Medtech | RISE

Antimicrobial Materials, Surfaces and Coatings

Anitmicrobial Materials

Antimicrobial materials, surfaces and coatings are increasingly used in variety of products and devices intended for infection control and hygienic applications. However, the development of new antimicrobial materials and devices also requires a wide range of expertise and methods, as well as knowledge of regulatory requirements.

Laboratory testbeds (LT)

Not applicable

Sarunas Petronis

Forskare

+46 70 375 58 66 Read more about Sarunas

Lina Nyström

Forskare

+46 10 516 65 33 Read more about Lina

Off

Division: Division Bioeconomy

Besides the general knowledge of surface and materials science, RISE can assist with:

synthesis or selection of antimicrobial agents
chemical formulations and techniques for embedding them into material or attaching to the surface
investigation of antimicrobial efficiency and biological safety
hygienic design and cleanability evaluation
testing according to relevant standards for regulatory compliance
life-cycle and environmental impact analysis
assessment of material potential to induce antimicrobial resistance

Our experimental facilities cover a wide range of surface chemical and physical characterisation techniques (AFM, SEM, profilometry, Raman, FTIR, XPS, EDX, TOF-SIMS, XRF, equipment for surface energy and wettability determination, mechanical testing and accelerated aging). We have several dedicated microbiology labs for surface antimicrobial efficiency testing according ISO 22196 (Measurement of Antibacterial Activity on Plastic Surfaces), ISO 27447 (Test for Antimicrobial Activity of Photocatalytic Materials), JIS Z 2801 (Japanese Test for Antimicrobial Activity and Efficacy), Standard Zone of Inhibition Test (Kirby Bauer Qualitative Test for Growth Inhibition), Minimum Biofilm Eradication Concentration (MBEC, ASTM E2799-22), ISO 7581 (Evaluation of Bactericidal Activity of a Non-porous Antimicrobial Surface Used in a Dry Environment) , EN 17854:2024 (Antimicrobial Wound Dressings — Requirements and Test), Certika, MIC and other related methods. We also offer services of a GLP-approved cell biology lab for biocompatibility/cytotoxicity and skin-irritation testing required to assure that the materials not only efficiently kill bacteria, fungi or virus but also are safe to the users.

Welcome to contact us!

RISE

Buildings and infrastructure Health and Life Sciences Food and agriculture Materials Pulp, paper and packaging Security and defence

Infection control Chemical and biological analysis Medical devices Risk and safety Textile Surface technology

Medtech4health

Infection control / Expertise

Antimicrobial peptides

Do you work with research and development of products based on antimicrobial peptides? For example new types of antibiotics, implants with active coatings, wound care products or products with other uses such as antifouling products for marine application? Then we would like to cooperate with you.

Materials and durability / Test & demo

Surface Analysis and Surface Design

The Surface Analysis and Surface Design test bed includes laboratories equipped for characterization and optimization of surfaces and surface interactions. We, at RISE, offer complete solutions to support our customer through the entire technological process. Using our broad expertise and a world-leading infrastructure we can help our customers from product idea to market. We can assist all the way in the development process, especially when specific challenges arise, for example to legal requirements or environmental issues.

Medtech / Service

Biocompatibility evaluation

All medical devices have to undergo a biological evaluation of biocompatibility to fulfill the requirements in the EU Medical Device Regulation (MDR). We can help you with everything from setting up a biological safety evaluation plan according to ISO 10993 and ISO 14971 to performing the required tests.

Chemical and biological analysis / Test & demo

ToF-SIMS

By using ToF-SIMS, we can provide molecular information about material surfaces and image the spatial distribution of different components. All solid materials can be analyzed, but the method is particularly powerful for organic compounds. Very low sample quantities are required for the analysis and specific molecules can be imaged at high spatial resolutions, at a level of detail and sensitivity that is not possible with other analytical methods.

Food / Test & demo

Cleaning Innovation

A test bed with a holistic approach to the efficiency aspects, as well as environmental aspects of cleaning and disinfection.

Medtech / Test & demo

BioSafe

We offer everything from biological analysis related to human health to providing solid advice regarding or taking responsibility for the biological evaluation of a product. We perform cell-and tissue-based, microbiological and animal based experiments, according to standards or customised, in order to evaluate function or safety of a product.

Infection control / Expertise

Cleaning and disinfection

Is it not as clean as it should? Which chemicals or materials are the best? How do you measure cleanliness? How can one resource optimise its cleaning process?

Materials and durability / Expertise

Surface analysis

When it comes to material design, the surface properties of your product are often very important to achieve the desired performance. Surface analyses at RISE can provlde solutions to many of your challenges, for example to use when troubleshootlng your product.

Division (OLD):
Division Bioeconomy
Division Materials and Industry Mer information:

Files to download:

Relevant standards

Past and running projects within RISE

Bifoga dokument:

RISE publications related to infection control (pdf, 207.29 KB)

Infection control Sekundär områdes navigation:
Medtech
Materials and durability

Toxicology - for maximised safety

Our team of toxicologists can assist with a wide range of chemical, pharmaceutical and material safety challenges, both in terms of human and environmental health.

We can prepare comprehensive risk assessment reports to meet your needs, provide project support, manage the necessary testing, or collaborate on regulatory submission documents. Our toxicologists have experience with a range of regulatory frameworks covering chemical, pharmaceutical, environmental, cosmetic and medical device safety listed below:

Pharmaceuticals

Within pharmaceutical safety we can assist at multiple stages of the development from early stage up to clinic. We can evaluate target safety assessments for active ingredients, provide mutagenicity assessment of impurities under ICH M7 guidelines, write weight of evidence (WoE) report for waiving studies according to ICH S1B(R1) or calculate appropriate human equivalent dose (HED) for clinical studies.

Additionally, we also provide safety evaluation of pharmaceutical excipients and calculation of safe doses for new formulations for generic and biosimilar pharmaceuticals.

Medical devices

We are experienced in biocompatibility assessment of medical devices of all classes and can provide support in writing and reviewing your Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER) according to ISO 10993 and ISO 14971 or other relevant standards such as the ISO18562 series. We can also help you carry out the necessary tests and subsequent evaluations required for toxicological and biological risk assessment reports for your medical device. Our toxicologists can provide advice, guidance and interpretation of results for submission to the relevant authorities.

We also offer regulatory advice, study monitoring services and toxicological safety evaluation of ancillary medicinal substances in medical devices and of combination products.

Chemicals

We work with a broad variety of chemicals and can assist with evaluating their safety, outsourcing studies and making testing recommendations depending on intended use. Our expertise includes calculation of permissible daily exposure (PDE), acceptable daily intake (ADIs), margins of safety (MoS) or risk characterization ratios (RCR).

Additionally, we work within the REACH regulation and can provide expertise in writing chemical safety reports (CSR), testing proposals, waiving of studies, read-across approaches and provide guidance for your chemical REACH registration.

Cosmetics

We can assist with evaluation of cosmetic ingredients as well as outsourcing of studies in line with European regulation (EC) No 1223/2009 on cosmetic products. Our services include comprehensive toxicological risk assessments, Cosmetic Product Safety Reports (CPSR), and support with Product Information File (PIF) preparation.

Occupational exposure

We can aid in assessing the risk of substances used in production and calculating Occupational Exposure Limits (OELs) and Occupational Exposure Bands (OEBs) for new chemicals in order to protect workers. This assessment includes hazard assessment, identification of significant effects, exposure estimations, calculations and recommendations to ensure workplace safety and is relevant within pharmaceutical, chemical, food, cosmetic and medical device manufacturing. Additionally, recommendations for appropriate risk management measures and personal protective equipment (PPE) can be provided.

Environmental safety

We offer evaluation of ecotoxicological safety and environmental distribution and can calculate ecotoxicological risk indices such as the predicted environmental concentration (PEC) and predicted no-effect concentration (PNEC) in order to understand potential safety concerns to the environment.

Computational and predictive toxicology

We have expertise with computational approaches within toxicology such as quantitative structure-activity relationship (QSAR) modelling, read-across and toxicokinetic modelling. This can be used to assist you in the selection of safer compounds at an early stage of your product development, even before experimental testing has been initiated. These approaches can be used to plan testing strategies for new products.

Additionally, we have experience working within the safe and sustainable by design (SSbD) framework and are committed to helping develop safer products.

Lectures and training

We are happy to offer tailor-made lectures in general toxicology, risk assessment, environmental toxicology and any of the other areas listed above.

Getting in touch is a good start!

We provide solutions for bringing safe new medicines, chemicals and devices to market. If you are unsure whether your needs fit within the above services, please contact us and we can direct you to appropriate experts at RISE or offer tailor-made solutions.

Charlotte Nilsson

Toxikolog

+46 10 516 63 76 Read more about Charlotte

Artificial intelligence / Expertise

AI for chemistry and toxicology

AI for Chemistry and Toxicology is based on the competence of several RISE units: Process Chemistry, Toxicology and AI/Digital Systems. WE OFFER: Unique edge in the combination of computer science, toxicology, chemistry and materials and projects in chemical processes, toxicology and AI/ML as descriptors, prediction and pattern establishment.

Medtech / Service

Biocompatibility evaluation

Division (OLD): Division Bioeconomy Division: Division Bioeconomy Medtech

Flexible X-ray detectors (Flex-Ray)

Flex-Ray

Unlike traditional X-ray film, today's digital detectors are rigid, which means that they can't be used to analyze three-dimensional surfaces.

This project developed technology for flexible digital X-ray detectors.

Project participant

Completed

Fibre optics and photonics Digitalisation Electronics Medical devices Generic metrology and measurement technology Sensors and sensor systems

2020-09-01

3.5 years

753 kEuro

TWI Hellas Univ of Sheffield Optoelectronica 2001 Fraunhofer HHI

EU H2020 FET Open

Division: Division Digital Systems and Societal Transformation

Flex-Ray project page

TWI Hellas

Joao Pereira Åsa Claesson Per Olof Hedekvist Nazila Safari Yazd

X-ray analysis is important in many applications, such as medical technology, food safety, materials testing and particle physics.

Today, digital detectors are often used instead of traditional photographic films. But with digital detectors, which are rigid instead of flexible, it is difficult to make a detailed analysis of three-dimensional objects because the geometry is distorted when the measurement does not take place on the surface.

This project developed methods and systems to provide digital X-ray detectors that are flexible. A new type of scintillating optical fiber was combined with shape sensing systems, photomultipliers and ultra-fast electronics to create detector surfaces.

Experts in fiber optics, measurement technology and electronics participated from RISE. Our focus was on scintillating fiber arrays.

RISE publications from the project

"Flexible Liquid-Filled Scintillating Fibers for X-Ray Detection", M. Lindblom, M. Patzauer, U. Vogt, S. Wilbur, N. Safari Yazd, K. Hey Tow, W. Margulis, Å. Claesson, S-C. Ebenhag. IEEE SENSORS, Conference proceedings (Nov 2023) DOI.
"Flexible X-ray imaging detectors using scintillating fibers", S. Wilbur, C. Anastopoulos, M. Angelmahr, G. Asfis, J. Koch, M. Lindblom, K. Lohwasser, W. Margulis. Journal of Instrumentation, 17 (10) 2022. DOI.

This project has received funding from the European Union's Horizon 2020 research and innovation program under grant agreement 899634. The project runs within the 'Future emerging technologies' program.

Nazila Safari Yazd

Forskare

+46 10 228 42 66 Read more about Nazila

3. Good health and well-being

9. Industry, innovation and infrastructure

Fiber optics and photonics / Expertise

Fiber optics

Want to measure temperature at hundreds of positions in a harsh environment? Do you need to bring intelligence into systems where you can't use electricity? Do you want to develop new solutions for minimally invasive surgery? Then fiber optics can be the solution for you.

Fiber optics and photonics / Expertise

Specialty optical fiber

At RISE Fiberlab, we develop and manufacture custom-designed optical fibers for advanced applications where standard telecom fibers don’t suffice. With more than 25 years of experience, we support everything from early-stage research to small-scale production and qualification.

Fiber optics and photonics / Expertise

Fiber optic sensors

Fiber optic sensors are insensitive to electromagnetic fields, can be interrogated at a distance, and can withstand harsh environments.

Metrology / Expertise

Position, Navigation and Time

Technology development in the society is progressing faster. Determination of position, navigation and time is part of daily life regardless of whether one buys a bus ticket, purchase food, communicates via mobile phone or navigate. In order for these functions to function faultlessly, there must be a tracible distribution of PNT.

National Metrology Institute / Expertise

National Laboratory for Time and frequen

RISE is Sweden's NMI (National Metrology Institute) and, according to the Swedish constitution, is responsible for the fundamental measurement quantities in the International System of Units, SI.

National Metrology Institute / Expertise

The National Laboratory for Photometry a

RISE is Sweden's NMI (National Metrology Institute) and is, according to the Swedish constitution, responsible for the fundamental measurement quantities in the International System of Units, SI.

Fiber optics and photonics / Expertise

Photonics

The 21st century belongs to Photonics. Just like electronics revolutionized 20th century, photonics opens up fantastic new possibilities.

Division Digital Systems and Societal Transformation

Projekt logo:

Project end date: Sun, 12/31/2023 - 12:00 Fiber optics and photonics Sekundär områdes navigation:
Metrology
Sensors and sensor systems
Semiconductors and power electronics
Medtech

Individualiserade organ ska testas på patienter

Det finns ett stort intresse globalt för ATMP, Advanced Therapy Medicinal Products. Det handlar om regenerativmedicin, det vill säga cellterapi, genterapi och vävnadsterapi som alla bygger upp eller ersätter organ i kroppen. RISE har under många år samarbetat med biotech-bolaget VERIGRAFT, det handlar om en ny metod för att individanpassa blodkärl för transplantation av vener med klaffar.

Miljontals människor världen över har sjukdomen kronisk venös insufficiens, en sjukdom som beror på att en eller flera av de djupa vener som innehåller klaffar i benen har slutat att fungera. Denna sjukdom saknar idag effektiv behandling. Klaffarna sluter inte tätt och det kan leda till svullnade ben och svårläkta sår på grund av att blodet inte pumpas tillbaka till hjärtat från benen tillräckligt bra. Med den nya behandlingen kan ett individualiserat kärl med klaffar transplanteras till patienten, och då utan att få en immunologisk avstötningsreaktion. Transplantation av organ är aldrig enkelt och patienten behöver äta immundämpande mediciner i resten av sitt liv för att inte riskera att kroppen stöter bort organet. RISE har hjälpt VERIGRAFT att ta fram sin produkt Personalised tissue engineered veins, P-TEV, med en metod som undviker att patientens kropp vill stöta bort det transplanterade organet.

– Hela industrin vill gå mot att individualisera organen innan transplantation. Vi har börjat använda en ny metod där vi decellulariserar organet, alltså tvättar bort alla cellerna så att endast bindvävsstrukturerna blir kvar. Bindvävsstrukturen rekonditioneras sedan med patientens eget blod och förbereds för recellularisering när organet transplanteras in i kroppen, säger Joakim Håkansson, forskare på RISE.

Stor efterfrågan

VERIGRAFT och RISE arbetar tillsammans kring både klaffar i vener och artärer men har kommit längst i studierna för vener och testerna har slagit väl ut. Nu förbereds kliniska studier, det vill säga studier på patienter, i Spanien. Studierna var egentligen tänkta att påbörjas innan sommaren 2020 men på grund av Coronapandemin har det dragit ut på tiden och återupptas igen inom kort.

Metoden kan användas inom fler områden. Till exempel för kranskärlsoperationer, på njursjuka där de återkommande dialyserna kan göra att patienternas blodkärl skadas så mycket att de behöver ersätta kärlen med en arteriell venshunt.

– Trots att det är mycket fokus på ATMP så saknas bra strukturer i Sverige inom området. Det finns inte heller något större utbud på produktionsanläggningar. VERIGRAFT är ett av de bolag som har kommit längst i världen med sin produkt, säger Joakim Håkansson.

Det goda samarbetsklimatet och höga kompetensnivån hos RISE medarbetare har varit helt avgörande

Från idé till färdig produkt

Att RISE varit med och hjälpt till med VERIGRAFTs produktutveckling i flera steg bäddar för långa och goda relationer. Samarbetet med VERIGRAFT är ett bra exempel där RISE har varit med i hela utvecklingsfasen och projektet är både ett uppdragsprojekt men där offentliga medel sökts, och erhållits, genom gemensamma forskningsansökningar.

– VERIGRAFT har sedan 2014 arbetat tillsammans med RISE och organisationens experter i en serie olika projekt. RISE har framför allt varit viktiga i VERIGRAFTs flaggskeppsprojekt, P-TEV, som har som mål att för första gången testa företagets individualiserade vener med klaffar i människa. Forskare och projektledare på RISE har här bidragit med, för VERIGRAFT, helt avgörande kompetens. Exempel på vad RISE har bidragit med är funktionsutvärderingsmodeller, kvalitetstester, steriliseringsmetoder, automatisering av tillverkningsprocessen och regulatorisk dokumentation. RISE har fyllt luckor i VERIGRAFTs egen kompetens som hade varit mycket svårt att erhålla på annat sätt. Det goda samarbetsklimatet och höga kompetensnivån hos RISE medarbetare har varit helt avgörande för VERIGRAFTs utveckling, berättar Petter Björquist, VD VERIGRAFT.

– RISE lyssnar på industrin och utgår alltid från kundens behov. Vi tar gärna en roll som partner och är med hela vägen från idé till färdig produkt. Vi är många på RISE som arbetar inom området och har bland annat kunskap inom säkerhet, funktion, automatisering, sterilisering, utveckling och metodutveckling. Tillsammans med kunderna kan vi accelerera utvecklingen och göra stor skillnad för många människor, avslutar Joakim Håkansson.

Joakim Håkansson

Forskare

+46 10 516 54 10 Read more about Joakim

Medicinteknik

Kalibrering – för att veta att det du mäter är rätt

Mätinstrument måste vara tillförlitliga och bör därför kalibreras. Om beslut fattas på felaktiga grunder kan det leda till felaktiga konstruktioner och resultat. För att få tillförlitliga mätinstrument ska man regelbundet kalibrera dem hos ett kalibreringslaboratorium. Kalibreringslaboratoriet jämför mätinstrumentet med ett korrekt mått, det vill säga en spårbar normal.

På RISE utför vi kalibrering inom alla storhetsområden. I flera fall kan vi även utföra kalibrering i din verksamhetsmiljö. Som kund får du nära tillgång till mätteknisk kompetens för flera teknikområden. Vi har lång erfarenhet av inventering av instrumentparker, kravnivåer och mätbehov i industrin.

Vi hjälper dig med att inventera instrumentparker och göra en bedömning av vilka instrument som behöver kalibreras, till vilken omfattning och till vilken noggrannhetsnivå. Kalibreringsingenjörerna har åtkomst till hela den spårbarhetskedja som moderna kvalitetssystem kräver för kalibrering av mätinstrument. Genom att delta i den löpande utvecklingen av ny mätteknik och i internationella jämförelsemätningar kan vi även säkra spårbarheten från de nationella normalerna eller referenserna till dina mätningar – allt under samma tak.

Glöm inte att det är experter som har hand om ditt objekt. RISE personal består av en mix av mättekniker, civilingenjörer, doktorer och forskare, vilket under åren kommer leda till en kontinuerlig utveckling av den kalibreringstjänst som du som kund erhåller. Om du har önskemål om vad det än månde vara, så kan du ställa frågan till din mätingenjör. Högst troligt så finns det alltid någon i organisationen som du kan bolla dina tankar med.

Kontakta oss via formuläret eller ring 010-516 51 01.

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Medicinteknik
Produktion och tillverkning

Speech-to-Text System using Augmented Reality for People with Hearing

STAR

The aim of the project is to study visual, optical and ergonomic conditions for a speech-to-text
system that, through Augmented Reality (AR)-technology, presents text for people with hearing
impairments. STAR is a project for innovation which both develops the technology and studies the basic conditions for such a system.

Coordinator

Completed

Digitalisation

Region Stockholm

2019-11-18

15 months

1630000 SEK

Division: Division Digital Systems and Societal Transformation

Kjell Brunnström

The project will explore visual, optical and ergonomic conditions for a speech-to-text system that will present text to people with hearing impairment using technologies based on Augmented Reality and automatic speech recognition (Speech-to-Text System using Augmented Reality ”, abbreviated STAR).

The goals are to
1. create a demonstrator for an AR-based speech-to-text system
2. implement an experimental set up and
3. investigate basic visual, optical and ergonomic principles for presenting text in AR for people
with hearing impairments, to create a demonstrator for an AR-based speech-to-text system, with
related guidelines.

The project will be led and carried out by RISE Research Institutes of Sweden in close collaboration with De Hörselskadades Riksförbund, HRF (the organisation in Sweden for people with hearing impairments).

Project members at RISE are: Börje Andrén, Kjell Brunnström, Pär Johanson and Bo Schenkman

This project is now finished, but continues in RISE funded projects about digital aids for people with sensory disabilities and medical equipments

Kjell Brunnström

Forskare

+46 70 841 91 05 Read more about Kjell

Division Digital Systems and Societal Transformation

Project end date: Wed, 02/17/2021 - 12:00 Medtech Sekundär områdes navigation:
Artificial intelligence
Design
Advanced electronics

Testing of protective devices

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): Testing of protective devices Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

Testing of products and devices according to EN 149, EN-ISO 20743, EN 14683, EN 1500,EN 1499, EN 166 and EN ISO 18526-3.

Purpose/Benefit:

During the corona pandemic (Covid-19), RISE focuses and prioritises efforts to support the hospitals and producing companies. This could be testing products and changing their production line. Part of this is testing of protective equipment such as respiratory protection, antibacterial textiles and disinfectants to document that the protective equipment meets current legal requirements in order to be delivered to the healthcare system. Examples of what we offer are:

EN 149 - Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
SS-EN 14683:2019 Medical face masks - Requirements and test methods.
SS-EN 1500:2013 Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements
SS-EN 1499 Chemical disinfectants and antiseptics - Hygienic handwash - Test method and requirements
ISO 20743:2013 Textiles — Determination of antibacterial activity of textile products
EN 166 Personal eye protection. Specifications
EN ISO 18526-3 sections 6.2 and 6.3 Eye and face protection. Test methods. Physical and mechanical properties

Method (what/which methods are used to perform the service):

EN 149 - Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
SS-EN 14683:2019 Medical face masks - Requirements and test methods.
SS-EN 1500:2013 Chemical disinfectants and antiseptics - Hygienic handrub - Test method and requirements
SS-EN 1499 Chemical disinfectants and antiseptics - Hygienic handwash - Test method and requirements
ISO 20743:2013 Textiles — Determination of antibacterial activity of textile products
EN 166 Personal eye protection. Specifications
EN ISO 18526-3 sections 6.2 and 6.3 Eye and face protection. Test methods. Physical and mechanical properties

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

Results are delivered in a written report.

Area:
Infection control
Life Science Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Sara Bogren, Avdelningschef

person with protective clothing preparing for surgery

Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: No preparation required Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Order information: Contact the persons listed

Medtech / Service

Medical device management system certification - ISO 13485

Do you manufacture or distribute medical devices in Europe? If so, you must comply with the MDR and IVDR. RISE certifies your management system to ISO 13485 – an accredited route to regulatory compliance that gives you credibility with authorities, customers and partners.

Divison (OLD): Division Materials and Industry Delivery level:
Accredited
Non-accredited

sara.bogren@ri.se

/en/node/9710

More information:

Contacts - all methods
Simonetta Granello, 010-2284801, simonetta.granello@ri.se
Sara Bogren, 070 915 18 08, sara.bogren@ri.se

Contact- for EN 149
Simonetta Granello, 010-2284801, simonetta.granello@ri.se

Contact- for SS-EN 14683
Sara Bogren, 070 915 18 08, sara.bogren@ri.se

Contact - for ISO 20743
Josefin Caous, +46 10 516 59 96, josefin.caous@ri.se

Contact - for SS-EN 1500 and SS-EN 1499
Jenny Johansson, +46 10 516 5360, jenny.johansson@ri.se

Contact -EN 166
Kristina Follin, +46 10 516 5221, kristina.follin@ri.se

Contact - EN ISO 18526-3
Konrad Tarka, +46 10 516 5680, konrad.tarka@ri.se

3. Good health and well-being

Order

form

Medtech Sekundär områdes navigation:
Metrology
Security of supply
Textiles Tjänstetyp tagg: Provning

UX Lab – Test environment for evaluating usability and accessibility

UX Lab

UX Lab is mainly used for testing and evaluating usability and user experiences on products and services. The lab is modular and simulates the natural environment of the products being evaluated. With the latest technology and cutting-edge expertise, we can offer a test environment for many different products and needs.

Testbeds in real life (TR)

Region Stockholm

Jessica Dagman

Enhetschef

+46 10 516 54 30 Read more about Jessica

Off

Division: Division Digital Systems and Societal Transformation

User Experience (UX) is a design process about getting insight into what the user says, does, uses, knows, feels, wants and needs. By acquiring knowledge about your users, you also increase the opportunities to create meaningful products, services and experiences that meet their needs.

In the UX Lab various forms of user tests, market research and focus group discussions can be carried out. High quality video recordings of user tests can be performed and the findings summarized, which can be useful for further development of the product as well as for communication and presentation. To enhance your understanding and knowledge of your users even further, your team has the opportunity to participate and observe the users' tests, either at the lab or through a live stream.

When live streaming, multiple camera views in combination with the mirroring of a smartphone and/or digital prototype can then be shown to observers online. Remote tests, where the user and moderator are in different locations, can also be arranged and performed through UX Lab.

The lab rent always includes a technician who helps to prepare the room according to your wishes. If you need recommendations and help in planning and conducting various studies, we have experts at hand. This implies that you choose whether you want to rent the lab with or without Usability Researchers.

RISE

Other

Circular transition Design Digitalisation Digital health Internet of Things Professional education Medical devices Mobility Perception Service innovation

Not applicable

2015

Design / Expertise

UX, usability and user research

Understanding users and their needs is essential for achieving success. Through qualitative and quantitative methods such as user tests, heuristic evaluations, focus groups and questionnaires we offer you knowledge about usability and user experience. This is a necessity today for creating competitive products and services.

Design / Service

We test, analyze, and improve your product—for real.

We help you understand how people actually use your product, service, or environment—and how you can make it better.With over 20 years of experience, flexible working methods, and one of Sweden’s most advanced UX labs, we deliver insights that reduce risks, save time, and lead to solutions that work for more users.

Social sustainability in urban development / Expertise

Accessibility

Accessibility means that people with various disabilities should be able to take part of what you are developing. Design choices can inadvertently exclude people from being able to use a product or service. We help you create accessible design for a socially sustainable society, and as a result, the solutions are usually better for everyone to use.

Division (OLD): Division Digital Systems and Societal Transformation Design Sekundär områdes navigation:
Digital health
Medtech

Biological evaluation of medical devices according to ISO 10993

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): Biocompatibility evaluation Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

Purpose/Benefit:

The aim of the biological safety evaluation is to ensure that possible negative effects on human health caused by the materials in the product shall be identified and managed. We are a dedicated collaboration partner with solid knowledge about current regulations, available test methods and good test strategies. We are also the only laboratory in Sweden to offer cell based test methods according to the quality system Good Laboratory Practice (GLP) to external customers.

In the EU and in the US, the legislative requirements for biocompatibility of materials in medical devices are similar. The standard series ISO 10993, describing test strategies and – methods to ensure biocompatibility, is combined with the standard ISO 14971, which concerns risk management for medical devices. These two standards form the framework for generating a biological safety evaluation plan.

Method (what/which methods are used to perform the service):

Generating a biological safety evaluation plan is performed in several steps:

Planning and executing a biocompatibility evaluation according to ISO 10993-1, choice of suitable methods and waiving of certain tests.
Toxicological evaluation of included parts and chemical substances according to ISO 10993-17 and relevant regulations.
Determination of leachables and/or extractables from ceramic, metallic or polymeric materials according to ISO 10993-18.
Chemical characterisation of included materials with techniques such as FTIR, DSC, XRF, CHN, XRD, surface area determinations, polymer molecular weight determination, etc, according to ISO 10993-19.
Determination of degradation products from materials according to ISO 10993-9, ISO 10993-13, ISO 10993-14, and ISO 10993-15.
Biological testing of materials according to ISO 10993-1, such as cytotoxicity, skin sensitization and skin irritation.
Risk evaluation and risk management plans for residual risk.

RISE has extensive personnel and instrumental resources available, to perform all steps up to a complete biological safety evaluation plan.

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

Results from testing or evaluation are presented in one or several reports in Swedish or in English as agreed with the customer. For tests performed according to GLP, a study plan is set up before the start of the test.

Delivery time:

Stated in the tender and depends on the type of assignment.

Area:
Medical devices
Product safety Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Charlotte Nilsson, Toxikolog

Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: Description of preparation Preparation information:

In case testing shall be performed, information about the test item(s) is given in a sample submission form submitted to us at RISE together with the test item(s). It is the responsibility of the customer to characterise the test item(s) sufficiently to fulfill GLP requirements.

Standards:

ISO 10993-series, ISO 14971, ISO/IEC 17025, OECD principles of Good Laboratory Practice

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Order information: Please contact our toxicologist at the bottom of this page.

Medtech / Service

ISO 10993-5 Cytotoxicity Test - in vitro

Cytotoxicity testing is a crucial part of the biological evaluation of medical devices and is a necessary step to meet the requirements of the Medical Device Regulation (MDR). RISE conducts cytotoxicity testing according to ISO 10993-5 and is accredited under ISO/IEC 17025 or GLP (Good Laboratory Practice).

Medtech / Service

ISO 10993-23 Skin Irritation - in vitro

Irritation testing is a critical component of the biological evaluation of medical devices and a necessary step to meet the requirements of the Medical Device Regulation (MDR). RISE conducts irritation tests according to ISO 10993-23 and adheres to Good Laboratory Practice (GLP).

Divison (OLD): Division Bioeconomy Delivery level: Not applicable

charlotte.nilsson@ri.se,

/en/node/9710

More information:

Please feel free to contact us for advice on 10993 tests – we’ll help you find the right solution.

Application of interest

form

Medtech Sekundär områdes navigation:
Biotechnology
Materials and durability Tjänstetyp tagg: Provning

ISO 17665 Validation of Sterilization Instructions

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): ISO 17665 Validation of Sterilization Instructions Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

In the Instruction for Users (IFU), supplied with reusable medical devices or medical devices to be sterilized by the user, there should be a validated instruction for sterilization. We can validate the sterilization of your product, according to EN ISO 17665:2024.

Purpose/Benefit:

Contribute to healthcare safety by providing clear and validated instructions for sterilization.

Fulfill requirements in MDR.

Method (what/which methods are used to perform the service):

Sterilization validation is performed by showing a sterility assurance level (SAL) of 10^-6 using, for the method most resistant organism, Geobacillus stearothermophilus, at a concentration enough to show a sterility assurance level (SAL) of minimum 10^-6. Inoculated devices are packed according to the instructions and processed with moist heat following the partial cycle approach i.e. a shorter time than stated in the instructions is used. Potential surviving spores on the devices are incubated in growth medium and evaluated for turbidity according to ISO 11737-2.

We can also evaluate that the drying time after sterilisation is enough, to ensure safe storage of the product. RISE provides a Systec DX-90, validated according to ISO 17665 with external temperature probes.

We can also validate the instructions for cleaning and disinfection according to ISO 17664-1/2, ISO 15883-5 and ANSI/AAMI ST98: Validation of instructions and processes for cleaning and disinfection of medical devices | RISE

Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

Methods and results are presented in a written report.

Delivery time:

Area:
Infection control
Chemical and biological analysis
Medical devices Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Louise Wogelred, Forsknings- och utvecklingsingenjör

Field measurements: No Price type: 1 Priceinformation:

Please contact us for price information

Division: Division Materials and Industry Preparation: Description of preparation Preparation information:

The customer prepares the test items unless otherwise agreed

Medtech / Service

ISO 17664 Validating Instruction for Users - cleaning and disinfection

For reusable medical devices, there must be a validated Instruction for Users (IFU) for cleaning and disinfection. We assist in creating a functional instruction according to both ISO 17664-1 and ISO 17664-2 and validate that the products are properly cleaned and disinfected.

Medtech / Service

ISO 10993-5 Cytotoxicity Test - in vitro

Medtech / Service

ISO 10993-23 Skin Irritation - in vitro

Divison (OLD): Division Materials and Industry Delivery level: Non-accredited

louise.wogelred@ri.se,

/en/personal-data-processing/candidate-database

3. Good health and well-being

Order

form

Medtech Sekundär områdes navigation:
Metrology
Risk and security Tjänstetyp tagg: Verifiering och validering

Sarunas Petronis

Lina Nyström

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