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 25 lipnja 2024. Database contains 4917 unique substances/entries.
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605-015-1
155569-91-8
Acute Tox. 3; STOT SE 1; STOT RE 1; 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.
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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
241-178-1
17109-49-8
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
Details
200-449-4
60-00-4
Eye 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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P Parasites
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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
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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.
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Carc. 1B
Details
BAE; BENZOYLACRYLATE D'ETHYLE; BENZOYLACRYLATE D'ÉTHYLE (TRANS); BENZOYLACRYLIC ACID ETHYL ESTER; BENZOYLACRYLSÄURE ETHYLESTER
408-040-4
15121-89-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
227-197-8
5707-69-7
Acute Tox. 3
Details
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P Parasites
Details
219-459-5
2439-10-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
250-778-2
31717-87-0
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
Details
216-474-9
1593-77-7
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
Details
431-760-5
27460-02-2
Skin Irrit. 2
Details
205-570-6
142-90-5
STOT SE 3
Details
428-020-9
6195-20-6
Skin Sens. 1
Details
214-620-6
1166-52-5
Skin Sens. 1
Details
208-762-8
540-97-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
219-196-6
2385-85-5
Carc. 2; Repr. 2; Lact.; Acute Tox. 4
Details
208-601-1
534-52-1
Muta. 2; Acute Tox. 2; Acute Tox. 1; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
207-944-4
502-55-6
Acute Tox. 4
Details
BP AMOCO IV; E-326 CATALYST; KAT MSA; MSA-KATALYSATORTABLETTEN
407-130-0
65232-89-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
Details
215-239-8
1314-62-1
Muta. 2; Carc. 1B; Repr. 2; Lact.; Acute Tox. 3; Acute Tox. 2; STOT SE 3; STOT RE 1
Details
206-354-4
330-54-1
Carc. 1B; STOT RE 2
Details
222-098-6
3347-22-6
Acute Tox. 4
Details
231-201-3
7446-18-6
Acute Tox. 2; STOT RE 1; Skin Irrit. 2
Details
225-875-8
5131-24-8
Skin Irrit. 2; Skin Sens. 1
Details
233-036-2
10025-67-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
Details
206-054-3
298-04-4
Acute Tox. 1; Acute Tox. 2
Details
202-607-8
97-77-8
Acute Tox. 4; STOT RE 2; Skin Sens. 1
Details
205-259-5
149-26-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains a relatively large proportion of saturated aliphatic hydrocarbons.
265-052-0
64741-51-1
Carc. 1A
Details
A complex combination of hydrocarbons from the multiple distillation of products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C10 through C18.
270-662-5
68475-80-9
Carc. 1B
Details
A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and boiling in the range of approximately 270°C to 600°C (518°F to 1112°F). This stream is likely to contain 5 wt.% or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
274-685-1
70592-78-8
Carc. 1B
Details
A complex combination of hydrocarbons obtained by distillation of thermal-cracking heavy tars. It consists predominantly of highly alkylated aromatic hydrocarbons boiling in the range of approximately 100°C to 250°C (212°F to 482°F).
309-866-7
101316-61-4
Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by distillation of thermally cracked naphtha and/or gas oil. It consists predominantly of olefinic hydrocarbons having a carbon number of C5 and boiling in the range of approximately 33°C to 60°C (91°F to 140°F).
271-631-9
68603-00-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists of paraffinic and olefinic hydrocarbons, predominantly isoamylenes such as 2-methyl-1-butene and 2-methyl-2-butene and boiling in the range of approximately 31°C to 40°C (88°F to 104°F).
271-634-5
68603-03-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the extractive distillation of thermal cracked naphtha and/or gas oil. It consists predominantly of hydrocarbons having a carbon number of C5 with some dimerized C5 olefins and boiling in the range of approximately 33°C to 184°C (91°F to 363°F).
271-632-4
68603-01-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C20 and boiling in the range of approximately 150°C to 345°C (302°F to 653°F).
265-088-7
64741-86-2
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C7 and boiling in the range of approximately -88°C to 99°C (-127°F to 210°F).
270-077-5
68410-05-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the distillation of the products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C7 through C16 and boiling in the range of approximately 90°C to 290°C (190°F to 554°F).
265-194-3
64742-91-2
Asp. Tox. 1
Details
A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C8 through C12.
270-737-2
68477-54-3
Asp. Tox. 1
Details

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