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What is Cytotoxicity in Medical Devices? Cytotoxicity refers to the potential of a substance or material to cause damage to living cells. In the context of medical devices, cytotoxicity testing is a critical part of the biocompatibility evaluation…

Why Biocompatibility Matters in Medical Devices In medical devices, innovation often takes the spotlight. Shiny new materials, novel coatings, and futuristic 3D-printed structures attract attention. But behind every device that actually reaches patients lies an unsung hero: biocompatibility. …

This article explores cytotoxicity testing, a critical step in assessing the biocompatibility of medical devices. It explains how cytotoxicity studies are conducted using in vitro methods to evaluate whether materials used in a device cause cell damage or death.

Why is ISO 10993-12 Important? The ISO 10993 series set out the expected standards for medical devices that generally, come into direct contact with the patient. There are currently 23 parts to the standard that describe elements of testing depending on the…

Why does Over-Extraction Mislead Results? ISO 10993-18 defines the framework for chemical characterisation of medical devices. The intention is clear: to protect patients by identifying…

What Remains After Sterilisation and Why Does Residual Hydrogen Peroxide Matter? If you’ve ever worked in a lab long enough, you’ll know that the smallest details often carry the biggest weight. I was reminded of this recently while reviewing…

Introduction When developing or modifying a medical device, it’s not enough to prove that it works once. You must demonstrate that it continues to perform safely and effectively throughout its entire service life. That’s where service life validation…

How We Validate Reusable Medical Devices? At Test Labs, we specialise in validating the cleaning, disinfection, and sterilisation processes of reusable medical devices. Our validation process includes both manual and automated methods. Manual processes often involve hands-on…

Real-World Challenges in Reprocessing Imagine a crucial step in patient safety being overlooked. That’s often the reality for sterile processing departments (SPD). Without proper inclusion and clear communication, the risk of improper reprocessing skyrockets, putting patients in harm’s way…

What is a total viable count? Total viable count (TVC) is a measurement that estimates the total amount of living microorganisms in a sample, this includes bacteria, yeast or mould species. TVC counts are usually regarded as ‘non-selective’ as the…

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…

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

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…

Highly Accelerated Life Testing HALT HALT, or Highly Accelerated Life Testing was a term coined by Gregg K. Hobbs in 1988, describing an aggressive methodology of stress testing. It was intended to rapidly discover flaws in a device or part…

What Is Quality Testing in Medical Devices and Why Does it Matter?  When people think of medical devices, they often picture the final product – sleek, sterile, and ready for use. But behind every safe and effective…

What is BS ISO 15727 standard? Disinfection via ultraviolet C (UV-C) irradiation can be fast and efficient, but to achieve this level of efficiency a high output is required (output, in this context, is the UV-C radiation power of a…

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 ultraviolet C irradiation? Ultraviolet C (UV-C) irradiation is an effective means of disinfection, but it is also a potential health risk. Exposure to UV-C radiation can potentially cause a number of health issues, particularly to the skin and…

Disinfection systems utilising ultraviolet C (UV-C) irradiation are becoming more and more common, but this increased usage can lead to an increased risk of harmful exposure to UV-C radiation. UV-C exposure can lead to some unpleasant health issues, particularly in…

What is UV irradiation? UV irradiation has been a validated technology for the decontamination of surfaces, as well as air and water, for several decades. UV light covers a wavelength spectrum from 100 to 380 nm and is…

Why Does Electrical Safety Matter in Medical Technology? Electrical safety is of the utmost importance in medical technology because medical devices, which range from simple diagnostic tools to complex life support systems, interact directly with patients and medical personnel. One…

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 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…

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 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…