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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 28 March 2024. Database contains 4821 unique substances/entries.
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433-360-6
34036-80-1
STOT RE 2; Skin Sens. 1
203-905-0
111-76-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
203-933-3
112-07-2
Acute Tox. 4
SR 48001 A
424-560-4
151257-01-1
Acute Tox. 4; Eye Irrit. 2
C11-NEODIAMINE
412-700-7
137605-95-9
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
2-BUTYL-4-CHLORO-5-FORMYLIMIDAZOLE; BCFI
410-260-0
83857-96-9
Skin Sens. 1
425-150-8
94723-86-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
201-174-2
79-07-2
Repr. 2; Acute Tox. 3; Skin Sens. 1
201-864-3
88-88-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1
424-520-6
65753-47-1
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
2-CHLORO-4,5-DIFLUORO BENZOIC ACID; BA-6; CDFBA
405-380-5
110877-64-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2-CHLOR-4-METHYLSULFONYLBENZOESÄURE; CMSBA
406-520-8
53250-83-2
Eye Dam. 1
427-020-6
141772-37-4
STOT RE 2; Skin Sens. 1
204-502-2
121-87-9
Acute Tox. 4
2-CHLORO-5-CHLOROMETHYLTHIAZOLE
429-830-5
105827-91-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
2-CHLORO-5-METHYLPYRIDINE; CMP
418-050-0
18368-64-4
Acute Tox. 4; Skin Irrit. 2
AF-377
407-750-1
137193-60-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
ROT CO
411-440-1
131657-78-8
Acute Tox. 4; Skin Sens. 1
433-890-8
2040-90-6
Muta. 1B; Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
435-170-9
16634-82-5
Eye Dam. 1; Skin Sens. 1
2-CHLOR-4-TOLUOLSULFONYLCHLORID
412-890-1
42413-03-6
Skin Corr. 1B; Skin Sens. 1
201-956-3
89-98-5
Skin Corr. 1B
212-836-5
873-32-5
Acute Tox. 4; Eye Irrit. 2
203-459-7
107-07-3
Acute Tox. 2; Acute Tox. 1
B8510-020; CHLORMETHYLPYRIDIN; CHLORMETHYLPYRIDINE; CHLOROMETHYLPYRIDINE
416-440-5
72830-09-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1

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