YY/T 0681.8-2011 English PDF

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YY/T 0681.8-2011: Test methods for sterile medical device package. Part 8: Coating/adhesive weight determination
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0681.8-2011	209	Add to Cart	3 days	Test methods for sterile medical device package. Part 8: Coating/adhesive weight determination	Valid

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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

---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 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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