Advanced Ceramics in the Medical Industry. Medical Technology and Ceramics

Advanced Ceramics in the Medical Industry

After a complete review of our materials used in our parts and the manufacturing process, we can advise you, our customers, that GBC Advanced Materials is RoHS 3 compliant.

December 21,2021

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 since 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.

  • 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

GBC Advanced Materials makes ceramics, and sells no chemical substances, but is a supplier to EU companies and companies supplying into the EU. GBC Advanced Materials has been asked by numerous customers to confirm that our ceramics are Reach Compliant.

GBC Advanced Materials supports the goals of REACH, which are consistent with our own commitment to promote the responsible manufacturing, use, and handling of chemicals. After a complete review of our materials used in our parts and the manufacturing process, we can advise you, our customers, that GBC Advanced Materials is Reach compliant to the 205 substances now on the SVHC list. https://echa.europa.eu/candidate-list-table

Understanding REACH

REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.

REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU.

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1 June 2007.

GBC Advanced Materials the Defense Industry as a sub-tier contractor to the Department of Defense (DoD) requiring GBC Advanced Materials compliance to DFARS Clause 252.204-7012 Cyber Security Compliance.

Controlled Unclassified Information (CUI) is safeguarded when residing on or transiting through GBC Advanced Materials internal digital information network.

Compliance to DFARS Clause 252.204-7012, Safeguarding Covered Defense Information and Cyber Incident Reporting requires GBC Advanced Materials implementation of NIST Special Publication (SP) 800-171, through STC System Security Plans, (SSP), including Plans of Action.

DFARS Clause 252.204-7012 requires contractors/subcontractors to:

  • Provide adequate security to safeguard covered defense information that resides on or is transiting through a contractor’s internal information system or network
  • Report cyber incidents that affect a covered contractor information system or the covered defense information residing therein, or that affect the contractor’s ability to perform requirements designated as operationally critical support
  • Submit malicious software discovered and isolated in connection with a reported cyber incident to the DoD Cyber Crime Center
  • If requested, submit media and additional information to support damage assessment
  • Flow down the clause in subcontracts for operationally critical support, or for which subcontract performance will involve covered defense information.