ANSI/AAMI/IEC 60601-1-8:2006/A2:2021
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS
04-06-2014
01-01-2012
Glossary of equivalent standards
Committee representation
Background of ANSI/AAMI adoption of
IEC 60601-1-8:2006 & A1:2012
FOREWORD
INTRODUCTION TO THE AMENDMENT
INTRODUCTION
1 Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 ME EQUIPMENT identification marking and documents
6 ALARM 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 (normative) - Symbols on marking
ANNEX D (informative) - Guidance for auditory ALARM SIGNALS
ANNEX E (informative) - Verbal ALARM SIGNALS
ANNEX F (normative) - Reserved melodies for ALARM SIGNALS
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, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
| Committee |
JWG
|
| DevelopmentNote |
New child AMD 2 2021 is added.
|
| DocumentType |
Standard
|
| ProductNote |
New child AMD 2 2021 is added.
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Identical |
| AAMI TIR71 : 2017 | GUIDANCE FOR LOGGING OF ALARM SYSTEM DATA |
| AAMI TIR72 : 2017 | DIALYSIS FLUID CHEMICAL COMPOSITION |
| AAMI HE48 : 1993 | HUMAN FACTORS ENGINEERING GUIDELINES AND PREFERRED PRACTICES FOR THE DESIGN OF MEDICAL DEVICES |
| ISO 3744:2010 | Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| AAMI EC57 : 2012 | TESTING AND REPORTING PERFORMANCE RESULTS OF CARDIAC RHYTHM AND ST SEGMENT MEASUREMENT ALGORITHMS |
| IEC TR 60513:1994 | Fundamental aspects of safety standards for medical electrical equipment |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 11429:1996 | Ergonomics — System of auditory and visual danger and information signals |
| ISO 11428:1996 | Ergonomics Visual danger signals General requirements, design and testing |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
| ISO 9703-2:1994 | Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals |
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