5D Health Protection Group limited

multi award winning microbiology laboratory

Sectors | Medical Devices

Medical Device Evaluation and Testing

Infections relating to medical implants such as catheters, stents and joint prosthesis can result in a number of healthcare problems. These include local and systemic infection, the need for implant replacement, patient pain and discomfort and associated healthcare costs. It is important during the innovation and development of a medical device that performance is evaluated as effectively as possible using different tests and models. At 5D we have the solutions to all you medical device testing needs ranging from the physical and chemical testing through to antimicrobial efficacy. 

We are routinely evaluating the performance of medical devices for customers. In particular we undertake in vitro antibiofilm and antimicrobial efficacy testing, biocompatibility and cytotoxicity testing, endotoxin detection testing, bioburden assessment and implantable device assessment. Medical devices that we regularly evaluate include antimicrobial washes, bone cements, wound technologies, contact lenses and catheters. Examples of some of the standard test methods we offer include ASTM D7907, BS EN 1616, BS EN ISO 10993 and ISO 22196. In particular we are routinely evaluating the performance of wound care technologies. More information about wound dressing testing and evaluation can be found on our our wound dressings testing services pages. For further information about our scientific testing services please visit our scientific testing services pages on our website. 

Standard and Customised Models and Test Methods For Medical Device Evaluation

5D Models and Test Methods

5D Medical Device Testing is undertaken for many global customers involved in all areas of medical device innovation and development. These generally include companies who are innovating and developing CE mark or 510K products or companies that have already commercialised their products and wanting reinvigoration. We have experience and are proficient in developing models and evaluating the performance of many medical devices in many areas. These include as examples:


A catheter is a medical grade tube material that can be inserted into the body. There are three types of catheters, indwelling catheters, external catheters and short term catheters. Indwelling catheters stay inside the body for long periods of time. These are often changed every month or every two months. Urinary catheters can be inserted into the bladder which helps to drain urine freely and so allow patients to recover after some surgical procedure. Other catheters include intravascular or central venous catheters. 5D have developed numerous catheter biofilm model to study the antibiofilm and antimicrobial performance of catheters. As well as evaluating the performance of the whole catheter we also perform testing on Catheter tubing, Catheter lock and lock-flush solutions, catheter insertion point devices, catheter bags and lubricating gels.

Over 25 Years of Specialist Scientific Knowledge in Medical Devices

Wound Dressings

Wounds are divided into acute wounds and chronic wounds. To help manage the patients wound there are a large number of different wound technologies each with their own features and benefits. These can range from wound dressings, diagnostic systems to hardware.

Unfortunately there is no one single wound dressing that is able to manage all the conditions needed to support and manage a patients wound. 5D has extensive experience in evaluating the performance of wound dressings and associated technologies. Please see the wound dressing section for further information regarding some of our standard and customised models and methods.


A stent is generally a plastic or metal tube that inserted into the lumen of a vessel. 5D have experience in evaluating the antimicrobial and antibiofilm efficacy of stents using an array of different test methods and models.

Point of Care Diagnostic Devices (POC) and Testing

Point of care devices are diagnostic testing that is undertaken near the site of the patient. At 5D we have experience of evaluating the performance of different POC devices.

Experts on Wound Dressing Development and Evaluation of Performance

Contact Lenses

Contact lenses are lenses which are very thin and placed on the eye. They are used for both therapeutic and cosmetic reasons. There are many different types of contact lenses that can be worn both short and long term. Whilst contact lenses are safe if used correctly many complications can occur. 5D have experience in evaluating contact lens for customers, in particular evaluating their ability to prevent the adhesion of microorganisms and formation of biofilms and evaluating their biocompatibility profile. 5D in particular have experience on evaluating the performance of surface coatings, cleaning solutions, peptides and also also undertaking the performance of preservative agents in contact lens solutions. 

Orthopaedic and Implantable Devices

Orthopaedic devices or implants are medical devices that are used to replace bone, a joint or damaged bones. They are generally composed of titanic or stainless steel often with a coating of plastic. Many of these orthopaedic devices are kept in place with bone cements. These cements often contain antimicrobials to prevent the formation of biofilms and reduce the infection risk to the patient. At 5D we have a lot of experience in evaluating the antimicrobial and antibiofilm ability of implantable devices and also the antimicrobial ability of bone cements. However, we also have applied our skills and knowledge in other areas of the orthopaedic ecosystem.

Unrivalled Scientific Support and Experience in Medical Device Testing

Examples of 5D Standard Test Methods and Models

In supporting medical device manufacturers we offer exemplary services in microbiology, antimicrobial and antibiofilm efficacy testing, endotoxin testing, biocompatibility testing and cell biology. A number of standard test methods that we offer to our customers include: 

  • ASTM D7907: Standard test methods for determination of bactericidal efficacy on the surface of medical examination gloves
  • BS EN ISO 10993: Biological evaluation of medical devices.
  • BS EN 1616: Sterile urethral catheters for single use
  • BS EN ISO 11737-1: Sterilisation of Medical devices – Microbiological Methods – Part 1: Determination of a population of microorganisms on products (Bioburden)
  • ISO 22196: Measurement of antibacterial activity on plastics and other non-porous surfaces
  • WHTM 01-01: Decontamination of medical devices within acute services

We presently offer many models that can be employed to valuate the antimicrobial and antibiofilm efficacy of a device swell as its biocompatibility. We utilise an array of different techniques to gain significant insight into the performance of the medical device. 

A Complete Medical Devices Scientific Testing Service Provider

Customised Test Methods

We provide expempalary skills and knowledge in many different tests and models. A few examples of test methods we have have employed include:

  • Evaluating the ability to medical devices to prevent biofilm development,
  • Evaluating the ability of medical devices to reduce microbial dissemination rates;
  • Evaluating the antimicrobial properties and longevity of medical devices in microbial challenge testing,
  • Studying the biofilm removal techniques,
  • Analysing the microbial percentage coverage analysis o f medical devices

In order to undertake many of the experiments needed to study the performance of medical devices we employ an array of different techniques including: Confocal laser microscopy incorporating LIVE/DEAD viability staying methods, qPCR techniques to investigate microbial bioburden and microbial identification, Scanning Electron Microscopy (SEM) to study biofilms and their coverage on the medical device.

As we are located on a university campus we also have access to a vast array of different pieces of equipment so we are able to offer a 'complete scientific service' to all our our customers.

We are Here To Support You on You Journey

Customer Testimonials

  • "We have found 5D Health Protection very informative and responsive to the work proposals, questions and final data. 5D Health were very helpful and clear in their support and advice throughout the study"
  • "5D provided an excellent service regarding product evaluation, consultancy and education"
  • "If anybody is looking to begin working with biofilms, they need to look at this course. It is run by top notch people, and they make it fun"
  • "Excellent communication of timelines"
  • “Always happy to discuss test methods and results with us”
  • “All testing was conducted as agreed, clear and professional report supplied”
  • "Very quick response to the initial request. Very professional and helpful advice to the requested studies. Very Supportive staff"
  • "If not for this course, we would likely never be able to get our lab up and running in a timely manner. This was a HUGE time saver in the long run"

5D Accomplishments, Partnerships and Collaborations

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  • Cardiff University


5D Health Protection Group Ltd

Accelerator Building
1 Daulby Street
L7 8XZ
United Kingdom


+44 (0) 151 702 9492

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