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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 11 rujna 2024. Database contains 4821 unique substances/entries.
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205-138-7
134-32-7
Acute Tox. 4
205-137-1
134-31-6
Acute Tox. 4
205-088-6
133-07-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
205-087-0
133-06-2
Carc. 2; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
205-073-4
132-67-2
Acute Tox. 4
205-057-7
132-32-1
Carc. 1B
205-055-6
132-27-4
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
205-042-5
131-89-5
Acute Tox. 3
205-037-8
131-73-7
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
205-025-2
131-52-2
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
205-017-9
131-18-0
Repr. 1B
yes
205-016-3
131-17-9
Acute Tox. 4
204-987-0
130-37-0
Eye Irrit. 2; Skin Irrit. 2
204-961-9
129-73-7
Carc. 2; Muta. 2
204-959-8
129-67-9
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
204-927-3
129-00-0
yes
204-857-3
127-68-4
Eye Irrit. 2; Skin Sens. 1
204-854-7
127-65-1
Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1
204-828-5
127-20-8
Skin Irrit. 2; Eye Dam. 1
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
204-825-9
127-18-4
Carc. 2
204-818-0
126-99-8
Flam. Liq. 2; Carc. 1B; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
204-817-5
126-98-7
Flam. Liq. 2; Acute Tox. 3; Skin Sens. 1
204-811-2
126-91-0
Skin Sens. 1B
204-810-7
126-90-9
Skin Sens. 1B
204-801-8
126-75-0
Acute Tox. 1; Acute Tox. 2
204-800-2
126-73-8
Carc. 2; Acute Tox. 4; Skin Irrit. 2
204-783-1
126-33-0
Acute Tox. 4
204-709-8
124-68-5
Eye Irrit. 2; Skin Irrit. 2
204-699-5
124-41-4
Self-heat. 1; Skin Corr. 1B
204-697-4
124-40-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
204-697-4
124-40-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
204-695-3
124-30-1
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
204-679-6
124-09-4
Acute Tox. 4; STOT SE 3; Skin Corr. 1B
204-677-5
124-07-2
Skin Corr. 1C
204-673-3
124-04-9
Eye Irrit. 2
204-662-3
123-92-2
Flam. Liq. 3
204-661-8
123-91-1
Flam. Liq. 2; Carc. 1B; Eye Irrit. 2; STOT SE 3
yes
204-659-7
123-88-6
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
204-658-1
123-86-4
Flam. Liq. 3; STOT SE 3
204-650-8
123-77-3
Resp. Sens. 1
yes
204-647-1
123-73-9
Flam. Liq. 2; Muta. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
204-646-6
123-72-8
Flam. Liq. 2
204-639-8
123-63-7
Flam. Liq. 3
204-638-2
123-62-6
Skin Corr. 1B
204-634-0
123-54-6
Flam. Liq. 3; Acute Tox. 4
204-626-7
123-42-2
Eye Irrit. 2
204-624-6
123-39-7
Repr. 1B; Acute Tox. 4
204-623-0
123-38-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2

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