Name: ASTM F 2051 : 2000
Brand: ASTM
Price: 122.77 AUD

ASTM F 2051 : 2000

Superseded

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Standard Specification for Implantable Saline Filled Breast Prosthesis

Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

10-07-2000

Publisher

American Society for Testing and Materials

CONTAINED IN VOL. 13.01, 2015 Defines 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.

1.1 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 F703 (Standard Specification for Implantable Breast Prostheses).

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.

Committee	F 04
DocumentType	Standard
Pages	6
ProductNote	Reconfirmed 2000
PublisherName	American Society for Testing and Materials
Status	Superseded
SupersededBy	ASTM F 2051 : 2000 : R2006

ASTM G 195 : 2018	Standard Guide for Conducting Wear Tests Using a Rotary Platform Abraser
ASTM F 703 : 2018	Standard Specification for Implantable Breast Prostheses
ASTM F 1441 : 2003 : R2014	Standard Specification for Soft-Tissue Expander Devices

AAMI ISO 11134 : 1ED 93	STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - INDUSTRIAL MOIST HEAT STERILIZATION
ANSI/AAMI/ISO 11135:2014	STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ASTM D 1349 : 2014 : REDLINE	Standard Practice for Rubber—Standard Conditions for Testing
ASTM D 3389 : 2016 : REDLINE	Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
ASTM F 748 : 2016 : REDLINE	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
AAMI ISO 11137 : 94 AMD 1 2002	STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION
ASTM F 604 : 1994	Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)

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ASTM F 2051 : 2000

Superseded

Abstract

Scope

General Product Information

Standards Referenced By This Book

Standards Referencing This Book

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