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ASTM F2042-00(2011)
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
STANDARD published on 1.12.2011
The information about the standard:
Designation standards: ASTM F2042-00(2011)
Note: WITHDRAWN
Publication date standards: 1.12.2011
SKU: NS-52561
The number of pages: 7
Approximate weight : 21 g (0.05 lbs)
Country: American technical standard
Category: Technical standards ASTM
The category - similar standards:
Annotation of standard text ASTM F2042-00(2011) :
Keywords:
foam, gel, high consistency rubber, liquid silicone rubber, medical device material, moisture cure, peroxide cure, platinum cure, RTV, Gel foam, High-consistency rubber, Crosslinking, Liquid silicone rubber, Moisture cure, Peroxide cure, Platinum cure, Silicone surgical implant materials, Surgical implants--specifications, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
Additional information
| Significance and Use | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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This guide is intended to provide guidance for the specification and selection of fabrication methods for silicones used in medical devices. It also provides guidance relative to testing that might be done to qualify lots of acceptable material, based on desired performance properties. Silicone manufacturers supplying material to the medical device industry should readily provide information regarding non-proprietary product formulation to their customers either directly or through the US FDA Master File program. |
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| 1. Scope | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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1.1 This guide is intended to educate potential users of silicone elastomers, gels and foams relative to their fabrication and processing. It does not provide information relative to silicone powders, fluids, pressure sensitive adhesives, or other types of silicone products. 1.2 The information provided is offered to guide users in the selection of appropriate processing conditions for specific medical device applications. 1.3 Formulation and selection of appropriate starting materials is covered in the companion document, F2038 Part I. This monograph addresses only the curing, post-curing, and processing of elastomers, gels and foams as well as how the resulting product is evaluated. 1.4 Silicone biocompatibility issues can be addressed at several levels, but ultimately the device manufacturer must assess biological suitability relative to intended use. Biocompatibility testing may be done on cured elastomers prior to final fabrication, but the most relevant data are those obtained on the finished device. Data on selected lots of material are only representative when compounding, and fabrication are performed under accepted quality systems such as ISO 9001 and current Good Manufacturing Practice Regulations. Extractables analyses may also be of interest for investigation of biocompatibility, and the procedures for obtaining such data depend on the goal of the study (see F619, the HIMA Memorandum 7/14/93, and USP 23, for examples of extraction methods). |
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| 2. Referenced Documents | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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