ASTM F 2051 : 2000 : R2006
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Specification for Implantable Saline Filled Breast Prosthesis
Hardcopy , PDF
11-11-2014
English
01-09-2006
Important note : All end users must be registered with an Account prior to user licenses being assigned.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.
| Committee |
F 04
|
| DocumentType |
Standard
|
| Pages |
6
|
| ProductNote |
Reconfirmed 2006
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
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 F 703.
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.
| ASTM F 1441 : 2003 : R2014 | Standard Specification for Soft-Tissue Expander Devices |
| ASTM F 703 : 2018 | Standard Specification for Implantable Breast Prostheses |
| 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) |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.