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Don’t Let Regulated Standards Get in the Way of Product Development

For more than 25 years Hectronic has developed rugged embedded computer solutions for a broad spectrum of demanding markets and applications including transportation, medical, maritime and defense. In many cases the rugged embedded computer solution developed by Hectronic is required to meet the regulated standards of the customer’s market. 

In some cases the product also must comply with regulated standards for many different geographical markets. Examples of this can be a medical system that has different regulated standards depending on the end-market or a fleet management computer that needs to operate on vehicles all around the world.

Fleet management

Recently Hectronic developed such a computer for a customer for use in the fleet management market. The computer will be used in a transportation system that will have a wide range of different regulations and environmental challenges. The computer must be able to handle diverse weather situations, from scorching heat in South America to blistering cold in Northern Europe. The computer’s connectivity to GPS and mobile networks also means the computer must be able to connect seamlessly to different types of networks while travelling between countries and continents, complying with the regulated standards of the current location. This kind of mission critical requirements are all typical challenges that often are the differentiating reason for the customer’s decision to rely on Hectronic’s development expertise. 
With Hectronic’s extensive knowledge in developing, producing, and maintaining rugged computers that comply with regulated markets, the customer can be confident in the performance and reliability of the end-product.
• Intel Atom E3845/E3827
• 2xUSB, 4xCOM, 2xEth.
• 2xPCI Exp. Mini card slot
• Extensive certifications
Fanless Embedded System with Intel® Atom™ Processor E3845/E3827 with certifications for Vehicle, Railway and Marine use.


Almost all transportation systems like the one above rely on rugged computer systems to complete the task they are designed to do.  Regardless if it’s public transportation or rolling stock, our team of developers is experienced in making products that complies with the standards required for the specific market.  
In the transportation market the most common standards the products must live up to are EN50155 for rolling stock and RTCA DO-160 for civil and defense aviation, together with CE and E-mark according to the European Union’s Directive 72/245/EC. 
EN50155 is an international standard covering electronic equipment used on rolling stock for railway applications. The standard covers different capabilities including cooling, low temperature storage, heat, salt mist, and IP certification.
RTCA DO-160 is a standard for the environmental testing of avionics hardware. RTCA DO-160 outlines a set of minimal test procedures for airborne equipment for the entire spectrum of aircraft, all the way from helicopters to supersonic jets. The standard is applicable to a variety of characteristics, including temperature, altitude performance, vibration, humidity, EMC and IP certification.
Transportation computers must be specificed for extended temperature to ensure reliable performace in diverse weather situations.


Another highly regulated market is the medical market. As embedded computer solutions for medical use often are involved in treatment of patients, a malfunction may have life threatening consequences. In the medical market the most common standards the products must live up to are ISO 13485, EN 60601, FDA approval and CE marking according to the medical device directive.
ISO 13485 specifies requirements an organization needs to adopt to provide medical devices and connected services. The main objective of ISO 13485 is to simplify medical device requirements for quality management systems. As a result, it includes some specific requirements for medical devices and excludes some of the requirements of ISO 9001 that are not suitable as regulatory requirements.
IEC 60601 applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems for use in the healthcare environment. It applies regardless of whether the medical equipment is intended for use in home treatment or by trained healthcare personnel.


The most-often used regulatory requirements in maritime and offshore applications are defined by the standards IEC60945 for maritime navigation, radio communication equipment, and maritime systems, and the IACS E10 test specification for marine type approval.

IEC60945 specifies minimum performance requirements, methods of testing, and required test results for shipborne radio equipment, shipborne navigational equipment, bridge-mounted equipment, equipment in proximity to receiving antennas, and equipment capable of interfering with safe navigation of the ship and with radio communications.
The IACS E10 specification for marine type approval requires tests of electromagnetic compatibility, operating temperature ranges, shock, and vibration. It also specifies the IP code for protection against water, dust, or objects coming in contact with critical parts of the system.


Defense and Aerospace applications are required to follow military standards and meet government requirements as well as to operate under challenging environmental conditions. RTCA DO-160 for applications in military and civil aviation as previously described in the transportation market, as well as MIL-STD-810 on how to develop for harsh environments, are examples of applicable standards.
MIL-STD-810 addresses a broad range of environmental conditions that include low pressure for altitude testing, exposure to high and low temperatures, rain (including windblown and freezing rain), humidity, salt fog for rust testing, sand and dust exposure, explosive atmosphere, acceleration, shock, gunfire vibration, and random vibration. The MIL-STD-810 standard describes environmental management and engineering processes that can be of enormous value in generating confidence in the environmental worthiness and overall toughness of a systems design.

Hectronic and development for regulated standards

Hectronic is, as the leading designer and manufacturer of embedded computer solutions in the Northern European region, well equipped to deliver rugged systems and boards to our customers’ requirements. Hectronic’s in-house hardware and software departments help customers reach their goals by developing products that match the requirements of regulatory standards and rugged performance. 
Hectronic do keep the complete development process in-house, making future product support quicker and further development easier.
Do you have a project that’s about to start or is planned for the future? Are you considering developing products that must comply with regulated standards? Give us a call or send us an email to experience what Hectronic can offer in terms of embedded computer solutions that are tailored to your requirements.
If you are looking for more information, don’t hesitate to contact our sales department at +46 18 660 700 or send an email to sales@hectronic.se.

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