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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 svibnja 2024. Database contains 4821 unique substances/entries.
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287-476-5
85535-84-8
Carc. 2
yes
281-985-6
84082-38-2
yes
307-451-5
97659-46-6
yes
283-930-1
84776-06-7
yes
287-504-6
85536-22-7
yes
292-454-3
90622-53-0
Carc. 1B
701-376-5
1372804-76-6
yes
287-477-0
85535-85-9
Lact.
yes
283-931-7
84776-07-8
yes
285-195-2
85049-26-9
yes
270-652-0
68475-58-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-653-6
68475-59-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-654-1
68475-60-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
272-924-4
68920-70-7
yes
263-004-3
61788-76-9
yes
435-660-2
243662-67-1
Skin Irrit. 2; Skin Sens. 1
435-650-8
-
Acute Tox. 4; Skin Corr. 1A
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
202-270-7
93-71-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
203-470-7
107-18-6
Flam. Liq. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
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
202-473-0
96-05-9
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4
203-463-9
107-11-9
Flam. Liq. 2; Acute Tox. 3
603-801-9
134237-50-6
yes
-
-
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
231-208-1
7446-70-0
Skin Corr. 1B
240-877-9
16853-85-3
Water-react. 1; Skin Corr. 1A
244-088-0
20859-73-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 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
209-090-8
555-31-7
Flam. Sol. 1
604-314-4
142844-00-6
yes
212-634-7
834-12-8
Acute Tox. 4
-
919-76-6
Acute Tox. 4
262-977-1
61788-46-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
262-976-6
61788-45-2
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
263-125-1
61790-33-8
Acute Tox. 4; Asp. Tox. 1; STOT RE 2; Skin Corr. 1B
217-990-7
2032-59-9
Acute Tox. 3
672-776-4
348635-87-0
Carc. 2; Eye Irrit. 2
251-375-4
33089-61-1
Acute Tox. 4; STOT RE 2; Skin Sens. 1
200-521-5
61-82-5
Repr. 2; STOT RE 2
215-647-6
1336-21-6
Skin Corr. 1B
231-635-3
7664-41-7
Flam. Gas 2; Press. Gas; Acute Tox. 3; Skin Corr. 1B
640 AMMONIUM SALT; KSMIA; S-102; SMIA
405-990-1
97148-39-5
Flam. Sol. 1
700-242-3
62037-80-3
yes
441-050-7
223705-57-5
Skin Irrit. 2; Eye Dam. 1
215-676-4
1341-49-7
Acute Tox. 3; Skin Corr. 1B

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