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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 23 svibnja 2024. Database contains 4821 unique substances/entries.
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A complex combination of hydrocarbons obtained by distillation of products from a catalytic cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C12 and boiling in the range of approximately 140°C to 210°C (284°F to 410°F).
309-974-4
101794-97-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
309-987-5
101896-28-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of a cut from the catalytic cracking process, having undergone an alkaline washing. It consists predominantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130°C to 210°C (266°F to 410°F).
295-794-0
92128-94-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
297-853-6
93763-34-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained as solvents which have been subjected to hydrotreatment in order to convert aromatics to naphthenes by catalytic hydrogenation.
297-854-1
93763-35-0
Asp. Tox. 1
270-690-8
68476-50-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
297-857-8
93763-38-3
Carc. 1B
A combination of hydrocarbons obtained from the distillation of hydrotreated naphtha followed by a solvent extraction and distillation process. It consists predominantly of saturated hydrocarbons boiling in the range of approximately 94°C to 99°C (201°F to 210°F).
295-436-3
92045-55-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
231-595-7
7647-01-0
Press. Gas; Acute Tox. 3; Skin Corr. 1A
231-595-7
7647-01-0
Skin Corr. 1B; STOT SE 3
231-634-8
7664-39-3
Acute Tox. 2; Acute Tox. 1; Skin Corr. 1A
231-634-8
7664-39-3
Acute Tox. 2; Acute Tox. 1; Skin Corr. 1A
215-605-7
1333-74-0
Flam. Gas 1; Press. Gas
200-821-6
74-90-8
Acute Tox. 2; Acute Tox. 1
200-821-6
74-90-8
Flam. Liq. 1; Acute Tox. 2
231-765-0
7722-84-1
Ox. Liq. 1; Acute Tox. 4; Skin Corr. 1A
2-BUTANEDIOIC ACID, MONOAMIDE WITH N-(9-OCTADECENYL)-3-AMINO
402-970-4
148292-42-6
Skin Sens. 1
231-977-3
7783-06-4
Flam. Gas 1; Press. Gas; Acute Tox. 2
SICORIN E 10197
403-750-0
113036-91-2
Acute Tox. 4
423-310-1
61420-92-6
Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
641-410-5
130066-44-3
Skin Sens. 1A
232-259-2
7803-49-8
Unst. Expl.; Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
232-259-2
7803-49-8
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
258-872-5
53933-48-5
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
242-818-2
19098-16-9
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
244-077-0
20845-01-6
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
226-798-2
5470-11-1
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
233-154-4
10046-00-1
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
236-691-2
13465-08-2
Expl. 1.1; Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
DP-3337
405-710-8
23783-26-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
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-
P Parasites
-
-
P Parasites
233-000-6
10004-44-1
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
200-090-3
51-34-3
Acute Tox. 2; Acute Tox. 1
202-933-0
101-31-5
Acute Tox. 2
-
-
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.
252-615-0
35554-44-0
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Dam. 1
261-351-5
58594-72-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
261-351-5
58594-72-2
Acute Tox. 4; Skin Sens. 1
601-305-7
114311-32-9
Repr. 2
617-219-8
81334-34-1
Eye Irrit. 2
428-040-8
138261-41-3
Acute Tox. 3
431-510-5
18087-70-2
Acute Tox. 4; Eye Irrit. 2
206-019-2
288-32-4
Repr. 1B; Acute Tox. 4; Skin Corr. 1C
428-790-6
72963-72-5
Carc. 2; Acute Tox. 4; STOT SE 2
244-959-5
22398-80-7
Carc. 1B; Repr. 2; STOT RE 1
605-683-4
173584-44-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
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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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-
Acute Tox. 2; Acute Tox. 1; STOT RE 2
231-442-4
7553-56-2
Acute Tox. 4

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