The trend in the industry today is that an increasing part of the risk reduction is dependent on the correct operation of the machine's control system. This applies both to traditional machines but also to mobile machines. RISE is accredited by Swedac for evaluating control systems in machines and works with standards such as ISO 13849 and IEC 6206

RISE can help evaluate that the requirements of these machine safety standards are met. The reason for taking help from RISE can either be to build up your internal expertise in the area or that you need an independent evaluation of your design. If your product is classified as Logic Units for Protective Functions in accordance with point 21 of Annex 4 of the Machinery Directive 2006/42 / EC, we can issue an EC type-approval in addition to an evaluation report.

By using RISE early in your Product development, you avoid the risk of misinterpreting these functional safety standards. The first choice is whether you shall work with ISO 13849 which is based on the risk reduction measure Performance level or IEC 62061 which is based on the risk reduction measure SIL - Safety Integrity Level or alternatively if for your product there are other functional safety requirements stated directly in your product safety standard. Even when identifying the correct standard, there are many pitfalls, we usually stress how important it is to define the safety functions correctly before proceeding with the design of the associated software and hardware.

The evaluation is based on ISO 13849-1:2015 but we are also updated on the upcoming version ISO 13849-1:2023. The updates to the standard include (among other things):

• Clearer definitions of terms and concepts that will make it easier to understand and apply the standard.
• Expanded use of Performance level (PL)
• Updated documentation requirements to ensure that all necessary information on machinery safety is documented and available.
• The new standard emphasises more the human role in machinery safety, including the need to train and develop user competence in the use of machinery and safety-related parts of control systems.

The evaluation is based on our Swedac accredited methods for:

• ISO 13849
• IEC 62061

The result of the functional safety evaluation is summarized in an accredited RISE report.

Avaliable courses

ISO 13849 Safety of Machinery

IEC 62061 Safety of Machinery

Several new functional safety standards require that an independent safety review be conducted in parallel with the development work of components / systems. RISE is accredited by SWEDAC to perform functional safety assessment in accordance with IEC 61508, IEC 61511 and ISO 26262, among others.

RISE can be responsible for the role of functional safety assessor that is defined in the standard. RISE's work is based on SWEDAC accredited methods and our independence means that we can act in this role up to the cases where the standards fully require that an independent organization be responsible for functional safety assessment.

Often it can be difficult to find a person in your own organization who is both sufficiently familiar with the requirements of functional safety standards and who has also not been involved in the development work for a new product to be able to act in the independent role of functional safety assessor. In addition, the requirement for independence increases the higher the degree of risk reduction one wishes to achieve with control system functions and in some cases these standards require that an independent organization be responsible for the role of functional safety assessor. In addition, it is a quality measure to be able to demonstrate to your customers that an independent organization has been responsible for the functional safety assessment work.

RISE functional safety assessment is based on our SWEDAC accredited methods for:

• IEC 61508
• IEC 61511
• ISO 26262

When the functional safety assessment is finalized, the results are compiled in a RISE report. We can also offer to issue a certificate that briefly (1-2 pages) describes the safety requirements that the product meets.

IEC 61508

IEC 61511

ISO 26262

RISE offers evaluation of software in measuring instruments with regard to risks for incorrect measurements and measured values. The EU Directive for Measuring Instruments (MID) and guidelines from the WELMEC co-operation are the basis for the evaluation work.

Measuring instruments used in sales to private individuals in Europe must meet EU requirements. It is important that the measuring instruments are quality assured and provide reliable measurement results. The requirements are described in the Measuring Instruments Directive, 2014/32 / EU (MID). The MID includes various types of measuring instruments such as water meters, gas meters, electricity meters, heat meters, measurement systems for liquids other than water (such as petroleum pumps), automatic weighing instruments and taximeters. For non-automatic weighing instruments, there is a separate directive, 2014/31/EU (NAWI).

An approved test of a measuring instrument and the preparation of a certificate according to MID, opens up a market across the EU to the manufacturer. The approval procedure includes an evaluation of the software according to WELMEC Guide 7.2, or WELMEC Guide 2.3 (for non-automatic weighing instruments).

An approved test of a measuring instrument and the preparation of a certificate according to MID, opens up a market across the EU to the manufacturer. A RISE certificate is sufficient for marketing in all EU countries.

An accredited software test report can also be used by many national authorities outside Europé.

The software evaluation at RISE follows the guidelines in WELMEC Guide 7.2, OIML D31 and OIML R117. We work with design reviews, document reviews and functional tests. Long-term storage of measurement data, transfer of data, separation of the various parts of the software and download of legally relevant software are specially examined.

For non-automatic scales, the RISE follows the guidelines in WELMEC Guide 7.5. The protection of the software, the interfaces of the software and the identification of the software are specially examined. We work with design reviews, document reviews and functional tests.

RISE reviews, according to Welmec Guide 7.6,  that the risk analysis for the measuring instrument deals with protective assets, consequences of a fault, threats, attack vectors and techniques for reducing the risks. We work with design reviews and document Reviews.

The result of the RISE evaluation of software in measuring instruments or risk analysis assessment, is reported in a written report. The reports are part of the documentation needed to be able to issue a MID certificate for the measuring instrument.

The delivery time depends on whether the software for the measuring instrument is written before the evaluation is started, or if the evaluation is done in parallel with parts of the development work.

The manufacturer needs to compile documentation showing how the requirements of the WELMEC guide are met. For WELMEC Guide 7.2, it is especially important that documentation according to requirement U1 or P1 is available. 

The basis for the risk analysis shall be according to Welmec Guide 7.6 and at least contain Annex A including an assessment whether instrument specific attack vectors need to be defined, a description of the measuring instrument, method of use and environment. The risk analysis itself must describe, among other things, what should be protected, the consequences of identified, probability of failure and what techniques have been taken to reduce the risks.

WELMEC Guide 7.2, Software Guide (Measuring Instruments Directive 2014/32/EU1) See WELMEC Guide 7.2 v2020

WELMEC Guide 7.5, Guide for Examining Software (Non-automatic Weighing Instruments) See WELMEC Guide 7.5 v2020

WELMEC Guide 7.6, Guide for Software Risk Assessment for Measuring Instruments. See WELMEC GUIDE 7.6 v2021

Software Risk Assessment, Annex A. See WELMEC Guide 7.6 v2021, Annex_A

OIML D31

OIML R117

RISE is an accredited and independent body that verifies emissions reports within the EU ETS. We review emissions data for both EU ETS 1 and EU ETS 2 – so you can report accurately and meet your requirements.

The EU ETS covers the most energy-intensive sectors, where emissions are measured and reported annually according to strict requirements. To ensure high-quality reporting, an accredited and independent verification partner is required. RISE verifies:

• Annual emission reports in accordance with MRR and AVR
• Monitoring systems, measurement methods, and calculation models
• Activity level reports when applying for free allocation
• Supporting documentation reported to the Swedish Environmental Protection Agency and the EU ETS Reporting Tool (ERT)

EU ETS 2 – Verification of emission reports for buildings and road transport

EU ETS 2 means that the trading system is being expanded to include emissions linked to fuel distribution in the construction sector, road transport, and other less emission-intensive activities. This places entirely new demands on accurate reporting—and on the verification of reports by an independent and accredited party.

RISE offers verification of emissions reporting in accordance with EU ETS 2, including:

• Annual emissions reports based on fuel volumes and emission factors
• Review of monitoring and reporting procedures
• Quality assurance of data flows throughout the reporting chain
• Verification report that forms the basis for reporting to the authorities

See description of RISE verification and validation process.

Once verification has been completed, you as a customer/operator will receive a verification statement and a verification report in the EU ETS reporting tool, as well as approval in the Union Registry.

Why choose RISE?  

RISE is a national research institute with extensive experience in verification in the field of climate and sustainability. Our independent role and technical expertise enable us to support your business in both established and new emissions trading systems. We work flexibly, efficiently, and with high standards of integrity. Our verifiers are accredited and work in accordance with the ISO/IEC 17029 and ISO 14065 standards.