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ASTM F703-07
Standard Specification for Implantable Breast Prostheses (Withdrawn 2016)
Automaticky preložený názov:
Štandardné špecifikácie pre implantovateľných Protézy mliečne železami
NORMA vydaná dňa 1.4.2007
Informácie o norme:
Označenie normy: ASTM F703-07
Poznámka: NEPLATNÁ
Dátum vydania normy: 1.4.2007
Kód tovaru: NS-56172
Počet strán: 10
Približná hmotnosť: 30 g (0.07 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Anotácia textu normy ASTM F703-07 :
Keywords:
breast prosthesis, gel-saline prosthesis, implant, saline inflatable prosthesis, silicone elastomer, silicone gel prosthesis, soft tissue implant, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
Doplňujúce informácie
| 1. Scope | ||||||||||||||||
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1.1 This specification covers the requirements for silicone gel-filled and saline-inflatable silicone gel-filled implantable breast prostheses intended for use in surgical reconstruction, augmentation, or replacement of the breast. 1.2 Limitations—This specification does not cover custom fabricated implantable breast prostheses. 1.3 Single-use saline-inflatable, smooth, and textured silicone shell implantable breast prostheses are addressed in Specification F 2051. 1.4 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only. 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. |
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| 2. Referenced Documents | ||||||||||||||||
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