RoHS2 the new directive, Restriction of Hazardous Substances in Electrical Equipment, RoHS 2 (2011/65/EU) Electrical and adopted by the European Union in May 2011 is intended to replace the RoHS Directive (2002/95/EC). The new directive makes no mention of the new restricted substances, but has, however, a broader scope, affecting the documentation requirements for the performance of many companies.
NEW HEALTH PRODUCTS PRODUCT CATEGORIES
some of the new products include monitoring and control instruments and other non-electrical and electronic equipment of any other category. Although omitted above, physicians and health products In Vitro devices are now also covered by the Directive. RoHS 2 also lists restricted hazardous substances and the maximum permissible concentration in homogeneous materials as follows: Lead (Pb, 0.1%), mercury (Hg, 0.1%), Cadmium (Cd, 0.01%), Hexavalent Chromium (Cr VI, 0.1%), polybrominated biphenyls (PBB, 0.1%) and polybrominated diphenyl ethers (PBDEs, 0.1%).
AFFECTS HOW MEDICAL DEVICES?
Meets compliance 2 now refer to other medical devices such as magnetic resonance imaging equipment (MRI), computed tomography machines, equipment and X-ray July 22, 2014 is the deadline for MRI equipment machines and CT scan to demonstrate compliance with the RoHS legislation, whereas in vitro doctors and equipment chain reaction (PCR) have a time frame for compliance extended until July 22, 2017. Products implantable medical assets are not covered by RoHS standards 2 and spare parts that are already on the market before the deadlines mentioned above are excluded from compliance with the Directive.
WHAT ARE THE OBLIGATIONS OF MANUFACTURERS?
The new directive includes some changes to the legal requirements that have a direct impact on the responsibilities of manufacturers, requiring them to:
The CE marking now plays a dual role. This means that manufacturers are required to certify compliance with RoHS requirements not only as part of the technical documentation, but in the declaration of conformity of the EU. Consequently, the CE marking cannot be applied until the manufacturer can demonstrate compliance with RoHS 2.
In addition, an assessment of compliance, audit results / possible test results from suppliers, the use of standards and statements of compliance providers must also be provided with the technical documentation. This is why companies that were not affected by the scope of the original Directive will now have the difficult responsibility to develop and assemble all the necessary documents and avoid the risk of facing sanctions for non-compliance. The new Directive and the dual role of the brand also hits manufacturers already comply with CE RoHS, as this could involve more tests and documentation.
SGS HEALTH SERVICES CAN HELP
whatever the challenge, the team at SGS medical device is able to provide expert support of RoHS 2 compliance. As part of SGS - the parent company of verification, testing and certification in the world - we specialize in the partial and complete testing of finished products, and provide options for nondestructive testing.
Our RoHS related services for medical devices include:
NEW HEALTH PRODUCTS PRODUCT CATEGORIES
some of the new products include monitoring and control instruments and other non-electrical and electronic equipment of any other category. Although omitted above, physicians and health products In Vitro devices are now also covered by the Directive. RoHS 2 also lists restricted hazardous substances and the maximum permissible concentration in homogeneous materials as follows: Lead (Pb, 0.1%), mercury (Hg, 0.1%), Cadmium (Cd, 0.01%), Hexavalent Chromium (Cr VI, 0.1%), polybrominated biphenyls (PBB, 0.1%) and polybrominated diphenyl ethers (PBDEs, 0.1%).
AFFECTS HOW MEDICAL DEVICES?
Meets compliance 2 now refer to other medical devices such as magnetic resonance imaging equipment (MRI), computed tomography machines, equipment and X-ray July 22, 2014 is the deadline for MRI equipment machines and CT scan to demonstrate compliance with the RoHS legislation, whereas in vitro doctors and equipment chain reaction (PCR) have a time frame for compliance extended until July 22, 2017. Products implantable medical assets are not covered by RoHS standards 2 and spare parts that are already on the market before the deadlines mentioned above are excluded from compliance with the Directive.
WHAT ARE THE OBLIGATIONS OF MANUFACTURERS?
The new directive includes some changes to the legal requirements that have a direct impact on the responsibilities of manufacturers, requiring them to:
- Release a signed Declaration of Conformity (DoC)
- Technical documentation produce one record according to EN 50581:2012 or equivalent that meets the requirements of module A of Annex II to Decision 768/2008/EC
- OK test results of material for analysis by the IEC 62321 standard
- Keep the declaration of conformity and technical documentation file for a period of 10 years after the product has been put on the market
- Get the CE mark to demonstrate compliance with RoHS Standards 2
The CE marking now plays a dual role. This means that manufacturers are required to certify compliance with RoHS requirements not only as part of the technical documentation, but in the declaration of conformity of the EU. Consequently, the CE marking cannot be applied until the manufacturer can demonstrate compliance with RoHS 2.
In addition, an assessment of compliance, audit results / possible test results from suppliers, the use of standards and statements of compliance providers must also be provided with the technical documentation. This is why companies that were not affected by the scope of the original Directive will now have the difficult responsibility to develop and assemble all the necessary documents and avoid the risk of facing sanctions for non-compliance. The new Directive and the dual role of the brand also hits manufacturers already comply with CE RoHS, as this could involve more tests and documentation.
SGS HEALTH SERVICES CAN HELP
whatever the challenge, the team at SGS medical device is able to provide expert support of RoHS 2 compliance. As part of SGS - the parent company of verification, testing and certification in the world - we specialize in the partial and complete testing of finished products, and provide options for nondestructive testing.
Our RoHS related services for medical devices include:
- Complete Product and Material Testing to IEC 62321 standards
- Gap Analysis and Process Consulting
- Risk Assessment Product
- REACH-Annex 17
- RoHS Certificate of Compliance
- REACH-SVHC
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