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YY/T 0681.6-2011: Test methods for sterile medical device package. Part 6: Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0681.6-2011 | English | 139 |
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Test methods for sterile medical device package. Part 6: Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials
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YY/T 0681.6-2011
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Basic data | Standard ID | YY/T 0681.6-2011 (YY/T0681.6-2011) | | Description (Translated English) | Test methods for sterile medical device package. Part 6: Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.080.040 | | Word Count Estimation | 6,645 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB/T 2918 | | Adopted Standard | ASTM F2250-2003, MOD | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the printing inks, printing upper covering paint or coating chemical exposure affordability evaluation procedures. May be in contact with the package typical chemical substances include water, ethanol, acid. For special chemicals, as well as its method of choice to determine the measurement results determined in consultation with users to discuss. This section provides a list of the various methods to collect information on the measurement methods and recommendations. | YY/T 0681.6-2011: Test methods for sterile medical device package. Part 6: Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials
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Test methods for sterile medical device package.Part 6. Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials
ICS 11.080.040
C31
People's Republic of China pharmaceutical industry standards
Test methods for packaging sterile medical devices
Part 6. flexible packaging materials and inks
Coating chemical resistance evaluation
Part 6. Evaluationofchemicalresistanceofprintedinksand
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
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.
This part is proposed by the State Food and Drug Administration.
This part of the jurisdiction of the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.
This section is drafted. Shandong Medical Devices Product Quality Inspection Center, Ltd. Shandong Xinhua.
This section drafters. Zhang Limei, Dong Dandan at Xiaohui, Victor Li.
Test methods for packaging sterile medical devices
Part 6. flexible packaging materials and inks
Coating chemical resistance evaluation
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.
3.3 with the test chemicals should be printed and/or coated substrate compatibility (ie, no damage or degradation).
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.
4 Instrument
4.1 Method A Instrument
4.1.1 material it can hold about 45 ° inclined plane, so that the test chemicals shed.
4.1.2 installed for the test chemicals poured a small container or syringe.
Instruments 4.2 Method B
4.2.1 flat glass, which can cover the test sample size and easy to operate.
4.2.2 installed for the test chemicals poured a small container or syringe.
4.2.3 timer.
4.2.4 absorbing material.
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