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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.

Introduction Choosing the right biocompatibility standard is critical for regulatory success. ISO 10993 and ISO 18562 both assess medical device safety. But they apply to different risk pathways. Understanding their scope helps manufacturers design compliant devices, satisfy regulators, and…

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…

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. …

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…

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…

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…

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…

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 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…

Introduction  In the ongoing battle against infections, surface material compatibility often goes unnoticed, yet it significantly impacts both patient and healthcare provider 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…

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…

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

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 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…

Ultraviolet (UV) irradiation has been known for decades as a terminal disinfection method, widely used in a variety of applications including healthcare, agriculture, water and food treatment, as well as in airlines and many other settings. Due…

What is a disinfectant? A disinfectant is a chemical substance used to reduce the number of bacteria, viruses, fungi, and other harmful organisms. The most common disinfectants are alcohols, oxidising agents and bleaches which are applied to a variety of…

The importance of the EN 17272 test Healthcare-associated infections (HCAIs) are one of the biggest threats to the healthcare system. These infections are usually acquired after hospitalisation and manifest 48 hours after admission to the hospital. These infections are…

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…

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…

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…