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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 srpnja 2024. Database contains 4821 unique substances/entries.
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253-704-7
37894-46-5
Repr. 1B; Acute Tox. 4; STOT RE 2
200-814-8
74-84-0
Flam. Gas 1; Press. Gas
203-473-3
107-21-1
Acute Tox. 4
200-837-3
75-08-1
Flam. Liq. 2; Acute Tox. 4
200-578-6
64-17-5
Flam. Liq. 2
240-718-3
16672-87-0
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1C
250-010-6
30043-49-3
Skin Sens. 1
214-984-6
1239-45-8
Muta. 2; Acute Tox. 2; Acute Tox. 4
249-981-9
29973-13-5
Acute Tox. 4
209-242-3
563-12-2
Acute Tox. 3; Acute Tox. 4
245-949-3
23947-60-6
Acute Tox. 4
204-121-1
116-01-8
Acute Tox. 4
236-152-1
13194-48-4
Acute Tox. 2; Acute Tox. 1; Acute Tox. 3; Skin Sens. 1
202-075-7
91-53-2
Acute Tox. 4
211-694-1
687-47-8
Flam. Liq. 3; STOT SE 3; Eye Dam. 1
266-362-9
66441-23-4
Skin Sens. 1
230-391-5
7085-85-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
205-500-4
141-78-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
205-438-8
140-88-5
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
203-290-9
105-36-2
Acute Tox. 2; Acute Tox. 1
203-294-0
105-39-5
Acute Tox. 3
208-778-5
541-41-3
Flam. Liq. 2; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
203-721-0
109-94-4
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
275-897-7
71720-48-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
202-598-0
97-64-3
Flam. Liq. 3; STOT SE 3; Eye Dam. 1
202-597-5
97-63-2
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
244-845-5
22212-55-1
Acute Tox. 4
210-903-3
625-58-1
Unst. Expl.
203-722-6
109-95-5
Flam. Gas 1; Press. Gas; Acute Tox. 4
203-291-4
105-37-3
Flam. Liq. 2
200-834-7
75-04-7
Flam. Gas 1; Press. Gas; Eye Irrit. 2; STOT SE 3
202-849-4
100-41-4
Flam. Liq. 2; Acute Tox. 4; STOT RE 2; Asp. Tox. 1
209-940-8
598-56-1
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
200-815-3
74-85-1
Flam. Gas 1; Press. Gas; STOT SE 3
219-732-9
2514-53-6
Skin Irrit. 2
202-617-2
97-90-5
STOT SE 3; Skin Sens. 1
211-063-0
628-96-6
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-849-9
75-21-8
Press. Gas; Flam. Gas 1; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 3; STOT SE 3; STOT RE 1; Skin Corr. 1; Eye Dam. 1
202-506-9
96-45-7
Repr. 1B; Acute Tox. 4
yes
203-468-6
107-15-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
205-793-9
151-56-4
Flam. Liq. 2; Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 1; Skin Corr. 1B
219-991-8
2593-15-9
Carc. 2; Acute Tox. 4; Skin Sens. 1
253-855-9
38260-54-7
Acute Tox. 4
The extract oil boiling in the range of approximately 220°C to 265°C (428°F to 509°F) from coal tar alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove tar bases. Composed primarily of alkylnaphthalenes.
284-901-6
84989-12-8
Carc. 1B; Muta. 1B
The redistillate from the fractional distillation of dephenolated and debased methylnaphthalene oil obtained from bituminous coal high temperature tar and pyrolysis residual oils boiling in the approximate range of 220°C to 230°C (428°F to 446°F). It consists predominantly of unsubstituted and substituted dinuclear aromatic hydrocarbons.
295-329-1
91995-66-3
Carc. 1B; Muta. 1B
The aqueous extract produced by an acidic wash of alkali-washed carbolic oil. Composed primarily of acid salts of various aromatic nitrogen bases including pyridine, quinoline and their alkyl derivatives.
292-622-6
90640-99-6
Carc. 1B; Muta. 1B
The aqueous extract produced by an acidic wash of alkali-washed napthalene oil. Composed primarily of acid salts of various aromatic nitrogen bases including pyridine, quinoline and their alkyl derivatives.
292-623-1
90641-00-2
Carc. 1B; Muta. 1B
The extract produced by the acidic extraction of bases from crude coal tar aromatic oils, neutralization, and distillation of the bases. Composed primarily of collidines, aniline, toluidines, lutidines, xylidines.
273-077-3
68937-63-3
Carc. 1B; Muta. 1B
The extract from coal tar oil alkaline extract residue produced by an acidic wash such as aqueous sulfuric acid after distillation to remove naphthalene. Composed primarily of the acid salts of various aromatic nitrogen bases including pyridine, quinoline, and their alkyl derivatives.
266-020-9
65996-86-3
Carc. 1B; Muta. 1B
An acid sludge by-product of the sulphuric acid refining of crude high temperature coal. Composed primarily of sulfuric acid and organic compounds.
298-725-2
93821-38-6
Carc. 1B; Muta. 1B

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