{"id":59091,"date":"2024-10-17T10:58:55","date_gmt":"2024-10-17T10:58:55","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/astm-f2038-2011\/"},"modified":"2024-10-24T17:37:27","modified_gmt":"2024-10-24T17:37:27","slug":"astm-f2038-2011","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/astm\/astm-f2038-2011\/","title":{"rendered":"ASTM-F2038 2011"},"content":{"rendered":"

ASTM F2038-00-Reapproved2011<\/h3>\n

Historical Standard: Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I\u2014Formulations and Uncured Materials<\/h4>\n
\n

ASTM F2038<\/h4>\n

Scope<\/strong><\/p>\n

1.1 This guide is intended to educate potential users of silicone elastomers, gels, and foams relative to their formulation and use. It does not provide information relative to silicone powders, fluids, and other silicones. The information provided is offered to guide users in the selection of appropriate materials, after consideration of the chemical, physical, and toxicological properties of individual ingredients or by-products. This guide offers general information about silicone materials typically used for medical applications. Detail on the crosslinking and fabrication of silicone materials is found in Part II of this guide.<\/p>\n

1.2 Fabrication and properties of elastomers is covered in the companion document, F604, Part II. This monograph addresses only components of uncured elastomers, gels, and foams.<\/p>\n

1.3 Silicone biocompatibility issues can be addressed at several levels, but ultimately the device manufacturer must assess biological suitability relative to intended use.<\/p>\n

1.4 Biological and physical properties tend to be more reproducible when materials are manufactured in accordance with accepted quality standards such as ANSI ISO 9001 and current FDA Quality System Regulations\/Good Manufacturing Practice Regulations.<\/p>\n

1.5 The values stated in inch-pound units are to be regarded as standard. The values given in parentheses are mathematical conversions to SI units that are provided for information only and are not considered standard.<\/p>\n

1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. Users are also advised to refer to Material Safety Data Sheets provided with uncured silicone components.<\/span><\/span><\/p>\n

Keywords<\/strong><\/p>\n

elastomer; foam; gel; HCR; high consistency rubber; liquid silicone rubber; LSR; moisture cure; medical device material; peroxide cure; platinum cure; RTV; Medical materials\/applications–specifications; Orthopaedic medical devices–specifications; Silicone surgical implant materials; Surgical implants–specifications; Uncured elastomeric materials<\/p>\n

ICS Code<\/strong><\/p>\n

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)<\/p>\n

DOI:<\/strong> 10.1520\/F2038-00R11<\/p>\n<\/div>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nScope
Referenced Documents
Terminology <\/td>\n<\/tr>\n
3<\/td>\nSignificance and Use
Formulation
FIG. 1
FIG. 2 <\/td>\n<\/tr>\n
4<\/td>\nPackaging, Labeling, and Storage
Health and Safety
Sterilization
Quality Control Provisions <\/td>\n<\/tr>\n
5<\/td>\nKeywords
X1. RATIONALE
X1.1
X1.2 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

F2038-00(2011) Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I\u00e2\u20ac\u201dFormulations and Uncured Materials<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
ASTM<\/b><\/a><\/td>\n2011<\/td>\n5<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":59092,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2637],"product_tag":[],"class_list":{"0":"post-59091","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-40","7":"product_cat-astm","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/59091","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/59092"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=59091"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=59091"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=59091"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}