EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 10 rujna 2024. Database contains 4821 unique substances/entries.
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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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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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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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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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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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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
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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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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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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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.
[Man-made vitreous (silicate) fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+ MgO+BaO) content less or equal to 18 % by weight]
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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: -
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: -
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Carc. 1B
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Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
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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
428-630-5
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Skin Sens. 1
PDN 2287
417-450-2
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Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
PRODUKT 1245
420-980-7
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Eye Dam. 1
424-510-1
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Eye Dam. 1
PES-SOLID
420-070-1
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Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
E-101
420-310-3
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Acute Tox. 4
YELLOW MGI 1301
424-250-9
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Eye Dam. 1
SHC 3000
401-530-9
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Flam. Sol. 1; STOT SE 1; Acute Tox. 4
431-120-5
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Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
439-540-0
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Skin Irrit. 2; Skin Sens. 1
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yes
ORANGE LEP 2471
421-290-9
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STOT RE 2
435-180-3
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Asp. Tox. 1; Skin Irrit. 2
GA161895; GLUCAMIDE
411-130-6
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Eye Dam. 1
P2-800; P2-935LV
415-870-0
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Skin Sens. 1
NOIR SANDODERM HH 1050; SANDODERM BLACK HH 1050; SANDODERM BLACK R; SANDODERM BLACK R CONC.; SANDODERM SCHWARZ R; SANDODERM SCHWARZ R KONZ.
402-850-1
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Eye Dam. 1
RED MDO 358
414-620-8
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Eye Dam. 1; Skin Sens. 1
444-050-5
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Eye Dam. 1
428-400-4
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Eye Dam. 1
428-260-4
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Eye Dam. 1
ARQUAD 3.16
405-620-9
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Eye Dam. 1
438-310-7
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Self-react. C; Repr. 2; Acute Tox. 4; STOT RE 2
432-230-6
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STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
EBO
417-540-1
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Eye Dam. 1
ITC 288/S
410-800-5
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Skin Sens. 1
429-440-5
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Eye Dam. 1
PRICARE
411-910-6
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
DRIMAREN NAVY R-GRL; NAVY 14 08 723
407-100-7
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Skin Sens. 1
427-740-0
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Eye Dam. 1; Skin Sens. 1
TASP
411-250-9
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Skin Sens. 1
EVAPORATED ELEMINOL JS-2 MATERIAL
410-230-7
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Skin Corr. 1B; Skin Sens. 1
433-860-4
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Eye Irrit. 2; Skin Sens. 1
422-500-1
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STOT RE 2
COLUMBIADUNKELBLAU R
415-350-3
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Eye Dam. 1
432-100-9
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Eye Dam. 1
450-010-8
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Eye Dam. 1; Skin Sens. 1
423-010-0
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Eye Dam. 1
423-580-0
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STOT RE 2
COMPLEXING AGENT BN
410-650-0
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Eye Dam. 1; Skin Sens. 1
VERNETZER TMAG
412-790-8
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Carc. 1B; Muta. 2; STOT RE 2
PERGASCRIPT BLACK 20223 AMIDE INTERMEDIATE
420-600-1
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STOT RE 2
414-340-6
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Flam. Liq. 3; Acute Tox. 4; STOT SE 2; Eye Dam. 1; Skin Sens. 1
430-050-2
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Skin Sens. 1
REACTIVE YELLOW FC 75560
419-450-8
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Skin Sens. 1
434-240-6
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Skin Sens. 1
CYANEX (R) EXTRACTANT; CYANEX 923 EXTRACTANT
403-470-9
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Skin Corr. 1B
434-420-4
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Skin Irrit. 2; Eye Dam. 1
PRICARE
411-860-5
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Skin Sens. 1
426-840-1
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Eye Dam. 1
DYE K
402-660-9
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Repr. 1B
435-960-3
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Carc. 1B; Muta. 1B; Skin Sens. 1
427-140-9
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Carc. 2
OLOA 224 (OIL FREE)
420-470-4
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Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
NEWLON AM-92I
407-490-9
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Acute Tox. 4; Skin Corr. 1B
429-990-6
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Eye Dam. 1; Skin Sens. 1
SP 7077
430-180-1
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Skin Irrit. 2
SP 7053
415-930-6
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Repr. 2; Skin Sens. 1
422-920-5
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STOT RE 2
MDI
406-550-1
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Skin Sens. 1
MCP 455
406-240-6
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Flam. Liq. 3; Skin Corr. 1B
A-88820.605
414-810-0
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STOT RE 2; Eye Dam. 1
AMMONIUM DIAS
407-320-3
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Skin Irrit. 2; Eye Dam. 1
DP 15
410-640-6
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Skin Irrit. 2; Eye Dam. 1
INTERMEDIAIRE AR HT 3728
410-065-0
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Skin Sens. 1
T-4240 FLUOROCHEMICAL URETHANE DERIVATIVE
413-640-4
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STOT RE 2
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
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Muta. 2; Skin Sens. 1
R 7623 TECHNICAL
403-250-2
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Carc. 2; Repr. 1B; Acute Tox. 4
423-750-4
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Eye Irrit. 2
34 DIAZO
417-080-1
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Self-react. D; Skin Sens. 1
FORMYLTRICYCLODECEN, EXO
410-480-7
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Skin Sens. 1
431-440-5
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Eye Dam. 1
DISPERSIONSROT 2754
411-880-4
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Skin Sens. 1
435-440-6
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Eye Dam. 1
440-510-4
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Eye Dam. 1; Skin Sens. 1
ROT Y; RUBINOT Y; RUBINROT Y
408-240-1
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Acute Tox. 4
ACRYLSKUM; T-2816 FOAMER
407-810-7
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STOT RE 2
442-800-6
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Skin Irrit. 2
MMA-10R
423-670-1
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Eye Dam. 1; Skin Sens. 1

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