
Subclause 210.8.2.2.6 \u2013 Responses of the PCLCS <\/td>\n<\/tr>\n
40<\/td>\nBibliography <\/td>\n<\/tr>\n
43<\/td>\nIndex of defined terms used in this particular standard <\/td>\n<\/tr>\n
45<\/td>\nTitle page <\/td>\n<\/tr>\n
46<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
47<\/td>\nContents <\/td>\n<\/tr>\n
48<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
49<\/td>\nCommittee representation <\/td>\n<\/tr>\n
50<\/td>\nBackground of ANSI\/AAMI adoption of Amendment 1 to IEC 60601-2-21:2009 <\/td>\n<\/tr>\n
51<\/td>\nForeword <\/td>\n<\/tr>\n
53<\/td>\nList of amendments <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

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<\/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>\n57<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198128,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198124","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\/198124","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\/198128"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198124"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198124"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198124"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}