Medical Devices—IEC International Standards and Conformity Assessment Services in Support of Medical Regulation and Governance

2021 ◽  
pp. 209-216
Author(s):  
Gabriela Ehrlich
Keyword(s):  
Medical Devices ◽  
International Standards ◽  
Conformity Assessment ◽  
Medical Regulation

scholarly journals Development and Conformity Assessment of ECG-Photometric Complex Software

2021 ◽  
pp. 115-128
Author(s):  
Vitalii Budnyk ◽  
Tetiana Ryzhenko ◽  
Mykola Budnyk
Keyword(s):  
Life Cycle ◽  
Medical Practice ◽  
Medical Devices ◽  
International Standards ◽  
Conformity Assessment ◽  
Treatment And Prevention ◽  
Medical Institutions ◽  
Develop Software ◽  
Technical Regulations ◽  
Separate Product

Introduction. The article is devoted to the software "PulseWave", which is used as part of the ECG-photometric complex for research in medical institutions. For further implementation of the complex in medical practice, it is necessary to assess the compliance of this software in accordance with the requirements of the technical regulations for medical devices. There are two ways to perform software conformity assessment: as part of the ECG photometric complex or separately from it (stand alone). In this paper, the option of conducting a stand alone conformity assessment was chosen, i.e. as a separate product. This approach is the most promising, given the development of "cloud" storage and data processing environments and the need to introduce into medical practice of treatment and prevention facilities in Ukraine. The purpose of the article is to develop software and prepare it for conformity assessment in accordance with the requirements of the technical regulations for medical devices. Results. The authors consider the structure and principle of operation of the software "PulseWave" ECG-photometric complex. The main stages of the life cycle of this software according to international standards are given. A risk assessment report has been developed, which shows and evaluates the main errors that may occur in the work of the software; and ways to eliminate them. Conclusions. The software development, development of its life cycle and risk analysis provide an opportunity to start the procedure of assessing its compliance with the requirements of the technical regulations for medical devices in accordance with international standards. Keywords: software, conformity assessment, life cycle, application risks.

Neurosurgical materials and devices

1976 ◽  
Vol 45 (3) ◽  
pp. 251-258 ◽  
Author(s):  
Charles V. Burton ◽  
Joseph T. McFadden
Keyword(s):  
Medical Device ◽  
Drug Administration ◽  
Medical Devices ◽  
Food And Drug Administration ◽  
International Standards ◽  
Current Status ◽  
Reference Source ◽  
Legal Authority ◽  
Content Type ◽  
Fine Print

✓ The current status of voluntary consensus standards writing procedures in neurosurgery and the current progress of government efforts to regulate materials and devices are described. A survey of the national and international standards writing bodies is presented, along with an introduction to related organizations and agencies and nomenclature. The intent of this review is to provide the neurosurgeon with a reference source regarding past and present neurosurgical activities in the materials and devices field. When President Ford signed the 1976 Medical Device Amendments on May 28, 1976, the Food and Drug Administration assumed direct legal authority to control medical devices and potentially assumed the power to regulate those professionals using them.

Clinical Trial of a Novel Starch-Based Adhesive Bandages for Medical Dressing

2020 ◽  
Vol 990 ◽  
pp. 96-100
Author(s):  
Sittiporn Punyanitya ◽  
Banyong Khantawa ◽  
Sakdiphon Thiansem ◽  
Rungsarit Koonawoot ◽  
Phanlob Chankachang ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Medical Devices ◽  
Raw Materials ◽  
Low Cost ◽  
International Standards ◽  
Preparation Methods ◽  
Safety And Efficacy ◽  
Plastic Components ◽  
Adhesive Bandage ◽  
Novel Starch

A typical adhesive bandage comprises of four main parts; the backing is often made of plastic; the adhesive sheet is usually plastic; the adhesive is commonly acrylate; the absorbent pad is often made of cotton. This adhesive bandages are made from starch based adhesive and natural paper, which have no plastic components. A starch-based adhesive bandages are tested on 100 volunteers and the result shows good performances with high confident of safety and efficacy. The raw materials and preparation methods are low cost, easily reproducible and eco-friendly, according to the international standards of medical devices regulation.

scholarly journals 3D LASER SCANNING AND IMAGING LASER SCANNING IN STORAGE TANKS METROLOGY CONTROL PROCESS

2018 ◽  
Vol 13 (1) ◽  
Author(s):  
Ankica Milinkovic
Keyword(s):  
Laser Scanning ◽  
Control Process ◽  
International Standards ◽  
Conformity Assessment ◽  
Engineering Practice ◽  
Geometrical Shape ◽  
3D Laser Scanning ◽  
Storage Tanks ◽  
Legal Metrology ◽  
Main Target

In order to secure that tanks are confirmed with the requirements of legal metrology, tanks shall be built in accordance with sound engineering practice. The main target during the process of construction and building of tanks is the ability of tanks to protect the storage fluid. Geometrical shape, hydro-static preassure and temperature are the main influencers to the capability of the fluid, so this three parameter must be permanently controld. In accordance with international standards and methods in the scope of legal metrology and calibrated laboratories, ths paper will present an analysis of two methods for tank control. It will be shown excample of conformity assessment of the thank you results collected by Leica MS60 and Leica BLK360 scanner stations.

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