I.S. EN ISO 80601-2-56:2017/A1:2020
Current
The latest, up-to-date edition.
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
09-06-2020
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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Foreword
Introduction
1 * Scope, object and related standards
2 Normative references
3 Terms and definitions
4 General requirements
5 General requirements for testing of ME EQUIPMENT
6 Classification of ME EQUIPMENT and ME SYSTEMS
7 ME EQUIPMENT identification, marking and documents
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 CLINICAL THERMOMETER for testing the LABORATORY ACCURACY minus RCT) versus the average OUTPUT TEMPERATURES of two thermometers
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[24]
Annex DD (informative) Terminology — Alphabetized index of defined terms
Bibliography
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT.
| Committee |
TC 121
|
| DocumentType |
Standard
|
| Pages |
86
|
| ProductNote |
The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 80601-2-56:2017/Amd 1:2018 | Identical |
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