{"id":58576,"date":"2024-10-17T10:50:29","date_gmt":"2024-10-17T10:50:29","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/astm-f1635-2\/"},"modified":"2024-10-24T17:33:38","modified_gmt":"2024-10-24T17:33:38","slug":"astm-f1635-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/astm\/astm-f1635-2\/","title":{"rendered":"ASTM-F1635"},"content":{"rendered":"

ASTM F1635-11<\/h3>\n

Historical Standard: Standard Test Method for in vitro<\/i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants<\/h4>\n
\n

ASTM F1635<\/h4>\n

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

1.1 This test method covers in vitro<\/span> degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.<\/p>\n

1.2 The requirements of this test method apply to HDPs in various forms:<\/p>\n

1.2.1 Virgin polymer resins, or<\/p>\n

1.2.2 Any form fabricated from virgin polymer such as a semi-finished component of a finished product, a finished product, which may include packaged and sterilized implants, or a specially fabricated test specimen.<\/p>\n

1.3 This test method provides guidance for mechanical loading or fluid flow, or both, when relevant to the device being evaluated. The specifics of loading type, magnitude, and frequency for a given application are beyond the scope of this test method.<\/p>\n

1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.<\/p>\n

1.5 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.<\/span><\/p>\n

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

absorbable; bioabsorbable; degradation; in vitro<\/span>; hydrolytically degradable polymer; hydrolysis; PLA, poly(l<\/span>-lactic acid); poly(d<\/span>-lactide); poly(d,l<\/span>-lactide); PGA, poly(glycolide); poly(caprolactone); poly(p<\/span>-dioxanone); surgical implant; in vitro<\/i> Evaluation; Biodegradation; Degradation–surgical devices\/applications; PLLA (poly(L-lactic acid)) resin; Polymers (surgical applications); Surgical implant resins; Surgical implants; Testing methods–surgical implants<\/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\/F1635-11<\/p>\n<\/div>\n

PDF Catalog<\/h4>\n\n\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
2<\/td>\nSummary of Test Method
Significance and Use <\/td>\n<\/tr>\n
3<\/td>\nMaterials and Apparatus
Sampling
Sample and Test Specimen
Procedure <\/td>\n<\/tr>\n
4<\/td>\nTest Termination
Report <\/td>\n<\/tr>\n
5<\/td>\nPrecision
Keywords
X1. RATIONALE
X1.1
X1.2
X1.3
X1.4
X1.5 <\/td>\n<\/tr>\n
6<\/td>\nX1.6
X1.7
X1.8
X1.9
X1.10
X2. TERMINOLOGY
X2.1
X2.2 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

F1635-11 Standard Test Method for in vitro<\/i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants<\/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>\n7<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":58577,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2637],"product_tag":[],"class_list":{"0":"post-58576","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\/58576","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\/58577"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=58576"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=58576"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=58576"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}