Medical And Combination Device Testing News

All airway devices must now be validated against this standard for breathing component biocompatibility. A relative easy task for a face mask, more complicated for a long term ventilator, most... More

MET has been delivering validation testing of medical and combination devices since 1997. During this period we have helped hundreds of clients in dozens of countries, ensuring that their master... More

In 2018, ISO 10993 introduced the BEP as an essential step in the biological evaluation of medical devices. The BEP has now developed into a risk analysis process which... More

All measurements have an inherent uncertainty. This also applies to analytical chemistry even if those PPB numbers do look incredible accurate. It is a pretty complicated field. Fortunately you don’t... More

Sections 1 to 7 of the combination device standard ‘Needle based injection systems for medical use’ have been updated. More

MET has published a guide to the interplay between the Biocompatibility Evaluation of Medical Devices standard and the Biocompatibility Evaluation of Breathing Pathway Applications standard. More

In April 2022 a much larger and more detailed version of the auto injector pen and prefilled syringe standard has been published. Here we review the changes.  More

We all know that inhalers are used intermittently to deliver specific drugs to a specific location. Does that make them a medicinal product or a medical device? More

A team of FDA scientists have published a review of practices used for chemical characterisation in the American Chemical Society’s ACS Biomaterials Science and Engineering. More

It is according to EN 13544-2 Respiratory therapy equipment – Part 2: Tubing and connectors that MET tests oxygen tubing used in any kind of therapeutic scenario. Suitable... More

This standard is coming up to four years old now, and MET is one of the most experienced labs in its application. More

Medical Engineering Technologies’ Analytical Chemistry Manager has joined the technical team working on the chemical characterisation aspects of the biocompatibility standard ISO 10993-18. More

MET has published details of our experience working with ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management... More

The FDA CDRH has recently made a resource available to assist and guide evaluations.   More

At MET we have been testing to ISO 18562 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process, for... More

The 2018 /2020 edition of ISO 10993-1 emphasises a chemical knowledge of materials over any testing of a device and especially over biological testing. The new FDA Guidance  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/select-updates-biocompatibility-certain-devices-contact-intact-skin  pursues... More

We have published a series of new analytical chemistry pages. At MET we understand the needs of the medical and drug delivery device industries. These four new pages explain... More

What is the IP code? “The IP code is a coding system that indicates the degrees of protection provided by an enclosure against access to hazardous parts, ingress of... More

In a variety of regulatory regions all medicines should be tested for the presence of nitrosamine (N-Nitrosodimethylamine). More

USP 1207 Closed Container Integrity Testing can be performed using a Vacuum Pressure Decay method. The method is also suitable for leak testing of impermeable medical device packaging . More

A clear explanation of requirements and how to provide evidence of compliance has been published in Ondrug Delivery magazine. More

ISO 80369: Small-bore connectors for liquids and gases in healthcare applications. ISO 594: Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment. More

The new (2018) version of ISO 10993 moves the emphasis of biocompatibility from biological testing to risk analysis and chemical characterisation with toxicity risk assessment   What does... More

The current version of this standard is now over a year old. How much has changed in ISO 11607-1:2019 Packaging for terminally sterilized medical devices and how much had... More

The options are pharmaceutical container extractables and leachables studies or following ISO 10993 the medical device biocompatibility standard. Medical Engineering Technologies has published a guide to progressing your projects in... More

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This FDA emergency injector guidance published in April 2020, indicates how to select a marketing application route and how to make that application. Because emergency injectors are used in... More

At MET we are helping battle Coronavirus with our chemistry team hard at work. Testing ventilation systems, we are busy performing particle and vapour release analyses. More

The revised version of this standard gives information on the generation of chemical characterisation data for your Biological Evaluation Report. More

The Washington post has published an article which explains very, very clearly how isolation and social distancing influences the spread of the Corona Virus. (Acceptance of the free subscription is... More

Medical Engineering Technologies (MET) has published a guide to ISO 10993-1:2018. The article ‘ The mysteries of the 2018/2019 edition of biocompatibility standard ISO 10993’ appears in Medical Plastic News... More

Increased interest in biologics and biosimilars is one of the factors driving the need for delivery devices at the interface between devices and pharmaceuticals. More

MET Ltd, société Britanique basée à Douvres, annonce le lancement de sa filiale Medical Engineering Technologies SAS, ouvrant ses portes en France dans la Côte d’Opale More

ISO 21726:2019 Biological evaluation of medical devices -- Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents - is a new standard to aid... More

Sections both one and two of ISO 11607 Packaging for terminally sterilized medical devices have been revised this year. The changes are mostly subtle; the biggest is (maybe) the addition... More

Testing is provided to ISO 20072 Aerosol drug delivery device design verification. Requirements and test methods. More

Traditionally, the main area of concern regarding interactions between a formulation and a device has been limited to the container storage system for the formulation. There is mounting interest in... More

The European Medicines Agency has published draft quality requirements EMA/CHMP/QWP/BWP/259165/2019 for delivery devices and other integral and non-integral DDCs. Non integral DDCs include such things as refillable injector pens,... More

Published in January, ISO 11040-6:2019 Prefilled Syringes - Part 6: Plastic barrels for injectables and sterilized sub assembled syringes ready for filling, has several changes from previous versions. More

If a medical device has short term surface contact, it clearly does not require the same amount of vigour in the investigation of the availability of chemicals (to the end... More

The standard, ISO 19761 Additional Lubricants for natural rubber condoms – effects on strength, has some significant variations from ASTM D 7661. More

Here, we explain the difference between Safety Concern Threshold (SCT) and Analytical Evaluation Threshold (AET).   More

Does my medicinal product need to comply with MDR Article 117?   More

When will my containers need to comply with USP <661.1> and USP <661.2>?   More

ISO 7864: Sterile hypodermic needles for single use - Requirements and test methods is a standard which provides validation tests for a very specific size of needle. There are many... More

ISO 19227  Implants for Surgery--Cleanliness of Orthopaedic Implants--General Requirements – was published early in 2018. It is a new standard issued with the intention of reducing diversity in the application... More

ISO 11607-2 Packaging for terminally sterilised medical devices — Part 2: Validation requirements for forming, sealing and assembly processes, has been revised and will be republished in November 2018. Part... More

MET is providing full testing to ISO 20696, which replaces EN 1616 for Foley catheters. More

Assessment of ambulatory injection devices by MET Innovation continues to drive the development of new wearable injector devices with the need for adapting to different dosing regimens and fluid... More

For these kinds of validations, the pens and syringes are mounted in a transparent chamber. The inside of the chamber is then subjected to simulated air transit whilst the air... More

The Bubble Emission Test is a method of determining the integrity of medical packaging. Bubble testing involves the application of pressure to the underside of a submerged material.  More

For medical device package validation, shelf life testing and transit simulation are often treated as entirely separate issues. But can we really be so quick to separate the two? More

This article first appeared in Medical Packaging Innovation The shelf life of terminally sterilised medical devices should be validated using both accelerated and ‘real time’ ageing, according to ISO 11607.... More