YY/T 0681.12-2022Test methods for sterile medical device package - Part 12: Flex durability of flexible barrier materials (English PDF)

Foreword

This document was drafted in accordance with the rules given in GB/T 1.1-2020 "Directives for standardization - Part 1: Rules for the structure and drafting of standardizing documents".

This document is Part 12 of YY/T 0681 "Test methods for sterile medical device package". The following parts of YY/T 0681 have been issued.

- Part 1: Test guide for accelerated aging;

- Part 2: Seal strength of flexible battier materials;

- Part 3: Internal pressurization failure resistance of unrestrained packages;

- Part 4: Detecting seal leaks in porous packages by dye penetration;

- Part 5: Detecting gross leaks in medical packaging by internal pressurization (bubble test);

- Part 6: Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials;

- Part 7: Evaluating inks or coating adhesion to flexible packaging materials using tape;

- Part 8: Coating/adhesive weight determination;

- Part 9: Burst testing of flexible package seals using internal air pressurization weight restraining plates;

- Part 10: Test for microbial barrier ranking of porous package material;

- Part 11: Determining integrity of seals for medical packaging by visual inspection;

- Part 12: Flex durability of flexible barrier films;

- Part 13: Slow rate penetration resistance of flexible barrier films and laminates;

- Part 14: Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air;

- Part 15: Performance testing of shipping containers and systems;

- Part 16: Test for climatic stressing of packaging system;

- Part 17: Testing the microbial barrier performance of porous package materials using aerosol filtration method;

- Part 18: Nondestructive detection of leaks in packages by vacuum decay method.

This document replaces YY/T 0681.12-2014 "Test methods for sterile medical device package. Part 12: Flex durability of flexible barrier films". Compared with YY/T 0681.12-2014, in addition to the structural adjustments and editorial changes, the main technical changes in this document are as follows.

a) The scope of the standard is changed (see Chapter 1 of this Edition; Chapter 1 of Edition 2014);

b) "Terms and definitions" is added (see Chapter 3 of this Edition);

c) The description of evaluation methods for breathable materials such as paper and polyolefin nonwovens is added (see 4.2 of this Edition; 3.2 of Edition 2014);

d) Articles 4.1 and 4.5 of "Significance and application" are deleted (see 4.1 and 4.5 of Edition 2014);

e) The dimensional accuracy of "flexing tester" is added (see 6.1 of this Edition; 5.1 of Edition 2014);

f) "Determination of flexing test results" is added (see 9.3 of this Edition);

g) "Pinhole counting" is deleted (see 8.3 of Edition 2014);

h) The content of "Report" is modified (see Chapter 10 of this Edition; Chapter 9 of Edition 2014);

i) "Annex A Precision and bias" is deleted (Annex A of Edition 2014);

j) "Pinhole counting test" is added (see Annex A of this Edition);

k) "Gas and/or water vapor transmission rate test" is added (see Annex B of this Edition).

1 Scope

This document describes test methods for the flex durability of flexible barrier materials.

This document applies to the testing of the flex durability of flexible barrier materials.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

GB/T 2918, Plastics - Standard atmospheres for conditioning and testing

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

4 Overview of test methods

4.1 Unless otherwise specified, the flexing test is performed on specimens of flexible barrier materials under standard atmospheric conditions.

4.2 The degree of damage to the structural and/or mechanical properties of the material is judged by the flexing test. The properties to be evaluated in the flexing test determine the appropriate level of test conditions.

4.3 The various test conditions are summarized as follows.

5 Application

5.1 The various conditions described in this test are to prevent the occurrence of too many pinholes that are inconvenient to count and meaningless when testing a specimen structure, and the occurrence of too few pinholes is also meaningless. Generally, the number of pinholes on each sample shall be between 5~50.Material construction, purpose of the test, and agreement between interested parties are important factors to consider when selecting the level of test conditions.

5.2 This test method does not measure any part of wear associated with flux-to-break.

6 Test instruments

6.1 Flexing tester. is designed to be set up according to the specifications listed in Chapter 9: The instrument shall mainly consist of a (90±1)mm diameter fixed shaft and a (90±1)mm diameter moving shaft. When the moving shaft is at the initial position of the stroke (that is, the maximum distance), the two shafts face to face are separated by (180±2)mm. Both shafts shall have vents to protect the sample from pressure. The width

1) Test methods such as tensile strength and/or air permeability.

6.2 Flexible double-sided pressure-sensitive tapes. the width shall not exceed 13mm.

6.3 Templates. used for cutting samples of 200mmx280mm.

7 Specimen preparation

7.1 The samples are cut into sheets of 200mm x 280mm. The 200mm dimension is the test direction. This is also the direction of the flexing tester shaft.

7.2 Four samples are flexed in each of their machine direction and cross direction. In addition, four flexed samples are taken from positions adjacent to the samples in two directions as control samples.

8 Conditioning

According to the provisions of GB/T 2918, the sample shall be conditioned for at least 24h under the conditions that the relative humidity is (50±5)% and the temperature is (23±2)°C (unless otherwise specified between the supplier and the purchaser).

9 Procedures

10 Report

10.1 The sample conditioning and test environment used.

10.2 Sample specifications (thickness/gram weight), structure (if appropriate).

10.3 Flexing test conditions.