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Chemical indicators have been used for decades to validate sterilisation and decontamination parameters and to ensure that the process has met the standard required for such procedures. However, there aren’t many published materials on their efficacy in delivering or providing…

What is Good Laboratory Practice? Good Laboratory Practice (GLP) refers to a set of principles designed to be implemented within a testing facilities quality management system. These principles define the processes and conditions under which non-clinical health and environmental safety…

Medical Device Cleaning Procedures Cleaning procedures are critical for medical devices as they reduce the risk of infection when being handled between uses. For this reason, cleaning procedures…

What is a Medical Device ‘Instructions for Use’? ‘IFU’ stands for Instructions for Use, and it is an acronym that is a common buzzword heard in the medical device field. In its most basic definition, an IFU…

What is barcode verification? Barcode verification is a process in which 1-D and 2-D barcodes are graded according to specific quality parameters defined by the industry. With technologies advancing and regulations changing, verification is becoming a fundamental step to…

Introduction Medical devices are subject to rigorous testing standards in order to meet regulatory requirements…

The Increasing Demand for Chemical Disinfectants It is no surprise that since the COVID-19 pandemic, there has been a surge in the disinfectant market, as manufacturers produced more and more in order to meet the increasing demand. However, this increase…

What is material compatibility? Medical device safety testing includes material compatibility studies. Material compatibility is determining the resistance between a surface (or product) and disinfectant products and technologies. An adverse reaction resulting in incompatibility of different components can impact the…

What is IEC 60601-1? IEC 60601 is a series of safety standards examining the safety and performance of medical electrical equipment. IEC 60601-1 is the general standard of the series: it includes the basic safety and essential performance requirements for…

The COVID-19 influence on cleaning practices As we are all aware, the consequences of the COVID-19 pandemic were wide-ranging and varied. In the world of medical devices, one impact in particular has been frequently overlooked: a pronounced increase in the…

Medical Devices: Are they compatible with IPC? As a medical device manufacturer, your products contribute towards the treatment, care and recovery of millions of people around the world. But while they are designed to function reliably, many medical devices are…

What is IEC 60601-1? First published in 1977 by the International Electrotechnical Commission, IEC 60601-1 General requirements for basic safety and essential performance is the general standard of the 60601 series and gives requirements that must be met throughout the…

What is Good Laboratory Practice? Good Laboratory Practice (GLP) refers to a set of principles designed to be implemented within a testing facilities quality management system. These principles define the processes and conditions under which non-clinical health and environmental safety…

Laboratory Training Course for Medical Device Manufacturers We have been listening to our client feedback, and in response to market need, Lorit Consultancy and Test Labs have co-developed a laboratory training course specifically designed for medical device manufacturers. This course…

What is IEC 60601-1? IEC 60601 is a series of safety standards examining the safety and performance of medical electrical equipment. IEC 60601-1 is the general standard of the series: it includes the basic safety and essential performance requirements for…