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Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
Automaticky přeložený název:
Standardní zkušební metoda pro stanovení neporušenosti pečetí pro balení léků vizuálním
NORMA vydána dne 10.7.1998
Označení normy: ASTM F1886-98
Poznámka: NEPLATNÁ
Datum vydání normy: 10.7.1998
Kód zboží: NS-51956
Počet stran: 4
Přibližná hmotnost: 12 g (0.03 liber)
Země: Americká technická norma
Kategorie: Technické normy ASTM
Keywords:
channels, medical packaging, minimum seal width, spotty seals, sterile package integrity, visual seal inspection, ICS Number Code 55.040 (Packaging materials and accessories)
1. Scope | ||
1.1 this test method covers the determination of channels in the package seal down to a width of 75 um (0.003 in.) with a 60-100% probability (see Section 8). 1.1.1 The ability to visually detect channel defects in package seals is highly dependent on the size of channel, the degree of contrast from sealed and unsealed areas, the amount and type of adhesive between the two package layers, reflecting light angle, types of material used, the use of magnification, an the inspector's level of training and experience. 1.2 This test method is applicable to flexible and rigid packages with at least one transparent side so that the seal area may be clearly viewed. 1.3 The values states in SI units are to be regarded as the standard. The values given in parentheses are for information only. 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 and health practices and determine the applicability of regulatory limitations prior to use. |
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2. Referenced Documents | ||
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