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 12 lipnja 2024. Database contains 4917 unique substances/entries.
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Details
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B Bacteria and similar species
Details
204-673-3
124-04-9
Eye Irrit. 2
Details
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1
Details
204-123-2
116-06-3
Acute Tox. 2; Acute Tox. 3
Details
206-215-8
309-00-2
Carc. 2; Acute Tox. 3; STOT RE 1
Details
240-896-2
16871-90-2
Acute Tox. 3
Details
240-934-8
16893-85-9
Acute Tox. 3
Details
240-968-3
16919-19-0
Acute Tox. 3
Details
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Acute Tox. 4
Details
270-651-5
68475-57-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
292-456-4
90622-55-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
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
287-504-6
85536-22-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
292-454-3
90622-53-0
Carc. 1B
Details
701-376-5
1372804-76-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
287-477-0
85535-85-9
Lact.
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
283-931-7
84776-07-8
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
285-195-2
85049-26-9
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
270-652-0
68475-58-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
270-653-6
68475-59-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
270-654-1
68475-60-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
272-924-4
68920-70-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
263-004-3
61788-76-9
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
435-660-2
243662-67-1
Skin Irrit. 2; Skin Sens. 1
Details
435-650-8
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Acute Tox. 4; Skin Corr. 1A
Details
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
Details
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
Details
202-270-7
93-71-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
203-470-7
107-18-6
Flam. Liq. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
203-442-4
106-92-3
Flam. Liq. 3; Carc. 2; Muta. 2; Repr. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
202-473-0
96-05-9
Flam. Liq. 3; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
Details
203-463-9
107-11-9
Flam. Liq. 2; Acute Tox. 3
Details
603-801-9
134237-50-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
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Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
Details
231-208-1
7446-70-0
Skin Corr. 1B
Details
240-877-9
16853-85-3
Water-react. 1; Skin Corr. 1A
Details
244-088-0
20859-73-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
Details
231-072-3
7429-90-5
Water-react. 2; Flam. Sol. 1
Details
231-072-3
7429-90-5
Water-react. 2; Pyr. Sol. 1
Details
209-090-8
555-31-7
Flam. Sol. 1
Details
604-314-4
142844-00-6
C Carcinogenic (article 57a)
Details
212-634-7
834-12-8
Acute Tox. 4
Details
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919-76-6
Acute Tox. 4
Details
262-977-1
61788-46-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
Details
262-976-6
61788-45-2
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
Details
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details

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