Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

054

Date of Entry 07/06/2020

FR Recognition Number

7-297

Standard

ISO TS 20914 First edition 2019-07
Medical laboratories - Practical guidance for the estimation of measurement uncertainty

Scope/Abstract

This document provides practical guidance for the estimation and expression of the measurement uncertainty (MU) of quantitative measurand values produced by medical laboratories. Quantitative measurand values produced near the medical decision threshold by point-of-care testing systems are also included in this scope. This document also applies to the estimation of MU for results produced by qualitative (nominal) methods which include a measurement step. It is not recommended that estimates of MU be routinely reported with patient test results, but should be available on request.

Extent of Recognition

Complete standard

Rationale for Recognition

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Relevant FDA Guidance and/or Supportive Publications*

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Marina V. Kondratovich

FDA/CDRH/OPEQ/OIDRH/

301-796-6036

marina.kondratovich@fda.hhs.gov

Paul Liu

FDA/CDRH/OPEQ/OHTVII/DMD/VIR2/

240-401-3837

paul.liu@fda.hhs.gov

Standards Development Organization

ISO

International Organization for Standardization