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 24 svibnja 2024. Database contains 4917 unique substances/entries.
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211-057-8
628-86-4
Expl. 1.1; Acute Tox. 3; STOT RE 2
Details
231-299-8
7487-94-7
Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1; Skin Corr. 1B
Details
231-106-7
7439-97-6
Repr. 1B; Acute Tox. 2; STOT RE 1
Details
217-991-2
2032-65-7
Acute Tox. 3
Details
205-769-8
150-76-5
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
246-147-6
24307-26-4
Acute Tox. 4; Acute Tox. 3
Details
213-447-3
950-10-7
Acute Tox. 1; Acute Tox. 2
Details
432-140-7
110235-47-7
Carc. 2
Details
201-123-4
78-57-9
Acute Tox. 4
Details
204-987-0
130-37-0
Eye Irrit. 2; Skin Irrit. 2
Details
277-543-7
73581-79-0
Eye Irrit. 2; Skin Irrit. 2
Details
UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17
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Alkanes, C14-17, chloro EC / List no: 287-477-0 | CAS no: 85535-85-9
Tetradecane, chloro derivs. EC / List no: - | CAS no: 198840-65-2
di-, tri- and tetrachlorotetradecane EC / List no: 950-299-5 | CAS no: -
Alkanes, C14-16, chloro EC / List no: 701-376-5 | CAS no: 1372804-76-6
799-971-8
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PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
219-634-6
2487-01-6
Acute Tox. 3; Acute Tox. 4
Details
205-275-2
137-05-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
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-
Acute Tox. 4; Eye Dam. 1
Details
221-106-5
3006-10-8
Skin Corr. 1; Eye Dam. 1
Details
219-993-9
2595-54-2
Acute Tox. 3
Details
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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
246-831-4
25319-90-8
Acute Tox. 4
Details
202-360-6
94-74-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
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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
Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Azadirachta indica, Meliaceae.
283-644-7
84696-25-3
Repr. 2; Skin Sens. 1
Details
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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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P Parasites
Details
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P Parasites
Details
239-924-6
15825-70-4
Expl. 1.1
Details
239-924-6
15825-70-4
Unst. Expl.
Details
232-089-9
7785-87-7
STOT RE 2
Details
215-202-6
1313-13-9
Acute Tox. 4
Details
235-654-8
12427-38-2
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
616-995-5
8018-01-7
Carc. 2; Repr. 1B; STOT RE 2; Skin Sens. 1
Details
203-703-2
109-77-3
Acute Tox. 3
Details
203-571-6
108-31-6
Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1A
Details
203-742-5
110-16-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
204-497-7
121-75-5
Acute Tox. 4; Skin Sens. 1
Details
219-441-7
2437-29-8
Repr. 2; Acute Tox. 4; Eye Dam. 1
Details
209-322-8
569-64-2
Repr. 2; Acute Tox. 4; Eye Dam. 1
Details
BLACK JR 578
419-230-1
-
Skin Sens. 1
Details
BLACK UL 1253
417-280-9
30785-74-1
Eye Dam. 1
Details
422-610-1
-
Eye Dam. 1
Details
442-650-1
56450-90-9
STOT RE 2
Details
231-104-6
7439-95-4
Water-react. 1; Pyr. Sol. 1
Details
231-104-6
7439-95-4
Flam. Sol. 1; Water-react. 2; Self-heat. 1
Details
235-023-7
12057-74-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
Details
241-022-2
16949-65-8
Acute Tox. 3
Details
DUPLOSAN-DP-MAGNESIUM
413-360-2
164058-21-3
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
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Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
Details
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F Fungi
Details
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F Fungi
Details
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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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