Os produtos WS Audiology são considerados 'artigos' (conforme definido no Artigo 3 (3) do Regulamento REACH) que não se destinam a liberar quaisquer substâncias sob condições de uso normais e razoavelmente previsíveis, portanto, nossa empresa não tem obrigação de registro nem de fornecer fichas de dados de segurança (SDS).


Em conformidade com o artigo 33.º, n.º 1, se uma substância estiver presente acima de 0,1% m / m nos nossos artigos, comunicaremos imediatamente essa informação. Não se espera que nossos produtos contenham as substâncias das 209 entradas atualmente na Lista de candidatos SVHC publicada pela ECHA (última atualização: 2020-06-25), exceto para conteúdo que pode ser aplicável - consulte a nota.

As informações acima são fornecidas de acordo com nosso melhor conhecimento na data deste documento, com base na documentação fornecida por nossos fornecedores; não analisamos a presença dessas substâncias e não podemos garantir a ausência dessas substâncias. Como as condições de uso e as leis aplicáveis podem diferir de um local para outro e podem mudar com o tempo, o destinatário deste documento é responsável por determinar se as informações são adequadas para seu uso. Uma vez que não temos controle sobre como essas informações podem ser usadas, toda a responsabilidade é expressamente negada e não assumimos nenhuma obrigação ou responsabilidade, portanto. Nenhuma garantia, expressa ou implícita, é dada, nem pode ser inferida a isenção de qualquer patente de nossa propriedade ou de terceiros. Além disso, as informações acima não constituem aconselhamento jurídico ou orientação sobre qualquer legislação ou regulamentação e não devem ser consideradas como tal. Nem nós nem qualquer uma de nossas empresas afiliadas terá qualquer responsabilidade para com o destinatário deste documento, de qualquer forma, decorrente de qualquer confiança depositada ou uso dessas informações por tal destinatário.

Para obter mais informações, entre em contato com nosso departamento de Proteção Ambiental Relacionada a Produtos de P&D (PREP) em RoHSmatters@sivantos.com.

• The RoHS restriction of DEHP, BBP, DBP and DIBP for medical devices shall apply from 22 July 2021 onwards.
• Some suppliers of SMD components have reported lead (EC no.: 231-100-4, CAS no.: 7439-92-1) which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use (RoHS exemption 6(c) applicable).
• Some suppliers of SMD components have reported lead titanium trioxide (EC no.: 235-038-9, CAS no.: 12060-00-3) which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use (RoHS exemption 7(c)-I applicable).
• Some suppliers of SMD components have reported lead monoxide (EC no.: 215-267-0, CAS no.: 1317-36-8) which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use (RoHS exemption 7(c)-I applicable).
• Some suppliers of turned parts have reported lead dinitrate (EC no.: 233-245-9, CAS no.: 10099-74-8) which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use (RoHS exemption 6(a)-I applicable).
• Some suppliers of SMD components have reported diboron trioxide (EC no.: 215-125-8, CAS no.: 1303-86-2) which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.
• Some suppliers of PCB underfill have reported 4,4′-isopropylidenediphenol (Bisphenol A, EC no.:  201-245-8, CAS no.: 80-05-7)  which may be above 0.1% w/w; however this substance, in its original molecular form, is contained in the material as residue and cannot be released under normal or reasonably foreseeable conditions.
• Some suppliers of PCB underfill have reported hexahydromethylphthalic anhydride (EC no.: 247-094-1, CAS no.: 25550-51-0) which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.
• Some suppliers of silicone containing components have reported octamethylcyclotetrasiloxane (D4, EC no.: 209-136-7, CAS no.: 556-67-2), decamethylcyclopentasiloxane (D5, EC no.: 208-764-9, CAS no.: 541-02-6) and dodecamethylcyclohexasiloxane (D6, EC no.: 208-762-8, CAS no.: 540-97-6), which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.
• Some suppliers of components with adhesive cement in coil assembly have reported nonyl-phenol (EC no.: 284-325-5, CAS no.: 84852-15-3) which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.
• Some suppliers of PCB have reported 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one (EC no.: 71868-10-5, CAS no.: 400-600-6) as component in solder mask which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.
• Some suppliers of PCB have reported  2-benzyl-2-dimethylamino-4’morpholinobutyrophenone (EC no.: 119313-12-1CAS no.: 404-360-3) as component in solder mask  which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.
• In some of our accessories, Ag-Zn rechargeable battery cell may be used. Some suppliers have reported lead monoxide (EC no.: 215-267-0, CAS no.: 1317-36-8) as part of the battery cathode additive which may be above 0.5% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use. EU RoHS Directive does not apply to batteries. This battery model complies with the EU Battery Directive (2006/66/EC).
• In some of our accessories, primary lithium button battery cell – CR2450 may be used. Some suppliers have reported 1,2-dimethoxyethane; ethylene glycol dimethyl ether (EGDME, EC no.: 203-794-9, CAS no.: 110‐71‐4) as part of the battery electrolyte solvent which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.
• In some of our accessories, rechargeable lithium-ion battery pack may be used. Some suppliers have reported 1,3-propanesultone (EC no.: 214-317-9, CAS no.: 1120-71-4) as part of the battery electrolyte solvent which may be above 0.1% w/w, however this substance cannot be released during normal or reasonably foreseeable conditions of use.