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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 13 lipnja 2024. Database contains 4821 unique substances/entries.
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422-950-9
17193-28-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1
426-200-1
172015-79-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
ZK RT 1507
417-760-8
134164-24-2
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
HYDRAMETHYLNON
405-090-9
67485-29-4
STOT RE 1; Acute Tox. 4; Eye Irrit. 2
WL 125892
402-190-4
113674-95-6
STOT RE 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
432-230-6
-
STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2-NPP
410-360-4
5428-02-4
STOT RE 1; Acute Tox. 4; Skin Sens. 1
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 140°C to 220°C (284°F to 428°F).
265-191-7
64742-88-7
STOT RE 1; Asp. Tox. 1
TZ 02508
413-320-4
869-59-0
STOT RE 1; Skin Irrit. 2
200-618-2
65-85-0
STOT RE 1; Skin Irrit. 2; Eye Dam. 1
RED E190
411-560-4
-
STOT RE 1; Skin Sens. 1
DOW CORNING (R) 4-2920 INTERMEDIATE
406-930-7
96-29-7
STOT RE 1; Skin Sens. 1
428-230-0
79568-06-2
STOT RE 2
421-080-7
161462-35-7
STOT RE 2
434-820-9
106461-41-0
STOT RE 2
5-CHLOR-2-PENTANON-NEOPENTYLKETAL; 5-CHLORO-2-PENTANONE-NEOPENTYLKETAL; CHLORKETAL
417-650-1
88128-57-8
STOT RE 2
444-860-9
474510-57-1
STOT RE 2
BTA-A; FLUTAMIDE BTA-A
406-740-4
1939-27-1
STOT RE 2
ADDITIVE F6
421-600-2
719-86-8
STOT RE 2
LONZACURE M-MIPA
415-150-6
16298-38-7
STOT RE 2
JKY-120
405-730-7
51601-57-1
STOT RE 2
Substance identity is confidential or pending assessment. If possible, following assessment the proper substance identifiers will be displayed.
-
-
STOT RE 2
201-378-1
81-82-3
STOT RE 2
603-520-1
131807-57-3
STOT RE 2
232-089-9
7785-87-7
STOT RE 2
425-190-6
119916-05-1
STOT RE 2
427-880-2
90357-53-2
STOT RE 2
604-430-5
144651-06-9
STOT RE 2
215-648-1
1336-36-3
STOT RE 2
HFR-990
423-180-6
-
STOT RE 2
419-610-7
171866-24-3
STOT RE 2
ACRYLSKUM; T-2816 FOAMER
407-810-7
-
STOT RE 2
T-4240 FLUOROCHEMICAL URETHANE DERIVATIVE
413-640-4
-
STOT RE 2
422-920-5
-
STOT RE 2
PERGASCRIPT BLACK 20223 AMIDE INTERMEDIATE
420-600-1
-
STOT RE 2
423-580-0
-
STOT RE 2
422-500-1
-
STOT RE 2
ORANGE LEP 2471
421-290-9
-
STOT RE 2
605-752-9
175217-20-6
STOT RE 2
KAYASET BLACK T-2
405-110-6
88377-66-6
STOT RE 2
GLYOXYLATE DE MENTHYLE HYDRATÉ; MENTHYL GLYOXYLATE HYDRATE
416-810-6
111969-64-3
STOT RE 2; Eye Dam. 1
421-560-6
-
STOT RE 2; Eye Dam. 1
A-88820.605
414-810-0
-
STOT RE 2; Eye Dam. 1
SQ 26999
412-170-7
83623-61-4
STOT RE 2; Eye Dam. 1; Skin Sens. 1
425-260-6
244634-31-9
STOT RE 2; Eye Dam. 1; Skin Sens. 1
PERKALINK 900
412-570-1
119462-56-5
STOT RE 2; Eye Dam. 1; Skin Sens. 1
424-660-8
-
STOT RE 2; Eye Dam. 1; Skin Sens. 1
SAFRANIN SHMN
406-770-8
149057-64-7
STOT RE 2; Eye Dam. 1; Skin Sens. 1
AMINODARONE OXALATE; SR33580A
448-700-9
500791-70-8
STOT RE 2; Eye Dam. 1; Skin Sens. 1
POTASSIUM N-(4-FLUOROPHENYL)GLYCINATE
415-710-1
184637-63-6
STOT RE 2; Eye Dam. 1; Skin Sens. 1
Z-29
418-990-1
778577-53-0
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2
MORTRACE SB CONC.
410-610-2
111850-24-9
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
251-084-2
32534-81-9
STOT RE 2; Lact.
F7641; MTSI
410-550-7
79277-18-2
STOT RE 2; Resp. Sens. 1; Skin Sens. 1
MORTRACE ST CONC.
410-600-8
124719-26-2
STOT RE 2; Skin Irrit. 2
XU 40304.03L ANTIMICROBIAL
405-640-8
36362-09-1
STOT RE 2; Skin Irrit. 2; Eye Dam. 1
AF-368
406-400-5
4595-26-0
STOT RE 2; Skin Irrit. 2; Skin Sens. 1
430-620-0
76145-91-0
STOT RE 2; Skin Sens. 1
C25-ALDEHYD
415-770-7
1638-05-7
STOT RE 2; Skin Sens. 1
FAT 40'398; FAT 40'398/E
411-100-2
136213-73-5
STOT RE 2; Skin Sens. 1
433-360-6
34036-80-1
STOT RE 2; Skin Sens. 1
427-020-6
141772-37-4
STOT RE 2; Skin Sens. 1
2-NAPHTHYLAMIN-6-SULFOMETHYLAMID; FAT 92'365/A
412-120-4
104295-55-8
STOT RE 2; Skin Sens. 1
LICHTSCHUTZMITTEL 1071
413-510-7
147374-67-2
STOT RE 2; Skin Sens. 1
217-617-8
1912-24-9
STOT RE 2; Skin Sens. 1
442-820-5
149877-41-8
STOT RE 2; Skin Sens. 1
DBBT
402-210-1
99688-47-8
STOT RE 2; Skin Sens. 1
226-031-1
5234-68-4
STOT RE 2; Skin Sens. 1
429-020-1
204254-96-6
STOT RE 2; Skin Sens. 1
615-273-7
71283-80-2
STOT RE 2; Skin Sens. 1
HOSTALUX VP 3481
401-410-6
10357-99-0
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
401-190-1
101200-48-0
STOT RE 2; Skin Sens. 1
680-302-2
95266-40-3
STOT RE 2; Skin Sens. 1B
206-742-3
371-86-8
STOT SE 1
215-548-8
1330-78-5
STOT SE 1
426-900-7
203118-12-1
STOT SE 3
205-570-6
142-90-5
STOT SE 3
211-479-2
650-51-1
STOT SE 3
209-008-0
552-30-7
STOT SE 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
221-319-3
3066-71-5
STOT SE 3; Skin Irrit. 2
427-480-8
176429-22-4
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
427-280-0
176429-27-9
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
432-200-2
1379679-02-3
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
232-752-2
9014-01-1
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
428-390-1
86393-34-2
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
203-080-7
103-11-7
STOT SE 3; Skin Irrit. 2; Skin Sens. 1
202-617-2
97-90-5
STOT SE 3; Skin Sens. 1
235-180-1
12122-67-7
STOT SE 3; Skin Sens. 1
231-176-9
7440-67-7
Self-heat. 1
231-890-0
7775-14-6
Self-heat. 1; Acute Tox. 4
212-737-7
865-34-9
Self-heat. 1; Skin Corr. 1B
213-029-0
917-58-8
Self-heat. 1; Skin Corr. 1B
212-736-1
865-33-8
Self-heat. 1; Skin Corr. 1B
205-487-5
141-52-6
Self-heat. 1; Skin Corr. 1B
204-699-5
124-41-4
Self-heat. 1; Skin Corr. 1B
FEKPDTA; KFEPDTA
405-680-6
148434-01-9
Self-heat. 2
444-250-2
144111-81-9
Self-react. C
AIZEN SPILON BLACK TRH; AIZEN SPILON SCHWARZ TRH; THR-1; TRH
400-110-2
109125-51-1
Self-react. C
PS-6 SENSITIZER
413-840-1
121870-66-4
Self-react. C

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