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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 17 svibnja 2024. Database contains 4821 unique substances/entries.
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203-512-4
107-70-0
Flam. Liq. 3; Acute Tox. 4
425-860-8
125971-57-5
Skin Sens. 1
PRISMANTOL
406-330-5
122760-84-3
Skin Irrit. 2; Skin Sens. 1
PRISMYLATE
406-560-6
122760-85-4
Skin Irrit. 2; Skin Sens. 1
POWDERLINK (R) MTSI
415-040-8
14653-91-9
Acute Tox. 4; STOT SE 3; Eye Dam. 1
205-502-5
141-79-7
Flam. Liq. 3; Acute Tox. 4
203-551-7
108-11-2
Flam. Liq. 3; STOT SE 3
203-550-1
108-10-1
Flam. Liq. 2; Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
203-626-4
108-89-4
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-811-7
100-02-7
Acute Tox. 4; STOT RE 2
203-251-6
104-91-6
Muta. 2; Acute Tox. 4; Eye Dam. 1
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
POLYSTAY K; WINGSTAY K
404-160-6
164907-73-7
Skin Sens. 1
419-240-6
171054-89-0
Eye Dam. 1
202-848-9
100-40-3
Carc. 2
204-255-0
118-48-9
Eye Irrit. 2; Skin Sens. 1
204-525-8
122-15-6
Acute Tox. 3
PIGMENTROT 1017; SUBSTANCE H112287
405-100-1
115662-06-1
Repr. 2
421-170-6
138937-28-7
Acute Tox. 4; Eye Dam. 1
410-530-8
107815-88-3
Skin Sens. 1
WAY-128170
420-820-6
153042-18-3
Flam. Liq. 3; Acute Tox. 4
414-410-6
1379676-83-1
Eye Dam. 1; Skin Sens. 1
ROUGE REACTIF REN 208
418-380-5
168113-78-8
Eye Dam. 1
433-530-1
143446-73-5
Acute Tox. 4; Skin Sens. 1
5-ACETYL-3-AMINO-IMINODIBENZYL.HCL
410-490-1
138451-65-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
CP-13,853
412-200-9
17630-75-0
Repr. 2; Acute Tox. 4; Skin Sens. 1
203-737-8
110-12-3
Flam. Liq. 3; Acute Tox. 4
BISOX HCL
404-840-2
164578-13-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
ROUGE TZ 4075
418-340-7
157707-94-3
Eye Dam. 1
BLEU REN 20
418-000-8
163062-28-0
Eye Dam. 1
204-327-1
119-47-1
Repr. 1B
yes
239-732-2
15662-33-6
Acute Tox. 4
ELFADOX EN 3001
406-680-9
104788-63-8
Org. Perox. C; Eye Dam. 1; Skin Sens. 1
PAP
410-850-8
128275-31-0
Org. Perox. D; Eye Dam. 1
AF-507; M-3181
404-680-3
1862-07-3
Acute Tox. 4; Skin Corr. 1B
ENS 131
404-550-6
130263-41-1
Skin Sens. 1
UK-103,442
422-460-5
137234-87-8
Acute Tox. 4
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
yes
DM-C-TDA; DMTDA; ETHACURE (R) 300 CURATIVE
403-240-8
106264-79-3
Acute Tox. 4; Skin Sens. 1
ORANGE BIREACTIVE DYE
407-050-6
117715-57-8
Skin Sens. 1
TACS
403-690-5
111298-82-9
Resp. Sens. 1; Skin Sens. 1
424-850-0
189702-72-5
Eye Dam. 1
429-400-7
199327-61-2
Repr. 1B
203-437-7
106-87-6
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4
-
10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
3,3-TETRAMETHYLENE GLUTARIMIDE
427-770-4
1075-89-4
Acute Tox. 3
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
416-360-0
162221-28-5
Skin Sens. 1

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