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BSI - BS EN ISO 18113-1

In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) Part 1: Terms, definitions and general requirements

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Organization: BSI
Publication Date: 28 February 2010
Status: inactive
Page Count: 60
ICS Code (In vitro diagnostic test systems): 11.100.10

Document History

21/30416029 DC
August 11, 2021
Draft BS EN ISO 18113-1 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling). Part 1: Terms, definitions, and general requirements
A description is not available for this item.
BS EN ISO 18113-1
October 31, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) -Part 1: Terms, definitions and general requirements
A description is not available for this item.
BS EN ISO 18113-1
October 31, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) Part 1: Terms, definitions and general requirements
A description is not available for this item.
BS EN ISO 18113-1
February 28, 2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) Part 1: Terms, definitions and general requirements
A description is not available for this item.

References

This document references:
15223-1 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Published by ISO on July 1, 2021
This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available...
This document references:
IEC 60601-1-6 - Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability
Published by IEC on July 1, 2020
This International Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL...
This document references:
IEC 61010-2-101 - Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Published by IEC on October 1, 2018
Equipment included in scope This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. IVD medical equipment,...
This document references:
GP10-A - Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Approved Guideline
Published by CLSI on December 1, 1995
This guideline outlines the steps and principles for designing a prospective study to evaluate the intrinsic diagnostic accuracy of a clinical laboratory test, i.e., its fundamental ability to...
This document references:
IEC 60050-300 - AMENDMENT 3 International electrotechnical vocabulary – Electrical and electronic measurements and measuring instruments – Part 314: Specific terms according to the type of instrument
Published by IEC on August 1, 2017
A description is not available for this item.
This document is referenced by:
BS EN ISO 18113-4 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
Published by BSI on November 30, 2011
A description is not available for this item.
This document is referenced by:
BS ISO 17593 - Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
Published by BSI on May 31, 2007
A description is not available for this item.
This document is referenced by:
BS EN ISO 18113-2 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
Published by BSI on November 30, 2011
A description is not available for this item.
This document is referenced by:
BS EN ISO 18113-3 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) Part 3: In vitro diagnostic instruments for professional use
Published by BSI on November 30, 2011
A description is not available for this item.
This document is referenced by:
BS EN ISO 18113-5 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
Published by BSI on November 30, 2011
A description is not available for this item.
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