YY/T 0681.8-2011Test methods for sterile medical device package - Part 8: Coating/adhesive weight determination (English PDF)
无菌医疗器械包装试验方法 第8部分：涂胶层重量的测定
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY/T 0681.8-2011 is the English-translated version of 无菌医疗器械包装试验方法 第8部分：涂胶层重量的测定.
YY/T 0681.8-2011 is the Chinese pharmaceutical industry standard that gives the method for measuring the amount of adhesive applied to a substrate such as film, paper or nonwoven fabric, expressed as a mass per unit area in grams per square metre.
It is the eighth part of the YY/T 0681 series on test methods for sterile medical device packaging and sets out the specimens, the conditioning atmosphere taken from GB/T 10739, the weighing procedure and the calculation of the result.
The coating weight it measures governs how a pouch or lid seals and peels, so the method is used both in development and in routine control of packaging materials. Issued on 31 December 2011, it has applied since 1 June 2013.
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Document preview — YY/T 0681.8-2011
National Standard of the People's Republic of China
- Classification
- C 31
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Significance and application
- 5 Instruments
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 ASTM F2250-03 "flexible packaging material printing ink and coating chemical resistance evaluation", mainly for editorial modify.
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
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.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 10739-2023 — Paper, board and pulps - Standard atmosphere for conditioning and testing
YY/T 0681.9-2011 — Test methods for sterile medical device package - Part 9: Burst testing of flexible package seals using internal air pressurization weight restraining plates
YY/T 0681.7-2011 — Test methods for sterile medical device package - Part 7: Evaluating inks or coating adhesion to flexible packaging materials using tape
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