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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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203-815-1
110-91-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
205-628-0
144-41-2
Acute Tox. 3
248-505-7
27519-02-4
Skin Sens. 1B
201-328-9
81-14-1
Carc. 2
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
200-806-4
74-31-7
Skin Sens. 1
202-831-6
100-22-1
Acute Tox. 4
203-744-6
110-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
203-336-8
105-83-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
200-679-5
68-12-2
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
yes
210-338-2
613-35-4
Carc. 1B; Muta. 2; Acute Tox. 4
227-062-3
5625-90-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1; Eye Dam. 1
202-959-2
101-61-1
Carc. 1B
yes
205-319-0
138-24-9
Acute Tox. 3
205-149-7
134-62-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
202-088-8
91-66-7
Acute Tox. 3; STOT RE 2
204-495-6
121-72-2
Acute Tox. 3; STOT RE 2
210-199-8
609-72-3
Acute Tox. 3; STOT RE 2
202-805-4
99-97-8
Acute Tox. 3; STOT RE 2
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
204-493-5
121-69-7
Carc. 2; Acute Tox. 3
220-623-3
2836-04-6
Acute Tox. 3
200-316-0
57-14-7
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; Skin Corr. 1B
247-161-5
25646-71-3
Acute Tox. 4; Skin Sens. 1
211-952-3
719-96-0
Skin Irrit. 2
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
205-223-9
135-88-6
Carc. 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
204-658-1
123-86-4
Flam. Liq. 3; STOT SE 3
205-480-7
141-32-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
202-615-1
97-88-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
209-669-5
590-01-2
Flam. Liq. 3
203-700-6
109-74-0
Flam. Liq. 2; Acute Tox. 3
200-652-8
67-43-6
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
202-411-2
95-33-0
Skin Sens. 1
220-250-6
2687-91-4
Repr. 1B
203-135-5
103-69-5
Acute Tox. 3; STOT RE 2
203-777-6
110-54-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
202-969-7
101-72-4
Acute Tox. 4; Skin Sens. 1
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
yes
211-795-0
696-44-6
Acute Tox. 3; STOT RE 2
207-531-9
479-45-8
Expl. 1.1; Acute Tox. 3; STOT RE 2
210-260-9
611-21-2
Acute Tox. 3; STOT RE 2
210-769-6
623-08-5
Acute Tox. 3; STOT RE 2
201-182-6
79-16-3
Repr. 1B
yes
202-870-9
100-61-8
Acute Tox. 3; STOT RE 2
204-624-6
123-39-7
Repr. 1B; Acute Tox. 4
218-130-3
2051-79-8
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
205-547-0
142-59-6
Acute Tox. 4; STOT SE 3; Skin Sens. 1
206-098-3
300-76-5
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2

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