YY/T 0681.6-2011Test methods for sterile medical device package - Part 6: Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials (English PDF)

Foreword

YY/T 0681 "sterile medical devices packaging materials, test methods" 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. Evaluation of flexible packaging material with adhesive tape or coating ink fastness;

--- Part 8. coating layer weight determination;

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

--- Part 10. breathable packaging material and microbial penetration level test. This section YY/T Section 60681 of. This section drafted in accordance with GB/T 1.1-2009 given rules.

This section YY/T 0681 amendments adopted ASTMF2250-03 "flexible packaging material printing ink and coating chemical resistance Review Price ", mainly for editorial changes.

1 Scope

This section YY/T 0681 describes ink, printing or coating lacquer covering the upper tolerance chemical exposure evaluation procedures. may Typical chemicals and packaging contact include water, ethanol and acid. For special chemicals, the method of selection and the measurement results do Scheduled to discuss consultation with users. Various methods listed in this section provides recommendations on how to measure and collect information.

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 Significance and Use

3.1 packaging material in its life cycle may be exposed to water, alcohol, acid and other chemicals. If the packing material is expected to chemicals Contact after contact with the ink or coating does not degrade, soften or dissolve very important.

3.2 Test portion includes a pair applicable to the design of a print stabilization and coated surface of the material to a particular chemical.

3.4 section details four methods. Stringency these methods to gradually increase from Method A Method D. It should be based on the expected exposure Type selection. For example, it is expected casual contact (such as the chemical spill or spilled on the surface) using the pour method (Method A).

When it is desired chemical resistance depends on the expected exposure levels (B) or wiping level (C) is, respectively, using Method B or Method C. Method D represents Chemicals and materials and the need for continuous contact with chemical resistance (for example, the packaging is immersed in a certain time and chemicals by wiping).

3.5 does not deal with acceptance criteria, which requires the supply and demand of goods and mutually agreed based on the expected type of contact.

3.3 with the test chemicals should be printed and/or coated substrate compatibility (ie, no damage or degradation).

4 Instrument

4.2.2 installed for the test chemicals poured a small container or syringe.