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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 18 lipnja 2024. Database contains 4821 unique substances/entries.
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209-030-0
553-00-4
Carc. 1A; Acute Tox. 4
265-294-7
64969-36-4
Carc. 1B; Acute Tox. 4
277-985-0
74753-18-7
Carc. 1B; Acute Tox. 4
210-322-5
612-82-8
Carc. 1B; Acute Tox. 4
252-984-8
36341-27-2
Carc. 1A; Acute Tox. 4
244-236-4
21136-70-9
Carc. 1A; Acute Tox. 4
208-520-1
531-86-2
Carc. 1A; Acute Tox. 4
208-519-6
531-85-1
Carc. 1A; Acute Tox. 4
205-801-0
152-16-9
Acute Tox. 1; Acute Tox. 2
203-300-1
105-46-4
Flam. Liq. 2
213-104-8
924-43-6
Flam. Liq. 2; Acute Tox. 4
237-732-7
13952-84-6
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
247-554-1
26259-45-0
Acute Tox. 4; Eye Irrit. 2
231-957-4
7782-49-2
Acute Tox. 3; STOT RE 2
272-271-5
68784-75-8
yes
234-363-3
11120-22-2
yes
253-461-7
37321-15-6
Carc. 1A; STOT RE 1; Skin Sens. 1
206-991-8
409-21-2
Carc. 1B
233-054-0
10026-04-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
231-853-9
7761-88-8
Ox. Sol. 2; Skin Corr. 1B
204-535-2
122-34-9
Carc. 2
213-801-7
1014-70-6
Acute Tox. 4
A complex combination of hydrocarbons obtained as a raffinate by treatment of a petroleum slack wax fraction with sulfuric acid treating process. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
292-659-8
90669-77-5
Carc. 1B
A complex combination of hydrocarbons obtained by treatment of a petroleum slack wax fraction with natural or modified clay in either a contacting or percolation process. It consists predominantly of saturated straight and branched hydrocarbons having carbon numbers predominantly greater than C20.
292-660-3
90669-78-6
Carc. 1B
A complex combination of hydrocarbons obtained by treating slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
295-523-6
92062-09-4
Carc. 1B
A complex combination of hydrocarbons obtained by treatment of low-melting petroleum slack wax with hydrogen in the presence of a catalyst. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-525-7
92062-11-8
Carc. 1B
A complex combination of hydrocarbons obtained from a petroleum fraction by solvent deparaffination. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C12.
295-524-1
92062-10-7
Carc. 1B
A complex combination of hydrocarbons obtained from a petroleum fraction by solvent crystallization (solvent dewaxing) or as a distillation fraction from a very waxy crude. It consists predominantly of saturated straight and branched chain hydrocarbons having carbon numbers predominantly greater than C20.
265-165-5
64742-61-6
Carc. 1B
Product obtained from recycling of the end electrolyte of copper refining electrolysis followed by evaporation to separate the residual sulfuric acid. Consists primarily of nickel and iron sulfates with small amounts of the sulfates of zinc, alkali earths and alkali metals.
295-859-3
92129-57-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
231-132-9
7440-23-5
Water-react. 1; Skin Corr. 1B
224-580-1
4418-26-2
Acute Tox. 4
205-055-6
132-27-4
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
204-857-3
127-68-4
Eye Irrit. 2; Skin Sens. 1
263-560-7
62476-59-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
247-852-1
26628-22-8
Acute Tox. 2
215-608-3
1333-83-1
Acute Tox. 3; Skin Corr. 1B
207-838-8
497-19-8
Eye Irrit. 2
231-887-4
7775-09-9
Ox. Sol. 1; Acute Tox. 4
231-889-5
7775-11-3
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
213-030-6
917-61-3
Acute Tox. 4
234-190-3
10588-01-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
231-890-0
7775-14-6
Self-heat. 1; Acute Tox. 4
205-487-5
141-52-6
Self-heat. 1; Skin Corr. 1B
231-667-8
7681-49-4
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
200-548-2
62-74-8
Acute Tox. 2; Acute Tox. 1
231-587-3
7646-69-7
Water-react. 1
231-665-7
7681-38-1
Eye Dam. 1
231-548-0
7631-90-5
Acute Tox. 4
215-185-5
1310-73-2
Skin Corr. 1A
231-668-3
7681-52-9
Skin Corr. 1B; Eye Dam. 1

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