YY/T 0681.6-2011 English PDFUS$139.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. 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
Basic dataStandard 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---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. 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 ForewordYY/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 evaluation1 ScopeThis 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 referencesThe 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 environment3 Significance and Use3.1 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 Instrument4.1 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. ...... |
