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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 15 listopada 2024. Database contains 4821 unique substances/entries.
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203-804-1
110-80-5
Flam. Liq. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4
yes
203-839-2
111-15-9
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
239-622-4
15571-58-1
Repr. 1B; STOT RE 1
yes
201-963-1
90-04-0
Carc. 1B; Muta. 2; Acute Tox. 3
yes
203-713-7
109-86-4
Flam. Liq. 3; Repr. 1B; Acute Tox. 4
yes
203-772-9
110-49-6
Repr. 1B; Acute Tox. 4
yes
ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
400-600-6
71868-10-5
Repr. 1B; Acute Tox. 4
yes
211-765-7
693-98-1
Repr. 1B
yes
687-833-9
1119449-38-5
yes
248-743-1
27942-27-4
yes
219-682-8
2497-59-8
yes
604-395-6
14409-72-4
yes
247-816-5
26571-11-9
yes
622-370-8
1522-92-5
yes
ZOLDINE MS-PLUS
421-150-7
143860-04-2
Repr. 1B; Skin Corr. 1B
yes
201-025-1
77-40-7
yes
209-218-2
561-41-1
yes
202-027-5
90-94-8
Carc. 1B; Muta. 2; Eye Dam. 1
yes
202-974-4
101-77-9
Carc. 1B; Muta. 2; STOT SE 1; STOT RE 2; Skin Sens. 1
yes
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
yes
-
-
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
202-977-0
101-80-4
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
AP-5
401-720-1
6807-17-6
Repr. 1B; Eye Irrit. 2
yes
-
-
yes
621-341-7
2315-61-9
yes
205-426-2
140-66-9
Skin Irrit. 2; Eye Dam. 1
yes
257-907-1
52427-13-1
yes
635-388-6
521947-27-3
yes
-
-
yes
272-233-8
68784-25-8
yes
635-389-1
186825-36-5
yes
635-391-2
142731-63-3
yes
635-696-0
186825-39-8
yes
200-453-6
60-09-3
Carc. 1B
yes
217-862-0
1987-50-4
yes
-
-
yes
608-055-8
27147-75-7;27459-10-5
yes
608-055-8
27147-75-7;27459-10-5
yes
202-453-1
95-80-7
yes
284-325-5
84852-15-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
-
-
yes
-
-
yes
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
202-591-2
97-56-3
Carc. 1B; Skin Sens. 1
yes
202-679-0
98-54-4
Repr. 2; Skin Irrit. 2; Eye Dam. 1
yes
621-345-9
2315-67-5
yes
-
-
yes
-
-
yes
-
-
yes

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