{"id":198123,"date":"2024-10-19T12:36:46","date_gmt":"2024-10-19T12:36:46","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-60601-2-19-2009-ra-2014-a1-2016\/"},"modified":"2024-10-25T05:09:58","modified_gmt":"2024-10-25T05:09:58","slug":"aami-60601-2-19-2009-ra-2014-a1-2016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-60601-2-19-2009-ra-2014-a1-2016\/","title":{"rendered":"AAMI 60601 2 19 2009 RA 2014 A1 2016"},"content":{"rendered":"

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.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nANSI\/AAMI\/IEC 60601-2-19:2009,
\nMedical Electrical Equipment \u2014
\nPart 2-19: Particular requirements for the basic safety
\nand essential performance of infant 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 60601-2-19:2009 <\/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 ESSENTIAL PERFORMANCE of INFANT INCUBATORS
201.5 General requirements for testing ME EQUIPMENT <\/td>\n<\/tr>\n
19<\/td>\n201.6 Classification of ME EQUIPMENT and ME SYSTEMS
201.7 ME EQUIPMENT identification, marking and documents
201.7.2.101 * 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 <\/td>\n<\/tr>\n
20<\/td>\n201.7.9.2.2 * Warning and safety notices
201.7.9.2.8 * Start-up PROCEDURE
201.7.9.2.9 * Operating instructions <\/td>\n<\/tr>\n
21<\/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
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 <\/td>\n<\/tr>\n
22<\/td>\n201.9.6.2.1.103 * 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 <\/td>\n<\/tr>\n
23<\/td>\n201.9.8.101 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 <\/td>\n<\/tr>\n
24<\/td>\n201.11.2 * 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 <\/td>\n<\/tr>\n
25<\/td>\n201.12 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 <\/td>\n<\/tr>\n
26<\/td>\n201.12.1.104 * 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 <\/td>\n<\/tr>\n
27<\/td>\n201.12.1.108 * 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 <\/td>\n<\/tr>\n
28<\/td>\n201.12.1.112 * Weighing scale
201.12.2 Usability
201.12.2.101 * Indication of SKIN TEMPERATURE <\/td>\n<\/tr>\n
29<\/td>\n201.12.2.102 * 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 <\/td>\n<\/tr>\n
30<\/td>\n201.12.3.103 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 <\/td>\n<\/tr>\n
31<\/td>\n201.13 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 <\/td>\n<\/tr>\n
32<\/td>\n201.15.3.101 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 <\/td>\n<\/tr>\n
34<\/td>\n201.15.4.2.2 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 \u2013 Requirements and test
202.6.2.3 Radiated RF electromagnetic fields
202.6.2.3.1 Requirements <\/td>\n<\/tr>\n
35<\/td>\n210 Requirements for the development of physiologic closed-loop controllers
Annexes <\/td>\n<\/tr>\n
36<\/td>\nAnnex AA (informative) Particular guidance and rationale
Subclause 201.1.3 \u2013 Collateral standards
Subclause 201.4.3 \u2013 ESSENTIAL PERFORMANCE <\/td>\n<\/tr>\n
37<\/td>\nSubclause 201.5.3 a) \u2013 Ambient temperature, humidity, atmospheric pressure
Subclause 201.7.2.101 \u2013 Oxygen monitor
Subclause 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 <\/td>\n<\/tr>\n
38<\/td>\nSubclause 201.7.9.2.9 \u2013 Operating instructions
Subclause 201.9.6.2.1.101 \u2013 Sound level within the COMPARTMENT
Subclause 201.9.6.2.1.102 \u2013 Audible alarm sound level <\/td>\n<\/tr>\n
39<\/td>\nSubclause 201.9.6.2.103 \u2013 Audible alarms sound level within COMPARTMENT
Subclause 201.9.8.3.101 \u2013 Barriers
Subclause 201.11.2 \u2013 Fire prevention
Subclause 201.11.6.2 \u2013 Overflow in ME EQUIPMENT
Subclause 201.11.6.6 \u2013 Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS
Subclause 201.12.1.101 \u2013 Stability of INCUBATOR TEMPERATURE <\/td>\n<\/tr>\n
40<\/td>\nSubclause 201.12.1.102 \u2013 Uniformity of INCUBATOR TEMPERATURE
Subclause 201.12.1.103 \u2013 Accuracy of SKIN TEMPERATURE SENSOR
Subclause 201.12.1.104 \u2013 Accuracy between SKIN TEMPERATURE and CONTROL TEMPERATURE
Subclause 201.12.1.105 \u2013 Accuracy of INCUBATOR TEMPERATURE indication
Subclause 201.12.1.106 \u2013 *Accuracy of INCUBATOR TEMPERATURE control
Subclause 201.12.1.107 \u2013 Warm-up time
Subclause 201.12.1.108 \u2013 Overshoot of INCUBATOR TEMPERATURE <\/td>\n<\/tr>\n
41<\/td>\nSubclause 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 201.12.1.112 \u2013 Weighing Scale
Subclause 201.12.2.101 \u2013 Indication of SKIN TEMPERATURE indication
Subclause 201.12.2.102 \u2013 Indication of the mode of operation <\/td>\n<\/tr>\n
42<\/td>\nSubclause 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 201.13.2.6 \u2013 Leakage of liquid
Subclause 201.15.4.1.101 \u2013 Temperature sensors
Subclause 201.15.4.2.1 aa)
Subclause 201.15.4.2.1 dd) and ee) <\/td>\n<\/tr>\n
43<\/td>\nSubclause 201.15.4.2.2.101 \u2013 AIR CONTROLLED INCUBATOR range
Subclause 201.15.4.2.2.102 \u2013 BABY CONTROLLED INCUBATOR range
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
44<\/td>\nBibliography <\/td>\n<\/tr>\n
45<\/td>\nIndex of defined terms used in this particular standard <\/td>\n<\/tr>\n
47<\/td>\nTitle page <\/td>\n<\/tr>\n
48<\/td>\nAAMI Standard
Copyright information <\/td>\n<\/tr>\n
49<\/td>\nContents <\/td>\n<\/tr>\n
50<\/td>\nGlossary of equivalent standards <\/td>\n<\/tr>\n
51<\/td>\nCommittee representation <\/td>\n<\/tr>\n
52<\/td>\nBackground of ANSI\/AAMI adoption of Amendment 1 to IEC 60601-2-19:2009 <\/td>\n<\/tr>\n
53<\/td>\nForeword <\/td>\n<\/tr>\n
55<\/td>\nList of amendments <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

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<\/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>\n58<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198127,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198123","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\/198123","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\/198127"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198123"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198123"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198123"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}