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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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425-520-9
197179-61-6
Eye Dam. 1
243-193-9
19622-19-6
Acute Tox. 4
217-775-8
1951-97-9
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
419-570-0
195006-58-7
Acute Tox. 4
243-105-9
19485-03-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
UK-88,861-04
421-810-4
194602-27-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
425-870-2
19450-38-5
Skin Sens. 1
243-072-0
19438-60-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
2-PHENYLETHYLISOCYANAT; 2-PHENYLETHYLISOCYANATE; PHENYL ETHYL ISOCYANATE
413-080-0
1943-82-4
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
2-EPH
421-460-2
19398-06-2
Carc. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
1,3-PDTA; AGENT CHELATANT KODAK NO.1; DISSOLVINE PDZ; HAMPSHIRE PDTA; KODAK CHELATING AGENT NO.1; TRILON R FS
400-400-9
1939-36-2
Acute Tox. 4; Eye Dam. 1
BTA-A; FLUTAMIDE BTA-A
406-740-4
1939-27-1
STOT RE 2
-
19372-20-4
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
217-710-3
1937-37-7
Carc. 1B; Repr. 2
yes
429-730-1
193562-37-7
Eye Dam. 1; Skin Sens. 1
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
217-685-9
1929-88-0
Acute Tox. 4
217-682-2
1929-82-4
Acute Tox. 4
217-681-7
1929-77-7
Acute Tox. 4
430-900-2
192725-50-1
Eye Dam. 1
F.H.D.A.
403-510-5
19247-05-3
Acute Tox. 3; STOT RE 2; Skin Sens. 1
205-892-7
192-97-2
Carc. 1B
426-860-0
191877-09-5
Eye Dam. 1
620-362-9
1918-18-9
Acute Tox. 4
217-638-2
1918-16-7
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
217-637-7
1918-13-4
Acute Tox. 4
217-635-6
1918-00-9
Acute Tox. 4; Eye Dam. 1
217-617-8
1912-24-9
STOT RE 2; Skin Sens. 1
217-615-7
1910-42-5
Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
205-886-4
191-30-0
Carc. 1B; Muta. 2
205-883-8
191-24-2
yes
242-818-2
19098-16-9
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
AMINOBUTYRALDEHYDE DIMETHYL ACETAL
407-690-6
19060-15-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
424-850-0
189702-72-5
Eye Dam. 1
217-588-1
1897-45-6
Carc. 2; Acute Tox. 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
TETRACHLOROTEREPHTHALONITRILE
401-550-8
1897-41-2
Skin Sens. 1
606-168-7
189278-12-4
Carc. 2
432-470-1
189012-93-9
Eye Dam. 1; Skin Sens. 1
205-878-0
189-64-0
Carc. 1B; Muta. 2
205-877-5
189-55-9
Carc. 1B; Muta. 2
427-680-5
188907-52-0
Eye Dam. 1; Skin Sens. 1
242-624-8
18854-01-8
Acute Tox. 3
424-290-7
188070-47-5
Skin Sens. 1
SUBSTANCE S44176
414-570-7
18759-96-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
EXPERIMENTAL CROSSLINKER S17762-80(S); MELAMINE BASED CROSSLINKER (MBC); TACT
420-390-1
187547-46-2
Skin Sens. 1
426-590-3
187412-41-5
Skin Sens. 1
428-700-5
1873-90-1
Acute Tox. 4
C.I. DIRECT VIOLET 107; PRO-JET FAST MAGENTA 2 COLOUR; S161629
413-180-4
187285-15-0
Eye Dam. 1
242-533-3
18721-51-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
242-522-3
18718-11-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1

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