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 30 svibnja 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of approximately 32cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
276-738-4
72623-87-1
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C24 through C50 and produces a finished oil with a viscosity in the order of 16cSt to 75cSt at 40°C (104°F).
309-877-7
101316-72-7
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of vacuum distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C25 and produces a finished oil with a viscosity in the order of 32cSt to 37cSt at 100°C (212°F).
309-874-0
101316-69-2
Carc. 1B
Details
295-424-8
92045-43-7
Carc. 1B
Details
A complex combination of hydrocarbons obtained from solvent extraction and dewaxing processes. It consists predominantly of saturated hydrocarbons having carbon numbers in the range C15 through C50.
278-012-2
74869-22-0
Carc. 1B
Details
CGA 184699
410-690-9
103055-07-8
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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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
202-987-5
101-90-6
Carc. 1B; Muta. 2; Acute Tox. 3; Acute Tox. 4; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
Details
203-577-9
108-39-4
Acute Tox. 3; Skin Corr. 1B
Details
PRODUCT 5899
404-150-1
17092-80-7
Skin Irrit. 2
Details
202-729-1
99-09-2
Acute Tox. 3; STOT RE 2
Details
203-584-7
108-45-2
Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
Details
208-790-0
541-69-5
Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
Details
203-583-1
108-44-1
Acute Tox. 3; STOT RE 2
Details
247-722-4
26471-62-5
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
203-576-3
108-38-3
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
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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F Fungi
Details
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F Fungi
Details
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-
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
Details
DUPLOSAN-DP-MAGNESIUM
413-360-2
164058-21-3
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
241-022-2
16949-65-8
Acute Tox. 3
Details
235-023-7
12057-74-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
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
442-650-1
56450-90-9
STOT RE 2
Details
422-610-1
-
Eye Dam. 1
Details
BLACK UL 1253
417-280-9
30785-74-1
Eye Dam. 1
Details
BLACK JR 578
419-230-1
-
Skin Sens. 1
Details
209-322-8
569-64-2
Repr. 2; Acute Tox. 4; Eye Dam. 1
Details
219-441-7
2437-29-8
Repr. 2; Acute Tox. 4; Eye Dam. 1
Details
204-497-7
121-75-5
Acute Tox. 4; Skin Sens. 1
Details
203-742-5
110-16-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
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
203-703-2
109-77-3
Acute Tox. 3
Details
616-995-5
8018-01-7
Carc. 2; Repr. 1B; STOT RE 2; Skin Sens. 1
Details
235-654-8
12427-38-2
Repr. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
215-202-6
1313-13-9
Acute Tox. 4
Details
232-089-9
7785-87-7
STOT RE 2
Details
239-924-6
15825-70-4
Expl. 1.1
Details
239-924-6
15825-70-4
Unst. Expl.
Details
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P Parasites
Details
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P Parasites
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
202-360-6
94-74-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
246-831-4
25319-90-8
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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