Medical And Combination Device Testing News

The podcast is one in a series produced by the Leaders Council of Great Britain and Northern Ireland. This is an organisation which has been set up to promote good... 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

Testez vos dispositifs médicaux en France More

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 as 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

This interview with Mark Turner was originally published in Medical Device Developments Magazine, October 2019. 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

Medical Engineering Technologies SAS, is headquartered in France and will be providing services from a base in Calais. 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 which is... More

The Parliamentary Review is an organisation which promotes ‘best practice’ largely in the business environment, but also in education and healthcare. The idea is to showcase successful and well run... More

Both sections 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

MET will be exhibiting at: 2019 The Universe of Pre-filled Syringes and Injection Devices Oct 22 - Oct 23, 2019, Gothenburg, Sweden. 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, now interest is growing 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 thing 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

Analytical Evaluation Threshold / Safety Concern Threshold, Explained More

Medical Device Testing Laboratory’s Website Fully Available in German Language www.met-de.de 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

Does my device require revalidation under the new MDR? 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.... 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 viscosities.... More

Testing of contraceptive devices and gynaecological rings by MET More

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 bubble and stopper positions are... More

Cleaning Validation and Verification of Residual Removal 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

Needleless injectors used for administering medicines to humans must be tested rigorously to ensure they are safe. MET has developed a needleless injector testing plan for design validation of the... 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

Personal lubricants (also known as intimate lubricants) must undergo personal lubricant testing to show that they are safe and effective, before they can be marketed. Here are some of the tests we... More

When testing the strength of your sterile package is it better to use a peel test or a burst test? The answer is not straightforward. This article first appeared... 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

ISO 15747 details the required physical, chemical and biological testing for parenterals and other infusion systems which are stored and/or dispensed from plastic containers. MET provides a full suite of... More