EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).

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Medium-chain chlorinated paraffins (MCCP)

UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17 EC / List no: 799-971-8 CAS no: -
EU REACH: List of SVHC
PBT Persistent, Bioaccumulative and Toxic (article 57d)

VPVB very Persistent and very Bioaccumulative (article 57e)

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Group members
This group of substance has the following member substances:
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Name EC / List no. CAS no. Association
Alkanes, C14-17, chloro 287-477-0 85535-85-9 Official source
di-, tri- and tetrachlorotetradecane 950-299-5 - Official source
Tetradecane, chloro derivs. - 198840-65-2 Official source
Alkanes, C14-16, chloro 701-376-5 1372804-76-6 Official source