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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 13 lipnja 2024. Database contains 4821 unique substances/entries.
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BMS 208143-01; BTHC
429-670-6
105996-54-1
Eye Dam. 1; Skin Sens. 1
LUPRAGEN VP 9159
401-660-6
1000-78-8
Skin Irrit. 2; Skin Sens. 1
435-010-8
26157-73-3
Muta. 2
445-760-8
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Eye Dam. 1; Resp. Sens. 1
429-380-1
133336-92-2
Skin Sens. 1
435-860-1
214417-91-1
Skin Sens. 1
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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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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
SYSTHANE TECHNICAL
410-400-0
88671-89-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
201-328-9
81-14-1
Carc. 2
248-505-7
27519-02-4
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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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.
205-628-0
144-41-2
Acute Tox. 3
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
203-815-1
110-91-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
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B Bacteria and similar species
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29873-36-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
225-062-8
4636-83-3
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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7411-47-4
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; 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.
205-766-1
150-68-5
Carc. 2; Acute Tox. 4
429-570-2
213990-58-0
Skin Sens. 1
217-129-5
1746-81-2
Acute Tox. 4; STOT RE 2
230-042-7
6923-22-4
Muta. 2; Acute Tox. 2; Acute Tox. 3
203-083-3
103-16-2
Eye Irrit. 2; Skin Sens. 1
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Z-22
415-880-5
779343-34-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
200-820-0
74-89-5
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-820-0
74-89-5
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B

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