The medical industry is one of the main market segments that Engineered Ceramics China Ltd. serves. Engineered Ceramics China Ltd. manufactures and supplies brazed, hermetic biocompatible components that are used in a variety of medical applications. These include:

Cochlear implants
Hermetically-sealed ceramic cases for implantable devices
Pacemakers
Sensor/Detector Implants
Neurostimulators
Surgical Imaging Tools
Endoscope Windows
Artificial Heart Components
Feedthroughs
Autoclave safe surgical equipment

Engineered Ceramics China Ltd. works very closely with customers from the concept stage all the way through serial production to design custom hermetic medical components. Through years of experience producing medical components, Engineered Ceramics China Ltd. has developed a very robust quality management system. Our robust QMS has allowed IJ Research to be a qualified supplier for major medical OEMs around the globe.

Certifications

Click below to view our Quality Certifications, Registrations and Compliance

AS9100 & ISO 9001

Engineered Ceramics China Ltd. RoHS Compliance Statement

Engineered Ceramics China Ltd. (Engineered Ceramics China Ltd.) makes no stand-alone electronic or electrical products but is proud to be a subcontractor of ceramics used in electronic and electrical products. Engineered Ceramics China Ltd. has been asked by numerous customers to confirm that our ceramics are RoHS Compliant.

After a complete bi-annual review of the materials used in our parts and the manufacturing process, we can advise you, our customers, that Engineered Ceramics China Ltd. is RoHS & RoHS 3 compliant.

January 24, 2024

RoHS stands for Restriction of Hazardous Substances and impacts the entire electronics industry and many electrical products as well. The original RoHS, also known as Directive 2002/95/EC, originated in the European Union in 2002 and restricts the use of six hazardous materials found in electrical and electronic products. All applicable products in the EU market from July 1, 2006, must pass RoHS compliance.

Directive 2011/65/EU was published in 2011 by the EU, which is known as RoHS-Recast or RoHS 2. RoHS 2 includes a CE-marking directive, with RoHS compliance now being required for CE marking of products. RoHS 2 also added Categories 8 and 9 and has additional compliance recordkeeping requirements.

Directive 2015/863 is known as RoHS 3. RoHS 3 adds four additional restricted substances (phthalates) to the list of six.

EU 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, which took effect July 22, 2019.

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 3 (EU Directive 2015/863) adds Category 11 (catch-all) products and adds four new restricted substances – all phthalates. The four phthalates are mainly used as insulation plasticizers and are on the REACH list of SVHC (Substances of Very High Concern). The expanded list for RoHS 3 is thus as follows:

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 %)
Diisobutyl phthalate (DIBP) (0.1 %)

Download a PDF of our registration letter here.

Medical

Certifications

ITAR Registered

View our ITAR Registration Letter

ITAR Registered

View our ITAR Registration Letter