UNLIMITED FREE
ACCESS TO THE WORLD'S BEST IDEAS

SUBMIT
Already a GlobalSpec user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your GlobalSpec Experience

Select Your Free Newsletters

Industry Newsletters

Select Your Free Product Alerts

Finish!
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

BSI - 21/30416041 DC

Draft 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

pending
Organization: BSI
Publication Date: 11 August 2021
Status: pending
Page Count: 19
ICS Code (In vitro diagnostic test systems): 11.100.10

Document History

21/30416041 DC
August 11, 2021
Draft 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
A description is not available for this item.
BS EN ISO 18113-4
November 30, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
A description is not available for this item.
BS EN ISO 18113-4
November 30, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) Part 4: In vitro diagnostic reagents for self-testing
A description is not available for this item.
BS EN ISO 18113-4
February 28, 2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) Part 4: In vitro diagnostic reagents for self-testing
A description is not available for this item.

References

This document references:
CLSI EP24 - Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline
Published by CLSI on November 1, 2011
This guideline outlines the steps and principles of prospectively planned and retrospective studies to evaluate the intrinsic diagnostic accuracy of a clinical laboratory test, defined as its...
This document references:
CLSI EP28 - Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline
Published by CLSI on October 1, 2010
This document provides diagnostic laboratories and diagnostic test manufacturers with updated guidelines for determining reference intervals for quantitative laboratory tests. It includes specific...
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...
View Less
View All
Advertisement