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    Medical And Combination Device Testing News

News From MET

Welcome to the MET news section, be sure to check back here regularly for news on MET and in the Medical Device Testing industry itself.

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May 16, 2024
By Luminita Moraru & Elena Henderson
The long-awaited update to the ISO 18562 standard for biocompatibility evaluation of breathing medical gas pathways is here! Medical Engineering Technologies (MET) is pleased to announce that our experts Luminita... More

Apr 17, 2024
By Marlon Ayling Allen
Deep Dive into Pre-Filled Syringes with MET Expert Zhané Healey Available Now: Watch MET's Zhané Healey Lead Cormica's Informative Webinar on Pre-Filled Syringes. More

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Apr 4, 2024
By Marlon Ayling Allen
Register for the free webinar More

Feb 14, 2024
By Stephen Malbon
In January 2024, the release of ASTM F1929-23 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration marked an update from its predecessor, ASTM F1929-15.... More

Jan 26, 2024
By Stephen Malbon
Unlocking Excellence in Luer Testing: A Glimpse into MET's Expertise In the realm of medical device validation and verification, precision and reliability are paramount. At Medical Engineering Technologies (MET),... More

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Jan 24, 2024
By Luminita Moraru MSc | MRSC | MBTS
The British Standard has implemented the EN ISO10993-18:2020 +A1:2023. This version is identical to ISO10993-18:2020 incorporating the amendment 1:2022 and it supersedes BS EN ISO 10993-18:2023 which is now withdrawn. ... More

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Jan 10, 2024
By Luminita Moraru MSc | MRSC | MBTS
Medical Engineering Technologies Ltd (MET), a leading provider for medical and combination device batch release and design validation testing, announces its commitment to adhering to the latest guidance on... More

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Jan 3, 2024
By Angela Bell
Medical Engineering Technologies (MET) of Dover, Kent and a Cormica laboratory, is proud to announce major enhancements in our stability testing capabilities. As a globally recognized test laboratory specialising in... More

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Dec 20, 2023
By Aiden Tingley
Medical Engineering Technologies Ltd, a Cormica Laboratory, is proud to participate in the upcoming Pre-Filled Syringes and Injectable Drug Devices Conference in London. Join us to explore the forefront... More

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Nov 28, 2023
By Naomi Allkins
ISO/IEC 17025 is the international standard that sets out the general requirements for the competence of testing and calibration laboratories. ISO/IEC 17025 is recognised worldwide, where some guidance’s such... More

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Nov 22, 2023
By Luminita Moraru
ISO10993-17:2023 Biological evaluation of medical devices From Establishment of allowable limits for leachable substances To Toxicological risk assessment of medical device constituents There have been many articles published... More

Oct 13, 2023
By Steven
Download Fact Sheet More

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Sep 21, 2023
By Aiden Tingley
Download Article More

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Sep 20, 2023
By Aiden Tingley
MET (Medical Engineering Technologies Ltd) and Cormica, are excited to announce we are participation in the upcoming 2023 PDA Universe of Pre-Filled Syringes and Injection Devices Conference. This event will... More

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Aug 29, 2023
By Aiden Tingley
Needle-free injection systems (NFIS) are a wide range medical devices that deliver medication or vaccines into the body without the use of a needle. NFISs use novel ways to directly... More

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Jul 7, 2023
By Aiden Tingley
On the 23/08/2023 at 11:00AM MET &  Cormica will be presenting a new webinar titled "Chemical Analysis & the Non-Targeted Screening of Medical Devices" More

Oct 16, 2022
By M.Turner
Volume 2 of this extremely useful series of aids for medical device engineers, new and seasoned, is now available on request from MET. More

Aug 19, 2022
By govicinity
We will be exhibiting at the 2022 PDA Universe of Pre-Filled Syringes and Injection Devices Conference in Palm Springs, if you're going we'd love to meet you and have a chat, our... More

Aug 8, 2022
By M.Turner
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

Jun 13, 2022
By M.Turner
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

May 26, 2022
By M.Turner
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

May 22, 2022
By M.Turner
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

May 22, 2022
By M.Turner
Sections 1 to 7 of the combination device standard ‘Needle based injection systems for medical use’ have been updated. More

May 12, 2022
By M.Turner
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

Apr 20, 2022
By M.Turner
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

Apr 12, 2022
By M.Turner
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

Mar 25, 2022
By M.Turner
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

Jan 6, 2022
By M.Turner
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

Nov 15, 2021
By M.Turner
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

Oct 19, 2021
By M.Turner
Volume one – Guide Book to Combination Device Validation – is now available on request. More

May 18, 2021
By M.Turner
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

May 10, 2021
By M.Turner
The FDA CDRH has recently made a resource available to assist and guide evaluations.   More

Mar 3, 2021
By M.Turner
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

Jan 19, 2021
By M.Turner
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

Nov 2, 2020
By M.Turner
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

Oct 27, 2020
By M.Turner
A clear explanation of requirements and how to provide evidence of compliance has been published in Ondrug Delivery magazine. More

Oct 19, 2020
By M.Turner
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

Sep 3, 2020
By govicinity
When the pandemic hit British shores in March 2020, businesses up and down the country were forced to change tack, some had to batter down the hatches whilst others had... More

Jun 22, 2020
By M.Turner
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

Jun 11, 2020
By M.Turner
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

May 29, 2020
By M.Turner
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

May 20, 2020
By M.Turner
Testez vos dispositifs médicaux en France More

May 11, 2020
By M.Turner
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

Apr 6, 2020
By M.Turner
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

Mar 20, 2020
By M.Turner
The revised version of this standard gives information on the generation of chemical characterisation data for your Biological Evaluation Report. More

Mar 16, 2020
By M.Turner
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

Feb 12, 2020
By M.Turner
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

Nov 15, 2019
By M.Turner
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

Oct 30, 2019
By M.Turner
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

Oct 28, 2019
By M.Turner
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

Aug 2, 2019
By M.Turner
Testing is provided to ISO 20072 Aerosol drug delivery device design verification. Requirements and test methods. More

Feb 28, 2019
By M.Turner
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

Feb 7, 2019
By M.Turner
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

Jan 16, 2019
By M.Turner
Here, we explain the difference between Safety Concern Threshold (SCT) and Analytical Evaluation Threshold (AET).   More

Dec 6, 2018
By M.Turner
Does my medicinal product need to comply with MDR Article 117?   More

Dec 6, 2018
By M.Turner
When will my containers need to comply with USP <661.1> and USP <661.2>?   More

Nov 1, 2018
By M.Turner
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

Oct 31, 2018
By M.Turner
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

Oct 16, 2018
By M.Turner
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

Oct 15, 2018
By M.Turner
There are a variety of international standards pertaining to medical needles. For pen injectors and insulin needles the most relevant is IS0 11608-2 . There are a variety of other... More

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Aug 30, 2018
By M.Turner
IS0 11608 is the most important standard for dose accuracy testing when it comes to injection devices. More

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Aug 28, 2018
By M.Turner
MET is expanding ISO 11040 and IS0 11608 laboratory testing capacity, to help address your pre-filled syringe regulatory requirements. More

Sep 16, 2016
By M.Turner
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

Jun 23, 2014
By M.Turner
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

Apr 1, 2014
By M.Turner
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

Oct 25, 2013
By M.Turner
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