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ANSI/AAMI HA60601-1-11:2015

Current
Current

The latest, up-to-date edition.

MEDICAL ELECTRICAL EQUIPMENT - PART 1-11: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS USED IN THE HOME HEALTHCARE ENVIRONMENT
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

08-25-2015

Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of IEC 60601-1-11:2015
Foreword
U.S. Deviations to IEC 60601-1-11:2015
Introduction
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 General requirements for testing ME EQUIPMENT
6 Classification of ME EQUIPMENT and ME SYSTEMS
7 ME EQUIPMENT identification,
   marking and documents
8 Protection against excessive temperatures
   and other HAZARDS
9 Accuracy of controls and instruments and
   protection against hazardous outputs
10 Construction of ME EQUIPMENT
11 Protection against strangulation or asphyxiation
12 Additional requirements for ELECTROMAGNETIC
   EMISSIONS of ME EQUIPMENT and ME SYSTEMS
13 Additional requirements for ALARM SYSTEMS of
   ME EQUIPMENT and ME SYSTEMS
Annex A (informative) - General guidance and rationale
Annex B (informative) - Guide to marking and
        labelling requirements for ME EQUIPMENT and ME SYSTEMS
Annex C (informative) - Symbols on marking
Bibliography
Index of defined terms used in this collateral standard

Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.1, and specified by the MANUFACTURER in the instructions for use.

Committee
HA
DevelopmentNote
New child AMD 1 2021 is added.
DocumentType
Standard
ISBN
1-57020-593-0
Pages
82
ProductNote
New child AMD 1 2021 is added.
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

AAMI TIR49 : 2013 DESIGN OF TRAINING AND INSTRUCTIONAL MATERIALS FOR MEDICAL DEVICES USED IN NON-CLINICAL ENVIRONMENTS

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