• 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.
Dismiss alert

ASTM F 881 : 1994 : 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Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 Silicone Elastomer Facial Implants
Available format(s)

Hardcopy , PDF

Superseded date

14-10-2022

Language(s)

English

Published date

27-11-2014

CONTAINED IN VOL. 13.01, 2015 Defines the requirements for silicone elastomer implants used in facial surgery (that is, chin, nasal, malar, and ear implants).

1.1This specification covers the requirements for silicone elastomer implants used in facial surgery (that is, chin, nasal, malar, and ear implants).

1.2Limitations—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.

1.3The 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.

Committee
F 04
DocumentType
Standard
Pages
3
ProductNote
Reconfirmed 2014
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM F 1251 : 1989 : R1995 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices
ASTM D 2240 : 2000 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 2240 : 2004 Standard Test Method for Rubber Property—Durometer Hardness
CFR 21(PTS800-1299) : 0 FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299
ASTM D 412 : 2016 : EDT 1 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D 2240 : 2004 : EDT 1 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 412 : 2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D 2240 : 2015 : R2021 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 2240 : 2002 Standard Test Method for Rubber Property—Durometer Hardness
ASTM F 748 : 2016 : REDLINE Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
ASTM D 2240 : 2015 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 2240 : 2003 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 2240 : 2002 : REV B Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 2240 : 2015 : EDT 1 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 412 : 2016 : R2021 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
ASTM D 2240 : 2005 Standard Test Method for Rubber Property—Durometer Hardness
ASTM D 2240 : 2005 : R2010 Standard Test Method for Rubber Property—Durometer Hardness
ASTM F 604 : 1994 Specification for Silicone Elastomers Used in Medical Applications (Withdrawn 2001)
ASTM D 2240 : 2002 : REV A Standard Test Method for Rubber Property—Durometer Hardness
ASTM F 1251 : 1989 : R2003 Standard Terminology Relating to Polymeric Biomaterials in Medical and Surgical Devices (Withdrawn 2012)

View more information
£55.10
Excluding VAT

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.