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Ukrainian company wants to reach Swedish customers - now their gun safes are certified

 Man in a blue suit in a factory that manufactures gun safes

Paritet-K has identified Swedish hunters and target shooters as an important new customer base. After a somewhat unusual process with RISE, the company's gun safes are now certified to Swedish safety standards. This will enable the Ukrainian company to expand its business and contribute to the recovery of its home country.

The Ukrainian company, which has won several awards at home for its bank vaults, safes and gun safes, saw great potential in the Swedish market. But in order to add Sweden as its 55th export market, Paritet-K first had to prove that it complied with Swedish regulations.

We'll tell you how the company got there, but first let's go back to a market survey that marked the beginning of Paritet-K's Swedish story. Export Manager Evgen Dronov lists some of the findings about Sweden that the company picked up.

– Through our research we found out that almost three per cent of the Swedish population has a hunting licence, which strongly suggests that Sweden is an interesting market for us. Also the fact that its inhabitants have a comparatively high average income and that it is common practice to store insured and theft-prone possessions in safes, says Mr Dronov.

Certified according to Swedish safety standards

During the research phase, the company also found out about the national legislation for gun safes. In order to sell gun safes in Sweden, the products must be approved according to the SSF 3492 standard. A gun safe approved to SSF 3492 is protected against burglary by a thick special plate and a lock that cannot be manipulated.

With this information, Paritet-K contacted all the accredited certification bodies in Sweden. After careful comparison, Partitet-K chose RISE. The fact that RISE is an internationally recognised player had an impact, says Evgen Dronov. Their in-house laboratory testing capabilities was also a great advantage.

– Everything went very smoothly. RISE were both friendly and professional. The process was very similar to the one we went through to get the certificate in Germany. The biggest challenge we faced was that due to the war, RISE could not go to our production facility in Ukraine and make a physical visit, says Evgen Dronov and continues:

– Instead, RISE managed to conduct the audit via video. The inspection itself was not different than others, as we are ISO-certified in quality management and undergo annual inspections of our production facility.

Everything went very smoothly. RISE were both friendly and professional.

In search of partnerships

Companies like Paritet-K plays an important role in driving innovation, creating jobs and contributing to the reconstruction of Ukraine. This was a key consideration when RISE took on the certification assignment.

– The picture that emerged was of a well-organised, multi-award-winning company that was already certified by Polish and German certification bodies. We felt that this was enough for us to make a digital visit rather than a physical one. We wanted to help this Ukrainian company and not pull the rug out from under a serious player that needed certification to sell its products in Sweden,' says Nima Azarmehr, certification engineer at RISE:

– Paritet-K was an ideal customer for us in many ways. They responded quickly and sent additional information that made the process easier. I hope that we will soon be able to visit the company and meet them in person.

With the SSF 3492 approval in hand, the door to the Swedish market has been opened for Paritet-K. Now the work of building important partnerships has begun.

– At the moment we only sell to retailers, so our ideal customers are Swedish wholesalers of safety cabinets. Hunting shops are also an important group of partners. It is too early to analyse the results of our presence on the Swedish market, but it looks like it will increase our turnover and create positive economic results for our country,' says Evgen Dronov.

HOW THE CERTIFICATION PROCESS WORKS

As an approved certification body for the Swedish Theft Prevention Association (SSF), RISE can certify a variety of products, including safes, in accordance with SSF 3492. The process starts with the submission of an application together with documentation for the product to be certified. This is followed by a series of tests. In the case of security or armoury safes, these include manual break-in attempts. If the requirements are met, RISE will issue a certificate. This is followed by annual audits of the factory.

Nima Azarmehr

Ingenjör
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Last published: Physical protection and safety Sekundär områdes navigation:
Metrology
Built environment

Compounding, injection molding and extrusion of plastics

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

We have process equipment for compounding, injection molding and extrusion. We perform testing of new material compositions, vary process parameters and prepare samples for evaluation. We offer equipment in the range from lab to pilotscale, providing possibilities for product development and solving problems.

Purpose/Benefit:

Material and product development of plastics require process equipment in lab and pilotscale in order to test new ideas without disturbing a production or requiring too much material. Through our broad experience and close cooperation with our partners we contribute to development in order to reach new goals and targets.

Tests and experiments in small scale means advantages regarding time to develop a material or a process, or when working with optimization. We can easily vary the materials composition and parameters.

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

In our microcompounder in Borås, small batches can be mixed efficiently when there is a need for small-scale trials. We also have lab extruders of the Brabender Plasti-Corder®Labstation type with great flexibility and great opportunities for smaller batches, for example. from 100 to 5000 g/h. In connection, there is the possibility of injection molding of test specimens.

Our compounder in Mölndal is a double screw extruder of the type Coperion ZSK 26 with 255 mm screws and L/D 40. It is equipped with side feeder and vauum pump. The output capacity is in the range 0,5-25 kg/h and the compound is air or water cooled before pelletizing. We have various feeders in order to add and test different additives and for preparation of composites

Our injection molding machine, also in Möldanl is of the type ES 200/110 HV-L by Engel. We have tools for injection molding of test bars (dog bones) for evaluation of mechanical properties and tools for plates in order to evaluate impact by falling object or evaluation of transparency.  We have a spiral tool used for measuring flow length that will measure how the material behaves during molding at a specific temperature and varying pressure. Melt flow index (MFI) is often measured for injection molding materials and we evaluated according to the standard ISO 1133. Injection molding of test bars follow the standrd ISO 294 but for each plastic material there are standards that we follow which specify the temperature and pressure that is recommended for that material.

We can extrude film and foil that is up to 300mm wide and with a thickness in the range 0,1-1mm. The equipment has 3 extruders making it possible to create foils with 3 different layers.

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

We always have a dialogue with our customers and partners what is to be included in the deliveries. It can range from achieving an optimized recipe based on a certain specification of properties to that we, with you as a visiting customer on site,  make joint decisions upon alternatives for the next set of process parameters to be tested. It is important for us that you know what you can expect from us.

Area:
Material transition
Plastics
Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Christian Carlsson, Enhetschef
Extrusion of film
Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: No preparation required Standards:

ISO 294 Injection moulding of test specimens of thermoplastic materials

ISO 1133 Plastics — Determination of the melt mass-flow rate (MFR) and melt volume-flow rate (MVR) of thermoplastics

Certification and marking: Not applicable Type of service: Innovation services Instrument: Not applicable General area: Not applicable Delivery level: Not applicable
christian.carlsson@ri.se,fredrik.p.bergfeldt@ri.se
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12. Responsible consumption and production
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Plastics Sekundär områdes navigation:
Metrology
Production and manufacturing
Chemical products and processes
Tjänstetyp tagg: Produkttillverkning

Unlock the potential of aluminium: sustainable solutions and innovative partnerships

Sustainable aluminium

Aluminium is crucial for a sustainable and competitive future due to its lightweight properties, strength, and recyclability. However, challenges remain, such as energy-intensive production with significant carbon emissions and complex recycling processes that may negatively impact material quality. At RISE, we offer expert support to tackle these challenges, streamline processes, and unlock the sustainable potential of aluminium.

The role of aluminium in sustainability

Aluminium is an indispensable material, valued for its lightweight nature, strength, corrosion resistance, and recyclability. It plays a vital role in the transition to net zero, supporting sustainable solutions across various industries, including energy-efficient transportation and durable, lightweight construction materials.

The challenges in aluminium production and usage

Despite its advantages, significant challenges exist in the production and use of aluminium. Production is energy-intensive, with high carbon emissions and environmental impacts from bauxite mining. Although highly recyclable, effective recycling and scrap management pose challenges due to potential impurities and variations that can affect product quality. Additionally, by-products from the manufacturing process can be difficult to manage in an environmentally friendly and cost-effective way, potentially impacting profitability and competitiveness.

How RISE can support you

RISE is here to help minimise these challenges and promote the sustainable use of aluminium through a combination of services and expertise in research, development, and innovation.

What we can help you with

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Why choose RISE for your development project?

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How to become a RISE customer

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We'd like to hear from you

Contact me to drive progress and innovation in sustainable aluminium development. We are here to support you throughout the entire process, from concept development to the final product!

Johan Fast Berglund

Forskare
+46 10 228 47 04 Read more about Johan
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Do you have questions or want to know how RISE can support sustainable aluminum development? Get in touch with us!

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Division: Division Materials and Industry Casting Sekundär områdes navigation:
Circular transition
Metrology
Production and manufacturing

New system for monitoring hydraulic pump systems

MonPuForm
Engineer in control room

MonPuForm aims to develop a new monitoring system designed to offer knowledge-based support for managing hydraulic pumps used in hydraulic servo presses.

Coordinator
Completed
Upskilling Production and manufacturing
Not applicable
2,5 years
5,5 MSEK
Division: Division Materials and Industry

Purpose and Objectives

The main objective of MonPuForm is to minimize the risk of critical operational issues and wear, while improving the reliability of hydraulic pump systems. The project aims to identify key parameters and develop an integrated monitoring system that supports predictive maintenance, ensuring pumps are only serviced or replaced when a potential failure is anticipated.

Background and Challenge

The shift towards a resilient, climate-neutral industry requires greater digitalization, improved resource efficiency, and strengthened resilience across the entire value chain. This is especially true in the manufacturing sector, where the need for advanced plant technology that supports these goals is on the rise. Furthermore, there is increasing demand for production support of geometrically complex components based on novel materials with tailored properties.

In forming technology, the transition is reflected in modified and new process techniques (e.g., pulsation drawing, press hardening). The broader application of advanced forming processes leads to increased strain on machine components, particularly hydraulic drive systems for forming machines. Additionally, the boundary conditions related to load cases, and therefore the stress on the hydraulic drive system, are constantly changing due to a wide product range and smaller batch sizes, which is particularly relevant for small and medium-sized enterprises (SMEs).

These conditions can lead to significant damage to pump systems, potentially causing damage to the component in continuous operation, up to and including total failure.

Solution

A promising method for reducing operational uncertainties and detecting overloads or critical wear and tear conditions at an early stage is monitoring of the hydraulic pump system. While sensor-based monitoring systems for physical variables are already available in the market, they often struggle to accurately assess the operational status of complex hydraulic systems.

Therefore, MonPuForm aims to develop a condition monitoring system that provides knowledge-based support for the operation of hydraulic pumps used in hydraulic servo presses. The foundation of the project is a sensor system integrated into the hydraulic drive system. The key to effectively monitoring machine components lies in linking sensor data with technology-specific process and machine data.

Additionally, the information and data can be used to strengthen or redefine existing business relationships between machine and component manufacturers, as well as to develop new business models using the new monitoring system.

Expected Impact

The project is anticipated to have a range of positive effects for Sweden and its competitiveness. Currently, pumps are often replaced prematurely by adhering to standard service intervals. The implementation of the MonPuForm system would enable predictive maintenance, allowing pumps to be repaired or replaced only when the monitoring system predicts a risk of failure. Hydraulic servo presses are a significantly more resource- and energy-efficient alternative to conventional servo presses. Access to a predictive monitoring system that significantly reduces pump system failures would promote the wider use of hydraulic servo presses in the manufacturing sector, ultimately helping to conserve the Earth’s resources.

The development of an advanced monitoring system positions Sweden as a technological leader in the manufacturing industry and can help Swedish industry expand its presence in multiple markets. We also anticipate that the project will promote skills development and generate new expertise in areas such as data analysis, IoT technology, and industrial automation—factors that could attract young, talented workers to the manufacturing sector.

Successful project outcomes could be applied to other types of pump systems, thereby having an even greater impact on sustainability.

Carolina Pettersson

Forskare
+46 10 228 47 37 Read more about Carolina
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Thomas Skåre

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8. Decent work and economic growth
9. Industry, innovation and infrastructure
12. Responsible consumption and production
AP&T Sweden AB IPercept Technology AB HyPneu Service GmbH Fraunhofer Institute for Machine Tools and Forming Technology (IWU)
Project end date: Production and manufacturing Sekundär områdes navigation:
Metrology
Artificial intelligence
Data Science
Sensors and sensor systems
Digital infrastructure

Psychometric Evaluation Services and Survey Support

Psychometric Evaluation Services
People

Have you considered whether your survey questions actually capture what they are intended to measure? How do you build reliable decision-making support based on survey data? How can we measure things that cannot be observed directly, such as experiences, feelings, and attitudes?

RISE can assist with survey development and psychometric measurements

Scientifically grounded and reliable methods are essential when important decisions are made based on data and measurements. Surveys are increasingly used for data collection, but the questions and response scales are often not designed according to research on survey methodology and questionnaire design. In addition, survey-based measurements rarely undergo rigorous scientific quality assurance.

Using scientifically validated methods, we help design and refine surveys to ensure that every component contributes effectively to the overall purpose of the measurement.

Quality-Assured Survey Development

Perhaps the most important quality criterion for surveys and response scales is their ability to measure what they are intended to measure, that is, the validity of the survey. At the same time, the respondent experience must be taken into account. In an era of declining response rates and increasing survey fatigue, methods are needed that encourage high participation and elicit honest and reliable responses, ensuring that the results accurately reflect reality.

A thorough understanding of the survey response process, and ensuring that questions are interpreted consistently by all respondents, is essential. RISE has extensive expertise in questionnaire design, response scales, survey methodology, and cognitive testing methods. We can also support data collection methods, fieldwork, and non-response adjustment (see Statistical Analyses).

Quality-Assured Measures of Intangible Constructs

Sometimes what we want to measure is not directly observable, such as experiences, emotions, or attitudes. These constructs are often measured using survey questions with ordinal response categories, for example:

  1. Strongly agree
  2. Partly agree
  3. Hardly agree
  4. Do not agree at all

However, such responses are often analyzed as if they were numerical interval data, which can lead to biased estimates of the underlying construct (such as an attitude, ability, or experience).

Using Item Response Theory (IRT) and advanced measurement methods, we can transform ordinal data (category-based data) into interval-level data (data with equally spaced scale steps). RISE has extensive expertise in IRT, enabling us to ensure the validity, precision, and comparability of measurements.

Typical Project Process

1. Needs Assessment and Planning

Initial discussions to understand the purpose, objectives, and measurement needs. We can also provide expertise in impact evaluation and measurement.

2. Survey Design and Development

We identify and map the relevant theoretical frameworks underlying what is to be measured. We design and develop survey questions and response scales, or refine existing ones. For psychometrically based instruments, we place particular emphasis on ensuring validity and reliability. We often recommend pilot studies to test and evaluate survey items before implementation.

3. Analysis and Refinement

We analyze collected data to verify that the measures capture the intended constructs. We conduct quality assessments of the data and provide recommendations for improvement and adjustment.

4. Reporting

Delivery of finalized survey questions and response scales, together with a report containing implementation guidance and analytical recommendations.

Our Areas of Expertise at a Glance

Survey Development Support

Support in developing surveys that reliably measure the intended constructs.

Statistical Analyses

Quality-assured advanced data analysis using modern psychometric methods such as Item Response Theory (IRT) or Classical Test Theory (CTT).

Design of Statistical and Scientific Studies

Design and implementation of statistical and scientific investigations, including research design, sampling methodology, data collection, data analysis, and scientific reporting.

Nicklas Berg-Korsell

Forskare
+46 10 516 55 58 Read more about Nicklas
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Magnus Jansson

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Division: Division Safety and Transport Health and life science Sekundär områdes navigation:
Metrology
Digitalisation

Advanced Materials Technology Verification for Nuclear Energy

AMTVINE
Additive Manufacturing

AMTVINE is a framework for several work packages targeting verification of additively manufactured stainless steels and coated claddings during normal operation in light water reactors (LWRs). The project includes a unique examination and testing of novel fuel materials after operation in LWRs.

Coordinator
Active
Additive manufacturing
Not applicable
3 years
30 MSEK
Division: Division Materials and Industry

Purpose and goal

The main goal of AMTVINE is to advance the implementation of Additive Manufacturing (AM) and enhanced Accident Tolerant Fuel (ATF), in Swedish nuclear power. 

The challenge

The overall cost and time of building new plants and extending the lifespan of existing plants, along with the public perception of safety (risk of accidents), currently impedes the expansion of nuclear power production in Sweden, and globally. 

The solution

Additive Manufacturing and enhanced Accident Tolerant Fuel are two innovative fields experiencing rapid development, expected to play a key role in overcoming these challenges. Despite involving very different types of materials and manufacturing technologies, they share a common need for extensive verification prior to full-scale deployment in current and future light water reactors (LWRs), including small modular reactors (SMRs).

AM provides the capability to design and manufacture advanced fuel components with significantly improved performance, enabled by intricate geometries that conventional manufacturing methods cannot achieve. It also allows for efficient, rapid, and cost-effective production of various components, tools, and prototypes. In the context of SMRs, AM is expected to play a pivotal role in meeting cost and schedule targets.

Increased utilization of Accident Tolerant Fuel is in turn predicted to have a strong impact on nuclear safety. The technical screening criteria of the EU Complementary Climate Delegated Act (Taxonomy) require the use of ATF fuel for all new reactors and for lifetime extension of existing NPPs. 

Structure and expected outcomes

AMTVINE:s research and development activities are divided into four technical work packages:

  • WP1 - Investigation of an AM upper tie plate after in-reactor exposure
  • WP2 - Verification of coated claddings for reactor use
  • WP3 - Development/optimization of AM process for nuclear applications
  • WP4 - Advanced In-Reactor Materials Testing (AIRMATE)

The AMTVINE results will advance the implementation of AM and ATF in nuclear power generation in Sweden and, within 4-10 years, make additively manufactured components and coated claddings commercially available for use in the existing Swedish nuclear fleet. The technical and scientific expertise resulting from the project will benefit the entire Swedish nuclear power program, starting immediately and lasting for decades.

Carolina Pettersson

Forskare
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7. Affordable and clean energy
9. Industry, innovation and infrastructure
Chalmers University of Technology Studsvik AB Vattenfall Nuclear Fuel AB Framatome Westinghouse Electric Sweden AB OKG AKTIEBOLAG
Funders without URL: The Swedish Energy Agency Project end date: Nuclear power Sekundär områdes navigation:
Metrology
Additive manufacturing
Composites

EU reference laboratories for IVD class D devices

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

The European Commission has designated 5 different labs in Europe to become EU reference laboratories (EURLs) for high-risk in vitro diagnostic medical devices (IVDs) according to Article 100 of Regulation (EU) 2017/746.RISE has been designated in the scope "Respiratory viruses that cause life-threatening diseases" and " Blood grouping markers".

Purpose/Benefit:

The EURLs for high-risk in vitro diagnostic medical devices (IVDs) are designated according to Article 100 of Regulation (EU) 2017/746. This was done by the following implementing acts, Commission Implementing Regulation (EU) 2023/2713 and Commission Implementing Regulation (EU) 2025/2526 designating EU reference laboratories in the field of in vitro diagnostic medical devices.

The main tasks of the EURLs: advisory ones and those related to conformity assessment, particularly of the highest risk, i.e., class D devices. The EURLs were chosen on the criteria within and will work with the tasks listed in Commission Implementing Regulation (EU) 2022/944.

For conformity assessment of class D devices, the EURLs will:

  • verify the performance of class D devices and compliance with common specifications,
  • perform batch testing of class D devices. 

The designated laboratories are:  

1. RISE Research Institutes of Sweden, Sweden

2. Consulting Químico Sanitario SLU, Spain 

3. Instituto de Salud Carlos III, Spain

4. EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut, Germany

5. Consortium, Servicio Madrileño de Salud (SERMAS), consisting of 3 hospitals: 

a. Hospital General Universitario Gregorio Marañón, Spain 

b. Hospital Universitario la Paz, Spain 

c. Hospital Universitario Ramón y Cajal, Spain 

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

For new products, a performance test will be carried out, for products already tested, there will be a batch test. 

All communication from manufacturers is through Notified Body.

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

The EU reference laboratories are working with Notified Bodies and delivering to them. 

Delivery time:

The order is placed through the Notified Body.

Area: Life Science Contact person (Enter one name per field. Activated personal contact pages will appear automatically):
Benny Lyvén, Affärsutvecklare
Hardis Rabe, Forskare
RISE EU reference laboratory espiratory viruses that cause life-threatening diseases
Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: No preparation required Standards:

ISO17025

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation

What scopes of the class D devices are covered by the EURLs?

- Hepatitis and retroviruses
- Herpesviruses
- Bacterial agents
- Respiratory viruses that cause life-threatening diseases
- Parasites
- Blood grouping markers

Which scope are covered by which EURL?

Can be found in the Implementing act: https://eur-lex.europa.eu/eli/reg_impl/2023/2713/oj and https://eur-lex.europa.eu/eli/reg_impl/2025/2526/oj

Status of EU reference laboratories

The designation act includes transitional arrangements to allow the EURLs to form a network and harmonize their working methods and for manufacturers and notified bodies to adapt their processes to include EURL testing.

The EURLs have started their tasks in the conformity assessment of devices since1 October 2024.

EURLs have created a network to coordinate and harmonize their working methods. They are all both working as a whole network with all laboratories as well as scope specific networks. The general network and the sub-networks works on harmonization of methods, procedures, processes, etc. in particular on common laboratory test procedures for performance verification and batch testing of devices. The works also will also adopt common rules of procedure. RISE is coordinating this work.

What will the fee be for using the EURLs?

The fees that the EURLs are going to use are according to Commission Implementing Regulation (EU) 2022/945

Rules for Setting the Fees for EU Reference Laboratories (EURL)

Fee Coverage

Fees levied by EU Reference Laboratories may cover the following categories of costs:

1. Staff costs: Includes staff hours, travel, accommodation, and subsistence costs.
2. Equipment costs: Applicable when the equipment is not provided by the manufacturer of the device to be tested.
3. Consumables, test specimens, and reference materials.
4. Shipping costs: For sample transportation.
5. Translation costs.
6. General laboratory operation costs.

Outsourced Testing
When a task is outsourced to another laboratory under a contract, the fees may include the costs paid to that laboratory for completing the requested task.

Fee Calculation Principles
1. Fees must be non-discriminatory, fair, reasonable, andproportionate to the services provided.
2. Fees shall be calculated based on incurred costs.
3. If calculating the incurred costs for a particular category (staff, equipment, consumables, shipping, translation) is unreasonably burdensome, the EURL may estimate the costs based on average costs for that category.
4. The fee for general operation costsshall be determined as a percentage of the combined costs of the other categories and may not exceed 7% of those costs.

How do notified bodies work with EURLs?

We are currently working together with the NBGC Med-IVD Class D on how the EURLs and NB will be working together.
The EURLs will have contact with the Notified bodies for testing of devices and not with the manufacturers.

How do notified bodies work without EURLs?

For class D devices must be tested by the EU reference laboratory before they may be placed on the market, regardless of whether or not they are novel. There are two key types of testing – verification of performance and batch testing.

Regarding the conformity assessment of devices without a designated EURL, they may still be certified by notified bodies and placed on the EU market according to Regulation (EU) 2017/746.

The EURL-related elements of the conformity assessment do not apply to them until an EURL is designated. Please see MDCG 2021-4 for guidance on how the EURLs should be integrated into the conformity assessment process when designated.

What if there is no EURL for an class D testing scope yet?

For the remaining 2 categories, namely arboviruses and haemorrhagic fever and other biosafety level 4 viruses, there were either no laboratories that satisfied the criteria or their combined capacity was insufficient to cover the expected volume of requests. There has been a call for interest out for the remaining scopes, which is now processed by EC. Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical devices - European Commission (europa.eu)

Recommendations on suitable reference materials and reference measurement procedures of higher metrological order

According to IVD regulation 2017/746, Article 100 (2h), EURLs have to provide recommendations on (i) suitable reference materials and (ii) reference measurement procedures of higher metrological order for their specific scopes. This applies only to devices whose intended use is related to class D. The purpose of sharing this information is that class D IVD stakeholders have availability of references regarding standards and metrological traceability of IVD devices.

Information on (i) suitable reference materials:

EURL Scope 5, respiratory virus
Pathogen: MERS-CoV
Marker: MERS-CoV Antibody
Reference material: 1st International Standard for anti-MERS-CoV immunoglobulin G (human)
Reference and provider: 19/178, NIBSC

Pathogen: MERS-CoV
Marker: MERS-CoV Antigen
Reference material: Not available
Reference and provider: Not available

Pathogen: MERS-CoV
Marker: MERS-CoV RNA
Reference material: Not available
Reference and provider: Not available

Pathogen: Highly virulent Influenza virus (HVI)
Marker: Antibody HVI
Reference material: Not available
Reference and provider: Not available

Pathogen: Highly virulent Influenza virus (HVI)
Marker: Antigen HVI
Reference material: Not available
Reference and provider: Not available

Pathogen: Highly virulent Influenza virus (HVI)
Marker: RNA HVI
Reference material: Not available
Reference and provider: Not available

In relation to reference measurement procedures of higher metrological order (ii),
some database can be consulted. The JCTLM Database lists higher-order
reference materials, measurement methods and services to be used in calibration
hierarchies for value assigning calibrators and trueness control materials for
quantities measured by in vitro diagnostic medical devices. The listed reference
materials, measurement methods and services when applied following the models
described in ISO 17511:2020, ‘In vitro diagnostic medical devices —Requirements
for establishing metrological traceability of values assigned to calibrators, trueness
control materials and human samples’, can be used to establish metrological
traceability.

Besides JCTLM, other publications in relation to metrological traceability have
been also selected as possible source of recommended procedures of higher
metrological order and general framework for this topic:
• CLSI EP32 - Metrological Traceability and Its Implementation
• ILAC P10:07/2020 ILAC Policy on Metrological Traceability of Measurement
Results
• Establishing metrological traceability in laboratory medicine
• European Metrology Network (EMN) for Traceability in Laboratory Medicine
(TraceLab Med)
• MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.

Shipment instructions RISE-EURL-IVD

Please note that 100% of the cost for delivery/transport have to be paid by the manufacturer.

The kits should be sent to the following address:
RISE Research Institutes of Sweden AB
Att: EURL, Name
Brinellgatan 4, House 6 gate G
504 62 Borås
Sweden

EORI Nr. SE5564646874
VAT nr: SE556464687401

Companies that are not part of the European Union must create a Pro Forma invoice in order for the shipment to be cleared through customs to Sweden accompanied by a delivery note.

The Pro Forma invoice must contain the following information.
• The purpose of the export. (Use any of the following, “Sample for testing purposes according to IVD regulation” / “for in vitro use only” / “for testing purposes only” / “not for human use”)
• Contents/identity of the shipment. (Kit name, lot no.)
• Parcel type.
• Gross weight.
• Taric/HS code of the contents.
• The value of the contents followed by the text “No charge. Value for customs purposes only.”
• Country of Origin
• Delivery terms, Incoterms 2020 DDP Borås, Sweden.

The delivery note must contain (for both non-European companies and European companies):
• Product name and model.
• Number of items.
• Special information about the product. (The kits should be stored at the recommended storage temperature (e.g., 2-8°C).) This to avoid that the kits will be stored at too warm temperature in case there is any delay with the customs declaration. This special information must also be clearly and visibly written outside on the box.

Use express delivery or equal and make sure that the delivery will be made door-to-door to avoid unnecessary stops at airports or other storage terminals.

When the shipment is ready to be shipped, please contact us by e-mail and inform about the details including date, flight number or reference (track) number.

Collaborations with national reference laboratories (NRLs)

According to IVD regulation 2017/746, Article 100 (2h), and 2022/944 (art 15) EURLs have to set up and manage a network of national reference laboratories (NRLs) after consulting with the national authorities and publish a list of the participating NRLs and their respective tasks. The purpose of this interaction is among others to favor collaborations, sharing know-how and testing methods.
For corresponding scopes, the NRLs that have been identified and with which there has been interaction for possible collaborations are:
- Scope 5 (respiratory virus): Erasmus MC (Netherland), Hospices Civils de Lyon (France) and Folkehelseinstituttet (FHI) (Norway)

The tasks with these NRLs are planned to be (i) networking and (ii) harmonization of methods

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Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them.

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Calibrated Tachographs Contribute to Well Rested and Traffic-Safe Drivers

Tachograph

Trucks and buses must be equipped with tachographs that record speed and driving and rest times. These regulations exist to ensure that drivers are rested and traffic-safe, and to create a level playing field in competition. However, to rely on the tachograph's measurements, calibration is required, and this is where RISE plays an important role.

Tachographs must be inspected and calibrated regularly, which is crucial for ensuring the reliability of the information they provide. Not adhering to these regulations can be costly for both the driver and the transport company. Calibration is carried out by an accredited workshop.

"The workshop uses a so-called tachograph calibrator to perform the calibration. The calibrator pretends to be the truck and generates signals to the tachograph about, for example, distance, speed, and time. By comparing the information in the tachograph with the calibrator, we ensure that the tachograph is accurate," says Omer Alkarkhi, TIC engineer at the National Laboratory for Electrical Quantities.

The calibrator pretends to be the truck and generates signals to the tachograph about, for example, distance, speed, and time

But how do we know that the tachograph calibrator is accurate? To trust measurements, a chain of calibrations is required all the way up to the definition of the unit. Through this traceability chain, we can expect, for instance, a meter to be a meter worldwide, which is a prerequisite for international trade, research, and production.

"This is where we at RISE come in with our new service for calibrating tachograph calibrators. Workshops send their equipment to us, and we calibrate it, primarily concerning time and frequency," says Omer Alkarkhi.

RISE Meets the Need

Previously, a private company offered this service, but now RISE is the go-to for workshops.

"It's easier for us, working in many different adjacent metrological areas, to maintain the necessary expertise. This is an example of RISE's important role when industry and business cannot themselves meet the existing needs," says Maria Hammarquist, research and development engineer.

Closer to the End Customer

Usually, laboratories that perform calibrations for customers turn to the national laboratories at RISE to calibrate their equipment.
"But here, we work closer to the end customer, meeting the workshops that will actually use the equipment, which is very enjoyable," says Omer Alkarkhi.

Omer Alkarkhi

TIC-ingenjör
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Maria Hammarquist

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Fibre analysis, selection of SS-EN ISO 1833, ISO 21915-2, SS-EN ISO 20705, ISO/ TR 11827

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

The need to be able to identify fibres is increasing as textile recycling advances. RISE can offer a selection of different fibre analysis methods for both new and recycled synthetic and natural fibre types. 

Purpose/Benefit:

Being able to identify fibres can be crucial for subsequent processes. RISE provides both quantitative and qualitative methods for textile fibre identification.

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

RISE offers: 

  • Chemical Analysis: We use specific solvents to dissolve certain fibres, allowing for precise determination of the remaining fibre types.
  • Microscopic Analysis: Through microscopy, we identify and quantify the fibre content in textile samples. Dyeing before microscopy can be used to distinguish certain types of cellulose.
     
Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

Normal delivery time is 10-15 working days.

Area: Textile Contact person (Enter one name per field. Activated personal contact pages will appear automatically):
Carina Berglund, Forskare
Desiré Rex, Forskare
blue colored fibres
Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: No preparation required Standards:

SS-EN ISO 1833 Textiles - Binary fibre mixtures - Quantitative chemical analysis

ISO 21915-2 Textiles - Qualitative and quantitative analysis of some cellulose fibres (lyocell, cupro) and their blends - Part 2: Blend quantification using light microscopy method

SS-EN ISO 20705 Textiles - Quantitative microscopical analysis - General principles of testing

ISO/TR 11827 Textiles - Composition testing - Identification of fibres 

ISO 137 Wool - Determination of fibre diameter - Projection microscope method

SS-EN ISO 1973 Textile fibres - Determination of linear density - Gravimetric method and vibroscope method

SS-EN ISO 5079 Textile fibres - Determination of breaking force and elongation at break of individual fibres 

SS-ISO 6989 Textile fibres - Determination of length and length distribution of staple fibres (by measurement of single fibres)

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Delivery level: Not applicable
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Developing Quantum Metrology – and Metrology for Quantum Technology

Laser

Quantum mechanics has long been a natural part of metrology and has already revolutionised how we measure and realize physical units. The development of quantum technology is rapid which create opportunities for new measuring instruments while placing new demands on metrology to support this development.

Quantum mechanics is an overarching theory in physics that describes the world on its smallest scale, at the particle and photon level. The advancements in the early 20th century laid the groundwork for much of the technology we take for granted today, including computers, lasers, mobile phones, and satellite navigation systems. By controlling and manipulating individual quantum systems such as single atoms or photons, we can develop entirely new technology. In a second quantum revolution, new technical possibilities are now being created such as quantum computers, interception-proof communication and – not least – extremely sensitive measuring instruments.

“Future will show which technical advancements prove successful. Few researchers in the early 20th century could have predicted that their research in quantum physics would enable the construction of atomic clocks, which in turn have created the conditions for global navigation systems like GPS", says Martin Zelan, a researcher in laser and atomic physics who also works on coordinating and developing the research conducted at the national laboratories at RISE.

Quantum mechanics is such a natural part of measurement technology that one might not think about it being quantum

Quantum Metrology for More Accurate Measurements

A significant part of the future research at the national laboratories involves quantum metrology, that is, using quantum mechanics to improve measurements of physical quantities such as time, mass, and current, more than what is possible with conventional measurement methods. This can be done by developing new measuring instruments and new ways of measuring. In the future, for example, we could be using extremely precise atomic clocks to measure elevation above sea level to the centimetre, based solely on the fact that time moves slower or faster depending on gravity. Another important issue is to make the new measuring instruments more accessible by reducing their size and cost. Using quantum mechanical phenomena, we can also develop more accurate references, creating even better conditions for conventional measurements.

“Together with new measuring instruments, this contributes to even more accurate measurements in industry and society, and ultimately to more efficient production and new scientific breakthroughs”, says Martin Zelan.

Quantum Mechanics is Already Used Daily

Even though some applications are a few years away, and some many years in the future, quantum mechanics is already present in the daily work at the national laboratories through atomic clocks, lasers, and quantum standards.

“Quantum mechanics is such a natural part of measurement technology that one might not think about it being quantum. We invested in the first quantum standards for the electrical units volt and ohm already in the 90s. But the revision of the SI system has created conditions for new initiatives within the field, which has contributed to our expertise and our investments growing in recent years, says Karin Cedergren”, researcher and manager of the unit for Temperature and Primary Electrical Metrology, and continues:

“There is also a growing interest from industry and society. Each year, the number of projects that include quantum mechanics within metrology research increases. Somewhere there's a limit to what can be done with classical measurement methods, and that limit has been reached in many areas. Quantum mechanics is needed to improve those measurements further.”

A Swedish Quantum Agenda

The Swedish Research Council, Vinnova, Swelife, the Wallenberg Center for Quantum Technology, and RISE have produced the report A Swedish Quantum Agenda. The report provides an overview of the current state of quantum technology in Sweden and what needs to be done to promote development and strengthen Sweden's position. This involves, among other things, strengthening Sweden's expertise in quantum technology to enhance our competitiveness. The government has also taken the initiative for a national quantum strategy. And even though quantum mechanics is already a natural part of measurement technology, the national laboratories at RISE also need to improve.

“Partly, of course, by using quantum mechanics to make even more accurate measurements. And partly by developing technology and methods that can support companies and organizations developing quantum technology with the accurate measurements required. Both developing quantum metrology and developing metrology that supports quantum technology. To do this, we need to continue building expertise through collaborations with Swedish and European colleagues”, says Martin Zelan.

The national laboratories collaborate with European and Swedish colleagues through, for example, the European metrology organization EURAMET's European Metrology Network for Quantum Technologies, the Swedish Quantum Sweden Innovation Platform, and through research projects with universities such as Chalmers, Lund University, and Umeå University. Examples of areas where we are already active and successful include the realization of the unit for resistance (ohm) using graphene and within pressure measurements based on quantum methods.

“But we need and want to do even more. To measure quantum computer components, one needs equipment that allows measurements at around 10 millikelvin, which requires further investments from our side. It would also be exciting to continue contributing to the development of quantum standards, such as for the current unit, ampere, by counting the number of electrons per unit of time”, says Karin Cedergren.

Want to Know More About the Needs

A Swedish Quantum Agenda also identifies standardization as an important area, where RISE has extensive experience and a unique role as an independent research institute. RISE also has a special focus on supporting small and medium-sized enterprises, which may not fully have the resources required to develop quantum technology within the company.

“As an independent research institute, we can work closely with industry and the business sector on different applications. We are very interested in knowing more about the needs for measurements supporting quantum development, so that we can shape our offerings accordingly”, says Karin Cedergren.

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Karin Cedergren

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