D.L.S. offers a comprehensive program for compliance evaluation and testing for Medical Devices and Equipment for US-FDA, Canada-Health Canada and the European Medical Device Regulations found in EU 2017/745 and 2017/746. Basic requirements for this compliance program are based on EN IEC/ISO/ANSI/UL/FCC/ISED standards for electromagnetic compatibility, wireless and product safety. In additional D.L.S. supports several collateral 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, supporting a global marketplace. The latest 4th edition 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. Updated standards call out new requirements for products used in home health care and emergency vehicles.
Common EMC Standards
EN IEC 60601-1-2 General Requirements
AIM Standard – 7351731 Electromagnetic Immunity Test for RFID Readers
UKCA Compliance Requirements for the UK
Medical devices and 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 devices and equipment for medical equipment. D.L.S. can assist in determining the specific requirements needed to meet all US, Canada and EU regulatory requirements 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 compliance with CE marking requirements, as well as the requirements for the Medical Device Directive
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
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 300 440: 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 40GHzEN 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
EN 303 417: Wireless Power Transfer/Wireless Chargers
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. NRTL and Canada safety testing, EN and IEC requirements. D.L.S. offers a comprehensive one-stop approach that includes North American testing, combined with IEC testing for a global marketplace. This program includes all national deviations for the European Union to show CE safety compliance to the Medical Device Regulations and if applicable, the InVitro Medical Directive and other global requirements as well. Updated standards call out new requirements for products used in home health care and emergency environments.
Common Standards
UL 60601-1 General Requirements Medical Electrical Equipment
CSA/CAN NO C22.2 General Requirements Medical Electrical Equipment
ANSI/AAMI ES60601-1 General Requirements Medical Electrical Equipment
EN IEC 60601-1 General Requirements
EN IEC 60601-1-11 Home Health Care
EN IEC 60601- 1-12 Emergency Medical Services Environment
EN IEC 60601-2-10 Muscle and Nerve Stimulators
UKCA Compliance Requirements for the UK
A complete list of over 50 Medical Device standards
RoHS-Reduction of Hazardous Substances 2015/863/EU
The European Union and other countries have established regulatory requirements for medical devices and electrical and electronic equipment for the Reduction of Hazardous Substances. Medical devices are no longer considered exempt. D.L.S. provides a comprehensive review processes to ensure non- compliant components and sub-assemblies, as well as final products are identified.
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, including new requirements for the FDA, Health Canada, and the EU Medical Device Regulations found under (EU) 2017/745 for Medical Devices and Equipment and EU 2017/746 for In Vitro Medical Devices. 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.