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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
09-06-2020
01-01-2017
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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 |
| IEC 60601-2-19:2009+AMD1:2016 CSV | Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
| EN ISO 14937:2009 | Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009) |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| ISO 16142-1:2016 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
| EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
| IEC 80601-2-59:2017 | Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening |
| IEC 60601-1-8:2006+AMD1:2012 CSV | Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO/IEC Guide 99:2007 | International vocabulary of metrology Basic and general concepts and associated terms (VIM) |
| EN 60601-1-2:2015 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| EN 12470-5:2003 | Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device) |
| EN 60601-1-12:2015 | 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 |
| ISO 14159:2002 | Safety of machinery — Hygiene requirements for the design of machinery |
| IEC 60601-1-3:2008+AMD1:2013 CSV | Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects Good clinical practice |
| ISO 15223-1:2016 | Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements |
| EN 62366-1:2015/AC:2015 | MEDICAL DEVICES - PART 1: APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366-1:2015) |
| IEC 60601-1-9:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
| ISO 17664:2017 | Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
| EN 60601-1-11:2015 | 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 |
| EN 60601-1-8:2007/A11:2017 | 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 (IEC 60601-1-8:2006/A1:2012) |
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