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Standard Specification for Implantable Breast Prostheses
Přeložit název
NORMA vydána dne 1.2.2018
Označení normy: ASTM F703-18
Poznámka: NEPLATNÁ
Datum vydání normy: 1.2.2018
Kód zboží: NS-809959
Počet stran: 10
Přibližná hmotnost: 30 g (0.07 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
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, prosthetics and orthotics)
1. Scope | ||||||||||||||||
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 F2051. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 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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2. Referenced Documents | ||||||||||||||||
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