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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.

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…

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 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 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 does ATP stand for? ‘Mitochondria is the powerhouse of a cell’ is a phrase that should be engrained from many science lessons in school, but what exactly gives the mitochondria its power-like abilities? The answer is an intracellular small…

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…

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.

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…

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…

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

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…

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…

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 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 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…

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…

Do anti-microbial coating work? In the relentless pursuit of patient safety, the battle against nosocomial infections (hospital-acquired infections) has become more critical than ever. Plastics and non-porous surfaces, commonly found in medical device coatings, create an environment where bacteria…

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…

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…

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? 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…