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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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202-429-0
95-53-4
Carc. 1B; Acute Tox. 3; Eye Irrit. 2
yes
932-998-7
-
yes
938-618-6
-
yes
-
-
yes
939-993-9
-
yes
931-754-7
-
yes
931-753-1
-
yes
931-756-8
-
yes
931-755-2
-
yes
500-024-6
9016-45-9
yes
1 - 2.5 moles ethoxylated
500-209-1
68412-54-4
yes
246-672-0
25154-52-3
Repr. 2; Acute Tox. 4; Skin Corr. 1B
yes
206-400-3
335-76-2
Carc. 2; Repr. 1B; Lact.
yes
202-716-0
98-95-3
Carc. 2; Repr. 1B; Acute Tox. 3; STOT RE 1
yes
201-182-6
79-16-3
Repr. 1B
yes
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
yes
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
202-959-2
101-61-1
Carc. 1B
yes
200-679-5
68-12-2
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
yes
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
210-894-6
625-45-6
Repr. 1B; Acute Tox. 4; Skin Corr. 1B
yes
UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17
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Alkanes, C14-17, chloro EC / List no: 287-477-0 | CAS no: 85535-85-9
Tetradecane, chloro derivs. EC / List no: - | CAS no: 198840-65-2
Alkanes, C14-16, chloro EC / List no: 701-376-5 | CAS no: 1372804-76-6
di-, tri- and tetrachlorotetradecane EC / List no: 950-299-5 | CAS no: -
799-971-8
-
yes
BLEIMETHANSULFONAT; LEAD (II) METHANESULFONATE; LEAD METHANE SULPHONATE; LEAD SALT FP
401-750-5
17570-76-2
Repr. 1A; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
yes
235-727-4
12626-81-2
yes
235-038-9
12060-00-3
yes
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.
215-693-7
1344-37-2
Carc. 1B; Repr. 1A; STOT RE 2
yes
239-290-0
15245-44-0
yes
231-100-4
7439-92-1
Repr. 1A; Lact.
yes
234-853-7
12036-76-9
yes
215-267-0
1317-36-8
yes
232-064-2
7784-40-9
Carc. 1A; Repr. 1A; Acute Tox. 3; STOT RE 2
yes
229-335-2
6477-64-1
yes
233-245-9
10099-74-8
yes
236-542-1
13424-46-9
yes
206-104-4
301-04-2
Repr. 1A; STOT RE 2
yes
244-073-9
20837-86-9
yes
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77605.
235-759-9
12656-85-8
Carc. 1B; Repr. 1A; STOT RE 2
yes
231-846-0
7758-97-6
Carc. 1B; Repr. 1A; STOT RE 2
yes
237-486-0
13814-96-5
yes
609-346-2
37205-87-1
yes
234-284-4
11066-49-2
yes
-
-
yes
-
-
yes
616-584-0
7803-57-8
yes
206-114-9
302-01-2
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
247-094-1
25550-51-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
243-072-0
19438-60-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
260-566-1
57110-29-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
256-356-4
48122-14-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
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1,2,5,6,9,10-hexabromocyclodecane EC / List no: 221-695-9 | CAS no: 3194-55-6
alpha-hexabromocyclododecane EC / List no: 603-801-9 | CAS no: 134237-50-6
beta-hexabromocyclododecane EC / List no: 603-802-4 | CAS no: 134237-51-7
Hexabromocyclododecane EC / List no: 247-148-4 | CAS no: 25637-99-4
gamma-hexabromocyclododecane EC / List no: 603-804-5 | CAS no: 134237-52-8
247-148-4
25637-99-4
Repr. 2; Lact.
yes

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