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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 svibnja 2024. Database contains 4821 unique substances/entries.
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M1
422-060-0
137390-08-0
Acute Tox. 2
433-690-0
167678-46-8
Skin Corr. 1A; Skin Sens. 1
419-270-1
123599-82-6
Eye Irrit. 2
235-715-9
12607-70-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
419-840-8
169104-71-6
Flam. Sol. 1; Skin Corr. 1B; Skin Sens. 1
425-520-9
197179-61-6
Eye Dam. 1
SQ 28,796
415-820-8
137590-32-0
Eye Dam. 1; Skin Sens. 1
CCA-VERSUCHSPRODUKT SN 4001
405-080-4
118725-24-9
Eye Dam. 1
A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C (500°F to 554°F).
309-851-5
101316-45-4
Carc. 1B
603-921-1
135410-20-7
Acute Tox. 4
203-564-8
108-24-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
CGA 245704 TECH.
420-050-0
135158-54-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
203-453-4
107-02-8
Flam. Liq. 2; Acute Tox. 1; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
203-466-5
107-13-1
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
204-673-3
124-04-9
Eye Irrit. 2
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1
204-123-2
116-06-3
Acute Tox. 2; Acute Tox. 3
240-896-2
16871-90-2
Acute Tox. 3
240-934-8
16893-85-9
Acute Tox. 3
240-968-3
16919-19-0
Acute Tox. 3
701-376-5
1372804-76-6
yes
203-470-7
107-18-6
Flam. Liq. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-442-4
106-92-3
Flam. Liq. 3; Carc. 2; Muta. 2; Repr. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
203-463-9
107-11-9
Flam. Liq. 2; Acute Tox. 3
603-801-9
134237-50-6
yes
240-877-9
16853-85-3
Water-react. 1; Skin Corr. 1A
604-314-4
142844-00-6
yes
215-647-6
1336-21-6
Skin Corr. 1B
215-676-4
1341-49-7
Acute Tox. 3; Skin Corr. 1B
AIZEN SPILON BLACK TRH; AIZEN SPILON SCHWARZ TRH; THR-1; TRH
400-110-2
109125-51-1
Self-react. C
235-186-4
12125-02-9
Acute Tox. 4; Eye Irrit. 2
235-185-9
12125-01-8
Acute Tox. 3
433-560-3
15375-21-0
Repr. 2
202-910-5
101-05-3
Eye Irrit. 2; Skin Irrit. 2
204-371-1
120-12-7
yes
233-047-2
10025-91-9
Skin Corr. 1B
215-175-0
1309-64-4
Carc. 2
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-957-1
101794-75-6
Carc. 1B
A complex combination hydrocarbons obtained from mixed coal tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-956-6
101794-74-5
Carc. 1B
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-958-7
101794-76-7
Carc. 1B
601-649-8
12001-28-4
Carc. 1A; STOT RE 1
601-801-3
12172-73-5
Carc. 1A; STOT RE 1
601-650-3
12001-29-5
Carc. 1A; STOT RE 1
-
132207-32-0
Carc. 1A; STOT RE 1
217-617-8
1912-24-9
STOT RE 2; Skin Sens. 1
203-102-5
103-33-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2
603-524-3
131860-33-8
Acute Tox. 3
202-930-4
101-27-9
Acute Tox. 4; Skin Sens. 1
431-780-4
199876-46-5
Acute Tox. 4; STOT RE 2
236-760-7
13477-00-4
Ox. Sol. 1; Acute Tox. 4

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