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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 27 svibnja 2024. Database contains 4821 unique substances/entries.
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200-340-1
57-57-8
Carc. 1B; Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
Z-29
418-990-1
778577-53-0
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2
201-052-9
77-73-6
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
LICHTSCHUTZMITTEL 2577
407-600-5
120187-29-3
Muta. 2
DMA
407-500-1
21983-80-2
Skin Sens. 1
428-970-4
13595-25-0
Repr. 2; Skin Sens. 1
201-025-1
77-40-7
yes
209-321-2
569-61-9
Carc. 1B
DIGLYCERINDIFORMAL (DGDF)
423-230-7
56552-15-9
Eye Dam. 1
204-358-0
119-93-7
Carc. 1B; Acute Tox. 4
209-218-2
561-41-1
yes
202-027-5
90-94-8
Carc. 1B; Muta. 2; Eye Dam. 1
yes
B-TUM
418-770-5
151882-81-4
Carc. 2
207-762-5
492-80-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2
ZP-DK 2115
407-590-2
43151-99-1
Acute Tox. 3; STOT RE 2; Skin Sens. 1
202-974-4
101-77-9
Carc. 1B; Muta. 2; STOT SE 1; STOT RE 2; Skin Sens. 1
yes
AROCY L-10
405-740-1
47073-92-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1
420-530-1
177027-34-8
Resp. Sens. 1; Skin Sens. 1
AROCY M-10
405-790-4
101657-77-6
Skin Sens. 1
243-420-1
19900-65-3
Carc. 2; Acute Tox. 4
LONZACURE M-MIPA
415-150-6
16298-38-7
STOT RE 2
LUPRAGEN VP 9199 X
412-840-9
13474-64-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1A
225-863-2
5124-30-1
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
yes
202-966-0
101-68-8
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
431-850-4
7456-68-0
Expl. 1.1; STOT RE 2
DD-63
404-590-4
90884-29-0
Skin Sens. 1
-
-
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
HMPSC
403-330-7
24197-34-0
Eye Dam. 1
-
-
Carc. 1B; Acute Tox. 4
205-370-9
139-65-1
Carc. 1B; Acute Tox. 4
421-360-9
148043-73-6
Acute Tox. 4
CARBONATE DE TETRACHLOROETHYLENE
404-060-2
22432-68-4
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
AMINOBUTYRALDEHYDE DIMETHYL ACETAL
407-690-6
19060-15-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
TRIOXABICYCLOOCTAN; TRIOXABICYCLOOCTANE
421-750-9
57280-22-5
Eye Irrit. 2; Skin Sens. 1
AP-5
401-720-1
6807-17-6
Repr. 1B; Eye Irrit. 2
yes
264-843-8
64359-81-5
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
HOMOFARNESYLSÄURE
403-000-2
91853-67-7
Skin Irrit. 2
ORRINIFF
402-520-7
125352-06-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
-
-
yes
621-341-7
2315-61-9
yes
205-426-2
140-66-9
Skin Irrit. 2; Eye Dam. 1
yes
423-860-2
56309-94-5
Skin Sens. 1
257-907-1
52427-13-1
yes
ACRYLOYLMORPHOLIN
418-140-1
5117-12-4
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
635-388-6
521947-27-3
yes
WL 125892
402-190-4
113674-95-6
STOT RE 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
LICHTSCHUTZMITTEL 1071
413-510-7
147374-67-2
STOT RE 2; Skin Sens. 1
4-ALLYLOXYBENZOESÄURE-(4-METHACRYLOYL)PHENYLESTER
429-000-2
159235-16-2
Skin Sens. 1

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