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).

RELEVANT LEGISLATION
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hexabromocyclododecane

EC / List no: 247-148-4 CAS no: 25637-99-4
EU CLP (1272/2008)
Repr. 2; Lact.
EU REACH: List of SVHC
PBT Persistent, Bioaccumulative and Toxic (article 57d)

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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
alpha-hexabromocyclododecane 603-801-9 134237-50-6 Expert judgement (ECHA)
beta-hexabromocyclododecane 603-802-4 134237-51-7 Expert judgement (ECHA)
1,2,5,6,9,10-hexabromocyclodecane 221-695-9 3194-55-6 Expert judgement (ECHA)
Hexabromocyclododecane 247-148-4 25637-99-4 Expert judgement (ECHA)
gamma-hexabromocyclododecane 603-804-5 134237-52-8 Expert judgement (ECHA)