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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 28 svibnja 2024. Database contains 4821 unique substances/entries.
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210-894-6
625-45-6
Repr. 1B; Acute Tox. 4; Skin Corr. 1B
yes
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
200-679-5
68-12-2
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
yes
202-959-2
101-61-1
Carc. 1B
yes
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
yes
201-182-6
79-16-3
Repr. 1B
yes
202-716-0
98-95-3
Carc. 2; Repr. 1B; Acute Tox. 3; STOT RE 1
yes
206-400-3
335-76-2
Carc. 2; Repr. 1B; Lact.
yes
246-672-0
25154-52-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
1 - 2.5 moles ethoxylated
500-209-1
68412-54-4
yes
500-024-6
9016-45-9
yes
931-755-2
-
yes
931-756-8
-
yes
931-753-1
-
yes
931-754-7
-
yes
939-993-9
-
yes
-
-
yes
938-618-6
-
yes
932-998-7
-
yes
202-429-0
95-53-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2
yes
209-136-7
556-67-2
Repr. 2
yes
-
-
yes
215-235-6
1314-41-6
yes
237-560-2
13840-56-7
Repr. 1B
yes
250-339-5
30784-30-6
yes
201-280-9
80-46-6
yes
241-427-4
17404-66-9
yes
247-770-6
26543-97-5
yes
203-199-4
104-40-5
yes
287-196-3
85422-92-0
yes
307-202-0
97553-43-0
yes
276-745-2
72629-94-8
yes
235-067-7
12065-90-6
yes
256-418-0
49663-84-5
yes
603-902-8
13517-20-9
yes
600-611-8
10486-00-7
yes
600-419-4
10332-33-9
yes
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
206-793-1
375-73-5
yes
206-587-1
355-46-4
yes
206-801-3
375-95-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
-
21049-39-8
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
206-397-9
335-67-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
201-581-5
85-01-8
yes
-
-
yes
616-100-8
74499-35-7
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes
640-104-9
210555-94-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
yes

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