Значење и употреба

6.1 This Test methodology was developed by research conducted by Air Dispersion Limited (Manchester, UK) and funded by the Barrier Test Consortium Limited. The results of the study have been published in a peer-reviewed journal. 4 The study shows that the use of microorganisms to test the barrier properties of porous packaging materials is related to measuring the filtration efficiency of the materials.

6.2 This test method does not require the use of microbial methods; Додатно, test methods can be performed quickly and in a timely manner.

6.3 When measuring the filtration efficiency of porous packaging materials, a typical filtration efficiency curve is determined (види слику 1). Since the curvature of these curves depends on the properties of each material, the appropriate way to compare between materials is to use parameters that can measure the maximum permeability through the material.

Graph. 1 Typical curve shows the relationship between permeability and flow rate

A typical curve showing the relationship between permeability and flow rate

Белешка 1: The maximum penetration point is indicated by an upward triangle.

ASTM F2638-2018 Standard Test Method for Measuring the Performance of Porous Packaging Materials as Alternative Microbial Barriers Using Aerosol Filtration

6.4 Particle filtration is a quantitative procedure used to determine the microbial barrier properties of a material by challenging 1.0 µm particles over a differential pressure range from zero to approximately 30 cm water column (WC) (2942 Па). The test method is based on Tallentire and Sinclair 4’s research and uses physical test methods to quickly determine microbial barrier performance.

Корак 1: Обим

1.1 This test method measures the aerosol filtration performance of porous packaging materials by creating a defined 1.0μm particle aerosol and evaluating the filtration efficiency of the material using a single particle counter or a double particle counter.

1.2 This test method is applicable to porous materials used for packaging final sterilized medical devices.

1.3 The purpose of the test instrument is to determine the flow rate of the material through the maximum permeability.

1.4 Вредности изражене у СИ јединицама сматрају се стандардним. Вредности дате у заградама су само за референцу.

1.5 Овај стандард нема за циљ да одговори на све безбедносне проблеме повезане са његовом употребом. Одговорност корисника овог стандарда је да успоставе одговарајућу безбедност, здравствене и еколошке спецификације и да се утврди применљивост регулаторних ограничења пре употребе.

1.6 Овај међународни стандард је заснован на међународно признатим принципима стандардизације утврђеним Одлуком о принципима за израду међународних стандарда, Смернице и препоруке које је издала СТО Техничке баријере у трговини (ТБТ) Комитет.

ASTM F2638-2018 Standard Test Method for Measuring the Performance of Porous Packaging Materials as Alternative Microbial Barriers Using Aerosol Filtration

2. Погледајте фајл

АСТМ стандард

E171 / E171M Practices for regulating and testing flexible barrier packaging

Е177 Пракса коришћења термина тачност и одступање у АСТМ методама испитивања

Е691 Пракса спровођења међулабораторијских студија ради утврђивања тачности метода испитивања