D.L.S. offers a comprehensive program for compliance evaluation and testing for Machinery and Industrial Equipment for U.S., Canada and the European Union Machinery Regulation, EU 2023/1230. Basic requirements for this compliance program are based on IEC/EN/ANSI/UL/FCC/ISED standards for electromagnetic compatibility, wireless and product safety. In additional D.L.S. supports several collate or ancillary standards that are required for specific intended use or location of use that are required in addition to the basic requirements.
D.L.S. offers Electromagnetic Compatibility Testing in one of the largest EMC testing laboratories in North America, with technical support provided by iNARTE certified engineers, for both emissions and immunity required for formal compliance and approval. If applicable, testing can include both radiated and conducted emissions for North American requirements, as well as the additional radiated and conducted immunity tests for Europe/IEC requirements, including requirements for the EU EMC Directive 2014/30/EU supporting a global marketplace. The latest standards require manufacturers to include accessories for the specific requirements based on intended use. D.L.S. can support these requirements working in unison with our clients to ensure formal compliance with government and industry regulatory requirements.
Common EMC Standards
US FCC Part 15, FCC Part 18 Emissions Industrial Scientific and Medical
Canada ICES-001 Emissions Industrial Scientific and Medical
EU/International EN IEC 55011 Emissions Industrial Scientific and Medical
EU/International EN IEC 61000-6-1 Immunity Commercial-Light Industrial
EU/International EN IEC 61000-6-2 Immunity Industrial
EU/International EN IEC 61000-6-3 Emissions Commercial-Light Industrial
EU/International EN IEC 61000-6-4 Emissions Industrial
United Kingdom UKCA Compliance Requirements
Machinery and Industrial equipment that have wireless capabilities, transmitter-receiver, may have to meet wireless regulations as well as medical device and equipment regulations. Pre-approved wireless module certification in many cases is not enough to show compliance for medical devices and equipment. D.L.S. can assist in determining the specific requirements needed to meet all U.S., Canada, and EU regulatory requirements, including the Radio Equipment directive 2014/53/EU for your equipment. The European Union has established requirements under law for wireless enabled products to show compliance with the Radio Equipment Directive, as part of the CE marking requirements.
Common Wireless Standards
FCC Part 15.247 & 15.249: Bluetooth®, Zigbee®, Wi-Fi/WLAN, RFID
FCC Part 15.225: Operation within the band 13.110-14.010 MHz
FCC Part 15.231: Momentary operation of Remote Controls, Alarms, Security Systems
Radar Detectors
GPS Receivers
RSS-210, RSS-247, RSS/GEN, RSS-310: Bluetooth®, Zigbee®, Wi-Fi/WLAN, RFID, Remote Controls, Alarms, Security Systems, etc.
RSS-310: GPS Receivers
EN 300 220-2: Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment to be used in the 25MHz to 1000MHz frequency range with power levels ranging up to 500mW
EN 300 328: Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband Transmission Systems; Data transmission equipment operating in the 2.4GHz ISM band and using spread spectrum modulation techniques
EN 300 330: Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment to be used in the 9kHz to 25MHz frequency range and inductive loop systems in the 9kHz to 30MHz frequency range
EN 300 440: Electromagnetic compatibility and Radio spectrum Matters (ERM); Short Range Devices (SRD); Radio equipment to be used in the 1GHz to 40GHz frequency range
EN 301 489-1: Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements; Harmonized Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU and the essential requirements of article 6 of Directive 2014/30/EU
EN 301 489-3: Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 3: Specific conditions for Short Range Devices (SRD) operating on frequencies between 9kHz and 40GHz
EN 301 489-17: Electromagnetic compatibility and Radio spectrum Matters (ERM); Electromagnetic Compatibility (EMC) standard for radio equipment and services; Part 17: Specific conditions for Wideband data and HIPERLAN equipment
With a constant updating to safety requirements, many manufacturers must have older products retested and new products tested to show compliance with these new standards. These standards include U.S., Canada, and IEC requirements. D.L.S. offers a comprehensive one stop approach that includes North American NRTL and Canada safety testing, under the Nemko third party testing program, combined with EN and IEC, including the requirements for the EU Machinery Regulation EU 2023/1230 for a global marketplace access. This program includes all national deviations for the European Union to show CE safety compliance to the Machinery Regulation, and if applicable, the Low Voltage Directive 2014/35/EU and other global requirements as well.
EN IEC/UL/CSA 60204-1 General Safety-Machinery
EN IEC/UL/CSA 60730 General Safety-Industrial Controls
EN IEC/UL/CSA 61010-1 General Safety- Measurement, Control, and Laboratory Equipment
LVD – Low Voltage Directive EU 2014/35/EU
Machinery Regulation EU 2023/1230
UKCA Compliance Requirements for the UK
RoHS – Reduction of Hazardous Substances 2015/863/EU
The European Union and other countries have established regulatory requirements for the Reduction of Hazardous Substances in electronic and electronic equipment. These regulations require manufacturers of certain machinery and industrial equipment to show formal compliance. D.L.S. provides a comprehensive review processes to ensure non-compliant components and sub-assemblies, as well as final products, are identified and provide guidance on the updates that might need to be required to show compliance. The European Union has by law established compliance with the RoHS Directive to allow for CE marking on applicable devices and equipment.
Transitional Analysis
D.L.S. is offering a new transitional analysis program with respect to the newest update of the EMC and Product Safety standards to meet the requirements for compliance. This program provides a detailed review of testing previously performed to determine if it will show compliance to the new update. This comprehensive review involves not only previous test results, but the methodology and monitoring requirements when compared to a current ISO 14971 risk assessment. This program involves any previous testing, regardless of the performing testing laboratory or the dates when the tests were performed. Manufacturers of Machinery and Industrial devices must meet all the conditions for compliance to these new updated standards.
For new products coming to market, D.L.S. offers a comprehensive design review to identify non-compliant design related issues. This evaluation is recommended at an early stage in the development process, so any potential changes to the equipment being reviewed would have the least possible impact to both cost and delivery of a final approved product. Experienced D.L.S. engineers perform this process, working hand in hand with the manufacturer to insure the most capable design solutions for areas that may not meet the regulatory requirements.