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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 rujna 2024. Database contains 4821 unique substances/entries.
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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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