Standard Specification for Implantable Saline-Filled Breast Prostheses
NORMA vydána dne 1.12.2025
Proč Redline?
Redline představuje rychlý a snadný způsob jak porovnat všechny změny mezi aktuální platnou normou a předchozí verzí.
Díky redline se okamžitě dozvíte o:
Ušetřete si čas i starosti!
Díky Redline již nebudete muset ztrácet čas zjišťováním, co se v nové normě změnilo. Redline Vám ušetří čas a zaručí, že se o změnách v normě dozvíte.
Cena
Pokud si zvolíte možnost "Platná norma + Redline", pak dostanete oba dokumenty! A co je nejlepší, cena Platné normy + Redline je pouze o něco málo vyšší než cena samostatné platné normy.
Designation standards: ASTM F2051-25
Publication date standards: 1.12.2025
The number of pages: 7
Approximate weight : 21 g (0.05 lbs)
Country: American technical standard
Kategorie: Technické normy ASTM
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)