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Introduction For over three quarters of my life, biological evaluation meant absolutely nothing to me. But in this last quarter of my…

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…

In the medical device industry, patient safety and regulatory compliance are non-negotiable. One critical step in ensuring both is understanding which chemical substances may be released from a device during storage, handling, or clinical use. This is where Extractables and Leachables (E&L) testing comes in — a process governed by ISO 10993-18, the international standard for the chemical characterisation of medical device materials.

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…

Understanding the Role of Chemical Characterisation in Medical Devices Analytical chemistry was something that during my studies in Medicinal Chemistry, I assumed was largely applicable to the field of pharmaceuticals in drug discovery as well as in formulation…

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…

How Can Medical Device Manufacturers Validate Sterilisation? In the world of medical devices, the term “sterile” represents a crucial claim: that a medical device is free from viable microorganisms. This guarantee is essential for ensuring patient safety during critical…

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…

Understanding BS EN ISO 22441:2022 – The Standard Behind VHP Sterilisation  BS EN ISO 22441:2022 sets the global framework for validating low temperature hydrogen peroxide sterilisation processes, ensuring both safety and repeatability for medical device manufacturers.

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…

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 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…

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…

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? 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…

What is a biocide? A biocide is a chemical substance or microorganism which intention is to “control any harmful organism in a way that is not purely physical or mechanical”. They are commonly used as disinfectants, oxidising agents, insect repellents…

What classification of medical device is my disinfectant? Annex VIII of the EU 2017/745 Medical Device Regulation (MDR) outlines the classification rules for medical devices. Application of these classification rules should be determined by the intended use of the device.

What do air purification and disinfection systems do? Air purification and disinfection systems are being designed to effectively clean the air in the environment and reduce or inactivate harmful populations of airborne pathogenic microorganisms, aiming to provide significant assistance in…

What is Bioburden Testing? The word bioburden comes from ‘bio’ meaning life, and ‘burden’ meaning presence or load. Therefore, bioburden refers to the amount of living organisms – like bacteria or fungi- naturally present on a device. Bioburden testing is…

A mode of action describes a functional or anatomical change, resulting from the exposure of a living organism to a substance. Different biocides have a different mode of action and therefore work differently to destroy the living substance. Disinfectants are…

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…

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 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…

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…