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15/30312454 DC : 0

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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
Available format(s)

Hardcopy , PDF

Superseded date

09-30-2017

Language(s)

English

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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