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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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STANNOUS METHANE SULPHONAT; STANNOUS METHANE SULPHONATE; TIN (II) METHANE SULPHONATE; TIN METHANE SULPHONATE; TIN METHANESULFONATE; TIN SALT FS; ZINN(II) METHANESULFONATE; ZINN(II)-METHANSULFONAT
401-640-7
53408-94-9
Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
236-675-5
13463-67-7
Carc. 2
231-441-9
7550-45-0
Skin Corr. 1B
TITANYL OXALAAT
403-260-7
31363-92-5
Eye Dam. 1
260-515-3
57018-04-9
Skin Sens. 1B
203-625-9
108-88-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
265-697-8
65321-67-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
208-741-3
540-25-0
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
208-740-8
540-23-8
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
211-986-9
731-27-1
Acute Tox. 2; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
211-986-9
731-27-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
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-
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.
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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.
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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.
204-854-7
127-65-1
Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1
-
-
P Parasites
-
-
P Parasites
618-075-9
87820-88-0
Carc. 2; Acute Tox. 4
FC4010
417-290-3
147086-81-5
Acute Tox. 4
AMINODIOXEPAN
419-050-3
79944-37-9
Skin Sens. 1
229-977-3
6876-12-6
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
DHP OPT
445-770-2
42031-28-7
Eye Dam. 1
231-186-3
7443-52-9
Acute Tox. 4
SQ28,646
419-160-1
90657-55-9
Repr. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
SQ 27,616
416-020-1
96314-26-0
Repr. 2; Skin Sens. 1
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
205-860-2
156-60-5
Flam. Liq. 2; Acute Tox. 4
250-517-2
31218-83-4
Acute Tox. 3
443-150-6
101226-85-1
Flam. Liq. 3
405-060-5
118712-89-3
Skin Irrit. 2
BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
-
-
B Bacteria and similar species
218-962-7
2303-17-5
Acute Tox. 4; STOT RE 2; Skin Sens. 1
200-875-0
75-50-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-875-0
75-50-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
256-103-8
43121-43-3
Acute Tox. 4; Skin Sens. 1
259-537-6
55219-65-3
Repr. 1B; Lact.; Acute Tox. 4
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-
Pyr. Liq. 1; Skin Corr. 1B
620-368-1
1031-47-6
Acute Tox. 1; Acute Tox. 2
432-270-4
221354-37-6
Repr. 2; STOT RE 2
-
26766-27-8
Acute Tox. 4
245-986-5
24017-47-8
Acute Tox. 3; Acute Tox. 4
401-190-1
101200-48-0
STOT RE 2; Skin Sens. 1
204-800-2
126-73-8
Carc. 2; Acute Tox. 4; Skin Irrit. 2
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
-
-
Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
-
-
P Parasites
200-149-3
52-68-6
Acute Tox. 4; Skin Sens. 1
200-902-6
75-79-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
208-885-7
545-06-2
Acute Tox. 3
201-167-4
79-01-6
Carc. 1B; Muta. 2; Eye Irrit. 2; Skin Irrit. 2; STOT SE 3
yes
213-608-8
993-16-8
Repr. 2
206-326-1
327-98-0
Acute Tox. 2; Acute Tox. 3
200-930-9
76-06-2
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
233-042-5
10025-78-2
Flam. Liq. 1; Pyr. Liq. 1; Acute Tox. 4; Skin Corr. 1A
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-
F Fungi
-
-
F Fungi
-
-
P Parasites
222-182-2
3380-34-5
Eye Irrit. 2; Skin Irrit. 2
206-203-2
307-55-1
yes
215-548-8
1330-78-5
STOT SE 1
215-548-8
1330-78-5
Acute Tox. 4
255-559-5
41814-78-2
Acute Tox. 4
274-462-9
70225-16-0
yes
246-347-3
24602-86-6
Repr. 1B; Acute Tox. 4; Skin Irrit. 2
DYNASILAN BH N; DYNASILAN BSM 100 N; DYNASILAN NH 42
402-810-3
17980-47-1
Skin Irrit. 2
TRIETHYLARSENAT; TRIETHYLARSENATE; TRIETHYLARSENATE (TEASAT)
427-700-2
15606-95-8
Carc. 1A; Acute Tox. 3
yes
201-114-5
78-40-0
Acute Tox. 4
204-469-4
121-44-8
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
-
-
Acute Tox. 2; Acute Tox. 1
215-812-2
1420-06-0
Acute Tox. 4
604-237-6
141517-21-7
Lact.; Skin Sens. 1
614-708-8
68694-11-1
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
200-929-3
76-05-1
Acute Tox. 4; Skin Corr. 1A
219-014-5
2314-97-8
Muta. 2
216-428-8
1582-09-8
Carc. 2; Skin Sens. 1
603-146-9
126535-15-7
Carc. 2
235-688-3
12519-85-6
Carc. 1A; STOT RE 1; Skin Sens. 1
215-290-6
1319-46-6
yes
231-205-5
7446-27-7
Repr. 1A; STOT RE 2
222-979-5
3687-31-8
yes
235-252-2
12141-20-7
yes
ACID BLUE FC 77890
414-290-5
149564-65-8
Acute Tox. 4
IJA-286; IJBK-286; IJBK-286-LI
403-650-7
117409-78-6
Expl. 1.3
220-449-8
2768-02-7
Skin Sens. 1B
204-468-9
121-43-7
Flam. Liq. 3; Acute Tox. 4
1,3-PDTA; AGENT CHELATANT KODAK NO.1; DISSOLVINE PDZ; HAMPSHIRE PDTA; KODAK CHELATING AGENT NO.1; TRILON R FS
400-400-9
1939-36-2
Acute Tox. 4; Eye Dam. 1
257-765-0
52234-82-9
Muta. 2; Eye Dam. 1; Skin Sens. 1
-
-
Acute Tox. 2; Acute Tox. 1
680-302-2
95266-40-3
STOT RE 2; Skin Sens. 1B
236-771-7
13477-70-8
Carc. 1A; STOT RE 1; Skin Sens. 1
-
74646-29-0
Carc. 1A; STOT RE 1; Skin Sens. 1
233-844-5
10381-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
234-495-1
12007-02-2
Carc. 1A; STOT RE 1; Skin Sens. 1
234-829-6
12035-72-2
Carc. 1A; Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
-
12137-12-1
Carc. 1A; STOT RE 1; Skin Sens. 1
TZ 02508
413-320-4
869-59-0
STOT RE 1; Skin Irrit. 2

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