RoHS, REACH, WEEE, and conflict minerals
Any business, including medical device companies, that sells applicable electrical or electronic products, equipment, sub-assemblies, cables, components, or spare parts directly to RoHS (Restriction of Hazardous Substances) countries, or sells to resellers, distributors, or integrators that in turn sell products to these countries, is impacted if they use any of the restricted 10 substances. A component database integrated with their product-centric QMS solution helps medical device companies dramatically reduce environmental hazard compliance risks.
RoHS specifies maximum levels for the following 10 restricted substances. The first six applied to the original RoHS while the last four were added under RoHS 3.
- 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
Source: RoHS Guide Compliance4
Types of hazards can include energy, biological, environmental, software, user error, labeling, complexity of use, and functional failure. In addition to the chemicals regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), medical device companies that want to sell their products globally must report on the use of certain hazardous substances per the RoHS directive.5
RoHS applies to a wide array of medical devices including:
- Radiotherapy equipment
- Pulmonary ventilators
- Nuclear medicine
- Laboratory equipment
- In-vitro diagnostic devices
- Other appliances for detecting, preventing, monitoring, treating, or alleviating illness, injury, or disability
The WEEE Directive aims to minimize the impact of electrical and electronic goods on the environment by increasing reuse and recycling to reduce the amount of waste of electrical and electrical equipment going to landfills. WEEE dovetails with RoHS efforts to reduce hazardous materials in electronics products. Category four and five medical devices are subject to recovery and recycling targets under WEEE.
In addition, responsible sourcing and reporting of conflict minerals is necessary to demonstrate due diligence. Environmental regulations are an integral part of medical device product design. Documenting and tracking the components and raw materials that are used for production must occur throughout the entire lifecycle. Because of this, OEMs, distributors, and contract manufacturers rely on component databases like SiliconExpert and Octopart to manage substance declarations. A component database is the only practical and cost-effective way to comply with ever-changing compliance mandates and frequent updates. Linking your product-centric QMS solution to these types of component databases allows you to leverage the single source of product truth and maintain environmental compliance data.6