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 11 listopada 2024. Database contains 4918 unique substances/entries.
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257-175-3
51404-69-4
R Toxic for reproduction (article 57c)
Details
221-470-5
3108-42-7
Carc. 2; Repr. 1B; Lact.
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
228-098-2
6130-43-4
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
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
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4149-60-4
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
223-320-4
3825-26-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
237-222-4
13701-59-2
Repr. 1B; Acute Tox. 4; Acute Tox. 3
R Toxic for reproduction (article 57c)
Details
201-622-7
85-68-7
Repr. 1B
R Toxic for reproduction (article 57c)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
205-594-7
143-24-8
Repr. 1B
R Toxic for reproduction (article 57c)
Details
204-211-0
117-81-7
Repr. 1B
R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
Details
203-924-4
111-96-6
Flam. Liq. 3; Repr. 1B
R Toxic for reproduction (article 57c)
Details

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