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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 srpnja 2024. Database contains 4821 unique substances/entries.
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600-611-8
10486-00-7
Repr. 1B; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
yes
600-594-7
104653-34-1
Repr. 1B; Acute Tox. 1; STOT RE 1
600-533-4
104206-82-8
Repr. 2; STOT RE 2
600-425-7
103361-09-7
Repr. 2
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-419-4
10332-33-9
yes
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-363-0
102851-06-9
Acute Tox. 4; Skin Irrit. 2
600-130-3
100784-20-1
Repr. 1B
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
1 - 2.5 moles ethoxylated
500-209-1
68412-54-4
yes
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
500-036-1
25214-70-4
yes
500-033-5
25068-38-6
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
500-024-6
9016-45-9
yes
451-440-9
586372-44-3
Eye Dam. 1
451-430-4
500717-36-2
Eye Dam. 1; Skin Sens. 1
450-010-8
-
Eye Dam. 1; Skin Sens. 1
N,N DIMETHYL DIETHOXY-2,2 ACETAMIDE
449-950-1
34640-92-1
Eye Irrit. 2
448-720-8
363138-44-7
Acute Tox. 4; Eye Dam. 1
AMINODARONE OXALATE; SR33580A
448-700-9
500791-70-8
STOT RE 2; Eye Dam. 1; Skin Sens. 1
447-920-2
897393-42-9
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1
447-880-6
206565-89-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
447-860-7
144177-62-8
Repr. 2; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
PARADISAMIDE
446-190-2
406488-30-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
445-990-9
376588-17-9
Skin Sens. 1
445-890-5
201290-01-9
Acute Tox. 4; Skin Sens. 1
DHP OPT
445-770-2
42031-28-7
Eye Dam. 1
445-760-8
-
Eye Dam. 1; Resp. Sens. 1
445-750-3
839705-03-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
445-590-4
202197-26-0
Muta. 2; Acute Tox. 4; STOT RE 2
445-280-9
371921-40-3
Eye Dam. 1; Skin Sens. 1
444-970-7
7340-90-1
Flam. Liq. 3; Repr. 2; STOT RE 2; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1; STOT SE 3
444-950-8
99464-83-2
Muta. 2; Skin Sens. 1
444-860-9
474510-57-1
STOT RE 2
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
444-480-3
393517-29-8
Skin Irrit. 2
444-440-5
220689-12-3
Acute Tox. 4
444-350-6
133413-70-4
Eye Irrit. 2
444-320-2
-
Acute Tox. 4
444-290-0
508202-43-5
Eye Dam. 1; Skin Sens. 1
444-250-2
144111-81-9
Self-react. C
444-050-5
-
Eye Dam. 1
443-980-9
221215-20-9
Skin Sens. 1
443-870-0
163520-33-0
Acute Tox. 4; Skin Sens. 1
443-840-7
4084-38-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
443-560-5
88784-33-2
Eye Irrit. 2
443-150-6
101226-85-1
Flam. Liq. 3

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