ASTM F997 - 18 - Standard Specification for Polycarbonate Resin for Medical Applications

ASTM F997 - 18

Standard Specification for Polycarbonate Resin for Medical Applications

Status : Current   Published : December 2018

Format
PDF

Format
HARDCOPY



1.1 This specification covers polycarbonate resin and provides requirements and associated test methods for this thermoplastic when it is to be used in the manufacture of medical devices or components of medical devices.

1.2 As with any material, some characteristics may be altered by the processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using those test methods that are appropriate to assure safety and efficacy.

1.3 The properties included in this specification are those applicable for polycarbonate only. The biocompatibility of plastic compounds made up of polycarbonate resin containing colorants, fillers, processing aids, or other additives, as well as polymer blends which contain polycarbonate, should not be assumed. The biocompatibility of these modified polycarbonates must be established by testing the final (end-use) compositions using the appropriate methods of evaluation. In addition, the biocompatibility of the material depends to a large degree on the nature of the end-use application. It is, therefore, necessary to specify a set of biocompatibility test methods for each new and distinct application.

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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.

1.5  This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.




Standard NumberASTM F997 - 18
TitleStandard Specification for Polycarbonate Resin for Medical Applications
StatusCurrent
Publication Date01 December 2018
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors plastics (thermoplastic), plastic surgical devices/applications, polycarbonate (PC) plastics, polymers-surgical applications, resins-polycarbonate, seals
ICS11.100.99
83.080.20
PublisherASTM
FormatA4
DeliveryYes
Pages3
File Size70 KB
Price£36.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


BSOL

The faster, easier way to work with standards


Develop a PAS

Develop a fast-track standardization document in 9-12 months


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version