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Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
Automatische name übersetzung:
Standard-Handbuch für Biokompatibilität Bewertung der Medical Device Verpackungsmaterialien
NORM herausgegeben am 1.4.2011
Bezeichnung normen: ASTM F2475-11
Anmerkung: UNGÜLTIG
Ausgabedatum normen: 1.4.2011
SKU: NS-53958
Zahl der Seiten: 4
Gewicht ca.: 12 g (0.03 Pfund)
Land: Amerikanische technische Norm
Kategorie: Technische Normen ASTM
Other standards related to pharmaceuticsPackaging and distribution of goods in general
Keywords:
biocompatibility, cytotoxicity, medical device, medical device packaging, toxicity, Biocompatibility, Cytotoxicity, Medical devices/equipment, Medical/surgical packaging materials, Toxicity/toxicology, ICS Number Code 11.120.99 (Other standards related to pharmaceutics), 55.020 (Packaging and distibution of goods in general)
Significance and Use | ||
The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around or on the human body, these devices must do no harm. Therefore, the packaging materials that come in contact with the medical device must also be evaluated and determined to be safe for use with the human body in that they have no negative impact on the physical, chemical or biological properties of the device. . This evaluation may include both a study of relevant experience with and actual testing of packaging materials. Such an evaluation may result in the conclusion that no testing is needed if the material has a demonstrable history of safe use in the specific role that is the same as that of the package under design. The medical device manufacturer determines the need for appropriate testing, with consideration of the device/package interactions, if any. The responsibility of the packaging supplier is typically limited to the performance of cytotoxicity testing. |
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1. Scope | ||
1.1 This guide provides information to determine the appropriate testing for biocompatibility of materials (or packaging materials) in sterile barrier systems used to contain a medical device. 1.2 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 to determine the applicability of regulatory limitations prior to use. |
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2. Referenced Documents | ||
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1.11.2013
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1.2.2013
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1.10.2011
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1.10.2008
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