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From the 7th to the 8th MET is attending E and L Conference. Two of our highly trained technicians will help you with any needs or questions you have involving Extractables and Leachables and more! We are happy to help! So feel free to come visit our booth and talk to us!
MET wins prizes from the Shine charity!
Prefilled Syringe Testing Information is Now Available in Multiple Languages
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 other types of medical needle, some of which are not supported by consensus standards. The tests in ISO 7864 can, in many cases, be transferred.
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 of test methods and acceptance criteria for assessing residual materials left on the surface of the implants at the end of processing.
Staff from Medical Engineering Technologies Ltd. will be exhibiting at the extractables and leachables conference Europe (7-8 November 2018, London). To discuss your projects, for an informal chat or just to meet the team, come along to our booth, you will be most welcome.
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 1 - Requirements for materials, sterile barrier systems and packaging systems, will be updated at the same time.
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 standards for medical needles, including ISO 7864 and ISO 6009, for hypodermic needles. But, there is something of a gap for intravenous, suture and intra-muscular needles. Japanese standards include: JIS 3209 – Sterile Injection Needles, and JIS 3228 – Biopsy needles for single use.
Work has begun on the building of new lab capacity at Medical Engineering Technologies (www.met.uk.com).
Prize Winners at MET's Prefilled Syringe Booth
MET has arrived at the Orlando, Universe of Prefilled Syringes conference.
MET has published a paper in OnDrugDelivery magazine with the title: The Need for a Fully Informed Laboratory in Combination Device Validation Services.
A week today and PDA Universe of Pre-Filled Syringes and Injection Devices 2018 in Orlando, Florida will be in full swing. This event is the largest conference for the PDA this year. It is bringing together experts and companies from many fields to discuss the latest scientific breakthroughs, new technologies, and existing and expected new global market trends for Pre-Filled Syringes and Injection Devices.
MET’s service for medical device testing delivers your regulatory requirements according to a wide range of agreed standards, methods and protocols.
Our laboratories are driven by a strict adherence to quality and exacting attention to client requirements.
Medical Engineering Technologies Ltd. will be exhibiting at the Parenteral Drug Association, Universe of Prefilled Syringes and Injection Devices (8 – 9 October 2018). Come along to booth 821, and chat to our team about your projects, we are really helpful people.
MET meeting new contacts and discussing new and exciting products in a delightful venue in an amazing city.
Medical Engineering Technologies Ltd. are exhibiting at the Extractables and Leachables conference in Beijing China.
Medical Engineering Technologies Ltd. will be exhibiting at the extractables and leachables conference China (11 – 12 September 2018). Come along and chat to our team about your projects, we are really helpful people.
IS0 10993-1 updated to include emphasis on chemical assessment.
IS0 11608 is the most important standard for dose accuracy testing when it comes to injection devices.
MET is expanding ISO 11040 and IS0 11608 laboratory testing capacity, to help address your pre-filled syringe regulatory requirements.
MET is providing full testing to ISO 20696, which replaces EN 1616 for Foley catheters.
Medical Engineering Technologies’ packaging laboratory now has ISTA 2A and ASTM D4169 transit testing added to its accreditation.
The lab is fully equipped with vibration simulators for road and air transport, and impact testers for rail switching, concentrated impact and rough handling, with support from stacking simulators.
These processes are normally preceded by 72 hours conditioning. We have many options available – freezing, tropical, desert and more. The following process is sterile barrier validation through seal strength and integrity testing.
For more information click here
To see our new accreditation certificate click here.
MET is Contributing to Improvements in ISO 10993: Biological Evaluation of Medical Devices.