In many industries, measuring and testing equipment represents a significant investment and is essential for ensuring product quality, safety, and regulatory compliance. For permanently installed or highly sensitive systems, transporting equipment to the SIQ laboratory may introduce unnecessary risks and disrupt operations.

On-site calibration eliminates these risks by performing calibration directly at the customer’s premises. This approach avoids mechanical damage, changes in metrological characteristics caused by transportation, and additional interventions required when reinstalling the equipment.

Another key advantage is the significant reduction in downtime. Calibration can be scheduled during planned maintenance windows or performed simultaneously on multiple systems, minimizing production interruptions and maximizing equipment availability.

In environments such as cleanrooms, GMP-compliant manufacturing facilities, or safety-critical systems, on-site calibration also preserves existing validated conditions. Equipment remains within its actual process environment, eliminating the need for revalidation or system adjustments following transportation.

SIQ performs on-site calibrations in accordance with the requirements of ISO/IEC 17025, ensuring traceability to the SI units, documented evaluation of measurement uncertainty, and the use of validated procedures specifically developed for field calibration. This guarantees a level of technical validity equivalent to laboratory-based calibration.

Beyond technical compliance, on-site calibration also enhances collaboration. Direct interaction between SIQ experts and the customer’s engineers enables immediate clarification of measurement requirements, optimization of instrument settings, and the exchange of practical expertise. This frequently results in a better understanding of measurement processes and supports long-term operational improvements.

On-site calibration is particularly beneficial for large or permanently installed systems, equipment located in controlled environments, and where equipment transportation would require revalidation or compromise process integrity.
Through this approach, SIQ combines metrological expertise, reduced operational risk, and support for uninterrupted process continuity—delivered directly at the customer’s site.

On-site calibration reduces operational downtime, minimizes the risks associated with equipment transportation, and provides reliable, traceable measurements directly within the customer’s operating environment.

Contact our team of experts to receive a quote. Find out more about our accredited calibrations HERE.

The post Accredited On-Site Calibration appeared first on SIQ.

The Safety and Electromagnetics programme offered a rich agenda of technical presentations and workshops across four key product groups: ITAV (Information Technology and Audio/Video Equipment), MED/MEAS (Medical and Measurement Equipment), LITE (Lighting Products), and HOUS/TOOL (Household Appliances and Tools). Participants gained valuable insights into the latest developments in electrical safety, EMC, international approval requirements, product standards, cybersecurity, ecodesign legislation, and practical approaches to compliance. The programme also featured hands-on workshops on electrical safety and EMC, allowing attendees to deepen their technical knowledge through practical examples and real-world case studies.

The conference brought together technical experts from product development, testing, certification, and international approvals. Beyond the technical programme, the Summit served as an important meeting point for industry professionals and SIQ experts. Participants had the opportunity to discuss specific technical challenges, connect directly with SIQ specialists from different fields, and exchange experiences and best practices with their peers.

We would like to sincerely thank all speakers, partners, and participants for joining us and contributing to the success of SIQ Summit 2026. The strong attendance, high level of engagement, and positive feedback confirmed the value of bringing together experts from across industries to share knowledge and address the challenges of an increasingly complex compliance landscape.

We look forward to welcoming you again at future SIQ events.

The post SIQ Summit 2026: Safety and EMC Experts Exchange Knowledge and Experience appeared first on SIQ.

The assessment, performed by the European Testing, Inspection and Certification System (ETICS), confirmed SIQ’s continued compliance with the applicable requirements for participation in European certification schemes. The positive outcome demonstrates SIQ’s ongoing commitment to maintaining a high level of technical competence and quality in conformity assessment services.

SIQ is an active and long-standing participant in leading European certification schemes and operates within the frameworks of the following schemes:

• ENEC Scheme
• ENEC+ Scheme
• CCA – CENELEC Certification Agreement
• CCA EMC Scheme
• CIG Inspection Scheme

Through its participation in these schemes, SIQ provides internationally recognized testing and certification services, supporting manufacturers in obtaining recognized European certification marks for electrical products that demonstrate compliance with European standards.

More information:
Matej Žontar
E-mail: matej.zontar@siq.si
Tel.: +386 1 4778 251

The post SIQ Ljubljana Successfully Completes ETICS Reassessment appeared first on SIQ.

What has changed?
The FCC will no longer grant standard equipment authorization for certain foreign-manufactured routers. Instead, manufacturers must obtain additional approvals from relevant U.S. authorities before these products can be placed on the market.

The measure applies primarily to routers used in homes and small office environments, which are widely deployed and often serve as critical entry points to networks.

Importantly, devices already approved or currently in use are not affected and can continue to operate and receive updates.

What does this mean for industry?
This update reflects a broader global trend of increasing regulatory attention on cybersecurity and supply chain transparency.

Manufacturers and stakeholders should:

• review their production and sourcing strategies,
• evaluate compliance requirements for the U.S. market
• strengthen cybersecurity measures throughout the product lifecycle.

FCC announcement

FCC FAQ

More information:
Marjan Mak
E-mail: marjan.mak@siq.si
Tel.: +386 1 4778 178

The post FCC applies restriction for Foreign-Manufactured Routers appeared first on SIQ.

Manufacturers of power-supply units (PSUs) and DC/DC converters are therefore facing new challenges related to safety certification. The most commonly used safety standard for products in data-center environments is IEC 62368-1, which applies to audio/video, information and communication technology equipment. However, IEC 62368-1 is limited to equipment with a rated voltage not exceeding 600 V; therefore, equipment with an 800 V DC rated input or distribution interface falls outside its scope.

As a result, manufacturers are looking for alternative standards. One such option is IEC 62477-1, which covers power electronic converter systems and equipment and applies to rated system voltages up to 1 000 V AC or 1 500 V DC.

SIQ Ljubljana is accredited for both of the above-mentioned standards and participates in the IECEE CB Scheme. We can support certification of products with power ratings up to 400 kW. In addition to safety approvals, we also provide EMC and environmental testing services. Furthermore, we support short-circuit current testing in cooperation with our partner laboratories.

More information:
Boštjan Glavič
E-mail: bostjan.glavic@siq.si
Tel.: +386 1 4778 265

The post 800 V DC Distribution in Data Centers: Scope Limitations of IEC 62368-1 appeared first on SIQ.

Key requirements focus on protection against high temperatures, pressurized systems, hazardous chemicals, and risks related to fluid handling. Testing typically covers aspects such as leakage, mechanical strength, abnormal operation, and protection against operator exposure to heat and chemicals. A major challenge lies in addressing multiple interacting hazards within a single system, requiring a comprehensive safety approach.

Manufacturers often face difficulties in demonstrating compliance under realistic operating conditions, especially when designing compact systems with complex process cycles. Another challenge is ensuring durability and consistent performance under aggressive environments, such as exposure to steam, disinfectants, and corrosive substances.

Testing is essential not only for regulatory compliance, but also for ensuring operator safety, reducing liability, and enabling global market access.

SIQ is accredited for testing according to IEC 61010-2-040 and have this standard also within our CB Scheme scope, enabling efficient and internationally recognized certification.

We support our customers with:

• early design reviews and gap analysis,
• pre-compliance and full safety testing,
• certification support for international markets.

Applicable standards:

• IEC 61010-1:2010 + A1:2016
• EN IEC 61010-1:2010 + A1:2019
• IEC 61010-2-040:2020
• EN IEC 61010-2-040:2021

More information:
Matej Šmidovnik
E-mail: matej.smidovnik@siq.si
Tel.: +386 1 4778 267

The post Safety Testing of Sterilizers and Washer-Disinfectors according to IEC 61010-2-040 appeared first on SIQ.

For this reason, cybersecurity in medical devices is no longer an additional feature, but a fundamental requirement. Both regulators and manufacturers increasingly recognize that security must be addressed holistically – throughout the entire product lifecycle, from development to deployment and maintenance.

Security starts at the design stage.

Safety starts with design

Modern approaches to medical device development are based on the principle of “security by design.” This means that security requirements are not added at the end, but are integrated into the planning, development, and testing of software from the outset.

A key reference in this area is the IEC 81001‑5‑1 standard, which focuses on the cybersecurity of health software. It defines processes and activities to ensure that security measures are implemented across the entire lifecycle – from development to maintenance and vulnerability management.

Regulation and standards as a common language

In the field of medical devices, cybersecurity requirements are rapidly evolving. The European MDR regulation and similar frameworks increasingly emphasize the need for demonstrable security. Standards such as:

• IEC 81001‑5‑1 (health software),
• IEC 62443 (industrial systems),
• as well as other supporting standards and best practices,

are becoming key reference frameworks for manufacturers and testing organizations. Their role is to translate general regulatory expectations into concrete and verifiable activities.

However, it is important to note that standards alone do not guarantee security – what matters most is how the requirements are implemented in practice.

Challenges for manufacturers

Today, medical device manufacturers face growing demands related to:

• documenting security measures,
• managing cybersecurity risks,
• testing and validating security functionalities,
• monitoring devices throughout their post-market lifecycle.

Regulators have already begun rejecting products that fail to demonstrate adequate cybersecurity measures, highlighting the increasing importance of this area for market access.

There is also a growing need to address cybersecurity early in the development process. Many vulnerabilities do not become evident during laboratory testing but only emerge in real clinical environments, where devices operate as part of complex, interconnected systems. This requires a more systematic approach to software updates and lifecycle management of security patches.

The role of independent verification

In such an environment, independent cybersecurity assessment plays a crucial role. Through technical reviews, testing, and documentation analysis, it enables an objective evaluation of whether a device meets security requirements and whether risks are properly addressed.

Verification is not just about identifying vulnerabilities – it contributes to improving solution quality and building trust among manufacturers, regulators, and end users.

Co-creating safety in healthcare

Today, cybersecurity of medical devices is a shared responsibility – involving manufacturers, healthcare organizations, regulators, and expert institutions. Only through collaboration and a consistent approach to security can we ensure that new technologies truly contribute to safer and more effective healthcare.

Safety does not happen by itself – it is co-created.

More information:
Gregor Zakrajšek
E-mail: gregor.zakrajsek@siq.si
Tel.: +386 1 4778 034

The post Cybersecurity of Medical Devices: Safety as a Condition for Trust appeared first on SIQ.

This means that manufacturers can now receive both new registrations and renewals for a period of 5 years. Previously, new registrations were issued for 2 years, while renewals could be requested for 2, 3, 4, or 5 years.

However, even though the registration will be valid for 5 years, manufacturers must still pay the required BIS fees every year to keep the registration active.

Key Highlights:

• BIS CRS licence validity has been revised to five years,
• renewal of the licence will be granted for a further period of five years,
• applicable fees for grant, renewal and continuation of licence operation are payable annually in advance,
• manufacturers must submit production details together with the applicable annual fee,
• timely submission is required to keep the licence active and avoid regulatory action.

Please note that if BIS does not receive the annual fee along with the required production details by the prescribed due date, the relevant provisions relating to suspension, deferment, cancellation or expiry of the licence, as specified under the BIS (Conformity Assessment) Regulations, 2018, as amended, will apply.

All manufacturers and licence holders are therefore advised to review their BIS CRS compliance calendars and ensure timely annual fee payment and submission of production details.

More information:
Anja Jerovšek
E-mail: anja.jerovsek@siq.si
Tel.: +386 1 4778 147

The post BIS CRS Update: Revised Licence Validity, Renewal and Annual Fee Requirements appeared first on SIQ.

For Extended Reality products such as AR, VR and MR devices, the timeline is shorter. BIS states that the concurrent running period ended on 1 May 2026. Since that date has already passed, new licences for these products should now be processed under IS 62368-1:2023 only.

Main requirements

For existing BIS CRS licence holders, the migration is not just a paperwork change. They must submit complete test reports under IS 62368-1:2023 from a BIS-recognised laboratory for all lead models already covered in the licence. They must also provide an undertaking that the requirements have been implemented for the other series models covered under the same licence.

For some products, additional requirements may still apply. For example, TVs may also need to maintain compliance with IS 18112:2025, mobile phones with IS 16333 (Part 3):2022, and IP-based CCTV cameras with the applicable security requirements. If the migration to IS 62368-1:2023 affects those additional requirements, complete test reports must also be submitted; if not, a signed declaration is required.

MeitY also issued revised series guidelines on 20 May 2026. These allow up to 10 models in one series unless a specific product category allows more. The worst-case model must be selected for testing, and models in the same series generally need the same IP rating, enclosure concept, insulation class, energy-source classification, safeguard system and rated input voltage.

Difference between new and old applications

For new applications, manufacturers can already apply under IS 62368-1:2023. For most product categories, applications may still be processed under the old standards during the parallel-running period, but only until 1 November 2028. If an applicant uses the old standard during this period, they must give a declaration that they will migrate to IS 62368-1:2023 by the deadline.

For existing licences, the process is handled as a migration or standard-revision activity. The licensee must submit new IS 62368-1:2023 test reports for lead models and an undertaking for series models. If the licensee does not complete the required actions before the deadline, BIS will cancel the licence or delete models from the scope.

More information:
Anja Jerovšek
E-mail: anja.jerovsek@siq.si
Tel.: +386 1 4778 147

The post Latest IS 62368-1:2023 update for BIS CRS appeared first on SIQ.

Optical radiation can become an ignition source when it is absorbed by surfaces or particles, causing them to heat up. In special cases, a strong focused laser beam can also cause direct breakdown of gas and create plasma, which may ignite the surrounding explosive atmosphere. For this reason, optical systems used in hazardous areas must be assessed not only as electrical equipment, but also with regard to the energy and behaviour of the emitted light.

The standard is used together with IEC 60079-0 and applies to all equipment groups and all Equipment Protection Levels. It covers optical radiation in the wavelength range from 380 nm to 10 µm. The protection concept may be based on inherently safe optical radiation “op is”, protected optical radiation “op pr”, or optical systems with interlock “op sh”.

The new 2025 edition is a technical revision of the 2015 edition. Among the main changes are a clarified scope for laser equipment, optical fibre equipment and focused optical systems, removal of the ignition test option, a new structure with type verifications and tests, a new subclause for optical detectors, clarification that calculations may be used for optical power assessment, and additional marking examples.

At SIQ Ljubljana, we also test and certify Ex equipment and components using optical radiation. Certification can be carried out in accordance with Directive 2014/34/EU (ATEX) and the international IECEx certification scheme.

More information:
Matej Debenc
E-mail: matej.debenc@siq.si
Tel.: +386 1 4778 227

The post Optical radiation protection in explosive atmospheres appeared first on SIQ.