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).

Last updated 07 listopada 2024. Database contains 4918 unique substances/entries.
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HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
219-514-3
2451-62-9
Muta. 1B; Acute Tox. 3; STOT RE 2; Eye Dam. 1; Skin Sens. 1
M Mutagen (article 57b)
Details
TEPIC-H
423-400-0
59653-74-6
Muta. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
M Mutagen (article 57b)
Details
221-695-9
3194-55-6
Repr. 2; Lact.
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
247-384-8
25973-55-1
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
223-346-6
3846-71-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
287-476-5
85535-84-8
Carc. 2
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
281-985-6
84082-38-2
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
307-451-5
97659-46-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
283-930-1
84776-06-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details

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