Recommended ultrasound field safety classification for medical diagnostic devices.
Author: Preston, R C, Shaw, A
Source: Measurement Good Practice Guide No. 50 ,November 2001.
ISSN: 1368-6550
Abstract: Ultrasound has been used intensively in our hospitals for over twenty years and it continues to command an ever increasing share of the diagnostic imaging market with tens of millions of ultrasound examinations being undertaken in the EC each year. Acoustic output levels of diagnostic ultrasonic systems have increased over the years and it has always been recognised that there is potential for adverse biological effects during clinical examination. The aim of this Guide is to provide some basic principals for assessing the safety of medical diagnostic ultrasonic fields, a topic of great importance to the patient, clinical user and manufacturer. The principals laid down are based on the quantitative assessment of two important biophysical end-points, temperature rise and the likelihood of cavitation taking place. A safety classification scheme is defined that establishes two simple classes of ultrasonic field safety. Class A is the highest safety class representing ultrasonic fields that can be used with minimal concern for patient safety. Class B relates to ultrasonic fields which require indication of additional information concerning thermal and cavitational hazard. Threshold levels of 4 kelvin for temperature rise and 4 megapascals for acoustic stress (peak rarefactional acoustic pressure) define the safety classes, and test methods needed to detemine these biophysical quantities are specified. Various options are provided for the declaration of the safety class for either ultasonic fields, modes of operation, probes or consoles. Finally, guidance on the use of the safety classes is given for patients and clinical operators.

 

Weighing in the pharmaceutical industry.
Author: Scorer, T*, Perkin, M, Buckley, M*
Source: Measurement Good Practice Guide No. 70 ,June 2004.
ISSN: 1368-6550
Abstract: This document is intended as a guide to the best practice to be adopted when carrying out weighings in the pharmaceutical industry. It includes a discussion of the current regulations applicable to pharmaceutical weighing, descriptions of the types, performance and validation of balances typically used, and introductions to the different weighing styles that may be used. In conclusion there is a description of several methods of data analysis and uncertainty calculation.

Characterisation of polymeric tissue scaffolds .
Author: Tomlins, P, Grant, P V, Mikhalovsky, S*, Mikhalovska, L*, James, S*, Vadgama, P*
Source: Measurement Good Practice Guide No. 89 ,September 2006.
ISSN: 1368-6550
Abstract: This Guide describes current good measurement practice for obtaining structural information for polymer-based tissue scaffolds and methods for quantifying these data. It covers: Imaging techniques, for example, scanning electron microscopy and image analysis. Intrusion methods: mercury porosimetry and capillary flow porometry. Measurement of sample density and derivation of porosity using the buoyancy method. Example results are presented to illustrate and compare data generated by the above methods. Although this document focuses on polymer based tissue scaffolds the principles can be applied to other porous materials subject to their properties and the constraints of the techniques

 

Protocol for establishing and maintaining the calibration of medical radionuclide calibrators and their quality control .
Author: Gadd, R*, Baker, M, Nijran, K S*, Owens, S*, Thomas, W*, Woods, M J*, Zananiri, F*
Source: Measurement Good Practice Guide No. 93 ,May 2006.
ISSN: 1368-6550
Abstract: Guidance is given on the quality controls that should be undertaken on a routine basis for medical radionuclide calibrators to ensure the accuracy and traceability of measurements of the activities of radiopharmaceuticals. Sources of error and magnitudes of associated uncertainties are discussed.

 

Higher-order protein structure measurements for biopharmaceutical quality control.
Author: Ravi, J, LePevelen, D*, Tranter, G*, Knight, A
Source: AS 9, August 2007
ISSN: 1754-2928
Abstract: This report reviews the available techniques for measuring the higher-order structure of proteins, and assesses their suitability for quality control in the biopharmaceutical industry. FTIR is found to be the technique which best compliments CD, currently the dominant technique. We explore measurement issues of FTIR and make best practice recommendations. We also advide that FTIR should be used in combination with CD.

 

Val-CiD best practice guide: CD spectroscopy for the quality control of biopharmaceuticals.
Author: Jones, C*, Schiffman, D, Knight, A, Windsor, S A
Source: DQL-AS 008, October 2004
ISSN: 1744-0602
Abstract: No abstract available