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BSI - 21/30416045 DC

Draft 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

pending
Organization: BSI
Publication Date: 11 August 2021
Status: pending
Page Count: 17
ICS Code (In vitro diagnostic test systems): 11.100.10

Document History

21/30416045 DC
August 11, 2021
Draft 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
A description is not available for this item.
BS EN ISO 18113-5
November 30, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
A description is not available for this item.
BS EN ISO 18113-5
November 30, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instruments for self-testing
A description is not available for this item.
BS EN ISO 18113-5
February 28, 2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instruments for self-testing
A description is not available for this item.

References

This document references:
IEC 61010-1 - Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements
Published by IEC on January 1, 2017
Equipment included in scope This group safety publication is primarily intended to be used as a product safety standard for the products mentioned in the scope, but shall also be used by technical...
This document references:
IEC 62366-1 - Medical devices – Part 1: Application of usability engineering to medical devices
Published by IEC on June 1, 2020
This part of IEC 62366 specifies a PROCESS for a MANUFACTURER to analyse, specify, develop and evaluate the USABILITY of a MEDICAL DEVICE as it relates to SAFETY. This USABILITY ENGINEERING (HUMAN...
This document references:
ISO 15198 - Clinical laboratory medicine In vitro diagnostic medical devices Validation of user quality control procedures by the manufacturer
Published by ISO on July 15, 2004
A description is not available for this item.
This document references:
17593 - Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
Published by ISO on March 1, 2022
This document specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist oral anticoagulation therapy, including performance, quality assurance and user...
This document references:
ISO/IEC 15415 - Information technology - Automatic identification and data capture techniques - Bar code symbol print quality test specification - Two-dimensional symbols
Published by ISO on December 15, 2011
This International Standard — specifies two methodologies for the measurement of specific attributes of two-dimensional bar code symbols, one of these being applicable to multi-row bar code...
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