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AAMI 60601 1 12 2016

AAMI 60601 1 12 2016

$140.32

ANSI/AAMI/IEC 60601-1-12:2016 – 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.

Published By Publication Date Number of Pages
AAMI 2016 51
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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.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/IEC 60601-1-12:2016; 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
2 Objectives and uses of AAMI standards and recommended practices
3 Title page
4 AAMI Standard
Copyright information
5 Contents
7 Glossary of equivalent standards
8 Committee representation
10 Background on AAMI adoption of IEC 60601-1-12:2014
11 Foreword
13 Introduction
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
4.2 * Environmental conditions for me equipment
4.2.1 * Environmental conditions of transport and storage between uses
19 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
6 Me equipment identification, marking and documents
6.1 * Additional requirements for legibility of markings
6.2 * Additional requirements for marking of IP classification
23 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
24 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
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
25 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
26 8.3 * Additional requirements for internal electrical power source for me equipment
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
27 10.1.2 * Requirements for mechanical strength for fixed or permanently installed me equipment intended for use in a road ambulance
28 10.1.3 * Requirements for mechanical strength for transportable me equipment
29 10.1.4 * Requirements for mechanical strength for me equipment intended for airborne use
30 10.2 Requirements for mounting of me equipment
11 Additional requirements for electromagnetic compatibility of me equipment and me systems
31 Annex A (informative) General guidance and rationale
A.1 General guidance
32 A.2 Rationale for particular clauses and subclauses
36 Figure A.1 – Saturation water vapour pressure as function of temperature
37 Table A.1 – Saturation water vapour pressure as function of temperature
45 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
Table B.2 – ACCOMPANYING DOCUMENTS, instructions for use (1 of 2)
46 B.3 Accompanying documents, technical description
47 Table B.3 – ACCOMPANYING DOCUMENTS, technical description
Annex C (informative) Symbols on marking
Table C.1 – General symbols
49 Bibliography
50 Index of defined terms used in this collateral standard

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AAMI 60601 1 12 2016
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