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).

Last updated 15 October 2021. Database contains 4812 unique substances/entries.
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203-924-4
111-96-6
Flam. Liq. 3; Repr. 1B
yes
204-212-6
117-82-8
Repr. 1B
yes
BONTRON E-84; E-84
403-360-0
42405-40-3
Flam. Sol. 1; Acute Tox. 4
280-084-5
82985-35-1
Eye Dam. 1
DESMOPHEN VP-LS 2973 E; DESMOPHEN VP-LS 2975 E; DESMOPHEN VP-LS 2985 E
412-060-9
136210-32-7
Skin Sens. 1
404-420-9
71786-70-4
Skin Sens. 1
401-380-4
89066-61-5
Eye Irrit. 2
200-237-1
55-55-0
Acute Tox. 4; STOT RE 2; Skin Sens. 1
INTEROX-PMBP-70W; INTEROX-PMPB-70W
407-950-9
895-85-2
Org. Perox. B
205-137-1
134-31-6
Acute Tox. 4
208-832-8
542-88-1
Flam. Liq. 2; Carc. 1A; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
276-205-6
71957-07-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
421-660-1
-
Eye Dam. 1; Skin Sens. 1
418-370-0
143925-92-2
Skin Sens. 1
233-118-8
10039-54-0
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
SAFRANIN SHMN
406-770-8
149057-64-7
STOT RE 2; Eye Dam. 1; Skin Sens. 1
239-703-4
15627-09-5
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
608-595-4
312600-89-8
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
423-170-1
618-26-8
Flam. Liq. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
214-604-9
1163-19-5
yes
202-328-1
94-37-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
200-268-0
56-35-9
yes
201-279-3
80-43-3
Org. Perox. F; Repr. 1B; Skin Irrit. 2; Eye Irrit. 2
412-000-1
125051-32-3
Flam. Sol. 1; Repr. 2; STOT RE 2
421-560-6
-
STOT RE 2; Eye Dam. 1
216-823-5
1675-54-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
405-635-0
-
Skin Irrit. 2; Eye Dam. 1
413-930-0
130066-57-8
Skin Sens. 1
410-500-4
-
Eye Dam. 1
415-210-1
160236-81-7
Acute Tox. 4; Eye Dam. 1
201-245-8
80-05-7
Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1
yes
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
-
-
F Fungi
-
90568-23-3
yes
-
125022-34-6
yes
616-932-1
8011-63-0
Acute Tox. 4; Eye Dam. 1
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
233-139-2
10043-35-3;11113-50-1
Repr. 1B
yes
233-139-2
10043-35-3;11113-50-1
Repr. 1B
yes
-
22454-04-2
yes
-
14890-53-0
yes
-
25747-83-5
yes
215-604-1
1333-73-9
yes
233-657-9
10294-33-4
Acute Tox. 2; Skin Corr. 1A
233-658-4
10294-34-5
Press. Gas; Acute Tox. 2; Skin Corr. 1B
231-569-5
7637-07-2
Press. Gas; Acute Tox. 2; Skin Corr. 1A
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species

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