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Standard Specification for Polyethylene Plastics for Medical Applications
ASTM F639-09
Organization:
ASTM - ASTM International
Year: 2024
Abstract: X1.2 Significance X1.2.1 Concentrations of trace metals are measured as extracts in simulated body fluids. The metal’s concentration in extracts is based on the surface area of the plastic extracted from which the total amount of metal deliverable to the patient may be estimated.
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Standard Specification for Polyethylene Plastics for Medical Applications
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| contributor author | ASTM - ASTM International | |
| date accessioned | 2024-12-17T23:29:05Z | |
| date available | 2024-12-17T23:29:05Z | |
| date copyright | 2024 | |
| date issued | 2024 | |
| identifier other | F0639-09r24.pdf | |
| identifier uri | http://yse.yabesh.ir/std;query=author:%22NAVY%20-%20YD%20-%20Naval%20Facilities%20Engineering%20Command%22/handle/yse/337868 | |
| description abstract | X1.2 Significance X1.2.1 Concentrations of trace metals are measured as extracts in simulated body fluids. The metal’s concentration in extracts is based on the surface area of the plastic extracted from which the total amount of metal deliverable to the patient may be estimated. | |
| language | English | |
| title | Standard Specification for Polyethylene Plastics for Medical Applications | en |
| title | ASTM F639-09 | num |
| type | standard | |
| page | 4 | |
| status | Active | |
| tree | ASTM - ASTM International:;2024 | |
| contenttype | fulltext | |
| scope | 1.1 This specification covers polyethylene plastics (as defined in Terminology D883) intended for use in medical device applications involving human tissue contact devices, short-term indwellings of 30 days or less, and fluid transfer devices. The biocompatibility of these materials as a class has not been established. Biocompatibility tests must be conducted on the final product. 1.2 This specification is not applicable to ultra-high molecular weight polyethylene (UHMWPE) plastics, such as those used in joint implants, and so forth. 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 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. | |
| identifier DOI | 10.1520/F0639-09R24 |