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EMAS

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

An environmental management system registered according to EMAS provides conditions for effective and systematic environmental work that adds value to the organisation and its customers. The requirement to externally communicate their environmental performance development increases an organisation’s credibility among stakeholders, which in turn can

Purpose/Benefit:

EMAS is based on the values:

  1. Performance – by finding the right tools to improve environmental performance in line with industry practice on environmental management
  2. Credibility – third-party verification guarantees the external and independent nature of the EMAS registration process
  3. Transparency – organisations that register for EMAS make an active choice regarding the organisation’s openness relating to environmental management and environmental performance externally through their environmental audit and internally through the active involvement of employees

Management systems that are built up according to EMAS essentially follow the ISO 14001 structure with a number of specific additional requirements, including annual reporting of environmental performance and commitments concerning employee collaborations in environmental work. It contributes to the organisation’s understanding of the environmental performance development of its operations, and serves as a tool for reducing environmental impact through continuous improvement.  The management system is management’s tool for controlling how the organisation’s environmental work is planned, implemented, followed up, and continuously improved in connection with its environmental performance, which is measured through several predetermined core indicators.

The EU is developing sectoral guidelines on environmental management practices and performance, which will afford opportunities to compare operators in the industry in a harmonised manner.

Any organisation can register for EMAS, regardless of whether they already have an ISO 14001-certified management system.

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

The responsible authority in Sweden for registration and renewal of registration is the Swedish Environmental Protection Agency, with RISE serving as an accredited environmental verifier in the process.

An independent accredited environmental verifier at RISE reviews the organisation’s environmental investigation in the initial phase prior to the first registration. The organisation’s environmental policy is based on the report submitted to the Swedish Environmental Protection Agency along with other documents pertaining to the organisation’s registration application.

A compliance review based on the environmental audit and the performance development of the organisation is carried out during an annual audit at intervals of 12 months. Renewal of registration takes place every three years. For smaller companies, there is an option for extended intervals (EMAS Easy).

The approach to verification via RISE differs depending on whether the organisation already has an ISO 14001-certified management system.

The process is essentially similar to RISE’s description of our Certification Process for management systems.

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

When the organisation meets the requirements of EMAS, it is granted the right to use the EMAS logo for communication and promotional purposes. This increases awareness among customers and other stakeholders of the organisation’s environmental work, which can help increase the demand for the organisation’s goods and services.

Area: Not applicable Contact person (Enter one name per field. Activated personal contact pages will appear automatically):
Contact Certification
Mikael Süld, TIC-ingenjör
EMAS
Field measurements: No Price type: 1 Division: Do not use - Division Built Environment Preparation: No preparation required Certification and marking: Not applicable Type of service: Not applicable Instrument: Not applicable General area: Not applicable Order information: Quote inquiries and order confirmations can be taken via E-mail or by telephone. Divison (OLD): Do not use - Division Built Environment Delivery level: Accredited
ceforsaljning@ri.se,mikael.suld@ri.se
More information:
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Circular transition Sekundär områdes navigation: Production and manufacturing Tjänstetyp tagg: Verifiering och validering

Comparative testing for pulp and paper laboratories

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

Proficiency testing represents a valuable method for assessing and ensuring the quality of laboratory operations. These comparisons can encompass various aspects, including instrument performance and analysis methods.

Purpose/Benefit:

By comparing the results from different laboratories, one can detect any potential differences or deviations and identify areas where improvements can be made.

Such a forum for proficiency testing provides an excellent opportunity for open and constructive discussions within the laboratory community. It allows participants to share experiences, discuss best practices, and collectively work towards enhancing the quality and reliability of laboratory analyses. Additionally, it promotes increased awareness of the crucial role that laboratories play in various industries and society as a whole.

By actively participating in proficiency testing and discussions, laboratory personnel can enhance their competence, improve their skills, and develop a deeper understanding of the methods and techniques used within their field of work. This, in turn, can lead to improved accuracy, precision, and reliability in the analyses performed, benefiting both the laboratory's reputation and its ability to deliver high-quality results to its customers and partners.

RISE offers the following tre different test comparisons; PFI mill, ISO Brightness and emission parameters for forest industrial wastewater.

PFI mill - long fiber and short fiber (in collaboration with PFI Instruments)

By participating and comparing your own values ​​for refining with a reference pulp, you know how well your own refiner is calibrated. The results can also be a complement to traceable calibration before applying for accreditation or certification.

Once a year, RISE sends out reference pulp to the participating laboratories for refinering, handmade sheets and testing. The results are processed and compiled at RISE. Everything is presented in a report where the whole is reported in relation to the respective laboratory's values. Diagrams are obtained for each parameter as well as tables with the other participants' results.

The reference pulp is taken in large quantities at one time. This provides an opportunity for a direct comparison with the previous round and a long-term history.

ISO Brightness

The whole method will be tested and this is a good opportunity to easily compare the results from your own measurement with others' results. We will send out two pulps, a hardwood and a softwood. The results are sent to RISE and for compilation, including our own, and the participants are provided with the measurement results. In the compilation, the samples are deidentified so that each participant only knows his result but can compare himself with the other participants' results.

 

Emission parameters for forest industrial wastewater

Twice a year, May and November, we will send out frozen samples to you. A written summary is received a few months later where the results are presented anonymously. There are two content levels of each analysis. Report the analyzes that are of interest to you.

If there is a request for test rings, please contact us and we can discuss the possibility of starting them up.

You can also find us at EPTIS.

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

PFI-mill:

Refinery with 5 points (ISO 5264-2)
• SR (ISO 5267-1)
• CSF (ISO 5267-2)
• WRV (ISO 23714)
• Density (ISO 534)
• Tensile index (ISO 1924-3)
• Elongation (ISO 1924-3)
• TEA (ISO 1924-3)
• Burst strength (ISO 2758)
• s & k (ISO 9416)
• Air permeance Bendtsen (ISO 5636-3)
• Tear resistance (ISO 1974)

ISO Brightness: The laboratories manufacture their own laboratory sheets according to ISO 3688 and then the sheets are measured according to ISO 2470-1, ISO brightness.

Test comparison of emission parameters for forest industrial wastewater:

  • COD, TOC, Tot-N, Tot-P, suspended solids GF / A, conductivity, chlorate, sodium.
  • Coarse particles and fibers in wastewater (susp 70). Sample type: Fibers dissolved in water samples
  • pH. Sample type: Water sample
Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

RISE offers a comprehensive report where the results are presented in concise yet informative sections with clear diagrams and tables. All key parameters and relevant comments are included to provide a clear picture of the analyses and their results. By using diagrams and tables, it becomes easier to detect patterns and trends, facilitating decision-making.

Delivery time:

We're delighted to inform you that analysis results will be conveniently delivered via email.

To ensure a smooth registration process, kindly provide us with the following details: your name, company name, mailing address (for sample delivery), telephone number, email address, and invoice address.

Thank you for your cooperation! We look forward to assisting you further.

Area:
Biorefinery
Chemical processes and products
Pulp and paper
Production and manufacturing
Testing
Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Christina Wedin, Coordinator
Sheet Forming
Field measurements: No Price type: 1 Division: Division Bioeconomy Preparation: No preparation required Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Order information: Order via contact person Divison (OLD): Division Bioeconomy Delivery level: Not applicable
christina.wedin@ri.se,
/en/node/9710
9. Industry, innovation and infrastructure
11. Sustainable cities and communities
12. Responsible consumption and production
13. Climate action
15. Life on land
Metod - Header: Methods, Instruments and Expertise Delivery - Header: Delivery
Request for quote
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Pulp and paper Sekundär områdes navigation: Metrology Tjänstetyp tagg: Verifiering och validering

Electronic products in railway vehicles

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

Investigation of products according to EN 45545-2 - Railway applications - Requirements for fire behaviour of materials and components.
Subclause 4.3 - Grouping rules.

Purpose/Benefit:

Table 2 of EN 45545-2 lists the most common products for trains. Table 3 is for products that are not listed in Table 2 but are of a simpler design with few constituent materials or components. For more complex products such as electronic equipment consisting of a variety of materials and components, there are no clear requirements in EN 45545-2. For these products, an investigation is required to find out what needs to be tested in order for the product as a whole to be classifiable. The investigation follows the flow chart for grouping rules found in subclause 4.3 of the standard.

Each of the product's constituent materials/components must be handled in the flow chart. There are some rules to consider when it comes to the exposed surface, weight and and also distance.

A material or component weighing up to 10 g which is not in direct contact with any other material or component non-approved according to EN 45545-2 need not to be tested or grouped.

  • A group is defined as materials/components that are within 200 mm in vertical direction and 20 mm in horizontal direction of each other
  • Up to 100 g (interior) or 400 g (exterior) of combustibles are allowed per group with no requirements
  • Up to 500 g (interior) or 2000 g (exterior) of combustibles per group are allowed which are approved according to requirement set R24 (EN ISO 4589-2)
  • Combustibles in groups weighing more than 500 g (interior) or 2000 g (exterior) have to fulfil requirement set R22 (interior) eller R23 (exterior) (EN ISO 4589-2, EN ISO 5659-2, NF X 70-100-1 & -2 or EN 17084)

Above rules apply to groups but also to individual materials/components that have an exposed surface area of ​​less than 0.2 m2.

An exposed surface area larger than 0.2 m2 means fulfilment according to requirement set R1 (interior) or R7 (exterior) (ISO 5658-2, ISO 5660-1, EN ISO 5659-2+toxicity (EN 45545-2, annex C or EN 17084).

An alternative to the above investigation procedure is that the product meets any of the requirements as set out in 4.2 h in EN 45545-2. Here, among other options, is the opportunity to place the product in a technical cabinet that is protected by some kind of extinguishing system. Such a solution can mean that the product is approved to install without testing.

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

An investigation means that the product is weighed and measured and then taken apart to the greatest extent possible. The constituent materials/components are weighed and, if relevant, the distance between these materials/components is measures as well as the exposed surface area.

A report describes the conditions for approval of the product and has a summary, at the end, of what is needed in terms of testing, if any, for a possible classification of the product. The product and all its constituent materials/components are photographed on a scale where the weight is visible. These photos are included in the report together with a table listing the constituent materials/components and the applicable requirements according to EN 45545-2.

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

An investigation report, in Swedish or English, is delivered.

Area:
Fire safety
Mobility
Risk and safety
Contact person (Enter one name per field. Activated personal contact pages will appear automatically):
Anna Bergstrand, Affärsutvecklare
Susanne Blomqvist, Projektledare
Utredning EN 45545-2
Field measurements: No Price type: 1 Division: Division Safety and Transport Preparation: Description of preparation Preparation information:

Material needed for the investigation

1 unit of the end-use product together with a detailed product description

Link to order form: Order Specification Form Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Order information: Before testing we ask you to complete the ”Order Specification form” and send this together with your order. Also attach product and safety data sheets when possible. Divison (OLD): Division Safety and Transport Delivery level: Not applicable
Order
ordering
EMC Sekundär områdes navigation:
Metrology
Fire safety
Tjänstetyp tagg: Verifiering och validering

Verification of building acoustics loudspeaker

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

Building acoustics loudspeakers are used as sound source at determination of sound insulation and reverberation time in buildings.

Purpose/Benefit:

Verification of building acoustics loudspeakers is aiming to confirm that they fulfills the directivity requirements given in the most common test standards. 

Calibration and verification ensures that the test equipment is compliant with given requirements, which is neccesary for establishing credibility for the test result.

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

Building acoustics loudspeakers are verified by testing if their directivity is complying with the requirements in the standards ISO 16283-1 and ISO 3382. The loudspeaker can be excited either by a noise generator and power amplifier associated with the loudspeaker or supplied by RISE.

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

The results are reported in a digital report in Swedish or English which states if the loudspeaker is complying with the actual ISO standards.

When becoming a client you will also get access to our customer website for calibration, where you may also place orders. 

Customer website for calibration

Area:
Calibration
Generic metrology and measurement technology
Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Håkan Andersson, FoU ingenjör
Building acoustics loudspeaker
Field measurements: No Price type: 1 Division: Do not use - Division Built Environment Preparation: No preparation required Link to order form: Website Calibration Standards:

ISO 16283-1

ISO 3382

Certification and marking: Not applicable Type of service: Calibration Instrument: Acoustic measurement equipment General area: Sound and vibrations Order information: Order can be sent to risekalibrering@ri.se, or through the case management in our customer website Calibration. Divison (OLD): Do not use - Division Built Environment Delivery level: Non-accredited
hakan.andersson@ri.se,
/en/about-rise/operations/mission-governance/policy-documents/privacy-policy
form
Construction Sekundär områdes navigation: Metrology Tjänstetyp tagg: Verifiering och validering

Database for approved materials and products in trains

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

Welcome to the open access database for rolling stock materials and products classified according to the European railway standard EN 45545-2 – Railway applications – Fire protection on railway vehicles – Part 2: Requirements for fire behavior of materials and components.

Purpose/Benefit:

The database is searchable for the following parameters

– Name and contact details of manufacturers/suppliers
– Name or type of material/product
– Product no. according to EN 45545-2 (F1, EX6A, etc.)
– Product name according to EN 45545-2 (Floor composite, PCB, etc.)
– Requirement set (R1, R2, etc.)
– Classification (HL1-HL3)
– Test methods

The classifications listed in this database are based on tests performed by accredited test institutes. For more information on the products or to gain access to the test reports and classification reports, please contact the manufacturer/supplier directly.

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

Anyone wishing to list their material or product in the database completes the agreement form and sends it together with test reports to the specified contact person. After approval of the documents, the material or product is listed in the database.

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

Approved materials or products are listed in the database together with information on which class (HL1-HL3) has been achieved.

Area:
Fire safety
Mobility
Risk and safety
Contact person (Enter one name per field. Activated personal contact pages will appear automatically):
Anna Bergstrand, Affärsutvecklare
Susanne Blomqvist, Projektledare
Field measurements: No Price type: 2|Tjänstens pris (om tillämpat, t.ex prispaket, prislistor) Priceinformation:

Free listing for RISE customers, otherwise price according to tender.

Division: Division Safety and Transport Preparation: No preparation required Certification and marking: Not applicable Type of service: Not applicable Instrument: Not applicable General area: Not applicable Order information: Fill out the form "Agreement database rolling stock materials" and send it to specified contact person. URL: Rolling stock materials database Divison (OLD): Division Safety and Transport Delivery level: Not applicable PDF for order form.:
Order
ordering
Mobility Sekundär områdes navigation:
Fire safety
Digitalisation
Materials and durability
Tjänstetyp tagg: Verifiering och validering

Assessment of environmental properties according to SS 15 54 70

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): Greases which meet environmental requirements in SS 155470 Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

The use of lubricating grease on moving parts is essential to save energy and to diminish friction and wear. Since the grease used is consumed and may leak to the environment it is vital to use an environmentally adapted grease, especially in outdoor applications. Therefore, a Swedish standard has been drawn up that sets environmental requirements.

Purpose/Benefit:

The examination done by RISE covers the environmental properties of lubricating greases in accordance with section 5.2 of Swedish standard SS 155470. From an international perspective, the environmental requirements, as given in Section 5.2 in the standard, are rigorous and signify that the base fluid in the lubricating grease should be biodegradable, with minimal aquatic toxicity. Further an examination of chemical compounds with sensitising properties is required.

 The standard does not include any technical requirements as the performance is specified based on the area of application, but information about the technical properties, etc., of the lubricant is available from the suppliers. The products on the list are used in a wide range of applications, including universal lubrication, rail lubrication, lubrication for heavy forestry machinery and, in central lubrication systems for trucks and other vehicles.

Historically, the list has been called the "SP list" and was established by the project "Ren Smörja", which was started by the City of Gothenburg in 1998 in consultation with the Swedish Chemicals Agency (KEMI). These criteria have been elaborated and are now a part of the Swedish Standard "Lubricating Grease – Requirements and Test Methods – SS 155470". After an international hearing the standard was issued in 2002 and the official English version 2004. 

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

Expertise at RISE examines products regarding the environmental requirements in Swedish standard 155470, "Lubricants, industrial oils and similar products (Class L) Specifications for family X (Lubricating grease)". 

The examination is based on documentation that the client of the review is responsible for providing. The technical performance level is set by the standard and is fulfilled by self-claim by the manufacturers.

RISE also examines hydraulic fluids, and that list is available here.

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

The list is only published in pdf format on this website and is protected by copyright, which means that it may not be published in its entirety or as an excerpt without citation of source.

The list, which is only published in pdf format here, is protected by copyright, which means that it may not be published in its entirety or as an extract without indicating the source.

The current list of lubricating grease that meets the environmental requirements of Swedish standard SS 155470 can be downloaded via the link on the right.

Area:
Inspection
Chemical processes and products
Chemical and biological analysis
Material transition
Product safety
Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Anna S Strid, Rådgivare Substitutionscentrum Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: No preparation required Standards:

SS 155470

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

I have a product with a similar name to a product on the list, can you tell me if it also meets the requirements?

No, only the name on the list is subject to review. If a product name changes, the supplier/manufacturer is responsible for submitting updated information.

If I send you a safety data sheet of a lubricating grease, can you tell me if the product meets the requirements of the standard?

No, a review requires the submission of information on the full content of the product at the substance level. Therefore, it is the supplier/manufacturer who must request a review.

Instrument: Not applicable General area: Not applicable Order information: Please order via the contact persons listed below Divison (OLD): Division Materials and Industry Delivery level: Not applicable
anna.s.strid@ri.se,
Documents:

Request for quote
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Chemical and biological analysis Sekundär områdes navigation:
Health and life science
Chemical products and processes
Tjänstetyp tagg: Verifiering och validering

Environmental properties of hydraulic oils according to SS 15 54 34

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): Hydraulic Fluids which meet environmental requirements in SS 15 54 34 Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

Hydraulic Fluids are used to transfer power in the hydraulic systems of various machines such as forest machines, excavators, trucks, cranes, etc. However, leakage of these fluids may have an environmental impact. That’s why a Swedish Standard has been compiled with, among other things, environment requirements on Hydraulic Fluids.

Purpose/Benefit:

The major cities in Sweden, as well as the Swedish transport administration require that hydraulic fluids used meet the environmental requirements in Swedish standard SS 15 54 34 when procuring contracts that concern areas where precautionary measures are required (for example land below the groundwater level, drinking water sources and environmental protection areas).

RISE offers an examination of the environmental properties of hydraulic fluids according to the above-mentioned standard. Approved hydraulic fluids are published on the "SP list" which can be downloaded on the right.

A prerequisite for listing is that the hydraulic fluid also meets the technical requirements specified in the standard, but these are not covered by the review. According to the review agreement, however, RISE has the right to demand documentation that shows that the technical requirements are also met. RISE can also remove products that do not meet the requirements from the list with immediate effect. Information on technical properties is provided by the respective supplier/manufacturer. Changing the product must always be done in consultation with the machine manufacturer and the supplier of the hydraulic fluid.

From an international perspective, the environmental requirements are strict and mean that the hydraulic fluid must be biodegradable, have minimal negative impact on the water environment and not contain too high levels of allergenic substances as well as carcinogenic, reproductive toxic and mutagenic substances (CMR substances).

RISE also reviews the environmental properties of lubricating greases according to SS 15 54 70, that list is available here.

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

 

The review is based on information about the chemical content of the hydraulic fluid, and it is the customer (usually the supplier/manufacturer of the product) who is responsible for ensuring that all required documentation is available.

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

Hydraulic fluids that meet environmental requirements are added to the list of approved products. The list ("SP list") is only published on this website and is protected by copyright, which means that it may not be published in its entirety, or as an extract without reference to the source. The list is updated continuously, but at most every calendar month. It is the list most recently published on the website that is valid.

Area:
Inspection
Chemical processes and products
Material transition
Product safety
Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Anna S Strid, Rådgivare Substitutionscentrum Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: No preparation required Standards:

SS 15 54 34

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

I have a product with a similar name to a product on the list, can you tell me if it also meets the requirements?

No, only the name on the list is subject to review. If a product name changes, the supplier/manufacturer is responsible for submitting updated information.

If I send you a safety data sheet of a hydraulic fluid, can you tell me if the product meets the environmental requirements of the standard?

No, a review requires the submission of information on the full content of the product at the substance level. Therefore, it is the supplier/manufacturer who must request a review.

I have a product with information stating that it complies with SS 155434 but I cannot find it on the list, can I assume that the environmental requirements are still met?

No, you cannot. SS 155434 contains both technical and environmental requirements, and there are rules in the standard that indicate how products should be labeled. The technical requirements are mandatory, and if the environmental requirements are also met, the label must explicitly state that the product is environmentally acceptable.

Instrument: Not applicable General area: Not applicable Order information: Order by contacting the contact person below Divison (OLD): Division Materials and Industry Delivery level: Not applicable
anna.s.strid@ri.se,
Documents:

Request for quote
ordering
Chemical and biological analysis Tjänstetyp tagg: Verifiering och validering

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:

Contact us for estimated 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
Medical Devices – sterility validation
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

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Order information: Please find contact information below 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

ISO 17664 Validating Instruction for Users for cleaning and disinfection

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): ISO 17664 Validating Instruction for Users - cleaning and disinfection Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

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.

Purpose/Benefit:

It is crucial to follow ISO 17664-1 and ISO 17664-2 as these standards ensure that medical devices are handled in a way that minimizes the risk of infections. Proper cleaning and disinfection are essential to prevent the transmission of harmful bacteria to patients.

By adhering to these standards, manufacturers and healthcare providers can guarantee that products are safe to use and meet regulatory requirements, such as those outlined in the MDR.

This strengthens trust in the quality and reliability of the products, while contributing to enhanced patient safety.

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

The cleaning procedure is validated by soiling the product with appropriate contaminants, such as blood or artificial soil, followed by cleaning and analysis of any remaining soil residues through methods such as protein analysis or hemoglobin analysis, according to ISO 15883-5 (MDR) or ANSI/AAMI ST98 (FDA).

We can also evaluate automatic (thermal) disinfection with temperature probes to ensure that the product meets the expected A0 value, according to ISO 15883-1 (MDR). Manual (chemical) disinfection processes are validated according to ANSI/AAMI TIR12 (FDA).

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

Methods and results are presented in a written report, in Swedish or English.

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
Medical Devices – validation of cleaning and disinfection
Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: Description of preparation Certification and marking: Not applicable Type of service: Not applicable Instrument: Not applicable General area: Not applicable Order information: Please find contact information below Divison (OLD): Division Materials and Industry Delivery level: Non-accredited
louise.wogelred@ri.se,
/en/personal-data-processing/candidate-database
More information:

At RISE, we are pleased to offer services that ensure your products can be cleaned, disinfected, and sterilized safely and effectively according to ISO 17664-1/2, ISO 15883-5, ANSI/AAMI ST98, and ISO 17665:2024. We also provide testing services for evaluating the biocompatibility of medical devices according to ISO 10993-5:2009 and ISO 10993-23:2021.

By combining our services under these standards, we can help you ensure that your medical devices are biocompatible, sterile, and suitable for reuse—critical factors for patient safety and product success in the market.

Please feel free to contact me for a consultation.

3. Good health and well-being
Purpose - Header: Safe products, safe patients Metod - Header: Method
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RISE arranges intercomparisons for quality assurance

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

Intercomparisons and skills testing are a common way of determining the performance of a laboratory. It is used by laboratories and companies to ensure technical competence and ensure the quality of measuring equipment and design.

Purpose/Benefit:

Intercomparisons are a very effective tool for laboratories to show that they have good, accurate and quality assured measurement results. We offer intercomparisons in a number of different technology areas and also arrange courses within the subject.

We arrange comparisons between laboratories and provide the organization, execution and evaluation of calibrations or tests made on the same or similar objects or materials by two or more laboratories in accordance with predetermined conditions.

Competency testing can also be used to ensure measurement performance in a laboratory over time, as well as identifying areas of improvement. It is a good way to develop the expertise of laboratory personnel and to establish consistency between different laboratories.

The results of an intercomparison can be used to show that a company has a good technical basis when discussing business contacts as well as when developing laboratory measurement uncertainties.

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

An intercomparison measurement allows you to perform a measurement assignment with an instrument without knowing the instrument's performance or error in advance. The measurements are performed by the laboratory staff in the measurement context of the laboratory concerned. This is of great value because the results reveal relevant influences from the various parts of the laboratory's measurement system, such as the chosen measurement method, environment etc. The confidentiality of the competence test results is maintained by identifying each participant only with a unique code. The competency test organizer will not disclose confidential information to third parties. After listing for an intercomparison, your company will receive confirmation from the organizer.

Normally, it is up to each laboratory to plan when to participate in a comparison survey. However, an accredited laboratory must meet the requirements of ISO / IEC 17025 which prescribe participation in a number of quality assurance activities, including participation in comparative measurements. If there has been a major change in the operation of a laboratory, introduction of a new procedure, reference equipment etc., then participation in an intercomparison is normally recommended. Historically, it has been very difficult for laboratories in certain calibration and test areas to make these planned comparisons because there have been too few available times. RISE offers comparisons of a five-year plan where each laboratory can plan its activities for years to come.

Five-year Plan

All competency testing is planned and performed in accordance with a quality system that complies with ILAC G13: 200 "Guidelines for the Competence of Providers of Proficiency Testing Service" and which meets the requirements of ISO guide 43-1.

Variables

RISE cover comparisons within a wide range of measurement sizes, such as:

Electricity - Flow - Power - Length -  Torque - Optics - Temperature - Pressure - Vacuum - Volume

Commitments for participants in an intercomparison

  • The application is binding and refunds must be sent to the organizer before the deadline stated in the information. If rebates are sent after this date, the organizer may charge a full fee.
  • Reporting of results from the participants must be done according to the measurement instructions. If the results are presented in a different way, then the organizer of the intercomparison has the right to exclude these results from the final report.
  • Any complaints or comments about the intercomparison should be sent directly to the organizer. It is then up to the organizer or a reference group for the intercomparison to decide whether this should be included in the report or not.
  • The measurement and reporting schedule must be kept. If participants need more time, they should request this by contacting the organizer as soon as possible.
Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

Report

Delivery time:

See the respective intercomparison.

Area:
Calibration
Professional education
Generic metrology and measurement technology
Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Viktoria Jonasson, Projektledare
Welcome page RISE Intercomparison
Field measurements: No Price type: 1 Priceinformation:

Pris anges vid respektive jämförelse. Pris för kundanpassade jämförelser ges vid offertförfrågan. 

Division: Division Safety and Transport Preparation: No preparation required Standards:

ISO/IEC 17025

Certification and marking: Not applicable Type of service: Not applicable Instrument: Not applicable General area:
Photometry and radiometry
Force and torque
Length and geometry
Temperature
Pressure and vacuum
Volume and flow
Order information: Inquiries and orders are sent to jamforelser@ri.se Divison (OLD): Division Safety and Transport Delivery level: Non-accredited
viktoria.jonasson@ri.se,
/en/node/9710
More information:

RISE arranges intercomparisons, which forms a Center for Comparative Measurement (competency testing) and has been developed to serve calibration and test laboratories to ensure their measurement capability according to ISO / IEC 17025. We have previously been part of the CFI - Center for Intercomparisons.

RISE covers intercomparisons within a wide range of different measurement sizes, instruments and measurement accuracy levels and our goal is to serve both measurement laboratories and industrial users.

Since there are many non-accredited laboratories that also need to ensure their measurement capability, these are also serviced.

Comparison measurement or competency testing is also called audit, intercomparison, test comparison, ring text and round robin.

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