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 18 lipnja 2024. Database contains 4917 unique substances/entries.
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232-645-0
9001-98-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Details
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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: -
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: -
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
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Carc. 1B
Details
231-768-7
7723-14-0
Flam. Sol. 1
Details
FCC 963
410-880-1
147170-38-5
Acute Tox. 4; Skin Corr. 1B
Details
MP-2000; MP-2000X
406-620-1
129217-90-9
Skin Sens. 1
Details
ORGANOTUNGSTEN COMPOUND CONCENTRATE
408-250-6
121754-49-2
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
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
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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
432-440-8
220444-73-5
Carc. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
Details
426-860-0
191877-09-5
Eye Dam. 1
Details
500-033-5
25068-38-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
428-630-5
-
Skin Sens. 1
Details
PDN 2287
417-450-2
-
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
PRODUKT 1245
420-980-7
-
Eye Dam. 1
Details
424-510-1
-
Eye Dam. 1
Details
PES-SOLID
420-070-1
-
Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
Details
R633
406-230-1
224635-63-6
Flam. Liq. 3; Carc. 2; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
Details
E-101
420-310-3
-
Acute Tox. 4
Details
YELLOW MGI 1301
424-250-9
-
Eye Dam. 1
Details
TYZOR ZEC
417-110-3
1379678-99-5
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
Details
SHC 3000
401-530-9
-
Flam. Sol. 1; STOT SE 1; Acute Tox. 4
Details
431-120-5
-
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
Details
439-540-0
-
Skin Irrit. 2; Skin Sens. 1
Details
432-200-2
1379679-02-3
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
ADDITIV 104
412-780-3
1380226-46-9
Skin Irrit. 2; Skin Sens. 1
Details
ORANGE LEP 2471
421-290-9
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STOT RE 2
Details
435-180-3
-
Asp. Tox. 1; Skin Irrit. 2
Details
GA161895; GLUCAMIDE
411-130-6
-
Eye Dam. 1
Details
444-050-5
-
Eye Dam. 1
Details
428-400-4
-
Eye Dam. 1
Details
436-890-6
-
Eye Dam. 1
Details
428-260-4
-
Eye Dam. 1
Details
ARQUAD 3.16
405-620-9
-
Eye Dam. 1
Details
438-310-7
-
Self-react. C; Repr. 2; Acute Tox. 4; STOT RE 2
Details
432-230-6
-
STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
429-620-3
110028-14-3
Skin Irrit. 2; Skin Sens. 1
Details
CLARYCET
412-450-9
131766-73-9
Skin Sens. 1
Details
2-ISOPROPYL-5-CARBOXY-1,3-DIOXANE
418-170-3
116193-72-7
Eye Dam. 1
Details
ACETOXYACID
411-660-8
147027-04-1
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
CYRACURE PHOTOINITIATOR UVI-6990; CYRACURE PHOTOINITIATOR UVI-6992
403-490-8
104558-95-4
Eye Irrit. 2; Skin Sens. 1
Details
BDS-HEXAFLUOROPHOSPHATE; BDS-HEXAFLUORPHOSPHAT; ESACURE 1004
404-986-7
74227-35-3
Eye Dam. 1
Details
EBO
417-540-1
-
Eye Dam. 1
Details
ITC 288/S
410-800-5
-
Skin Sens. 1
Details
PROCION YELLOW PX-R; S154357; SUBSTANCE S154357
412-940-2
148878-18-6
Skin Sens. 1
Details
429-440-5
-
Eye Dam. 1
Details
PRICARE
411-910-6
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
PRIAZUL MYRISTOYL LACTYLATE; PRICARE MYRISTYL LACTYLATE (1:1.5)
412-580-6
174591-51-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
432-790-1
847871-03-8
Acute Tox. 4; Skin Corr. 1B; STOT SE 2
Details
ACID RED HT 3728; ERIONYL RED HT 3728
410-070-8
141880-36-6
Skin Sens. 1
Details
C.I. DIRECT VIOLET 107; PRO-JET FAST MAGENTA 2 COLOUR; S161629
413-180-4
187285-15-0
Eye Dam. 1
Details

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