YY/T 0681.12-2022 PDF English
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Test methods for sterile medical device package - Part 12: Flex durability of flexible barrier materials
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YY/T 0681.12-2022: Test methods for sterile medical device package - Part 12: Flex durability of flexible barrier materials
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0681.12-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
ICS 11.080.20
CCS C 31
Replacing YY/T 0681.12-2014
Test methods for sterile medical device package - Part 12.
Flex durability of flexible barrier materials
Issued on. MAY 18, 2022
Implemented on. JUNE 01, 2023
Issued by. National Medical Products Administration
Table of Contents
Foreword... 3
Introduction... 6
1 Scope... 8
2 Normative references... 8
3 Terms and definitions... 8
4 Overview of test methods... 8
5 Application... 9
6 Test instruments... 9
7 Specimen preparation... 11
8 Conditioning... 11
9 Procedures... 11
10 Report... 12
Annex A (informative) Pinhole counting test... 14
Annex B (informative) Gas and/or water vapor transmission rate test... 16
Bibliography... 17
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).
Attention is drawn to the possibility that some of the elements of this document may be
the subject of patent rights. The issuing authority shall not be held responsible for
identifying any or all such patent rights.
This document was proposed by National Medical Products Administration.
This document shall be under the jurisdiction of National Technical Committee on
Medical Infusion Set of Standardization Administration of China (SAC/TC 106).
The drafting organizations of this document. Shandong Provincial Medical Device
Product Quality Inspection Center, Shanghai Jianzhong Medical Device Packaging Co.,
Ltd., DuPont (China) R&D Management Co., Ltd., Henan Yadu Industrial Co., Ltd.
Main drafters of this document. Zhang Peng, Qian Jun, Song Yiqin, Gao Ranran, Duan
Shuxia, Zhang Lei, Xiong Wei, Shao Guojun.
The historical version of standard substituted by this document is.
- YY/T 0681.12-2014 that was issued in 2014 for the first time;
- This is the first revision.
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.
3.1 pinhole
A small opening of no particular shape or size that passes completely through all layers
of a flexible barrier material.
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 200mm×280mm.
7 Specimen preparation
7.1 The samples are cut into sheets of 200mm × 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
9.1 Test environment
Unless otherwise specified, the flexing test is carried out under the conditions described
in Chapter 8.
9.2 Flexing conditions
9.2.1 Condition A
9.2.2 Condition B
The test conditions are the same as Condition A. The samples are flexed for 20min at
45 cycles/min. (that is, a total of 900 cycles under full flexing and swirling action).
9.2.3 Condition C
The test conditions are the same as Condition A. The samples are flexed for 6min at 45
cycles/min. (that is, a total of 270 cycles under full flexing and swirling action).
9.2.4 Condition D
The test conditions are the same as Condition A. The samples are flexed for 20 times at
45 cycles/min. (that is, a total of 20 cycles under full flexing and swirling action).
9.3 Determination of flexing test results
9.3.1 Remove the flexible barrier material sample from the flexing tester. Mark a
150mm x 200mm area in the center. 150mm is the axial dimension of the tester. For
samples after flex durability testing, whether for pinhole or layer integrity inspection,
samples shall be taken in this area.
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.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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