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Plastic and Reconstructive Surgery

ASTM is one of the leading standards developers for medical devices. With 24 categories, addressing everything from surgical implements to automated analysis, ASTM medical device standards cover a truly wide range. With how much research and training goes into the medical industry, standardization plays a key role in productively actualizing that effort. Organized below for your convenience by usage, industry, and theme are over 300 standards. This list includes standards related to Plastic and Reconstructive Surgery.

ASTM F881-94(2014)

Standard Specification for Silicone Elastomer Facial Implants

1.1 This specification covers the requirements for silicone elastomer implants used in facial surgery (that is, chin, nasal, malar, and ear implants). 1.2 Limitations This specification does not cover implants containing silicone gels or other gels or liquids. It does not necessarily cover any custom-fabricated prosthesis manufactured to any other specification. 1.3 The following safety hazards caveat pertains only to the mechanical testing and test methods portion, Section 7 , of this specification: 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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ASTM F1441-03(2014)

Standard Specification for Soft-Tissue Expander Devices

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. 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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ASTM F2051-00(2014)

Standard Specification for Implantable Saline Filled Breast Prosthesis

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 and health practices and determine the applicability of regulatory limitations prior to use.

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