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AAMI 60601 1 12 2021

AAMI 60601 1 12 2021

$148.98

ANSI/AAMI/ IEC 60601-1-12:2016 & A1:2021, Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance— Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in emergency medical services environment

Published By Publication Date Number of Pages
AAMI 2021 57
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This standard applies to basic safety and essential performance of medical electrical equipment and medical electrical systems which are intended for use by their manufacturers for use in the EMS environment. Does not apply to equipment and systems intended for use solely in home healthcare environment or professional healthcare facilities. The amendment addresses changes to terminology and references since the main document was finalized.

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PDF Pages PDF Title
1 ANSI/AAMI/IEC 60601-1-12:2016 & A1:2021; Medical electrical equipment—Part 1-12: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment (Consolidated Text, Redline Version)
3 Title page
4 AAMI Standard
Copyright information
5 Contents
7 Committee representation
9 Background of ANSI/AAMI adoption of IEC 60601-1-12:2014 and Amendment1:2020
11 Foreword
14 Introduction
INTRODUCTION to Amendment 1
15 1 Scope, object and related standards
1.1 * Scope
1.2 * Object
16 1.3 Related standards
1.3.1 IEC 60601-1
1.3.2 Particular standards
2 Normative references
17 3 Terms and definitions
18 4 General requirements
4.1 * Additional requirements for supply mains for me equipment and me systems
19 4.2 * Environmental conditions for me equipment
4.2.1 * Environmental conditions of transport and storage between uses
20 4.2.2 * Environmental operating conditions
4.2.2.1 Continuous operating conditions
21 4.2.2.2 * Transient operating conditions
22 5 * Classification of me equipment and me systems
23 6 Me equipment identification, marking and documents
6.1 * Additional requirements for legibility of markings
6.2 * Additional requirements for marking of IP classification
24 6.3 * Instructions for use
6.3.1 Additional general requirements
6.3.2 * Additional requirements for an electrical power source
6.3.3 Additional requirements for me equipment start-up procedure
25 6.3.4 * Additional requirements for operating instructions
6.3.5 Additional requirements for me equipment messages
6.4 Technical description – fixed or permanently installed class i me equipment
7 * Protection against electrical hazards from me equipment
26 8 Protection against excessive temperatures and other hazards
8.1 Additional requirements for ingress of water or particulate matter into me equipment and me systems
8.1.1 * Ingress of water or particulate matter into me equipment
8.1.2 * Ingress of water or particulate matter into me systems
8.2 Additional requirements for interruption of the power supply to me equipment and me system
27 8.3 * Additional requirements for internal electrical power source for me equipment
28 9 * Accuracy of controls and instruments and protection against hazardous outputs
10 Construction of me equipment
10.1 * Additional requirements for mechanical strength of me equipment intended for the ems environment
10.1.1 General requirements for mechanical strength
29 Table 1 – Mechanical strength test applicability
10.1.2 * Requirements for mechanical strength for fixed or permanently installed me equipment intended for use in a road ambulance
30 10.1.3 * Requirements for mechanical strength for transportable me equipment
31 10.1.4 * Requirements for mechanical strength for me equipment intended for airborne use
32 10.2 Requirements for mounting of me equipment
11 Additional requirements for electromagnetic compatibility of me equipment and me systems
33 Annex A (informative) General guidance and rationale
A.1 General guidance
34 A.2 Rationale for particular clauses and subclauses
38 Figure A.1 – Saturation water vapour pressure as function of temperature
39 Table A.1 – Saturation water vapour pressure as function of temperature
48 Annex B (informative) Guide to marking and labelling requirements for me equipment and me systems
B.1 Marking on the outside of me equipment, me systems or their parts
Table B.1 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts
B.2 Accompanying documents, instructions for use
49 Table B.2 – ACCOMPANYING DOCUMENTS, instructions for use (1 of 2)
B.3 Accompanying documents, technical description
51 Annex C (informative) Symbols on marking
Table C.1 – General symbols (1 of 2)
54 Bibliography
56 Index of defined terms used in this collateral standard

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AAMI 60601 1 12 2021
$148.98