YY/T 0681.7-2011Test methods for sterile medical device package - Part 7: Evaluating inks or coating adhesion to flexible packaging materials using tape (English PDF)

Foreword

YY/T 0681 "Test Method for sterile medical device packaging" is divided into 10 parts.

--- Part 1. accelerated aging test guidelines;

--- Part 2. sealing strength flexible barrier material;

--- Part 3. Unconstrained pressure within the package of anti-sabotage;

--- Part 4. Determination of staining solution penetrate breathable packaging seal leakage;

--- Part 5. coarse leak was detected internal pressure (bubble method);

--- Part 6. flexible packaging material and ink coating chemical resistance evaluation;

--- Part 7. flexible packaging material ink or coating adhesion tape evaluation;

--- Part 8. coating layer weight determination;

--- Part 9. constraint plate internal pressure bursting test method flexible seal;

--- Part 10. Classification breathable packaging material and microbial tests. This section YY/T Section 70681 of. This section drafted in accordance with GB/T 1.1-2009 given rules.

YY/T 0681 Part revised adoption ASTM F2252-03 "tape evaluation of flexible packaging material ink and coating adhesion in prison."

This part of the National Technical Committee of Standardization for medical infusion set (SAC/TC106) centralized.

This section is drafted. Shandong Medical Devices Product Quality Inspection Center, Ltd. Shandong Xinhua.

This section drafters. Zhang Limei, Chen Fang, in Xiaohui, Wang Hongmin.

1 Scope

This section describes the ink or coating on flexible packaging materials firm Evaluation Method. This section is intended for the surface will stick tape And no damage to the surface of flexible packaging material removed.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 2918 plastic sample conditioning and testing of the standard environment

3 Meaning and application

Ink or coating adhesion is poor 3.1 matrix will affect the readability of printed material, affect the function of the coating material, or generate pollution.

This section provides an evaluation method for the flexible packaging material or coating adhesion of the ink.

3.2 To resolve inconsistencies between laboratories, this section of the test methods specified and controlled by the pressure method and the tape used (for example, Using a known weight of the drum), speed and angle of the tape when removing, etc. to be improved.

3.3 part does not involve the acceptance criteria, the supply and demand needs of the mutually agreed.

4 Instrument

This program uses a dedicated test tape 1), 19mm ~ 25mm wide. The choice of tape should be negotiated by the supply and demand sides.

Manufacturer tape recommended storage and shelf life should be determined by the actual time of the test and aging laboratory.

1) 3M produced by 3M