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YY/T 0681.8-2011: Test methods for sterile medical device package. Part 8: Coating/adhesive weight determination
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| YY/T 0681.8-2011 | English | 209 |
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Test methods for sterile medical device package. Part 8: Coating/adhesive weight determination
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YY/T 0681.8-2011
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Basic data | Standard ID | YY/T 0681.8-2011 (YY/T0681.8-2011) | | Description (Translated English) | Test methods for sterile medical device package. Part 8: Coating/adhesive weight determination | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.080.040 | | Word Count Estimation | 9,919 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB/T 10739 | | 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 measure is applied to the substrate (such as film, paper, non-woven fabric) on the amount of glue. Amount of glue to each expressed as weight of a given area (eg, g/m). | YY/T 0681.8-2011: Test methods for sterile medical device package. Part 8: Coating/adhesive weight determination
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Test methods for sterile medical device package.Part 8. Coating/adhesive weight determination
ICS 11.080.040
C31
People's Republic of China pharmaceutical industry standards
Test methods for packaging sterile medical devices
Determination of coating layer weight. Part 8
Part 8. Coating/adhesiveweightdetermination
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Foreword
YY/T 0681 "sterile medical device packaging test methods" consists of the following components.
--- 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 80681 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
The partial modification using ASTMF2250-03 "flexible packaging material printing ink and coating chemical resistance evaluation", mainly for editorial
modify.
This part is proposed by the State Food and Drug Administration.
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, Dong Dandan at Xiaohui, Victor Li.
Test methods for packaging sterile medical devices
Determination of coating layer weight. Part 8
1 Scope
This section YY/T 0681 specifies the amount of glue applied to the measurement of a substrate (such as film, paper, non-woven fabric) on. The amount of glue per given
By weight, said area (e.g., g/m2).
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 10739 paper, paperboard and pulp sample processing and testing standard atmospheric conditions (GB/T 10739-2002, eqvISO 187.
1990)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Coating coating
A material to improve the characteristics of the substrate to this voltage.
4 significance and application
4.1 coating weight used to describe certain properties of the coated substrate (eg, sealing stability, peel, appearance). Described in this section
The method is a means of measuring the weight of adhesive layer.
4.2 does not deal acceptable indicators. This requires mutually agreed by the user and the product manufacturer.
The method described in section 4.3 does not include an assessment of the operator to remove the coating efficiency. This is a subjective assessment, to get the same junction
If the need for operator training.
4.4 section applies only to the coating can be selected solvent soluble coated substrate. The solvent for the coating removal process with a very successful
The essential. For coated substrate, the manufacturer shall provide guidelines for the choice of solvent.
5 Instruments
5.1 Balance, accurate to 0.1mg, if the test results meet the required level of accuracy, precision can also use different scales.
5.2 solvent, the solvent used depends on the chemical composition of the coating and the substrate. The solvent used should dissolve rapidly coating, leaving the substrate remains undissolved.
To discuss with suppliers the choice of solvent.
5.3 fume hood.
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