EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database 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).

Last updated 11 listopada 2024. Database contains 4918 unique substances/entries.
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203-445-0
106-94-5
Flam. Liq. 2; Repr. 1B; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
R Toxic for reproduction (article 57c)
Details
203-794-9
110-71-4
Flam. Liq. 2; Repr. 1B; Acute Tox. 4
R Toxic for reproduction (article 57c)
Details
211-076-1
629-14-1
Flam. Liq. 2; Repr. 1A; Eye Irrit. 2
R Toxic for reproduction (article 57c)
Details
203-977-3
112-49-2
Repr. 1B
R Toxic for reproduction (article 57c)
Details
271-084-6
68515-42-4
Repr. 1B
R Toxic for reproduction (article 57c)
Details
276-158-1
71888-89-6
Repr. 1B
R Toxic for reproduction (article 57c)
Details
272-013-1
68648-93-1
R Toxic for reproduction (article 57c)
Details
284-032-2
84777-06-0
Repr. 1B
R Toxic for reproduction (article 57c)
Details
271-093-5
68515-50-4
Repr. 1B
R Toxic for reproduction (article 57c)
Details
271-094-0
68515-51-5
R Toxic for reproduction (article 57c)
Details
-
75166-30-2
R Toxic for reproduction (article 57c)
Details
-
75166-31-3
R Toxic for reproduction (article 57c)
Details
-
198840-65-2
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
X4261
401-850-9
255881-94-8
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
204-927-3
129-00-0
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
307-202-0
97553-43-0
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
287-196-3
85422-92-0
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
209-136-7
556-67-2
Repr. 2
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
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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di-, tri- and tetrachlorotetradecane EC / List no: 950-299-5 | CAS no: -
Alkanes, C14-17, chloro EC / List no: 287-477-0 | CAS no: 85535-85-9
Alkanes, C14-16, chloro EC / List no: 701-376-5 | CAS no: 1372804-76-6
Tetradecane, chloro derivs. EC / List no: - | CAS no: 198840-65-2
799-971-8
-
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
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1,2,5,6,9,10-hexabromocyclodecane EC / List no: 221-695-9 | CAS no: 3194-55-6
gamma-hexabromocyclododecane EC / List no: 603-804-5 | CAS no: 134237-52-8
Hexabromocyclododecane EC / List no: 247-148-4 | CAS no: 25637-99-4
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
247-148-4
25637-99-4
Repr. 2; Lact.
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
603-804-5
134237-52-8
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
205-912-4
206-44-0
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
208-762-8
540-97-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
950-299-5
-
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
208-764-9
541-02-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
200-268-0
56-35-9
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
214-604-9
1163-19-5
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
603-802-4
134237-51-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
205-883-8
191-24-2
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
204-371-1
120-12-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
603-801-9
134237-50-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
263-004-3
61788-76-9
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
272-924-4
68920-70-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
285-195-2
85049-26-9
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
283-931-7
84776-07-8
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
287-477-0
85535-85-9
Lact.
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
701-376-5
1372804-76-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
287-504-6
85536-22-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
283-930-1
84776-06-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
307-451-5
97659-46-6
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
281-985-6
84082-38-2
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
287-476-5
85535-84-8
Carc. 2
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
223-346-6
3846-71-7
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
247-384-8
25973-55-1
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
221-695-9
3194-55-6
Repr. 2; Lact.
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
TEPIC-H
423-400-0
59653-74-6
Muta. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
M Mutagen (article 57b)
Details
219-514-3
2451-62-9
Muta. 1B; Acute Tox. 3; STOT RE 2; Eye Dam. 1; Skin Sens. 1
M Mutagen (article 57b)
Details
-
-
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
206-793-1
375-73-5
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
203-615-4
108-78-1
Carc. 2; STOT RE 2
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details

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