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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 29 března 2024. Database contains 4821 unique substances/entries.
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203-313-2
105-60-2
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
PC-709
413-420-8
144736-29-8
Skin Corr. 1B; Skin Sens. 1
639-478-6
182635-99-0
Acute Tox. 4; Skin Corr. 1B
614-054-3
67375-30-8
Acute Tox. 3; STOT RE 2; STOT SE 3
202-853-6
100-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
202-847-3
100-39-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
229-851-8
6786-83-0
yes
201-254-7
80-15-9
Org. Perox. E; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
202-709-2
98-87-3
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
202-635-0
98-08-8
Flam. Liq. 2
202-634-5
98-07-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
226-009-1
5216-25-1
Carc. 1B; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
605-037-1
156052-68-5
Skin Sens. 1
231-176-9
7440-67-7
Water-react. 1; Pyr. Sol. 1
231-176-9
7440-67-7
Self-heat. 1
936-037-2
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yes
205-288-3
137-30-4
Acute Tox. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
235-180-1
12122-67-7
STOT SE 3; Skin Sens. 1
417-130-2
1379689-21-0
Eye Dam. 1
616-096-8
7446-19-7
Acute Tox. 4; Eye Dam. 1
231-793-3
7733-02-0
Acute Tox. 4; Eye Dam. 1
231-175-3
7440-66-6
Water-react. 1; Pyr. Sol. 1
425-240-7
-
Eye Dam. 1
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Chromic acid, potassium zinc salt EC / List no: 255-252-6 | CAS no: 41189-36-0
C.I. Pigment Yellow 36 EC / List no: 609-398-6 | CAS no: 37300-23-5
Pentazinc chromate octahydroxide EC / List no: 256-418-0 | CAS no: 49663-84-5
Potassium hydroxyoctaoxodizincatedichromate(1-) EC / List no: 234-329-8 | CAS no: 11103-86-9
Zinc chromate EC / List no: 236-878-9 | CAS no: 13530-65-9
Zinc dichromate EC / List no: 237-843-0 | CAS no: 14018-95-2
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Carc. 1A; Acute Tox. 4; Skin Sens. 1
231-592-0
7646-85-7
Acute Tox. 4; Skin Corr. 1B
238-270-9
14324-55-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
205-232-8
136-23-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Z-6
402-280-3
149144-82-1
Eye Irrit. 2; Skin Irrit. 2
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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.
219-364-9
2425-10-7
Acute Tox. 4
215-091-4
1300-73-8
Acute Tox. 3; STOT RE 2
215-089-3
1300-71-6
Acute Tox. 3; Skin Corr. 1B
215-535-7
1330-20-7
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
607-955-8
2655-14-3
Acute Tox. 4
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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.
601-810-2
12185-10-3
Pyr. Sol. 1; Acute Tox. 2; Skin Corr. 1A
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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.
The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.
295-549-8
92062-34-5
Carc. 1B
201-377-6
81-81-2
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
200-831-0
75-01-4
Press. Gas; Flam. Gas 1; Carc. 1A
203-545-4
108-05-4
Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 3

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