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 21 lipnja 2024. Database contains 4917 unique substances/entries.
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203-389-7
106-36-5
Flam. Liq. 3; Acute Tox. 4
Details
203-132-9
103-65-1
Flam. Liq. 3; Asp. Tox. 1; STOT SE 3
Details
203-572-1
108-32-7
Eye Irrit. 2
Details
200-879-2
75-56-9
Flam. Liq. 1; Carc. 1B; Muta. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
C Carcinogenic (article 57a)
M Mutagen (article 57b)
Details
201-155-9
78-90-0
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1A
Details
245-951-4
23950-58-5
Carc. 2
Details
232-966-6
9068-59-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Details
218-893-2
2275-18-5
Acute Tox. 1; Acute Tox. 2
Details
205-443-5
140-93-2
Acute Tox. 4; Skin Irrit. 2
Details
236-656-1
13457-18-6
Acute Tox. 4
Details
204-927-3
129-00-0
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
259-686-7
55512-33-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
Details
203-809-9
110-86-1
Flam. Liq. 2; Acute Tox. 4
Details
The complex combination of polyalkylated pyridines derived from coal tar distillation or as high-boiling distillates approximately above 150°C (302°F) from the reaction of ammonia with acetaldehyde, formaldehyde or paraformaldehyde.
269-929-9
68391-11-7
Carc. 1B; Muta. 1B
Details
223-296-5
3811-73-2
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
Details
240-062-8
15922-78-8
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
Details
236-671-3
13463-41-7
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1
Details
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
R Toxic for reproduction (article 57c)
Details
201-762-9
87-66-1
Muta. 2; Acute Tox. 4
Details
264-151-6
63449-41-2
Acute Tox. 4; Skin Corr. 1B
Details
237-031-6
13593-03-8
Acute Tox. 3; Acute Tox. 4
Details
220-529-2
2797-51-5
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1A
Details
205-711-1
148-24-3
Repr. 1B; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
Details
202-051-6
91-22-5
Carc. 1B; Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
Details
219-455-3
2439-01-2
Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
Details
201-435-0
82-68-8
Skin Sens. 1
Details
A complex combination of hydrocarbons obtained as the raffinate from the UDEX extraction process on the catalytic reformer stream. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C9.
270-088-5
68410-71-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
The complex combination of hydrocarbons obtained as a raffinate from a Lurgi separation unit. It consists predominantly of non-aromatic hydrocarbons with various small amounts of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8.
270-349-3
68425-35-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
231-768-7
7723-14-0
Flam. Sol. 1
Details
232-645-0
9001-98-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Details
294-843-3
91770-57-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained by treatment of a residual oil with a natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).
265-143-5
64742-41-2
Carc. 1B
Details
A complex residuum from the atmospheric distillation of the butane-butylene stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.
270-795-9
68478-16-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by solvent removal of paraffins from the residue of the distillation of acid-treated, hydrocracked heavy paraffins and boiling approximately above 380°C (716°F).
295-499-7
92061-86-4
Carc. 1B
Details
292-656-1
90669-74-2
Carc. 1B
Details
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly greater than C25 and boiling above approximately 400°C (752°F).
265-160-8
64742-57-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained as the solvent soluble fraction from C3 - C4 solvent deasphalting of a residuum. It consists of hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).
265-096-0
64741-95-3
Carc. 1B
Details
A complex combination of hydrocarbons obtained by removal of long, branched chain hydrocarbons from a residual oil by solvent crystallization. It consists of hydrocarbons having carbon numbers predominantly greater than C25 and boiling above approximately 400°C (752°F).
265-166-0
64742-62-7
Carc. 1B
Details
A complex combination of hydrocarbons, sulfur compounds and metal-containing organic compounds obtained as the residue from refinery fractionation cracking processes. It produces a finished oil with a viscosity above 2cSt. at 100°C.
298-754-0
93821-66-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained as the solvent insoluble fraction from solvent refining of a residuum using a polar organic solvent such as phenol or furfural. It consists of hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).
265-101-6
64742-01-4
Carc. 1B
Details
The residue from the fraction distillation of crude anthracene boiling in the approximate range of 340°C to 400°C (644°F to 752°F). It consists predominantly of tri- and polynuclear aromatic and heterocyclic hydrocarbons.
295-505-8
92061-92-2
Carc. 1B; Muta. 1B
Details
The residue from the fractional distillation of wash oil boiling in the approximate range of 270°C to 330°C (518°F to 626°F). It consists predominantly of dinuclear aromatic and heterocyclic hydrocarbons.
295-506-3
92061-93-3
Carc. 1B
Details
Residue from the fractional distillation of pitch distillate boiling in the range of approximately 400°C to 470°C (752°F to 846°F). Composed primarily of polynuclear aromatic hydrocarbons, and heterocyclic compounds.
295-507-9
92061-94-4
Carc. 1B
Details
A complex residuum from the distillation of streams from various refinery operations. It consists of hydrocarbons having carbon numbers in the range of C4 through C5, predominantly butane and boiling in the range of approximately -11.7°C to 27.8°C (11°F to 82°F).
271-010-2
68513-66-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex residuum from the atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-045-2
64741-45-3
Carc. 1B
Details
A complex residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly greater than C11 and boiling above approximately 200°C (392°F). This stream is likely to contain 5 wt.% or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
269-777-3
68333-22-2
Carc. 1B
Details
A complex residuum from the distillation of butane stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C6.
270-791-7
68478-12-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex residuum from the catalytic reforming of C6-8 feed. It consists of hydrocarbons having carbon numbers predominantly in the range of C2 through C6.
270-794-3
68478-15-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced as the residual fraction from the distillation of the products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C11 and boiling above approximately 200°C (392°F).
295-511-0
92061-97-7
Carc. 1B
Details
A complex residuum from the distillation of catalytic reformer fractionator residue. It boils approximately above 399°C (750°F).
270-792-2
68478-13-7
Carc. 1B
Details

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