The role of metrology in the field of medical devices

  title={The role of metrology in the field of medical devices},
  author={M. do C{\'e}u Ferreira},
  journal={International Journal of Metrology and Quality Engineering},
  • M. Ferreira
  • Published 2011
  • Medicine
  • International Journal of Metrology and Quality Engineering
Medical measurements are present in the everyday life of people and are fundamental processes in prevention, diagnosis and treatment of disease. Therefore, a growing interest lies in the role of metrological decisions and conformity assessment, namely where measurements are in support of health. This paper focuses on the use of medical devices looking to enhance its metrological traceability, highlighting the specific role of metrology in the field of health care and the impact of legal control… 

Tables from this paper

The Importance of Metrology in Medicine

This article will provide a clear approximation of the correct measurements in the medical field as a guide to medical metrology studies.


This paper presents achievements and activities of Institute of Metrology of Bosnia and Herzegovina (IMBIH) in the area of legal metrology for the particular group of medical devices with measuring function, including the adoption of appropriate legislation for type approval, verification, and creating an adequate legal framework for controlling medical devices after they are sold on the market.

IoMT-based biomedical measurement systems for healthcare monitoring: a review

The presented IoMT-based BMS are applied to healthcare applications concerning, in particular, heart, brain and blood sugar diseases as well as internal body sound and blood pressure measurements.

Testing of Anesthesia Machines and Defibrillators in Healthcare Institutions

The first digital electronical database of anesthesia machines and defibrillators used in healthcare institutions in Bosnia and Herzegovina is created and is a useful tool for tracking each device’s performance over time.

Combined Non-Invasive Optical Oximeter and Flowmeter with Basic Metrological Equipment

The purpose of this study is to develop a new instrument for non-invasive optical oximetry by means of substantiating and creating amore informative tissue oximeter with an enhanced number of measured parameters and equipped with the basic metrological tools—imitational measures.

Evaluation of the role of metrological traceability in health care: a comparison study by statistical approach

The protocol established by hospitals to acquire measurement instruments does not reflect metrological concerns, and the relationship between maintenance and meetingrological operation is not well established, and it is concluded that meetrological traceability is largely absent in the daily considerations of healthcare professionals and facilities.

Metrology in health: a pilot study

The purpose of this paper is to identify and analyze some relevant issues which arise when the concept of metrological traceability is applied to health care facilities. Discussion is structured

Establishing Traceability Chain of Infusion and Perfusor Pumps Using Legal Metrology Procedures in Bosnia and Herzegovina

Cost benefits analysis proved yearly savings of 50% if healthcare institutions follow legal metrology procedures compared with unnecessary manufactures attests, and importance of establishing traceability chain in protection of public health is emphasized.

Multiparametric quality by design-fuzzy model applied in the development of a biomedical measuring system

This work presents the adaptation of the Quality by Design (QbD) approach for application in the quality assurance of a biomedical measuring system under development, and develops a hybrid QbD-Fuzzy approach for multiparametric DS configuration.

Inspection and Testing of Dialysis Machines

The chapter presents development of dialysis from experiments to regular life-saving clinical practice, leading to modern dialysis machine organization and functionality, and overview of standards related to hemodialysis machines safety and risk management.



Metrology in Medicine

To ensure that medical measurement results are of known quality and to improve their accuracy and reliability, standards, reference methods, certified reference materials, and calibration are needed.

Metrology and Standards Needs for Some Categories of Medical Devices

The technological and economic status of five categories of medical devices are examined and a set of metrology needs is identified for each and suggestions are made to address them.

Manufacturing Metrology and Standards for the Health Care Enterprise Program Summary

The Manufacturing Metrology and Standards for the Health Care Enterprise program was initiated in FY2005 as part of the overall reorganization of the Manufacturing Engineering Laboratory (MEL), with

Balancing adoption and affordability of medical devices in Europe.

Introduction of ISO/TR 14969:2004 Medical devices-Quality management systems-Guidance on the application of YY/T0287-2003

The new international standard ISO/TR 14969:2004 provides a enchiridion of the quality management system of medical devices sector and this article gives a brief introduction about it.

Evidence Based Public Health

The use of evidence based approach helps in distinguishing effective interventions from less effective interventions, and half of the interventions re‐ viewed by task forces have been considered as insufficient evidence to determine the effectiveness.

An analysis of the causes of adverse events from the Quality in Australian Health Care Study

To examine the causes of adverse events (AEs) resulting from healthcare to assist in developing strategies to minimise preventable patient injury.


Os grandes avancos da metrologia na area cientifica e industrial nao tem paralelo na area da saude, onde apesar da obvia importância, sua aplicacao e ainda incipiente. A acelerada evolucao da