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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 16 August 2022. Database contains 4821 unique substances/entries.
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271-093-5
68515-50-4
Repr. 1B
yes
284-032-2
84777-06-0
Repr. 1B
yes
272-013-1
68648-93-1
yes
276-158-1
71888-89-6
Repr. 1B
yes
271-084-6
68515-42-4
Repr. 1B
yes
220-120-9
2634-33-5
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
203-977-3
112-49-2
Repr. 1B
yes
REACTIVE NAVY DER 7678
417-610-1
155522-09-1
Skin Sens. 1
3,4-DIACETOXY-1-BUTENE
421-720-5
18085-02-4
Acute Tox. 4
202-479-3
96-12-8
Carc. 1B; Muta. 1B; Repr. 1A; Acute Tox. 3; STOT RE 2
203-444-5
106-93-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-425-9
95-50-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-458-1
107-06-2
Flam. Liq. 2; Carc. 1B; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
yes
208-750-2
540-59-0
Flam. Liq. 2; Acute Tox. 4
201-152-2
78-87-5
Flam. Liq. 2; Carc. 1B; Acute Tox. 4
211-076-1
629-14-1
Flam. Liq. 2; Repr. 1A; Eye Irrit. 2
yes
1,2-DIETHOXYPROPANE; DIETHOXY-1,2-PROPANE
412-180-1
10221-57-5
Flam. Liq. 2
FAT 92'364/A
411-990-2
68612-94-2
Skin Sens. 1
204-427-5
120-80-9
Carc. 1B; Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
203-794-9
110-71-4
Flam. Liq. 2; Repr. 1B; Acute Tox. 4
yes
EXPERIMENTAL DIETHER MM; HISOLVE MMPOM
404-630-0
7778-85-0
Flam. Liq. 2
256-152-5
43222-48-6
Acute Tox. 4
PLINYL ACETATE
424-070-0
94346-09-5
Skin Irrit. 2
-
540-73-8
Carc. 1B; Acute Tox. 3
217-101-2
1739-84-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
208-431-8
528-29-0
Acute Tox. 2; Acute Tox. 1; STOT RE 2
203-438-2
106-88-7
Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
202-752-7
99-35-4
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
203-812-5
110-88-3
Flam. Sol. 1; Repr. 2; STOT SE 3
219-514-3
2451-62-9
Muta. 1B; Acute Tox. 3; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
TEPIC-H
423-400-0
59653-74-6
Muta. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
241-536-7
17557-23-2
Skin Irrit. 2; Skin Sens. 1
PERKALINK 900
412-570-1
119462-56-5
STOT RE 2; Eye Dam. 1; Skin Sens. 1
420-930-4
135756-61-5
Acute Tox. 4; Eye Dam. 1
H-604
428-350-3
93629-90-4
Muta. 2; Eye Dam. 1; Skin Sens. 1
423-300-7
128554-52-9
Skin Sens. 1
JAUNE REACTIF MUB 151
415-100-3
149850-29-3
Skin Sens. 1
203-450-8
106-99-0
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
DIPND-50-AL (META)
420-060-5
117663-11-3
Flam. Liq. 3; Org. Perox. D
208-792-1
541-73-1
Acute Tox. 4
202-491-9
96-23-1
Carc. 1B; Acute Tox. 3; Acute Tox. 4
1,3-DICHLOR-4-FLUORBENZOL; B-7
406-160-1
1435-48-9
Acute Tox. 4; STOT RE 2; Skin Irrit. 2
DCEMH
401-570-7
89415-87-2
Ox. Sol. 1; Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
208-826-5
542-75-6
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
DE 3
413-140-6
3459-83-4
Flam. Liq. 3
UTMS
414-180-7
10218-17-4
Acute Tox. 4; Skin Irrit. 2
202-776-8
99-65-0
Acute Tox. 2; Acute Tox. 1; STOT RE 2
211-463-5
646-06-0
Flam. Liq. 2
203-002-1
102-06-7
Repr. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
214-317-9
1120-71-4
Carc. 1B; Acute Tox. 4
yes

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