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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 25 lipnja 2024. Database contains 4821 unique substances/entries.
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215-185-5
1310-73-2
Skin Corr. 1A
432-400-1
10102-09-7
Skin Corr. 1A
215-236-1
1314-56-3
Skin Corr. 1A
200-579-1
64-18-6
Skin Corr. 1A
9,10-ANTHRACENEDIOL, DISODIUM SALT
426-030-8
46492-07-3
Skin Corr. 1A
201-199-9
79-36-7
Skin Corr. 1A
201-207-0
79-43-6
Skin Corr. 1A
SILAN DCS
407-180-3
770722-36-6
Skin Corr. 1A
SILAN MCS
410-270-5
770722-46-8
Skin Corr. 1A
221-106-5
3006-10-8
Skin Corr. 1; Eye Dam. 1
34 DIAZO
417-080-1
-
Self-react. D; Skin Sens. 1
429-710-2
-
Self-react. D; Acute Tox. 4
ASB
405-310-3
15980-11-7
Self-react. C; STOT RE 2; Eye Dam. 1; Skin Sens. 1
438-310-7
-
Self-react. C; Repr. 2; Acute Tox. 4; STOT RE 2
T-271
417-980-4
157321-59-0
Self-react. C; Carc. 2
T-69
414-770-4
140698-96-0
Self-react. C; Carc. 2
441-550-5
-
Self-react. C; Carc. 2
R-GLYCIDOL
404-660-4
57044-25-4
Self-react. C; Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
DIAZO W 6623-TS
413-290-2
93672-52-7
Self-react. C; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
201-132-3
78-67-1
Self-react. C; Acute Tox. 4
DIAZO-A-SALICYLSULFONATE
404-980-4
124737-31-1
Self-react. C; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
PS-6 SENSITIZER
413-840-1
121870-66-4
Self-react. C
AIZEN SPILON BLACK TRH; AIZEN SPILON SCHWARZ TRH; THR-1; TRH
400-110-2
109125-51-1
Self-react. C
444-250-2
144111-81-9
Self-react. C
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
204-699-5
124-41-4
Self-heat. 1; Skin Corr. 1B
205-487-5
141-52-6
Self-heat. 1; Skin Corr. 1B
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
213-029-0
917-58-8
Self-heat. 1; Skin Corr. 1B
212-737-7
865-34-9
Self-heat. 1; Skin Corr. 1B
231-890-0
7775-14-6
Self-heat. 1; Acute Tox. 4
231-176-9
7440-67-7
Self-heat. 1
235-180-1
12122-67-7
STOT SE 3; Skin Sens. 1
202-617-2
97-90-5
STOT SE 3; Skin Sens. 1
203-080-7
103-11-7
STOT SE 3; Skin Irrit. 2; Skin Sens. 1
428-390-1
86393-34-2
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
232-752-2
9014-01-1
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
432-200-2
1379679-02-3
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
427-280-0
176429-27-9
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
427-480-8
176429-22-4
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
221-319-3
3066-71-5
STOT SE 3; Skin Irrit. 2
209-008-0
552-30-7
STOT SE 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
211-479-2
650-51-1
STOT SE 3
205-570-6
142-90-5
STOT SE 3
426-900-7
203118-12-1
STOT SE 3
215-548-8
1330-78-5
STOT SE 1
206-742-3
371-86-8
STOT SE 1
680-302-2
95266-40-3
STOT RE 2; Skin Sens. 1B
401-190-1
101200-48-0
STOT RE 2; Skin Sens. 1
CARTASOL RED K-2BN; RED 10 25 501
408-000-6
118658-98-3
STOT RE 2; Skin Sens. 1

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