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ASTM F2042-00
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II - Crosslinking and Fabrication
Automaticky preložený názov:
Štandardné Sprievodca pre silikónové elastoméry , gély a Peny použité v lekárskej aplikácie Časť II - sieťovanie Fabrication
NORMA vydaná dňa 10.7.2000
Informácie o norme:
Označenie normy: ASTM F2042-00
Poznámka: NEPLATNÁ
Dátum vydania normy: 10.7.2000
Kód tovaru: NS-52562
Počet strán: 7
Približná hmotnosť: 21 g (0.05 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Anotácia textu normy ASTM F2042-00 :
Keywords:
foam, gel, high consistency rubber, liquid silicone rubber, medical device material, moisture cure, peroxide cure, platinum cure, RTV
Doplňujúce informácie
| 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, F 2038 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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