Risk and security

Global Market Access (GMA)

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

In order to place products on the market in different countries, the products must comply with regulations and standards specific to the countries and regions.

The process of managing compliance globally with regulatory requirements is often referred to as Global Market Access (GMA)

Purpose/Benefit:

We have a global network of partners we choose from to make the certification process as fast and smooth as possible and to ensure that your product meets the certification requirements in different countries globally.

RISE offers a comprehensive service to secure global EMC, radio and GMA approvals.

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

Many customers are already turning to RISE experts to fulfil the requirements for EMC and Radio on their products. By allowing us to assist in the GMA process, many manufacturers avoid the time-consuming and complex licensing process and thus get the benefits of being able to quickly place their product on the market.

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

Regulatory certificates and approvals from local authorities.

Where applicable, test reports are obtained from local authorities.

Delivery time:

According to offer

Area: Electronics Contact person (Enter one name per field. Activated personal contact pages will appear automatically):
Jonas Bremholt, Ingenjör
Ove Nilsson, Ingenjör

Field measurements: No Price type: 1 Priceinformation:

Price according to quotation

Division: Division Safety and Transport Preparation: Description of preparation Preparation information:

According to offer

Standards:

Complete documentation required for RED and / or FCC approval.

Certification and marking: Not applicable Type of service: Not applicable Instrument: Not applicable General area: Not applicable Order information: Order by contacting the persons below. URL: Here you will find all our services within EMC IKT Divison (OLD): Division Safety and Transport Delivery level: Not applicable

jonas.bremholt@ri.se

/en/node/9710

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EMC Sekundär områdes navigation:
Digital infrastructure
Risk and security
Advanced electronics Tjänstetyp tagg: Certifiering

EMC testing of marine products (from small components to whole systems) that can from the basis for EU type approval, wh

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

RISE performs tests to meet marine EMC requirements on everything from components to systems so that they can be approved for use.

Purpose/Benefit:

We perform tests according to a variety of standards and certifications. Among other things, we perform tests against marine requirements such as "Det Norske Veritas standard for certification No 2.4", which includes EMC and IACS E10, a test specification for marine type approval and the general standard for CE marking of marine navigation and communication equipment EN 60945.

EMC testing and combination testing in many areas.

Many of the sub-elements of, for example, the general EMC standards EN 61000-6-2/ EN 61000-6-4, which are common for equipment in industrial environments, also occur in the marine tests.

We have developed test packages that make it easier for manufacturers to get their products approved for both onshore industrial and offshore applications. By seeking coordination gains, you save a lot of time. In addition, if the highest test severity is used for each sub-sample, the product can cover more markets.

RISE also coordinates and performs the EMC tests with climate, environmental and some special tests, such as the "compass safe distance test". RISE can also offer certification against the Measuring Instrument Directive. We know that standards are required and together with the customer we develop a suitable test plan.

RISE delivers a test report with accreditation status, confirming that a 3rd party testing institute has tested your products.

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

The testing is performed accredited according to ISO/IEC 17025 in our laboratories in Borås.

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

RISE provides an accredited test report that can be used as a basis for certification.

Delivery time:

According to offer

Area: Electronics Contact person (Enter one name per field. Activated personal contact pages will appear automatically):
Daniel Lundgren, Enhetschef
Tommi Anttila, Högskoleingenjör

Field measurements: No Price type: 1 Division: Division Safety and Transport Preparation: Description of preparation Preparation information:

According to offer

Standards:

EN 60945

ISO 25197

IEC 60533

IACS E10

DNV 2.4

GL VI-Part7

DNVGL-CG-0339

Lloyds Register Test Specification no1

ABS Part 4

BV Part C,chapter 3,section 6

NK Part 7,chapter 1

RINA Part C,chapter 3,section 6

KR, Korean Register of Classification,chapter 3,section 23

Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Order information: Order by contacting the persons below. URL: Here you will find all our services within EMC IKT Divison (OLD): Division Safety and Transport Delivery level: Accredited

daniel.lundgren@ri.se

/en/node/9710

Order

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EMC Sekundär områdes navigation:
Metrology
Maritime
Risk and security Tjänstetyp tagg: Provning

Functional safety

Functional safety is that part of overall safety that depends on whether a system or component operates correctly with the input signals that it receives. RISE has a broad expertise within the field of functional safety.

Different types of risks

There are many different types of risks in technical systems: mechanical risks, chemical risks, electrical risks, explosion risks etc. When we say that a system, a piece of apparatus or a machine is safe, we mean that the risks presented by or to it are acceptably low.
Safety, in other words, means that the system etc. does not present unacceptable risks of physical damage or health or injury risks. Damage or injury can arise either directly or indirectly as a result of damage to property or the environment. Functional safety is that part of overall safety that depends on whether a system or component operates correctly with the input signals that it receives.

The difference between functional safety and electrical safety

Functional safety must not be confused with electrical safety, which is concerned with protection against electric shock and fires caused by electricity.
An example of functional safety is that of an overspeed trip to prevent a grinding wheel from running too fast, and thus introducing a danger of bursting. However, mechanical protection against injury caused by the rotating wheel is not an aspect of functional safety, and nor is sound attenuation intended to protect against the risk of damage to hearing. All these measures are important in assessing whether the grinder as a whole is regarded as sufficiently safe.

Standards

EN 62061 "Safety of machinery - Electrotechnical aspects"
EN ISO 13849 "Safety of machinery - Safety-related parts of control systems"
EN 61511 "Functional safety - Safety-instrumented systems for the process industry sector"
EN 61508 "Functional safety of electrical, electronic or programmable electronic safety-critical systems" (a total of seven parts)
ISO 26262 "Road vehicles - Functional safety"
EN 61513 "Nuclear power plants - Instrumentation and control for systems important to safety - General requirements for systems"

EN 61508 is intended primarily to be used in connection with the design of individual components that will form part of a safety function, while IEC 61511 and IEC 62061 describe how the complete safety function should be implemented using components designed to comply with IEC 61508.

ISO 13849-1 is applicable both to the design of individual machine components and to the creation of the complete safety function in a machine.

ISO 26262 "Road vehicles - Functional safety" is used when designing safety critical vontrol systems within road vehicles

Johan Hedberg Kristian Flink Ted Strandberg Fredrik Warg Per Stålberg Martin Skoglund Anders Thorsén

Johan Hedberg

Projektledare

+46 10 516 50 71 Read more about Johan

Division (OLD): Division Safety and Transport Division: Division Safety and Transport Risk and security

Risk analysis of machinery

RISE has a long experience of reviewing and providing guidance in conducting risk analyzes. By taking help from us early in the process, you reduce the risk of ending up at wrong level in this work process.

A Careful risk analysis is essential to identify all hazards and associated hazardous events that may occur in a machine. A detailed risk analysis will also serve as a summarizing document where you can track all the risk mitigation measures built into your design, from mechanical measures to enhanced quality in control systems and important information in user and installation manuals.

Our strength lies in helping you as a customer to structure your risk analysis work. An example of this that may seem simple is what information is to be placed in different columns in the risk analysis, what type of information should be placed under the heading hazard and what type of information should be placed under the heading hazardous event? Often, our work is based on standard EN ISO 12100, which is harmonized with the Machinery Directive 2006/42 / EC and which provides guidelines on how to perform a risk analysis for a machine.

Adding a little extra work to a risk analysis gives a lot of back and you increase the likelihood of detecting potentially dangerous hazardous events before they happen.
We at RISE believe that it is you yourself at your company who are experts in your own machines and associated hazards and hazardous events and that our strength is to guide you in how you plan the risk analysis work effectively. Normally, a risk analysis assignment usually involves one or a few visits on site with you as a customer to gain an understanding of your system. Thereafter, it is usually possible to have a follow-up meeting at a distance during ongoing risk analysis work.

By working with RISE, you will gain a partner with solid experience in risk analysis and after completing the assignment, you as a customer should feel that your risk analysis documentation has reached such a level that it provides a good overall picture of all risk mitigation measures implemented in your machine and that this document adds so much that you will actively work on update of risk analysis documentation in future design changes.

CE marking of machinery CE-marking, lifting accessories and lifting machinery Machine control systems Functional safety

Kristian Flink Johan Hedberg Per Landström

Johan Hedberg

Projektledare

+46 10 516 50 71 Read more about Johan

Division (OLD): Division Safety and Transport Division: Division Safety and Transport Risk and security

Post-treatment of PFAS contamination and PFAS-free fire extinguishing

The test bed offers evaluation of techniques for post-treatment methods for PFAS in soil and water as well as evaluation of methods and means for PFAS-free fire extinguishing.

Not applicable

Tove Mallin

Enhetschef

RISE

Energy and Clean Tech Health and Life Sciences Food and agriculture Security and defence

Fire safety Chemical processes and products Chemical and biological analysis Food Product safety Risk and safety Water

Not applicable

2019

Guiding substitution

The Swedish Centre for Chemical Substitution supports organizations in identifying hazardous substances and finding better alternatives, in order to reach the environmental quality objective “A non-toxic environment” set by the Swedish Government.

POPFREE Stage 3

POPFREE aims to, with product development and communication, contribute to the transition into a world free from non-essential use of PFAS.

POPFREE Industry - Towards a PFAS-free and circular industry

Chemical products and processes Sekundär områdes navigation:
Water
Fire safety
Risk and security

ISO 17665 Validation of Sterilization Instructions

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

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

Purpose/Benefit:

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

Fulfill requirements in MDR.

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

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

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

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

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

Methods and results are presented in a written report.

Delivery time:

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

Field measurements: No Price type: 1 Priceinformation:

Please contact us for price information

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

The customer prepares the test items unless otherwise agreed

Medtech / Service

ISO 17664 Validating Instruction for Users - cleaning and disinfection

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

Medtech / Service

ISO 10993-5 Cytotoxicity Test - in vitro

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

Medtech / Service

ISO 10993-23 Skin Irritation - in vitro

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

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

louise.wogelred@ri.se,

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

3. Good health and well-being

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

Testing for Fire Safety Cabinets Designated for Storing Flammable Goods in Retail Environments

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

SP Method 2369 - Protection System for Storage of Inflammable Goods in Retail Environments - Fire Safety Cabinets

Purpose/Benefit:

This method evaluates the construction of fire safety cabinets designed for storing flammable goods in retail environments and their ability to protect its contents from internal and external fires. The general function of this cabinet is to control and extinguish a large internal fire, but also that an external fire does not spread to its contents.

Fire safety cabinet’s that fulfill SPCR 102 requirements protects its contents, and their surroundings, up to 30 min in realistic early stage fire scenario’s. In this period, it is crucial that flammable goods do not get involved, or spread the fire, and cause control of the situation to be lost. An example of a fire safety cabinet preventing the total loss of a store is seen in the photograph at the bottom of this page. This cabinet successfully protected the flammable goods, and the retail facility.

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

SP Method 2369 may be divided into two types of tests, general tests and fire tests. The general tests are designed to evaluate the following requirements (note that the text refers to section numbers in SP Method 2369):

General construction (req. 6.1)
Wall construction (req. 6.1)
Mechanical integrity (req. 6.1 / test 7.2)
Hinges (req. 6.1)
Door closer (req. 6.1 / test 7.3)
Tightness and volume of the spill tray (6.1 / 7.4)
Equipment (req. 6.1).

Two fire tests are performed:

Internal fire exposure (req. 6.2 / test 7.5)
External fire exposure (req. 6.3 / test 7.6)

All tests are performed at RISE in Borås, Sweden.

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

After testing, a test report is delivered with the results which may be the basis for product approval (P-mark) according to SPCR 102.

Area:
Fire safety
Testing
Risk and safety Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Magnus Bobert, Civilingenjör

Retail, flammable goods, risk, cabinet, safety

Field measurements: No Price type: 1 Division: Division Safety and Transport Preparation: No preparation required Preparation information:

A total of 3 tests samples are needed.

Standards:

SP Method 2369 version 6

Fire safety / Test & demo

Large Fire Test Hall

One of the largest large scale fire test halls in Europe. Modern smoke and water cleaning systems fulfill high environmentally sustainable requirements.

Divison (OLD): Division Safety and Transport Delivery level: Accredited

magnus.bobert@ri.se

/en/node/9710

Documents:

SP Method 2369 Version 6 (pdf, 466.5 KB)

SPCR 102: Certification rules for fire safety cabinets for retail environments (pdf, 281.79 KB)

More information:

Request for quote

form

Fire safety Sekundär områdes navigation:
Metrology
Construction
Risk and security Tjänstetyp tagg:
Provning
Certifiering

Safe interaction with several levels of automation in vehicles

HARMONISE

This project addresses the changing role of the driver when more and more support systems, at different levels of automation, are introduced in vehicles in an evolutionary manner. The aim in this project is to investigate different means improve how drivers interact with the increasingly automated vehicle.

User studies and experiments

Completed

Automated vehicles

Västra Götaland Region

2017-01-01

3 years

10 044 000 SEK

The aim of this project is to investigate different means to harmonize, simplify, manage and improve the interaction design of technical systems that operate at different levels of automation, often in the same vehicle, in different situations. In particular, mode understanding and mode confusion will be addressed. The goal is twofold: to develop and evaluate different concepts which support the interaction between driver and vehicle in a multimodal way and to develop design requirements based on theoretical and empirical data achieved in the project.

In addition to the already available support systems in cars and trucks, new systems, or software modifications of existing systems, are frequently being introduced. The HARMONISE project addresses the challenges that emerge due to the incremental increase of automated driver support systems that gradually change the role of the driver over time. The challenges of mode understanding and mode confusion will be a particular focus during the project.

The project will develop and evaluate different concepts, which support the interaction between driver and vehicle in a multi-modal way and develop design requirements based on theoretical and empirical data collected in the project. The work will be theoretically grounded in recent advances within the distributed and embodied cognition approach to understand human action.

11. Sustainable cities and communities

Volvo Groups Truck Technology Volvo Cars

Project end date: Tue, 03/12/2024 - 12:00 Autonomous vehicles Sekundär områdes navigation:
Design
Risk and security

EN ISO 12952 -Fire testing of bedding items

Name of service (page headline, shown in promos – maximum of 70 characters incl. spaces): EN ISO 12952 -Fire testing of bedding items Lead (include SEO-words and the main benefits for your target groups. Stick to one paragraph, maximum 2-3 sentences):

EN ISO 12952-1:2010 - Textiles – Assessment of the ignitability of bedding items – Part 1: Ignition source: smouldering cigarette.

EN ISO 12952-2:2010 - Textiles – Assessment of the ignitability of bedding items – Part 2: Ignition source: match flame equivalent.

Purpose/Benefit:

The standard is used to assess the ignitability of bedding items when subjected to a smouldering cigarette and a match flame equivalent as ignition source.

These test methods only evaluates the ignitability of bedding products and does not evaluate the burning behavior of a specific item.

In Sweden, to be able to use bedding items in a high-risk health care environment, the bedding items must be able to resist ignition according to SS-EN ISO 12952-1 and SS-EN ISO 12952-2.

According to the standard for railway applications, EN 45545-2, bedding items are to be tested according to EN ISO 12952-2, ignition with a match flame equivalent.

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

The tests are performed in a test cabinet with a calibrated air flow. The test specimen is located on a substrate of mineral wool, on top of a steel rig. Ignition sources are applied on flat surfaces, quilts, edge tapes, underneath quilts, between sheets, etc.

During the cigarette test the bedding item is not allowed to smoulder or produce externally detectable amounts of smoke, heat or glowing after one hour from the beginning of the test. It is also not allowed to have any occurrence of flames initiated by the smouldering cigarette.

The test assembly is subjected to a gas flame for 15 seconds. No flaming is allowed to continue for more than 120 seconds after the removal of the ignition source, and the specimen should not burn until it is consumed within the test duration. The bedding item should not smoulder or produce externally detectable amounts of smoke, heat or glowing after 15 minutes following the removal of the ignition source.

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

After testing, a test report in Swedish or English is delivered with the results.

Area:
Fire safety
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, dimensions given in mm:

Duvet/quilt - 3 pieces with the dimension 450 ± 10 x 450 ± 10, edges should be sealed. At least 2 original edges per specimen.
Sheet/blanket/pillow case - 3 pieces with the dimension 450 ± 10 x 1350 ± 10.
Pillow/bolster - 3 pieces that may be cut to a length of 450.
Mattresscover/underlay/incontinence sheet and pad - 3 pieces with the dimension 450 ± 10 x 450 ± 10.
Complete set of bedding items - 3 of each item.

The materials should be washed according to standard prior to any testing

Standards:

Related standard EN 45445-2

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 fill out the "Order Specification Form" and attach your order as well as any product and safety data sheets. 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, 311.97 KB)

Order

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Fire safety Sekundär områdes navigation:
Metrology
Risk and security
Textiles Tjänstetyp tagg: Provning

Analysis of allergenic dispersion dyes according to OEKO-TEX

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

It is important that the textiles on the market are free of harmful and regulated substances. Chemical analysis is a way to gain control over the products' chemical content.

Purpose/Benefit:

Society and consumers set high demands on companies and their products. The legislation also means that you as an actor must have complete information and control over the chemicals in your product. It is especially important with products for children and goods with skin contact, such as clothes and accessories.

We can help you interpret the legal requirements in REACH and POPs and propose appropriate analysis.

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

OEKO-TEX analysis method

Sample amount 20 grams

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

Written report in Swedish or English

Delivery time:

After order and arrival of sample material - normal delivery time 10 working days

Area:
Chemical and biological analysis
Plastics
Product safety
Textile Contact person (Enter one name per field. Activated personal contact pages will appear automatically): Carina Berglund, Forskare

Field measurements: No Price type: 1 Division: Division Materials and Industry Preparation: No preparation required Certification and marking: Not applicable Type of service: Testing / Analysis / Evaluation Instrument: Not applicable General area: Not applicable Order information: Please order via the contact person(s) listed below.

Textiles / Area