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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 lipnja 2024. Database contains 4821 unique substances/entries.
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919-76-6
Acute Tox. 4
212-634-7
834-12-8
Acute Tox. 4
604-314-4
142844-00-6
yes
209-090-8
555-31-7
Flam. Sol. 1
231-072-3
7429-90-5
Water-react. 2; Pyr. Sol. 1
231-072-3
7429-90-5
Water-react. 2; Flam. Sol. 1
244-088-0
20859-73-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
240-877-9
16853-85-3
Water-react. 1; Skin Corr. 1A
231-208-1
7446-70-0
Skin Corr. 1B
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Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
603-801-9
134237-50-6
yes
203-463-9
107-11-9
Flam. Liq. 2; Acute Tox. 3
202-473-0
96-05-9
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4
203-442-4
106-92-3
Flam. Liq. 3; Carc. 2; Muta. 2; Repr. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
203-470-7
107-18-6
Flam. Liq. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-270-7
93-71-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
435-650-8
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Acute Tox. 4; Skin Corr. 1A
435-660-2
243662-67-1
Skin Irrit. 2; Skin Sens. 1
263-004-3
61788-76-9
yes
272-924-4
68920-70-7
yes
270-654-1
68475-60-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-653-6
68475-59-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-652-0
68475-58-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
285-195-2
85049-26-9
yes
283-931-7
84776-07-8
yes
287-477-0
85535-85-9
Lact.
yes
701-376-5
1372804-76-6
yes
292-454-3
90622-53-0
Carc. 1B
287-504-6
85536-22-7
yes
283-930-1
84776-06-7
yes
307-451-5
97659-46-6
yes
281-985-6
84082-38-2
yes
287-476-5
85535-84-8
Carc. 2
yes
292-456-4
90622-55-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-651-5
68475-57-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
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Acute Tox. 4
240-968-3
16919-19-0
Acute Tox. 3
240-934-8
16893-85-9
Acute Tox. 3
240-896-2
16871-90-2
Acute Tox. 3
206-215-8
309-00-2
Carc. 2; Acute Tox. 3; STOT RE 1
204-123-2
116-06-3
Acute Tox. 2; Acute Tox. 3
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1
204-673-3
124-04-9
Eye Irrit. 2
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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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yes
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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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