YY/T 1432-2016 English PDF

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YY/T 1432-2016: Test method for determination of heatsealability of flexible webs of medical devices as measured by seal strength
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1432-2016	239	Add to Cart	3 days	Test method for determination of heatsealability of flexible webs of medical devices as measured by seal strength	Valid

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Basic data

Standard ID: YY/T 1432-2016 (YY/T1432-2016)
Description (Translated English): Test method for determination of heatsealability of flexible webs of medical devices as measured by seal strength
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C48
Classification of International Standard: 11.080.040
Word Count Estimation: 12,180
Date of Issue: 2016-01-26
Date of Implementation: 2017-01-01
Quoted Standard: GB/T 2918; YY/T 0681.2
Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies): State Food and Drug Administration
Summary: This standard applies to the use of heat sealing knife sealing heat sealing machine heat sealing. This standard is mainly applicable to packaging materials intended for heat sealing on commercially available machines with reciprocating heat sealing knives such as forming and filling-sealing (FFS) packaging machines, flat heat sealing machines and the like. The duration of this machine and the heat sealing pressure conditions are different from rolling heat sealing machines. The procedures specified in this standard relating to the selection of heat seal conditions are applicable to the ultimate seal strength or thermal seal strength (

YY/T 1432-2016: Test method for determination of heatsealability of flexible webs of medical devices as measured by seal strength

---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 method for determination of heatsealability of flexible webs of medical devices as measured by seal strength ICS 11.080.040 C48 People's Republic of China Pharmaceutical Industry Standard By measuring the sealing strength of the heat seal sample Medical device soft packing material heat sealing parameters experiment method Testmethodfordetermination ofheatsealabilityofflexiblewebsofmedical 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard by the National Medical Pipeline Standardization Technical Committee (SAC/TC106) centralized. The main drafting unit of this standard. Shandong Province medical equipment product quality inspection center. This standard participates in the drafting unit. Jinan Languang Electromechanical Technology Co., Ltd., Shandong Hengxin Testing Technology Development Center. The main drafters of this standard. Dong Dandan, Qian Chengyu, Zhang Jing. By measuring the sealing strength of the heat seal sample Medical device soft packing material heat sealing parameters experiment method

1 Scope

This standard contains the heat sealing of the soft barrier material in the laboratory and the heat sealing strength data for determining the heat sealability of the material Processing and evaluation. This standard does not include the validation of materials and production equipment. The method of testing the strength or other properties after heat sealing is not covered by this standard. This standard applies to the use of heat sealing knife sealing heat sealing machine heat sealing. This standard is intended primarily for packaging materials intended for heat sealing on commercially available machines with reciprocating heat sealing knives such as forming Equipment - sealed (FFS) packaging machine, flat heat sealing machine. The duration of this machine and heat sealing pressure conditions are different from rolling heat sealing machines. The procedures specified in this standard relating to the choice of heat seal conditions apply to the cold seal strength (ultimateseal) or thermal seal strength (hottack) determination. The method specified in this standard applies to the determination of heat sealing parameters between the same or different packaging materials. Note. Single packaging material structure can be homogeneous or can be multi-layer (co-extruded, coated, composite, etc.). This standard does not include determining the heat sealability by determining the continuity of the seal (leakage, dyeing, penetration, visualization, microbial penetration, etc.).

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 2918 Standard conditions for the regulation and testing of plastic specimens YY/T 0681.2 Test methods for sterile medical device packaging - Part 2. Sealing strength of soft barrier materials

3 terminology

The following terms and definitions apply to this document. 3.1 Duration dweltime The heat seal is closed and the pressure period is continuously applied to the heat seal material. 3.2 Heat sealing curve heatsealcurve The measured seal strength corresponds to the heat seal temperature when the duration and pressure are constant. Note. This is the basic curve for comparing the sealing properties of materials. It depicts the retention time and pressure when the same, peel the heat seal after the test strip to destroy the required force, the force The value is a function of temperature. The influence of substrate damage at the higher heat sealing temperature of the curve can not accurately indicate the sealing strength. 3.3 Heat seal strength heatsealstrength The force required to peel the sealing area of the unit seal width. Note. In many seal strength tests, damage does not occur at the seal, but occurs at the substrate or composite layer. In these tests, the actual heat density The sealing strength may be higher than the force measured when the specimen is destroyed. Some materials are expected to be designed to break on the composite layer without damaging the heat seal interface. ......

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