Materials and Conformities of Siltec‘s Silicones
Siltec uses different types of silicone rubber to manufacture silicone components such as tubes, seals, profiles, sheets, molded parts, O-rings and assembled products.
The silicone components are available in different colors and can meet different material properties and legal standards depending on customer requirements.
Quality is always the top priority for Siltec. Thus, the verification of conformities, materials and colors used is of course also offered.
Silicone rubber used by Siltec
To produce our components, we process silicone rubber which contains polysiloxanes or siloxanes.
According to the components of the silicone rubber mixture different silicones can be produced, among them:
- VMQ (Vinyl-Methyl-Silicone)
- FVMQ (fluorosilicone)
- PVMQ (phenyl silicone)
The silicones occur in different forms:
- Liquid silicones
- LSR (liquid silicone rubber)
- RTV (room temperature vulcanizing)
- RTV1
- RTV2, e.g. silicone gel
- Solid silicones
- HCR (high consistency rubber)
Siltec silicone components can be cross-linked or catalysed in various ways depending on the customer’s requirements and the conformity to be fulfilled:
- Peroxide cross-linked
- Platinum catalysed
- Additions cross-linked
- Acetic acid cross-linked
Silicone rubber can also be enriched to have the following properties, among others:
- Thermal conductivity
- Electrical conductivity
- Detectability
- Magnetizability
- X-ray contrasting
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Color options for silicone components
Colors of silicone components play an important role in many fields of application, e.g. black coated tubes for light-sensitive drugs are used in medical technology or blue tubes for a better detectability in the food industry.
In addition to transparent and translucent versions, Siltec silicone components are also available in various standard colors (e.g. black, white, blue, green, red, yellow, brown) and many other color variants. The colors can be specified in RAL, NCS or Pantone.
On request, color adaptations and color developments are also possible as well as highly transparent silicones, which are mainly used as optical silicones.
Silicone products with FDA registration
Siltec production meets important standards required for the manufacture of medical devices. For many years, the company has complied with the ISO 13485 standard, providing quality management for the production of silicone parts for medical technology. In addition, Siltec can – by agreement – register as a contract manufacturer of a medical device with the U.S. Food and Drug Administration – the FDA. This allows Siltec to manufacture silicone medical tubes, silicone molded parts, or silicone seals for medical device companies who wish to distribute these silicone products in the United States.
Legal standards and conformities for silicone components of Siltec
Depending on your requirements and fields of application, we offer an almost endless list of different standards and conformities:
Medical technology
- ISO 10993
- FDA 21 CFR 820
- USP Class VI
- EP 3.1.9
- FDA §177.2600
Transportation
- DIN EN 45545-2
- UL94 standard e.g. UL94 V0, HB or V1
- 14 CFR/CS 25.853 (a), Appendix F, Part I (a) (1) (ii)
- 14 CFS/CS 25.853 (d), Appendix F, Part V
- AITM 3.0005
- UNECE R-107
- DIN 5510
Food industry
- FDA §177.2600
- BfR XV
- EU Regulation No. 1935/2004 and No. 10/2011
- Proposition 65 (OEHHA)
- KTW
- WRAS
- W270
Construction industry
- DIN 4102
- UL94 standard e.g. UL94 V0, HB or V1
- EN 45545
Industry
- DIN EN 45545-2
- UL94 standard e.g. UL94 V0, HB or V1
General standards and certifications
- Regulation (EC) 1935/2004
- Regulation (EC) 2023/2006
- ISO 9001:2015
- ISO 13485:2016
- REACH
- RoHS
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Material properties of Siltec’s silicone components
Upon request, our silicone components can have the following material properties: