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Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
Automaticky preložený názov:
Štandardné Sprievodca pre biokompatibilitou hodnotenia zdravotníckej pomôcky obalových materiálov
NORMA vydaná dňa 1.4.2011
Označenie normy: ASTM F2475-11
Poznámka: NEPLATNÁ
Dátum vydania normy: 1.4.2011
Kód tovaru: NS-53958
Počet strán: 4
Približná hmotnosť: 12 g (0.03 libier)
Krajina: Americká technická norma
Kategória: Technické normy ASTM
Ostatní normy týkající se farmacie
Balení a distribuce zboží všeobecně
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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