Customer Support: +44 (0)203 327 3140

Login to i2i Subscription Intertek.com
  • There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Go to AMERICAS site
Dismiss alert
Please enter a keyword to search
Advanced search

ASTM F 2051 : 2000 : R2014

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Specification for Implantable Saline Filled Breast Prosthesis
Available format(s)

Hardcopy , PDF

Superseded date

14-10-2022

Language(s)

English

Published date

27-11-2014

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.

1.1This 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.

1.2Limitations:

1.2.1This specification does not cover custom fabricated implantable breast prostheses.

1.2.2This specification does not cover gel/saline type implants, which are within the scope of Specification F703.

1.3This 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 2014
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

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
ASTM F 1441 : 2003 : R2022 Standard Specification for Soft-Tissue Expander Devices
ASTM F 703 : 2018 : R2022 Standard Specification for Implantable Breast Prostheses
ASTM G 195 : 2022 Standard Guide for Conducting Wear Tests Using a Rotary Platform Abraser

ASTM F 1251 : 1989 : R1995 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
AAMI ISO 11134 : 1ED 93 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - INDUSTRIAL MOIST HEAT STERILIZATION
ASTM D 1349 : 2014 : R2019 Standard Practice for Rubber—Standard Conditions for Testing
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 3389 : 2016 Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
ASTM D 3389 : 2021 Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
ASTM D 3389 : 2010 Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
ASTM D 3389 : 2005 Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
ASTM D 412 : 2016 : EDT 1 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D 1349 : 2014 : REDLINE Standard Practice for Rubber—Standard Conditions for Testing
ASTM D 412 : 2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D 1349 : 1999 Standard Practice for Rubber-Standard Temperatures For Testing
ASTM D 3389 : 2015 Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
ASTM D 3389 : 2016 : REDLINE Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform Abrader)
ASTM D 1349 : 2009 Standard Practice for Rubber-Standard Temperatures for Testing
ASTM D 1349 : 2014 Standard Practice for Rubber—Standard Conditions for Testing
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
ASTM D 3389 : 1994 : R1999 Standard Test Method for Coated Fabrics Abrasion Resistance (Rotary Platform, Double-Head Abrader)
AAMI ISO 11137 : 94 AMD 1 2002 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION
ASTM D 412 : 2016 : R2021 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D 1349 : 2007 Standard Practice for Rubber-Standard Temperatures for Testing
ASTM F 604 : 1994 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
ASTM F 1251 : 1989 : R2003 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)

View more information
£62.61
Excluding VAT
GBP
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English
PDF - English
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50

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.

Learn more on subscription solutions

or

Get in touch with us