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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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211-057-8
628-86-4
Unst. Expl.; Acute Tox. 3; STOT RE 2
-
-
Unst. Expl.; Acute Tox. 3
211-745-8
693-21-0
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-240-8
55-63-0
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
211-063-0
628-96-6
Unst. Expl.; Acute Tox. 2; Acute Tox. 1; STOT RE 2
201-084-3
78-11-5
Unst. Expl.
239-924-6
15825-70-4
Unst. Expl.
210-903-3
625-58-1
Unst. Expl.
266-583-0
67129-08-2
Skin Sens. 1B; Carc. 2
220-449-8
2768-02-7
Skin Sens. 1B
260-515-3
57018-04-9
Skin Sens. 1B
248-505-7
27519-02-4
Skin Sens. 1B
201-134-4
78-70-6
Skin Sens. 1B
204-811-2
126-91-0
Skin Sens. 1B
204-810-7
126-90-9
Skin Sens. 1B
204-262-9
118-58-1
Skin Sens. 1B
CGI 819
423-340-5
162881-26-7
Skin Sens. 1A
202-590-7
97-54-1
Skin Sens. 1A
641-410-5
130066-44-3
Skin Sens. 1A
250-863-4
31906-04-4
Skin Sens. 1A
257-187-9
51414-25-6
Skin Sens. 1A
227-633-7
5912-86-7
Skin Sens. 1A
227-678-2
5932-68-3
Skin Sens. 1A
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
605-037-1
156052-68-5
Skin Sens. 1
604-291-0
142469-14-5
Skin Sens. 1
RED JB 747
418-220-4
-
Skin Sens. 1
C.I. REACTIVE YELLOW 174; GIALLO REATTIVO 174; JAUNE REACTIF 174; REAKTIV GELB 174
402-170-5
106359-91-5
Skin Sens. 1
430-280-3
844491-96-9
Skin Sens. 1
BLEU REACTIF CAC 10; DIOXAZINE MONCHLORTRIAZINE; FAT NO. 40 407; REACTIVE BLUE CAC 10
410-130-3
136248-03-8
Skin Sens. 1
247-759-6
26523-78-4
Skin Sens. 1
yes
ACETOACETYLORTHOSINIC ACID, A6-SALT
403-760-5
68030-79-5
Skin Sens. 1
BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
AMINODIOXEPAN
419-050-3
79944-37-9
Skin Sens. 1
NAVY 14 05 711
411-470-5
141048-13-7
Skin Sens. 1
REACTIVE RED 202 (ESTER)
413-070-6
1379676-82-0
Skin Sens. 1
BLEU REACTIF 238; BLEU REATTIVO 238; C.I. REACTIVE BLUE 238; DISAZO MARINE TZ 2646; MARINE DIAZO TZ 2646; REACTIVE BLUE 238
404-320-5
116889-78-2
Skin Sens. 1
AMARELO INDOSOL SF-2RL; INDOSOL GELB SF-2RL; INDOSOL YELLOW SF-2RL; JAUNE INDOSOL SF-2RL; JAUNE WK 1913; SOLAR GOLDEN YELLOW R; YELLOW WK 1913
400-010-9
81898-60-4
Skin Sens. 1
C.I. REACTIVE BROWN 44
400-430-2
95078-21-0
Skin Sens. 1
BLEU REACTIF TZ 3533; BLEU REACTIVE TZ 3533; FAT 41'017/A; REACTIVE BLUE TZ 3533
411-240-4
143683-23-2
Skin Sens. 1
1291-F; FUCD-4
405-240-3
160683-19-2
Skin Sens. 1
FOOD BLACK 2, LITHIUM SALT
405-150-4
106028-58-4
Skin Sens. 1
429-270-1
136210-30-5
Skin Sens. 1
P3B
418-080-4
120307-06-4
Skin Sens. 1
PRO-JET BLACK 286 COLOUR; SUBSTANZ H112286
405-130-5
128351-36-0
Skin Sens. 1
C.I. DIRECT BLUE 301; DIRECT BLUE 301
408-210-8
124605-82-9
Skin Sens. 1
427-930-3
250639-69-1
Skin Sens. 1
218-953-8
2302-17-2
Skin Sens. 1
LU20
405-450-5
66531-87-1
Skin Sens. 1

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