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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 26 april 2024. Database contains 4821 unique substances/entries.
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433-490-3
6563-83-3
Skin Sens. 1
423-260-0
100988-63-4
Muta. 2; Skin Sens. 1
2691; CARTASOL BRILLANT SCHARLACH K-2GL KONZ.; CARTASOL BRILLANTSCHARLACH K-2GL FLÜSSIG (ZUBEREITUNG); CARTASOL BRILLANTSCHARLACH K-2GL GRANULAT (ZUBEREITUNG); CARTASOL BRILLIANT SCARLET K-2GL; CARTASOL BRILLIANT SCARLET K-2GL CONC.
402-060-7
108225-03-2
Carc. 1B; Eye Dam. 1
692-456-8
688046-61-9
Carc. 2
425-930-8
151213-39-7
Skin Corr. 1B; Acute Tox. 4; STOT RE 2
428-690-2
1668-86-6
Acute Tox. 4; Eye Irrit. 2
420-450-5
86552-32-1
Carc. 2; Eye Dam. 1
SULPHAZINE
406-090-1
81880-96-8
Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
SILANEOPHAN
405-020-7
105024-66-6
Repr. 1B
247-162-0
25646-77-9
Acute Tox. 3; STOT RE 2; Skin Sens. 1
SULPHONAMIDO-ANILINE
406-010-5
88918-84-7
Eye Dam. 1; Skin Sens. 1
PHOTOAMORCEUR 22074; RHODORSIL PHOTOINITIATOR 2074; TEPBI
422-960-3
178233-72-2
Acute Tox. 4; STOT RE 2
17-KETOBROMOHYDRINE
419-790-7
4229-69-0
Skin Sens. 1
PTH-AA
430-230-0
136522-17-3
Acute Tox. 4
444-350-6
133413-70-4
Eye Irrit. 2
420-380-5
136465-81-1
Acute Tox. 4; Eye Dam. 1
701-394-3
1782069-81-1
yes
T 1569; T001569
423-290-4
66938-41-8
Muta. 2
222-048-3
3327-22-8
Carc. 2
428-230-0
79568-06-2
STOT RE 2
CIN 10094329; SENSIBILISATOR KF 693 PINA; SENSITIZER KF 693 PINA
422-240-9
166596-68-5
Eye Dam. 1; Skin Sens. 1
427-200-4
76646-91-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
443-560-5
88784-33-2
Eye Irrit. 2
-
75166-30-2
yes
822-682-6
1417782-03-6
Skin Sens. 1
201-501-9
83-79-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
425-260-6
244634-31-9
STOT RE 2; Eye Dam. 1; Skin Sens. 1
4-AA; AOSA; AZETIDONE-KANEKA; GR91990X
408-050-9
76855-69-1
Eye Irrit. 2; Skin Sens. 1
433-820-6
118058-74-5
Eye Irrit. 2
UK-103,449-BV
427-100-0
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
-
75166-31-3
yes
420-370-0
6485-67-2
Eye Irrit. 2; Skin Sens. 1
440-620-2
920-36-5
Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A; STOT SE 3
287-470-2
85508-45-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
CLETOPROPAMINHYDROCHLORID
429-740-6
40722-80-3
Carc. 1B; Muta. 1B; STOT RE 2; Skin Sens. 1
BUTAMINONITRODARONE; SR33581
444-800-1
141645-23-0
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
X-17-17
417-410-4
61807-67-8
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
DWS
404-940-6
86608-70-0
Acute Tox. 4; Eye Dam. 1; STOT RE 2
430-910-7
13335-71-2
Acute Tox. 4; Eye Dam. 1
433-520-5
82911-69-1
Acute Tox. 4; Skin Sens. 1
430-620-0
76145-91-0
STOT RE 2; Skin Sens. 1
439-360-2
142877-45-0
Skin Irrit. 2; Eye Dam. 1
443-840-7
4084-38-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
BLUE 10 25 964
407-240-9
159604-94-1
Skin Sens. 1
CP-141,845-27
426-740-8
256369-40-1
Acute Tox. 4; Eye Dam. 1
220-384-5
2746-19-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
SERTRALINE STEP 2
420-560-3
79617-97-3
Eye Dam. 1
426-200-1
172015-79-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
G-EXOMETHYLENE SULFOXIDE ESTER
412-800-0
76109-32-5
Resp. Sens. 1

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