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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 srpnja 2024. Database contains 4821 unique substances/entries.
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427-850-9
202667-43-4
Skin Sens. 1
ACID RED FC 70013
414-250-7
149564-66-9
Acute Tox. 4; Eye Dam. 1
429-730-1
193562-37-7
Eye Dam. 1; Skin Sens. 1
REACTIVE BLUE FC 05 717
401-560-2
108624-00-6
Skin Sens. 1
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P Parasites
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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.
A complex combination of hydrocarbons having carbon numbers predominantly in the range of C12 through C50. May contain organic salts of alkali metals, alkaline earth metals, and/or aluminium compounds.
278-011-7
74869-21-9
Carc. 1B
A complex combination of hydrocarbons obtained by refining of crude oil. It consists predominantly of aromatics, naphthenics and paraffinics and produces a finished oil with a viscosity of 120 SUS at 100°F (23cSt at 40°C).
297-474-6
93572-43-1
Carc. 1B
A complex combination of hydrocarbons obtained by treating light vacuum gas oil and heavy vacuum gas oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of approximately 15cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
276-737-9
72623-86-0
Carc. 1B
A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C17 through C32 and produces a finished oil with a viscosity in the order of 17cSt to 23cSt at 40°C (104°F).
309-875-6
101316-70-5
Carc. 1B
295-423-2
92045-42-6
Carc. 1B
307-034-8
97488-95-4
Carc. 1B
A complex combination of hydrocarbons obtained by solvent deparaffination of the distillation residue from hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C40 and boiling in the range of approximately 370°C to 550°C (698°F to 1022°F).
305-594-8
94733-15-0
Carc. 1B
A complex combination of hydrocarbons obtained by solvent deparaffination of the hydrogenated raffinate obtained by solvent extraction of a hydrotreated petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C40 and boiling in the range of approximately 370°C to 550°C (698°F to 1022°F).
305-595-3
94733-16-1
Carc. 1B
A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C35 and produces a finished oil with a viscosity in the order of 37cSt to 44cSt at 40°C (104°F).
309-876-1
101316-71-6
Carc. 1B
A complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil, and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil having a viscosity of approximately 112cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
276-736-3
72623-85-9
Carc. 1B
A complex combination of hydrocarbons obtained by treating light vacuum gas oil, heavy vacuum gas oil and solvent deasphalted residual oil with hydrogen in the presence of a catalyst in a two stage process with dewaxing being carried out between the two stages. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of approximately 32cSt at 40°C. It contains a relatively large proportion of saturated hydrocarbons.
276-738-4
72623-87-1
Carc. 1B
A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of atmospheric distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C24 through C50 and produces a finished oil with a viscosity in the order of 16cSt to 75cSt at 40°C (104°F).
309-877-7
101316-72-7
Carc. 1B
A complex combination of hydrocarbons obtained by solvent extraction and hydrogenation of vacuum distillation residues. It consists predominantly of hydrocarbons having carbon numbers predominantly greater than C25 and produces a finished oil with a viscosity in the order of 32cSt to 37cSt at 100°C (212°F).
309-874-0
101316-69-2
Carc. 1B
295-424-8
92045-43-7
Carc. 1B
A complex combination of hydrocarbons obtained from solvent extraction and dewaxing processes. It consists predominantly of saturated hydrocarbons having carbon numbers in the range C15 through C50.
278-012-2
74869-22-0
Carc. 1B
CGA 184699
410-690-9
103055-07-8
Skin Sens. 1
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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.
202-987-5
101-90-6
Carc. 1B; Muta. 2; Acute Tox. 3; Acute Tox. 4; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
203-577-9
108-39-4
Acute Tox. 3; Skin Corr. 1B
PRODUCT 5899
404-150-1
17092-80-7
Skin Irrit. 2
202-729-1
99-09-2
Acute Tox. 3; STOT RE 2
203-584-7
108-45-2
Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
208-790-0
541-69-5
Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
203-583-1
108-44-1
Acute Tox. 3; STOT RE 2
247-722-4
26471-62-5
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
203-576-3
108-38-3
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
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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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F Fungi
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F Fungi
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Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
DUPLOSAN-DP-MAGNESIUM
413-360-2
164058-21-3
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
241-022-2
16949-65-8
Acute Tox. 3
235-023-7
12057-74-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
231-104-6
7439-95-4
Flam. Sol. 1; Water-react. 2; Self-heat. 1
231-104-6
7439-95-4
Water-react. 1; Pyr. Sol. 1
422-610-1
-
Eye Dam. 1
BLACK UL 1253
417-280-9
30785-74-1
Eye Dam. 1
BLACK JR 578
419-230-1
-
Skin Sens. 1
209-322-8
569-64-2
Repr. 2; Acute Tox. 4; Eye Dam. 1
219-441-7
2437-29-8
Repr. 2; Acute Tox. 4; Eye Dam. 1
204-497-7
121-75-5
Acute Tox. 4; Skin Sens. 1
203-742-5
110-16-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
203-571-6
108-31-6
Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1A

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