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YY/T 1286.1-2015Platelets storage container performances - Part 1: Determination of gas permeability of the film—Differential-pressure method (English PDF)

血小板贮存袋性能 第1部分:膜材透气性能测定 压差法

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 2, 2015

Implementation date

January 1, 2016

Scope

YY/T 1286.1-2015 is the English-translated version of 血小板贮存袋性能 第1部分:膜材透气性能测定 压差法.

YY/T 1286.1-2015 is the Chinese pharmaceutical industry standard that gives the differential-pressure method for determining the gas permeability of the film of a platelet storage container, the property on which the survival of the stored platelets depends.

It is the first part of the YY/T 1286 series and sets out the specimen and its mounting, the pressure difference applied across it, the measurement of the gas that passes and the calculation and reporting of the permeability. Issued on 2 March 2015, it has applied since 1 January 2016.

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Document preview — YY/T 1286.1-2015

National Standard of the People's Republic of China

ICS
11.040.20
Classification
C 31

Issued by: National Medical Products Administration of the People's Republic of China

Contents

  • Foreword
  • 1 Scope
  • 2 Terms and definitions
  • 4 Sample
  • 5 Apparatus and materials

Foreword

YY/T 1286 "platelet storage bag performance" sub-section intended publication, currently plans to release the following components.

--- Part 1. membrane permeability measured differential pressure method;

--- Part 2. Evaluation of platelet storage guidelines. This section YY/T 1286 Part 1. This section drafted in accordance with GB/T 1.1-2009 given rules.

This portion of the reference ISO 15105-1:2007 "plastic film and sheet determination of gas transmission rate - Part 1. differential pressure method" to develop consistency Not equivalent.

1 Scope

YY/T 1286 provisions of this part of the measurement of platelet membrane gas storage bag in a certain amount of pressure difference through the way.

2 Terms and definitions

The following terms and definitions apply to this document.

2.1 Gas transmission rate gaspermeance

Partial pressure of the material on both sides of the unit, the amount of gas per unit time through unit area of the plastic material.

Note 1. The oxygen gas is used, the value obtained is the oxygen transmission rate (PO2).

Note 2. The amount of gas is through international units per square meter second molar pascal [mol/(m2 · s · Pa)]. In a standard atmospheric pressure, usually cc 24 hours per square meter standard atmospheric pressure [cm3/(m2 · 24h · atm)] as a unit. Conversions between them as follows.

1mol/(m2 · s · Pa) = 1.9621 × 10-16cm³/(m2 · d · atm).

Although the amount of gas through the unit in a standard atmospheric pressure (atm) is not SI units, but most reflect the actual sample at atmospheric pressure ventilation situation. Some test instrument used to 0.1MPa (1bar) approximation instead of a atmospheric pressure (1atm = 101325Pa) units. cubic centimeters per M² day 0.1 MPa [cm3/(m2 · d · 0.1MPa)]. Conversions between different units as follows.

1cm³/(m2 · 24h · atm) = 0.9869cm³/(m2 · d · 0.1MPa) = 0.9869cm³/(m2 · d · bar) = 9.869 x 10^-6cm³ / (M2 · d · Pa).

Principle 3 The gas sample is placed in the test chamber (see Fig. 1), so that the gas between the upper and lower chambers (high-pressure chamber and the low pressure chamber) is formed by A sealed barrier. On the low-pressure chamber is evacuated, and then the high pressure chamber immediately evacuated. Test gas is introduced into the evacuated high-pressure chamber, and through Sample enters the low pressure chamber. By measuring the low pressure chamber of the pressure increment measured by the amount of the test gas sample.

4 Sample

4.1 Sample Preparation

On the platelet storage bag and cut the appropriate sample size. Note that clipping the sample area can not be wrinkled, folded, or pinholes, and blood Small board storage bag without labeling area. It should be larger than the area of the test chamber through the gas area.

4.2 Number of specimens

Unless otherwise specified or determined by the interests of stakeholders consultation carried out three test specimens.

5 Apparatus and materials

5.1 Overview

Figure 1 shows an example of determination of the amount of gas permeation instrument of pressure sensors. The instrument is designed for the sample gas through the gas-permeable

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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