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ASTM F2051-00(2022)
Standard Specification for Implantable Saline-Filled Breast Prostheses
Name übersetzen
NORM herausgegeben am 1.10.2022
Informationen über die Norm:
Bezeichnung normen: ASTM F2051-00(2022)
Ausgabedatum normen: 1.10.2022
SKU: NS-1086619
Zahl der Seiten: 6
Gewicht ca.: 18 g (0.04 Pfund)
Land: Amerikanische technische Norm
Kategorie: Technische Normen ASTM
Kategorie - ähnliche Normen:
Die Annotation des Normtextes ASTM F2051-00(2022) :
This specification covers the requirements for single use saline inflatable, smooth and textured silicone shell implantable breast prostheses, intended for use in surgical reconstruction, augmentation, or replacement of the breast. This specification does not cover custom fabricated implantable breast prostheses and other gel-saline type implants. The silicone elastomer compositions for use as primary material of construction of the shell including the exterior (tissue contact) surface shall include: (1) polymer types MQ or VMQ, (2) fillers A, B, or C, (3) additive J (for radiopacity), and (4) catalysts B, G, J, or K. The requirements for the following are specified: (1) fabrication including vulcanization and postcure, (2) volume and dimension of saline filled prostheses, (3) fixation sites, and (4) orientation means. The following tests shall be performed: (1) physical property tests such as shell leakage and tension tests (2) biocompatibility test, (3) shell rupture or failure test, (4) valve competence, and (5) abrasion test. The physical property requirements are specified for (1) shell percent elongation, breaking strength, and tensile set, and (2) critical and non-critical fused or adhered joints. Illustrations for testing fused or adhered joints are provided. Requirements for sterilization, packaging, labeling, and package inserts are detailed as well.
Keywords:
breast prosthesis, gel saline prosthesis, implant, saline inflatable prosthesis, silicone elastomer, soft tissue implant,, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
Ergänzende Informationen
| 1. Scope | ||||||||||||||
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1.1?This specification covers the requirements for single-use, saline inflatable, smooth and textured silicone shell implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast. 1.2?Limitations:? 1.2.1?This specification does not cover custom fabricated implantable breast prostheses. 1.2.2?This specification does not cover gel/saline type implants, which are within the scope of Specification F703. 1.3?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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.4?This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. |
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