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 srpnja 2024. Database contains 4917 unique substances/entries.
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236-666-6
13462-90-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
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16039-61-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
236-068-5
13138-45-9
Ox. Sol. 2; Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Details
234-823-3
12035-36-8
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
237-124-1
13637-71-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
Details
237-563-9
13842-46-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
Details
235-379-3
12201-89-7
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
237-205-1
13689-92-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
257-970-5
52502-12-2
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
247-430-7
26043-11-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
238-278-2
14332-34-4
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
234-348-1
11113-74-9
Carc. 1A; Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
248-585-3
27637-46-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
Product of blowing smelted nickel ore in a converter to lower the iron content.
273-749-6
69012-50-6
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
215-215-7
1313-99-1
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
208-933-7
547-67-1
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
234-323-5
11099-02-8
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
252-840-4
36026-88-7
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
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11132-10-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
239-125-2
15060-62-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
215-216-2
1314-05-2
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
250-788-7
31748-25-1
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
232-104-9
7786-81-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
234-349-7
11113-75-0
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
Details
235-260-6
12142-88-0
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
239-974-9
15852-21-8
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
239-967-0
15851-52-2
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
234-824-9
12035-38-0
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
235-752-0
12653-76-8
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
234-825-4
12035-39-1
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
239-876-6
15780-33-3
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
238-032-4
14177-51-6
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
274-755-1
70692-93-2
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
242-533-3
18721-51-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
287-468-1
85508-43-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
249-555-2
29317-63-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
287-469-7
85508-44-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
300-094-6
93920-10-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
300-093-0
93920-09-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
225-656-7
4995-91-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
Details
237-138-8
13654-40-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
222-102-6
3349-08-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
233-263-7
10101-96-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
244-578-4
21784-78-1
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
218-744-1
2223-95-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
231-827-7
7757-95-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
240-235-8
16083-14-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
Details
231-111-4
7440-02-0
Carc. 2; STOT RE 1; Skin Sens. 1
Details
231-111-4
7440-02-0
Carc. 2; STOT RE 1; Skin Sens. 1
Details
200-193-3
54-11-5
Acute Tox. 2
Details
217-682-2
1929-82-4
Acute Tox. 4
Details
231-714-2
7697-37-2
Ox. Liq. 2; Acute Tox. 1; Skin Corr. 1A
Details
231-714-2
7697-37-2
Ox. Liq. 3; Acute Tox. 3; Skin Corr. 1A
Details
238-076-4
14216-75-2
Ox. Sol. 2; Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Details
DABCO X-412
413-670-8
103969-79-5
Eye Irrit. 2; Skin Sens. 1
Details
201-188-9
79-24-3
Flam. Liq. 3; Acute Tox. 4
Details
217-406-0
1836-75-5
Carc. 1B; Repr. 1B; Acute Tox. 4
Details
233-272-6
10102-44-0
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B
Details
200-876-6
75-52-5
Flam. Liq. 3; Acute Tox. 4
Details
210-698-0
621-64-7
Carc. 1B; Acute Tox. 4
Details
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60999-18-0
Acute Tox. 3; STOT RE 2
Details
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B Bacteria and similar species
Details
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B Bacteria and similar species
Details
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B Bacteria and similar species
Details
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-
B Bacteria and similar species
Details
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-
B Bacteria and similar species
Details
203-931-2
112-05-0
Skin Irrit. 2; Eye Irrit. 2
Details
213-589-6
991-42-4
Acute Tox. 4
Details
-
2163-79-3
Acute Tox. 4
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
VULKANISATIONSBESCHLEUNIGER VP KA 9124
404-380-2
110799-28-5
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
ASIL-322; OS-5200
421-870-1
156145-66-3
Repr. 2; Acute Tox. 4; STOT RE 2
Details
KENODOX
404-300-6
116753-76-5
Org. Perox. C
Details
221-817-0
3244-90-4
Acute Tox. 4
Details
227-534-9
5873-54-1
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
202-423-8
95-48-7
Acute Tox. 3; Skin Corr. 1B
Details
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N,N'-(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis[3-oxobutyramide] EC / List no: 223-873-1 | CAS no: 4104-12-5
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-
Carc. 1B
Details
218-276-8
2104-64-5
Acute Tox. 1; Acute Tox. 2
Details
ETA; ETA 50 (50 %IGE ZUBEREITUNG); O-ETHYLHYDROXYLAMINE
402-030-3
624-86-2
Flam. Liq. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Sens. 1
Details
432-750-3
109202-58-6
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
434-350-4
103122-66-3
Flam. Liq. 3; Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
201-855-4
88-74-4
Acute Tox. 3; STOT RE 2
Details
202-430-6
95-54-5
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
210-418-7
615-28-1
Carc. 2; Muta. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
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N,N'-(3,3'-dimethylbiphenyl-4,4'-ylene)di(acetoacetamide) EC / List no: 202-111-1 | CAS no: 91-96-3
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Carc. 1B
Details
202-422-2
95-47-6
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
Details
204-695-3
124-30-1
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
Details
203-892-1
111-65-9
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
Details
204-677-5
124-07-2
Skin Corr. 1C
Details
PROCION BRILLIANT ORANGE H-EXL; S156745
412-960-1
148878-21-1
Eye Dam. 1; Skin Sens. 1
Details
H112339
413-550-5
-
Skin Irrit. 2; Eye Dam. 1
Details
247-761-7
26530-20-1
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
Details
213-853-0
1034-01-1
Acute Tox. 4; Skin Sens. 1
Details
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-
Skin Corr. 1A; STOT SE 3
Details
An inorganic pigment that is the reaction product of high temperature calcination in which nickel (II) oxide and silicon oxide in varying amounts are homogeneously and ionically interdiffused to form a crystalline matrix of olivine. Its composition may include any one or a combination of the modifiers alkali or alkaline earth halides.
271-112-7
68515-84-4
Carc. 1A; STOT RE 1; Skin Sens. 1
Details
214-197-8
1113-02-6
Acute Tox. 3; Acute Tox. 4
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

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