ASTM-F703 Standard Specification for Implantable Breast Prostheses

ASTM-F703 - 2018 R22 EDITION - CURRENT
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Standard Specification for Implantable Breast Prostheses
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Scope

1.1 This specification covers the requirements for silicone gel filled, saline inflatable silicone gel filled, and saline inflatable, smooth shell 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 pprostheses.

1.3 The values stated in SI units are to be regarded as the standard. The inch-pound units given in parentheses are for information only.

1.4 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.

Keywords

breast prostheses; implantable breast prostheses

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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Document Number

ASTM-F0703-18R22

Revision Level

2018 R22 EDITION

Status

Current

Modification Type

Revision

Publication Date

Oct. 11, 2022

Document Type

Specification

Page Count

10 pages

Committee Number

F04.32