I.S. EN ISO 80601-2-56:2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT (ISO 80601-2-56:2017)
Hardcopy , PDF
English
01-01-2017
09-06-2020
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
European foreword
Foreword
Introduction
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terms and definitions
201.4 General requirements
201.5 General requirements for testing of ME
EQUIPMENT
201.6 Classification of ME EQUIPMENT and ME
SYSTEMS
201.7 ME EQUIPMENT identification, marking and
documents
201.8 Protection against electrical HAZARDS from
ME EQUIPMENT
201.9 Protection against mechanical HAZARDS of ME
EQUIPMENT and ME SYSTEMS
201.10 Protection against unwanted and excessive radiation
HAZARDS
201.11 Protection against excessive temperatures and other
HAZARDS
201.12 Accuracy of controls and instruments and protection
against hazardous outputs
201.13 HAZARDOUS SITUATIONS and fault conditions
201.14 PROGRAMMABLE ELECTRICAL MEDICAL
SYSTEMS (PEMS)
201.15 Construction of ME EQUIPMENT
201.16 ME SYSTEMS
201.17 Electromagnetic compatibility of ME EQUIPMENT
and ME SYSTEMS
201.101 Laboratory performance requirements
201.102 CLINICAL ACCURACY VALIDATION
201.103 PROBES, PROBE CABLE EXTENDERS
and PROBE COVERS
202 Electromagnetic disturbances - Requirements and tests
206 Usability
208 General requirements, tests and guidance for alarm
systems in medical electrical equipment and medical
electrical systems
211 Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare
environment
212 Requirements for medical electrical equipment and
medical electrical systems intended for use in the
emergency medical services environment
Annex C (informative) - Guide to marking and labelling
requirements for ME EQUIPMENT and
ME SYSTEMS
Annex D (informative) - Symbols on marking
Annex AA (informative) - Particular guidance and rationale
Annex BB (informative) - Reference temperature source
Annex CC (informative) - Reference to the essential
principles of safety and performance
of medical devices in accordance with
ISO 16142-1
Annex DD (informative) - Terminology - Alphabetized
index of defined terms
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the essential requirements
of Directive 93/42/EEC [OJ L 169] aimed to be covered
Pertains to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. Also specifies the general and technical requirements for electrical CLINICAL THERMOMETERS.
| DevelopmentNote |
Supersedes I.S. EN 12470-3, I.S. EN 12470-4 & I.S. EN 12470-5. (11/2012)
|
| DocumentType |
Standard
|
| Pages |
74
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 80601-2-56:2017 | Identical |
| EN ISO 80601-2-56:2017 | Identical |
| BS EN ISO 80601-2-56:2017 | Equivalent |
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