Medical Device and Restricted Hazardous Substances
RoHS, or Restriction of Hazardous Substances, is a regulatory standard that affects the global electronics industry, including many electrical and electronic products. The original directive, 2002/95/EC, was introduced by the European Union in 2002 and limits the presence of six hazardous substances in electronic and electrical devices.
All applicable products sold in the EU after July 1, 2006 must comply with RoHS requirements. Businesses that manufacture or distribute electrical or electronic equipment, components, cables, sub-assemblies, or spare parts to RoHS-regulated countries are affected if any of the ten restricted substances are used.
RoHS 3 (EU 2015/863)
RoHS 3 (EU Directive 2015/863) broadens the scope by adding Category 11 (catch‑all) products and introduces four additional restricted phthalates. These phthalates, commonly used as plasticizers, are also listed under REACH as Substances of Very High Concern (SVHC). The full list of RoHS 3 restricted substances includes:
- Cadmium (0.01%)
- Lead (0.1%)
- Mercury (0.1%)
- Hexavalent chromium (0.1%)
- Polybrominated biphenyls (PBB) (0.1%)
- Polybrominated diphenyl ethers (PBDE) (0.1%)
- Bis(2-ethylhexyl) phthalate (DEHP) (0.1%)
- Butyl benzyl phthalate (BBP) (0.1%)
- Dibutyl phthalate (DBP) (0.1%)
- DIsobutyl phthalate (DIBP) (0.1%)
Extension for Medical Devices
Medical devices are granted a two-year extension to meet RoHS 3 compliance. According to the directive:
“The restriction of DEHP, BBP, DBP and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021.”
Category 11 products include all remaining electrical and electronic equipment not covered by other categories. Examples include two‑wheeled vehicles, electronic nicotine delivery systems (e-cigarettes), cannabis vaporizers, and vape pens. Electrical cables operating under 250V are also included.
As digital technology grows rapidly, production of electrical and electronic devices continues to expand. From mobile devices to IoT systems, robotics, drones, 3D printers, and home medical equipment, all fall under the scope of RoHS regulations.
EU RoHS Limits
The EU establishes maximum concentration values for the following ten substances:
- Cadmium (Cd): < 100 ppm
- Lead (Pb): < 1000 ppm
- Mercury (Hg): < 1000 ppm
- Hexavalent Chromium (Cr VI): < 1000 ppm
- Polybrominated Biphenyls (PBB): < 1000 ppm
- Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm
- Bis(2-Ethylhexyl) phthalate (DEHP): < 1000 ppm
- Benzyl butyl phthalate (BBP): < 1000 ppm
- Dibutyl phthalate (DBP): < 1000 ppm
- Diisobutyl phthalate (DIBP): < 1000 ppm
RoHS Testing Methods
Initial RoHS compliance testing typically uses X-Ray Fluorescence Spectroscopy (XRF), following ASTM F2617. XRF analyzers may be handheld, bench‑top, or standalone. Testing usually begins with components most likely to contain restricted substances. Additional analytical methods include:
- Fourier Transform Infrared Spectroscopy (FTIR)
- Scanning Electron Microscope (SEM) testing
- Gas Chromatography / Mass Spectrometry (GC/MS)
- Gas Chromatography / Flame Ionization Detection (GC/FID)
Phthalate testing requires solvent extraction of material samples, with the extract analyzed through GC/MS or GC/FID.
RoHS Certification Steps
The RoHS certification process includes the following key steps:
- Testing: Either on-site or XRF testing and/or lab phthalate solvent extraction testing is done to determine values of the ten restricted RoHS substances.
- Process Audit: Inspect all applicable manufacturing processes used towards RoHS compliance on-site.
- Documentation Review: Review the Bill of Materials, Technical File, assembly drawings, materials declarations, test reports, and conformance/compliance certificates from all suppliers. The Technical File must contain the following:
- General product description and design structure information
- Risk assessment of materials, parts and subassemblies
- Conformity information on materials, parts, and subassemblies
- Manufacturing documentation and records
- Harmonized standards, specifications, and conformity procedures
- Certification Statement: After a successful audit, a RoHS Certificate of Compliance (also known as a Certificate of Conformity or Declaration of Conformity) is issued.
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