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ASTM F1441-03(2014)
Standard Specification for Soft-Tissue Expander Devices
Automaticky preložený názov:
Štandard Specification mäkké tkanivá Expander zariadenia
NORMA vydaná dňa 1.10.2014
Informácie o norme:
Označenie normy: ASTM F1441-03(2014)
Poznámka: NEPLATNÁ
Dátum vydania normy: 1.10.2014
Kód tovaru: NS-50305
Počet strán: 5
Približná hmotnosť: 15 g (0.03 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Kategórie - podobné normy:
Anotácia textu normy ASTM F1441-03(2014) :
Keywords:
elastomer, expander, implant, implant material, medical device, plastic surgery, soft tissue expander,, ICS Number Code 85.100 (Equipment for the paper industry)
Doplňujúce informácie
| Significance and Use | ||||||||||||||||||
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5.1 This specification contains requirements based on state-of-art science and technology as applicable to various considerations that have been identified as important to ensure reasonable safety and efficacy as it relates to the biocompatibility and the mechanical integrity of the device components in soft tissue expander devices. 5.1.1 This specification is not intended to limit the science and technology that may be considered and applied to ensure performance characteristics of subject device in intended applications. When new information becomes available or changes in state-of-art science and technology occur and relevance to subject devices has been established by valid science, it is intended that this specification will be revised in accordance with ASTM guidelines. |
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| 1. Scope | ||||||||||||||||||
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1.1 This specification covers the requirements for single use saline inflatable, smooth and textured tissue expansion devices to be used intraoperatively or implanted for typically less than 6 months and then removed. 1.2 Limitations: 1.2.1 This specification applies only to soft-tissue expander devices fabricated with elastomer shells. It does not necessarily cover any custom fabricated soft tissue expander device manufactured to any other specification. 1.2.2 This specification applies, in part, to combination “expander/mammary” devices as classified in Section 4. 1.3 The values stated in SI units are to be regarded as standard, values in parentheses are for information only. 1.4 The following statement pertains only to the
test methods and requirements portion, Section 9, of this specification.
Standard Practice for Rubber´Standard
Conditions for Testing Standard Specification for Implantable
Breast Prostheses Standard Practice for Selecting Generic
Biological Test Methods for Materials and Devices Standard Terminology Relating to
Polymeric Biomaterials in Medical and Surgical Devices Standard Test Method for Tear Strength of
Conventional Vulcanized Rubber and Thermoplastic Elastomers Standard Guide for Silicone Elastomers,
Gels, and Foams Used in Medical Applications Part II´Crosslinking
and Fabrication Standard Specification for Implantable
Saline-Filled Breast Prostheses Standard Test Methods for Vulcanized
Rubber and Thermoplastic Elastomers—Tension Standard Guide for Silicone Elastomers,
Gels, and Foams Used in Medical Applications Part I´Formulations
and Uncured Materials |
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