15/30312454 DC : 0
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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BS EN ISO 80601-2-56 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-56: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF CLINICAL THERMOMETERS FOR BODY TEMPERATURE MEASUREMENT
Hardcopy , PDF
30-09-2017
English
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Foreword
Introduction
201.1 Scope, object and related standards
201.2 Normative references
201.3 Terminology 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 compatibility - 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
Annexes
Annex C (informative) - Guide to marking and
labelling requirements for ME EQUIPMENT and
ME SYSTEMS
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/TR 16142
Annex DD (informative) - Terminology - alphabetized
index of defined terms
Annex ZA (informative) - Relationship between this
International Standard and the Essential Requirements
of EU Directive 93/42/EEC
Bibliography
BS EN ISO 80601-2-56.
| Committee |
CH/121/5
|
| DocumentType |
Draft
|
| Pages |
68
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| EN 15986:2011 | Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates |
| 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 |
| IEC 60601-1-10:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
| 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 |
| 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 12470-5:2003 | Clinical thermometers - Part 5: Performance of infra-red ear thermometers (with maximum device) |
| ISO/TR 16142:2006 | Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices |
| 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 |
| 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 |
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