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IMO 2010 FTPC Part 5 - Fire testing of materials for ships

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): IMO 2010 FTPC Part 5 - Fire testing of materials for ships Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

IMO 2010 FTP Code Part 5 - Test for Surface flammability (test for Surface materials and primary deck coverings)

Purpose/Benefit:

IMO 2010 FTP Code Part 5 evaluates a material's ability to withstand a fire spreading along its surface. The method also evaluates the heat release from the material during combustion. The method is used to classify and certify materials used in marine and offshore applications.

Products and materials for maritime use is fire tested according to the International Maritime Organization (IMO) code, IMO 2010 FTP Code. The results from fire testing according to the FTP-code can be used as a basis for type approval (also called the wheel mark). Type approval is regulated in accordance with European Parliament Directive 2014/90/EU. RISE can perform the fire tests, issue the certificates and perform the production control required in order to gain the wheel mark.

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

The specimen is inserted in the specimen holder together with a substrate. It is vertically positioned during the test and is exposed to heat radiation from a radiation panel. The test is conducted with a pilot flame. The time is noted when the specimen is ignited as well as when the flame reaches each of the 50 mm stations along the specimen centre line. Other parameters that are notes are the time to flame out of the flame front on the center line, the burnt length and any occurrence of burning droplets.

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

A test report, in Swedish or English, is delivered with the test results after testing.

Area:
Fire safety
Risk and safety
Contact person (Enter one name per field. Activated personal contact pages will appear automatically):
Anna Bergstrand, Affärsutvecklare
Per Thureson, Senior Projektledare
IMO 2010 FTP Code part 5 equipment
Field measurements: No Price type: 1 Division: Division Safety and Transport Preparation: Description of preparation Preparation information:

Material needed for testing

Complete test

  • 6 specimens with dimensions 795 mm x 155 mm x nominal thickness (max 50 mm)

Indicative test

  • 2 specimens with dimensions 795 mm x 155 mm x nominal thickness (max 50 mm)
Standards:

Related standard: IMO 2010 FTP Code Part 2

Similar standard: ISO 5658-2

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: Accredited PDF for order form.:

Order Specification Form (pdf, 180.52 KB)

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ordering
Maritime Sekundär områdes navigation:
Metrology
Fire safety
Tjänstetyp tagg: Provning

IMO 2010 FTPC Part 10, Appendix 2 - Fire testing for ships

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): IMO 2010 FTPC Part 10, Appendix 2 - Fire testing for ships Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

IMO 2010 FTP Code, Part 10 - Test for fire-restricting materials for high-speed craft

Appendix 2 - Fire test procedures for heat release, smoke production and mass loss rate for materials used for furniture and other components of high-speed craft

Purpose/Benefit:

IMO 2010 FTP Code, Part 10 refes to ISO 5660-1 which is used to evaluate heat release rate, smoke production and time to ignition. The methods is used to classify and certify material in maritime and offshore applications.

ISO 5660-1 – Reaction-to-fire tests - Heat release, smoke production and mass loss rate, Part 1: Heat release rate (Cone calorimeter method) and smoke production rate (dynamic measurement). 

Products and materials for maritime use is fire tested according to the International Maritime Organization (IMO) code, IMO 2010 FTP Code. The results from fire testing according to the FTP-code can be used as a basis for type approval (also called the wheel mark). Type approval is regulated in accordance with European Parliament Directive 2014/90/EU. RISE can perform the fire tests, issue the certificates and perform the production control required in order to gain the wheel mark.

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

When testing a product according to ISO 5660-1, a sample with the dimension 100 mm x 100 mm is subjected to an irradiance level of 50 kW/m2. The surface of the sample is heated and starts to emit pyrolysis gases that ignite by an electric spark igniter. The emitted gases are collected in a hood and transported away through a ventilation system. The heat release is measured using the data on measured oxygen concentration in the emitted smoke.

The following parameters are measured: Time to ignition, heat release rate (kW/m2), total heat release (MJ/m2), and smoke production (m2/s).

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

A test report, in Swedish or English, is delivered with the test results after testing.

Area:
Fire safety
Maritime
Risk and safety
Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Anna Bergstrand, Affärsutvecklare
IMO Part 10
Field measurements: No Price type: 1 Division: Division Safety and Transport Preparation: Description of preparation Preparation information:

Material needed for testing

Complete test

  • 6  specimens with dimensions 100 mm x 100 mm x nominal thickness (max 50 mm).

Indicative test

  • 2 specimens with dimensions 100 mm x 100 mm x nominal thickness (max 50 mm).
Certification and marking: Not applicable Type of service: Not applicable 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 to below contact person. Divison (OLD): Division Safety and Transport Delivery level: Accredited PDF for order form.:

Order Specification Form (pdf, 180.52 KB)

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Maritime Sekundär områdes navigation:
Metrology
Fire safety
Materials and durability
Tjänstetyp tagg: Provning

Analysis of formaldehyde in food simulants and in water extract

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

Food contact safety is an issue of very high concern for all kinds of materials and products. Our core activity in this area is analysis of materials intended for food contact.

Purpose/Benefit:

We offer testing in compliance with regulations or requirements (e.g. EU Commission Regulation 10/2011, national regulations such as BfR XXXVI, Chinese standard GB 4806.8, FDA or industry guidelines).

The analytical results serve as the basis for demonstrating compliance with regulations, and support product development and problem solving.

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

The amount of formaldehyde in food simulant or water extract is determined by UV spectroscopy. The analysis is accredited according to ISO 17025.

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

The results are compiled into an analytical report.

For orders and consultation, please contact our experts!

FCM.productsafety@ri.se

Delivery time:

2-6 weeks depending on experimental conditions.

Area:
Packaging
Chemical processes and products
Chemical and biological analysis
Product safety
Contact person (Enter one name per field. Activated personal contact pages will appear automatically):
Flisa Henning, Labingenjör
Contact for FCM productsafety
Analysis of formaldehyde in food simulants and in water extract
Field measurements: No Price type: 1 Division: Division Bioeconomy Preparation: No preparation required Link to order form: Contact us Standards:

SS-EN 1541:2001

GB31604.48-2016

Certification and marking: Not applicable Type of service: Not applicable Instrument: Not applicable General area: Not applicable Order information: For orders and consultation, please contact our experts! Click the button below to send an e-mail to FCM.productsafety@ri.se Divison (OLD): Division Bioeconomy Delivery level: Accredited
FCM.productsafety@ri.se
/en/node/9710
9. Industry, innovation and infrastructure
12. Responsible consumption and production
Request for quote
form
Pulp and paper Sekundär områdes navigation:
Metrology
Food
Tjänstetyp tagg: Provning

EN IEC 60754-2 Acidity in flue gases from cables

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): Acidity in flue gases from cables EN IEC 60754-2 Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

EN IEC 60754-2 is a fire test method that generates data used to determine the acidity in fire gases from the combustion of cable material.
Test results forms a part of the basis for CE marking according to the CPR Construction Product Regulation.
Fire testing according to EN IEC 60754-2 also meets the requirements of EN IEC 50267-2-3

Purpose/Benefit:

In the product development context, it is important at an early stage to investigate the extent to which materials contribute to acidity in fire gases. Fire testing according to EN IEC 60754-2 generates data used to determine acidity in flue gases from combustion of material from cables.

Requirements according to the Construction Product Regulation CPR mean that cables must be CE marked and fire classified according to the Euroclass in order to be sold as construction products. In some applications, additional acidity classification is required. Data from tests according to EN IEC 60754-2 form the basis for CE marking with supplementary classification a1, a2 or a3.

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

Material samples are taken from the cable and divided into smaller pieces which are evenly distributed in a sample container "porcelain vessel", the amount of material sample is 1 g. The sample container with the material is placed in an oven that holds 935 - 965 °C, the test period is 30 minutes. During the test period, the material is gasified/burned in the furnace and fire gases are formed, these fire gases are bubbled through distilled water. When the test time is over, the pH and conductivity of the water are determined. The procedure is repeated twice after which an average value for the three tests is calculated.

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

The fire test results are summarized in English in a test report delivered in digital format.

RISE holds both accreditation and notification regarding this test method why the test report is valid as a part of the CE marking documentation.

Delivery time:

Delivery time for accredited test report is usually 4-8 weeks.
Preliminary test results can be shared when the pH- and conductivity measurements have been carried out, which is usually about 4 weeks after the test material has been delivered to RISE.

Area:
Fire safety
Certification
Testing
Contact person (Enter one name per field. Activated personal contact pages will appear automatically):
Johan Post, TIC-ingenjör
Haniyah Ashtiani, Projektledare
EN IEC 60754-2 Collection of acid content "acidity" in flue gases from combustion of cable material (EN IEC 60754-2)
Field measurements: No Price type: 1 Division: Division Safety and Transport Preparation: No preparation required Link to order form: CableTest@ri.se Standards:

EN 50575 Product standard
EN 13501-6 Fire classification

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Order information: By mail, please attach product description and safety data sheet. Divison (OLD): Division Safety and Transport Delivery level: Accredited
johan.post@ri.se,haniyah.ashtiani@ri.se
PDF for order form.:

Material description (pdf, 54.61 KB)

More information:
Provbehållare "porslinsskepp" med 1 g materialprov för bestämning av surhet "aciditet" enligt EN IEC 60754-2.
Image: Sven Karlsson
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Fire safety Sekundär områdes navigation:
Metrology
Construction
Advanced electronics
Tjänstetyp tagg: Provning

Evaluation of lighting and visual comfort

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

RISE offers evaluations of lighting and visual comfort in buildings, sports facilities and vehicles.

Purpose/Benefit:

Having good lighting and visual comfort is an important part of having a good work environment where tasks can be performed safely and correctly. It is also beneficial for comfort and well-being. Insufficient lighting, glare and flicker are examples of phenomena than can have a negative impact on productivity, well-being and health. 

Wether it's housing, workplaces, vehicles or sports facilities, there are various requirements and recommendations for lighting and visual comfort. A valuation by a third party helps to ensure that all requirements are fulfilled. RISE also offers certification of indoor environments with RISEs own certification mark called the P-mark. Lighting and visual comfort is included as one section in the certification of indoor environments. 

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

RISE is accredited for the evaluation of lighting and visual comfort. Examples of functions that can be evaluated are: 

  • Housing
  • Schools
  • Preschools
  • Offices
  • Industries
  • Workshops
  • Indoor environment in vehicles
  • Sports facilities

An evaluation of lighting and visual comfort involves the measurement of illumination, luminance, colour rendering, reflectance factor, daylight factor, optical flicker etc. 

In addition to being used in direct comparison with standadized requirements, the measured values are also used to evaluate comfort and well-being. 

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

The results are presented in an evaluation report in Swedish or in English. 

Area:
Work environment
Certification
Generic metrology and measurement technology
Testing
Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Maria Nilsson Tengelin, Forskare
Lighting and visual comfort
Field measurements: Yes Price type: 1 Division: Division Safety and Transport Preparation: No preparation required Standards:

SS-EN 12464-1, SS-EN 1789, SS-EN 13272

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Photometry and radiometry Order information: A request for tender is sent to the contact person. Divison (OLD): Division Safety and Transport Delivery level: Accredited
maria.nilssontengelin@ri.se
/en/node/9710
3. Good health and well-being
Request for quote
form
Architecture and planning Sekundär områdes navigation:
Metrology
Construction
Risk and security
Health and life science
Tjänstetyp tagg: Provning

Testing of shotcrete

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

Testing of shotcrete.

Purpose/Benefit:

Testing of shotcrete. Testing of compressive strength, flexural strength / residual strength, fibre content, frost resistance and adhesion. Order form is used.

We can help with pretesting, type testing and continuous testing. The result can be a part of quality control.

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

Testing of shotcrete in our laboratorium. For common methods, see Standards or contact us.

We can perform accredited and non accredited testing methods.

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

Test report according to method is included.

Delivery time:

Information about delivery time via the contact person.

Area:
Cement and concrete
Construction
Infrastructure
Built environment
Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Jesper Olsson, TIC-ingenjör
Sawing of sprayed concrete
Field measurements: No Price type: 1 Division: Do not use - Division Built Environment Preparation: No preparation required Standards:

SS-EN 12390-3 Tryckhållfasthet

SS-EN 14488-7 Stålfiberhalt (non-accredited)

SS 137244, utg 5 Frostresistens

SS-EN 14488-3 Böjdraghållfasthet

CBI-Metod 6 Vidhäftningshållfasthet

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): Do not use - Division Built Environment Delivery level:
Accredited
Non-accredited
jesper.olsson@ri.se,
PDF for order form.: More information:

During the summer holidays there is limited capacity for certain testing. Please contact us well in advance if you need testing during this period.

Normally we do not work on national holidays. Testing will be moved in agreement with clients.

See general and special terms and conditions applying to projects and accredited assignments Terms and conditions | RISE.

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Concrete and cement Sekundär områdes navigation: Metrology Tjänstetyp tagg: Provning

IMO 2010 FTPC Part 7 - Fire testing of vertical textiles in ships

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): IMO 2010 FTPC Part 7 - Fire testing of vertical textiles in ships Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

IMO 2010 FTP Code Part 7 - Test for vertically supported textiles and films.

Purpose/Benefit:

The standard is used for maritime safety to assess the ignitability of vertically supported textiles and films when subjected to a gas flame similar to that of a burning match.

This test method only evaluates the ignitability of vertically supported textiles and films. To evaluate the burning behavior, the object needs to be tested in full scale with larger ignition sources.

Products and materials for maritime use is fire tested according to the International Maritime Organization (IMO) code, IMO 2010 FTP Code. The results from fire testing according to the FTP-code can be used as a basis for type approval (also called the wheel mark). Type approval is regulated in accordance with European Parliament Directive 2014/90/EU. RISE can perform the fire tests, issue the certificates and perform the production control required in order to gain the wheel mark.

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

The testing is performed in a draught free cabinet. The textile or film is mounted on to a steel frame and put into the test cabinet. A series of pre-tests are performed to establish which ignition scenario is the worst case in warp and weft direction respectively. This is done by applying the ignition source to the surface and the edge of the specimens for 5 and/or 15 seconds. When the worst case is established, 5 further tests are performed in both warp and weft direction.

Performance criteria are in regard to burning droplets, flame spread, damaged length and after burn time.

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

A test report, in Swedish or English, is delivered with the test results after testing.

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

Material needed for testing

  • At least 20 specimens of the textile or film with the dimensions 220 mm x 170 mm. 10 specimens in the warp direction and 10 specimens in the weft direction. The warp must be clearly marked on each test specimen.

If the textile or film is treated with flame retardants it must also be tested after a washing procedure to ensure the performance of the flame retardant. This means double the amount of test specimens.

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: Accredited
henrik.fredriksson@ri.se,anna.bergstrand@ri.se
PDF for order form.:

Order Specification Form (pdf, 36.64 KB)

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Maritime Sekundär områdes navigation:
Metrology
Fire safety
Textiles
Tjänstetyp tagg: Provning

Fire testing according to FAR/JAR 25.853 (horizontal)

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): Fire testing according to FAR/JAR 25.853 (horizontal) Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

FAR/JAR Part 25- Airworthiness Standard: Transport Category Airplanes

Subpart D - Design and construction, Fire protection, §25.853, Appendix F - Part I

Aircraft Materials Fire Test Handbook, Chapter 3, Horizontal Test for Cabin, Cargo compartment and Miscellaneous materials.

Purpose/Benefit:

The method measures the burn rate of materials in passenger and crew compartments in aircrafts. The requirements are described in Part I of Appendix F to Part 25.

To be allowed to introduce an aircraft to the market, safety requirements, including fire safety, shall be met. For the United States, aviation safety is controlled by the FAA (Federal Aviation Administration) and in Europe it is governed by the EASA (European Aviation Safety Agency). The documents with requirements are called FAR (Federal Aviation Requirements) and JAR (Joint Aviation Requirements) and are identical to each other.

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

The test takes place in a specified test chamber in which the specimen is mounted horizontally. The exposed surface of the material is facing down towards the flame. The material is brought against the gas flame. It is recorded how far the material burns and how long it takes for the flames to spread in the material. The result (burn rate) is expressed in mm/min.

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

A test report, in Swedish or English, is delivered with the test results after testing.

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

Material needed for testing

  • 4 specimens with dimensions 51 mm x 305 mm x nominal thickness (max 13 mm)

In case of production direction in the material, specimens need to be prepared in two directions.

Standards:

Related standards: FAR/JAR 25.853 (vertical)

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 to below contact person. Divison (OLD): Division Safety and Transport Delivery level: Non-accredited PDF for order form.:

Order Specification Form (pdf, 193.07 KB)

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Fire safety Sekundär områdes navigation: Metrology Tjänstetyp tagg: Provning

Testing and certification of electricity meters

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

We offer testing and certification of electricity meters according to Swedish, European and international standards.

Purpose/Benefit:

Common rules for the entire EU apply to the control and approval of new electricity meter types according to the Measuring Instruments Directive (MID). RISE is a notified body for MID and can therefore issue approvals for the entire EU. All testing is accredited by Swedac, the official accreditation body in Sweden.

Even for electricity meters that are not regulated by the MID, electricity meter manufacturers can benefit greatly from a certificate from a reputable third-party laboratory such as RISE. Each test result is compiled in a report or certificate, which minimizes questions and objections when launching new electricity meters on the market.

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

We carry out testing according to all or part of the standards, including mechanical tests and EMC evaluation.

We perform accredited testing according to these standards:

  • Swedish and European standards for MID: SS EN 50470-1, SS EN 50470-3. The tests according to these standards can then be the basis for approvals according to MID modules B and F from the RISE certification department.
  • Swedish and European standards outside MID: SS EN 62052-11, SS EN 62053-21/22/23/24.
  • International standards: IEC 62052-11, IEC 62053-21/22/23/24.

We also perform some testing and certification for requirements beyond the above standards:

  • SP method 1618, for tests with 12 kV impulse voltage.
Delivery (what does the client get after performed service – e.g. a report, certificate etc.):

MID approvals and certificates as above, in collaboration with RISE Certification.

Area:
Certification
Electronics
Energy
Generic metrology and measurement technology
Testing
Contact person (Enter one name per field. Activated personal contact pages will appear automatically):
Stefan Svensson, Forskare
Contact for high voltage
elmatarbord
Field measurements: No Price type: 1 Division: Division Safety and Transport Preparation: No preparation required Link to order form: highvoltage@ri.se Standards:

SS EN 50470-1, SS EN 50470-3, SS EN 62052-11, SS EN 62053-21/22/23/24, IEC 62052-11, IEC 62053-21/22/23/24, SP-metod 1618 for tests with 12 kV impulse voltage.

Certification and marking: Other Certifications Type of service:
Certification
Testing / Analysis / Evaluation
Instrument: Electricity meters General area: Electricity Order information: Order can be sent to highvoltage@ri.se Divison (OLD): Division Safety and Transport Delivery level: Accredited
highvoltage@ri.se
/en/node/9710
Order
form
Metrology Sekundär områdes navigation:
Energy transmission
Sensors and sensor systems
Tjänstetyp tagg:
Provning
Certifiering

Biological evaluation of medical devices according to ISO 10993

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

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

Purpose/Benefit:

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

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

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

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

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

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

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

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

Delivery time:

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

Area:
Medical devices
Product safety
Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Charlotte Nilsson, Toxikolog
evaluation of biocompatibility
Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: Description of preparation Preparation information:

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

Standards:

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

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Order information: Please contact our toxicologist at the bottom of this page. Divison (OLD): Division Bioeconomy Delivery level: Not applicable
charlotte.nilsson@ri.se,
/en/node/9710
More information:

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

Application of interest
form
Medtech Sekundär områdes navigation:
Biotechnology
Materials and durability
Tjänstetyp tagg: Provning