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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…

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. …

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

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 is Disinfection Validation Essential for Reusable Medical Devices? In every healthcare setting, several medical devices are utilised in the care, treatment, monitoring, and diagnosis of patients. These reusable medical devices may be used multiple times and for multiple…

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 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…

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…

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…

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 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 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…

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 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 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…

Photobiology is a field of science that has been around since ancient times, however, the technology used to understand the effect of light on organisms has grown exponentially over the centuries. So, what is photobiology? Broadly speaking, photobiology is a…

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…

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…

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 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…