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YY/T 1433-2016 English PDF

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US$299.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1433-2016: Test method of hot seal strength(hot tack)of flexible webs of medical devices
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1433-2016	299	Add to Cart	3 days	Test method of hot seal strength(hot tack)of flexible webs of medical devices	Valid

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Basic data

Standard ID: YY/T 1433-2016 (YY/T1433-2016)
Description (Translated English): Test method of hot seal strength(hot tack)of flexible webs of medical devices
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C48
Classification of International Standard: 11.080.040
Word Count Estimation: 15,166
Date of Issue: 2016-01-26
Date of Implementation: 2017-01-01
Regulation (derived from): China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies): State Food and Drug Administration

YY/T 1433-2016: Test method of hot seal strength(hot tack)of flexible webs of medical devices

---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 of hot seal strength (hot tack) of flexible webs of medical devices ICS 11.080.040 C48 People's Republic of China Pharmaceutical Industry Standard Medical equipment - Flexible packaging materials - Thermal sealing strength (Thermal adhesive strength) test method 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 release of this document The Agency does not assume responsibility for identifying 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. Zhang Jing, Zhang Peng, Wu Ping. Medical equipment - Flexible packaging materials - Thermal sealing strength (Thermal adhesive strength) test method

1 Scope

This standard contains the laboratory measurement of the heat seal between the thermoplastic surfaces after the formation of the seal in the cooling to ambient temperature before the heat sealing strength (hot strength). This standard is applicable to the ability to automatically heat the sample and quickly determine the strength of the hot seal during the exact time after the end of the sealing period Test instrument. This standard does not include manual procedures for the use of non-instruments such as springs, joysticks, pulleys and weights. Note. The result of manual operation will be affected by the operator's technology. This standard gives two test methods using different thermal adhesive strength test instrument parameters. Note 1. The difference between the two test methods is mainly reflected in two aspects. a) test the sealing sample when the separation rate of the fixture is different; b) drawing test machine generated test Test the cooling curve of the material, or measure the maximum force observed after setting the delay time. Both of these test methods can be used to measure this test Within the scope of the method and within the capabilities of the instrument used. Note 2. Appendix A gives a comparison between the two test methods specified in this standard. Appendix B gives the precision and bias of these two test methods.

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 0681.2-2010 Test methods for packaging of sterile medical devices - Part 2. Sealing strength of soft barrier materials

3 terminology

The following terms and definitions apply to this document. 3.1 Adhesive damage to adhesivefailure Seal the destruction mode at the original interface between the sealing surfaces. 3.2 Interval width breadth So that the peel force at the seal is the (constant) constant temperature range. 3.3 Melt through burnthrough The formation of molten holes and heat distortion of the heat sealing state or condition. Note. Melt-through instructions for sealing conditions (time or temperature, or both) are too high for acceptable seals. 3.4 Cohesive failure of cohesivefailure Peeling causes one or two pieces of sealing material to break in approximately parallel to the seal, and the seal itself does not break the failure mode. Note. See Figure 1. The definition of the term may be different when the adhesive material is used as an isolation assembly for sealing the system. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1433-2016_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1433-2016_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.

Question 2: Can I share the purchased PDF of YY/T 1433-2016_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1433-2016_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.

Question 3: Does the price include tax/VAT?

Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.