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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TYZOR ZEC
417-110-3
1379678-99-5
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
Details
YELLOW MGI 1301
424-250-9
-
Eye Dam. 1
Details
E-101
420-310-3
-
Acute Tox. 4
Details
R633
406-230-1
224635-63-6
Flam. Liq. 3; Carc. 2; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
Details
PES-SOLID
420-070-1
-
Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
Details
424-510-1
-
Eye Dam. 1
Details
PRODUKT 1245
420-980-7
-
Eye Dam. 1
Details
PDN 2287
417-450-2
-
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
428-630-5
-
Skin Sens. 1
Details
500-033-5
25068-38-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
939-460-0
1471311-26-8
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
939-460-0
1471311-26-8
ENDE Endocrine disrupting properties (Article 57(f) - environment)
Details
426-860-0
191877-09-5
Eye Dam. 1
Details
432-440-8
220444-73-5
Carc. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
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-
Carc. 1B; Muta. 2; Acute Tox. 4; Acute Tox. 3; STOT RE 2; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
Details
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-
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
Details
ORGANOTUNGSTEN COMPOUND CONCENTRATE
408-250-6
121754-49-2
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
MP-2000; MP-2000X
406-620-1
129217-90-9
Skin Sens. 1
Details
FCC 963
410-880-1
147170-38-5
Acute Tox. 4; Skin Corr. 1B
Details
231-768-7
7723-14-0
Flam. Sol. 1
Details
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Glass, oxide, chemicals
This category encompasses the various chemical substances manufactured in the production of inorganic glasses. For purposes of this category, 'glass' is defined as an amorfous, inorganic, transparent, translucent or opaque material traditionally formed by fusion of sources of silica with a flux, such as an alkali-metal carbonate, boron oxide, etc. and a stabilizer, into a mass which is cooled to a rigid condition without crystallization in the case of transparent or liquid-phase separated glass or with controlled crystallization in the case of glass-ceramics. The category consists of the various chemical substances, other than by-products or impurities, which are formed during the production of various glasses and concurrently incorporated into a glass mixture. All glasses contain one or more of these substances, but few, if any, contain all of them. The elements listed below are principally present as components of oxide systems but some may also be present as halides or chalcogenides, in multiple oxidation states, or in more complex compounds. Trace amounts of other oxides or chemical compounds may be present. Oxides of the first seven elements listed* comprise more than 95 percent, by weight, of the glass produced. @Aluminium*@Lead@Boron*@Lithium@Calcium*@Manganese@Magnesium*@Molybdenum@Potassium*@Neodymium@Silicon*@Nickel@Sodium*@Niobium@Antimony@Nitrogen@Arsenic@Phosphorus@Barium@Praseodymium@Bismuth@Rubidium@Cadmium@Selenium@Carbon@Silver@Cerium@Strontium@Cesium@Sulfur@Chromium@Tellurium@Cobalt@Tin@Copper@Titanium@Germanium@Tungsten@Gold@Uranium@Holmium@Vanadium@Iron@Zinc@Lanthanum@Zirconium
EC / List no: 266-046-0 | CAS no: 65997-17-3
Zirconia Aluminosilicate Refractory Ceramic Fibres
are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.1 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, and fulfil the three following conditions: a) oxides of aluminium, silicon and zirconium are the main components present (in the fibres) within variable concentration ranges b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres (µm). c) alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18% by weight
EC / List no: - | CAS no: -
Aluminosilicate Refractory Ceramic Fibres
are fibres covered by index number 650-017-00-8 in Annex VI, part 3, table 3.1 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, and fulfil the three following conditions: a) oxides of aluminium and silicon are the main components present (in the fibres) within variable concentration ranges b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres (µm) c) alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18% by weight
EC / List no: - | CAS no: -
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-
Carc. 1B
Details
232-645-0
9001-98-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Details
A complex combination of hydrocarbons obtained by the treatment of solvent-dewaxed petroleum residual oils with activated charcoal for the removal of trace polar constituents and impurities.
309-710-8
100684-37-5
Carc. 1B
Details
294-843-3
91770-57-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained by treatment of solvent-dewaxed petroleum residual oils with bleaching earth for the removal of trace polar constituents and impurities.
309-711-3
100684-38-6
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 cohesive powder composed of coal mineral matter and undissolved coal remaining after extraction of coal by a liquid solvent.
302-681-2
94114-46-2
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
A complex combination of hydrocarbons produced as the residual fraction from distillation of the product from a catalytic reforming process. It consists of predominantly aromatic hydrocarbons having carbon numbers predominantly in the range of C10 through C25 and boiling in the range of approximately 160°C to 400°C (320°F to 725°F). This stream is likely to contain 5 wt. % or more of 4- or 6-membered condensed ring aromatic hydrocarbons.
265-069-3
64741-67-9
Carc. 1B
Details
A complex combination of hydrocarbons produced as the residual fraction from the distillation of heavy coker gas oil and light vacuum gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C13 and boiling above approximately 230°C(446°F).
270-983-0
68512-61-8
Carc. 1B
Details
A complex combination of hydrocarbons produced as the residual fraction from distillation of the products of a hydrocracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F).
265-076-1
64741-75-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained by treating an atmospheric tower residuum with hydrogen in the presence of a catalyst under conditions primarily to remove organic sulfur compounds. 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.
265-181-2
64742-78-5
Carc. 1B
Details
A complex combination of hydrocarbons obtained as a residual fraction from the distillation of hydrotreated steam-cracked naphtha. It consists predominantly of hydrocarbons boiling in the range of approximately 200°C to 350°C (32°F to 662°F).
295-514-7
92062-00-5
Carc. 1B
Details

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