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.
Oct 16, 2022
Volume 2 of this extremely useful series of aids for medical device engineers, new and seasoned, is now available on request from MET. More
Sep 26, 2022
This presentation is now available on request from MET.
MET will be presenting this important paper at the Respiratory Drugs Hybrid Summit : from Development to Delivery,... More
Aug 19, 2022
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
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
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
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
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
Sections 1 to 7 of the combination device standard ‘Needle based injection systems for medical use’ have been updated. More
May 12, 2022
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
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
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
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
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
Dec 6, 2021
This standard is coming up to four years old now, and MET is one of the most experienced labs in its application. More
Nov 15, 2021
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
Volume one – Guide Book to Combination Device Validation – is now available on request. More
May 18, 2021
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
The FDA CDRH has recently made a resource available to assist and guide evaluations.
More
Mar 8, 2021
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
Mar 3, 2021
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 26, 2021
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
Jan 19, 2021
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
Dec 2, 2020
In a variety of regulatory regions all medicines should be tested for the presence of nitrosamine (N-Nitrosodimethylamine). More
Nov 2, 2020
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
A clear explanation of requirements and how to provide evidence of compliance has been published in Ondrug Delivery magazine. More
Oct 19, 2020
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
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
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
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
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
Testez vos dispositifs médicaux en France More
May 11, 2020
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
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
The revised version of this standard gives information on the generation of chemical characterisation data for your Biological Evaluation Report. More
Mar 16, 2020
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
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
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
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
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
Oct 1, 2019
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
Aug 2, 2019
Testing is provided to ISO 20072 Aerosol drug delivery device design verification. Requirements and test methods. More
Jun 20, 2019
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
Jun 10, 2019
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
Feb 28, 2019
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
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
Feb 1, 2019
The standard, ISO 19761 Additional Lubricants for natural rubber condoms – effects on strength, has some significant variations from ASTM D 7661. More
Jan 16, 2019
Here, we explain the difference between Safety Concern Threshold (SCT) and Analytical Evaluation Threshold (AET).
More
Dec 6, 2018
Does my medicinal product need to comply with MDR Article 117?
More
Dec 6, 2018
When will my containers need to comply with USP <661.1> and USP <661.2>?
More
Nov 1, 2018
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
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
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
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
Sep 4, 2018
IS0 10993-1 updated to include emphasis on chemical assessment
More
Aug 30, 2018
IS0 11608 is the most important standard for dose accuracy testing when it comes to injection devices. More
Aug 28, 2018
MET is expanding ISO 11040 and IS0 11608 laboratory testing capacity, to help address your pre-filled syringe regulatory requirements. More
Aug 21, 2018
MET is providing full testing to ISO 20696, which replaces EN 1616 for Foley catheters. More
Mar 17, 2017
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
Sep 16, 2016
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
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
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
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