Home Cart Quotation About-Us
www.ChineseStandard.net
SEARCH

YY/T 0681.15-2019 PDF English

US$335.00 · In stock · Download in 9 seconds
YY/T 0681.15-2019: Test methods for sterile medical device package - Part 15: Performance testing of shipping containers and systems
Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure
Status: Valid
Standard IDUSDBUY PDFDeliveryStandard Title (Description)Status
YY/T 0681.15-2019335 Add to Cart Auto, 9 seconds. Test methods for sterile medical device package - Part 15: Performance testing of shipping containers and systems Valid

Similar standards

YY/T 0681.16   YY/T 0681.17   YY/T 0681.14   YY/T 0681.12   

YY/T 0681.15-2019: Test methods for sterile medical device package - Part 15: Performance testing of shipping containers and systems


---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0681.15-2019
YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.080.40 C 31 Test methods for sterile medical device package - Part 15.Performance testing of shipping containers and systems Issued on. OCTOBER 23, 2019 Implemented on. OCTOBER 01, 2020 Issued by. National Medical Products Administration

Table of Contents

Foreword... 4 Introduction... 6 1 Scope... 7 2 Normative references... 7 3 Terms and definitions... 8 4 Test schedule applicable to the distribution cycle of sterile medical devices ... 10 5 Test sample... 10 6 Conditioning and test conditions... 11 7 Acceptance criteria... 12 8 Procedure... 12 8.1 Define the shipping unit... 12 8.2 Determine the assurance level... 12 8.3 Determine acceptance criteria... 13 8.4 Select the distribution cycle... 13 8.5 Prepare the test plan... 13 8.6 Select the test sample... 13 8.7 Sample conditioning... 13 8.8 Perform the test... 13 8.9 Evaluate the results... 13 8.10 Document the test results... 13 8.11 Monitor the transportation... 13 9 Test schedule corresponding to the hazard... 14 10 Schedule A – manual handling... 14 11 Schedule C – Carrying stacking... 15 12 Schedule E – carrying vibration... 18 12.1 Overview... 18 12.2 Random test... 19 12.3 Sinusoidal test... 21 13 Schedule F – Unconstrained vibration... 22 14 Schedule I – low pressure (high altitude) hazards... 23 15 Schedule J – Concentrated impact... 23 16 Report... 23 Appendix A (Informative) Examples of transport test plans... 25 Appendix B (Normative) Vacuum test method to determine the impact of high altitude on the packaging system... 28 Appendix C (Normative) Transport package concentrated impact test method ... 30 References... 33

Foreword

YY/T 0681 "Test methods for sterile medical device package" consists of the following parts. -- Part 1.Test guide for accelerated aging; -- Part 2.Seal strength of flexible battier materials; -- Part 3.Internal pressurization failure resistance of unrestrained packages; -- Part 4.Detecting seal leaks in porous packages by dye penetration; -- Part 5.Detecting gross leaks in medical packaging by internal pressurization (bubble test); -- Part 6.Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials; -- Part 7.Evaluating inks or coating adhesion to flexible packaging materials using tape; -- Part 8.Coating/adhesive weight determination; -- Part 9.Burst testing of flexible package seals using internal air pressurization weight restraining plates; -- Part 10.Test for microbial barrier ranking of porous package material; -- Part 11.Determining integrity of seals for medical packaging by visual inspection; -- Part 12.Flex durability of flexible barrier films; -- Part 13.Slow rate penetration resistance of flexible barrier films and laminates; -- Part 14.Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air; -- Part 15.Performance testing of shipping containers and systems; -- Part 16.Test for climatic stressing of packaging system. This Part is Part 15 of YY/T 0681. This Part was 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 issuing organization of this document is not responsible for identifying these patents. This Part was proposed by National Medical Products Administration. This Part shall be under the jurisdiction of National Technical Committee 106 on Medical Syringes of Standardization Administration of China (SAC/TC 106). The drafting organizations of this Part. Shandong Quality Inspection Center for Medical Devices, Shanghai MicroPort Medical (Group) Co., Ltd., Sealed Air (China) Co., Ltd. The drafters of this Part. Zhang Peng, Sun Haipeng, Li Yong, Chen Tianyou.

1 Scope

This Part of YY/T 0681 specifies a uniform method for evaluating the ability of sterile medical device shipping units to withstand the transport environment in the laboratory. This Part is used for guiding the user to design an appropriate test plan, so that the shipping unit can withstand a series of expected hazards to be experienced in a specific distribution cycle. This Part does not include performance testing of single parcel transport packages.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest edition (including all amendments) applies to this document. GB/T 4857.2, Packaging - Basic tests for transport packages - Part 2. Temperature and humidity conditioning GB/T 4857.4, Packaging - Basic tests for transport packages - Part 4. Compression and Stacking tests using a compression tester GB/T 4857.5, Packaging - Transport packages - Vertical impact test method by dropping GB/T 4857.7-2005, Packaging - Basic tests for transport packages - Part 7. Sinusoidal vibration test method at constant frequency

3 Terms and definitions

The following terms and definitions are applicable to this document. 3.1 Acceptance criteria The acceptable quality level that the shipping unit must meet after being subjected to the test plan. 3.2 Assurance level The level of test strength that is determined according to the probability of occurrence in a typical distribution cycle. Note. The assurance level I is the highest level of test strength, but the probability of occurrence is low; the level III is the lowest level of test strength, but the corresponding probability of occurrence is high; the test strength of level II is between level I and level III. 3.3 Distribution cycle; DC The sequence list that uses the test schedule to simulate the hazard elements that are expected to occur in the specific route of the shipping unit from production to consumption. Note. The distribution cycle which is given in Table 1 refers to DC 13 in ASTM D 4169-16. 3.4 Feeder aircraft The light aircraft that may not be pressurized in the warehouse, which is used to transport the packaged express. 3.5 Hazard element A specific event that may cause hazards to the shipping unit, which is generated during a distribution cycle. This element is usually simulated through a separate test schedule. 3.6 Less than truckload; LTL The transportation where the volume of goods is less than a truckload.

4 Test schedule applicable to the distribution cycle of

sterile medical devices 4.1 The recommended transport test of transport packages of sterile medical devices shall be carried out in sequence according to the test schedule that is given in Table 1. 4.2 The schedule which is given in Table 1 simulates the various hazards that the medical device is expected to experience during the transportation test. The test schedule is expected to be used in the following areas. 4.3 These tests should be carried out sequentially on the same shipping unit. For performance tests, this Part requires that the shipping unit is not opened before all tests are completed.

5 Test sample

5.1 The test sample consists of representative and complete samples of the shipping unit, including the actual contents. For valuable medical devices, if there is no need to conduct experimental research on the defects of the contents, and the defects have been recorded in the report, products of flaws or small defects can be used. 5.2 It shall be ensured that the product and packaging are not degraded when the test package arrives at the test site. 5.3 The number of tests performed depends on the intended purpose of the test and the availability of the same product and shipping container.

6 Conditioning and test conditions

The samples shall be tested under standard atmospheric conditions; the influence of any climatic conditions shall be compensated. Unless other temperature and relative humidity conditions are considered more appropriate, the shipping unit shall be placed in the standard atmosphere, where the temperature is (23±2) °C and the relative humidity is (50±2) %, as specified in GB/T 4857.2, for conditioning.

7 Acceptance criteria

7.1 Acceptance criteria shall be established before the test; the required state of the product should be considered when it is received. The organization that conducts the test can choose any acceptance criteria that suits its purpose. 7.2 In most cases, the acceptance criteria can be.

8 Procedure

8.1 Define the shipping unit Use terms such as specification and dimension, weight, and structural style to describe the shipping unit. 8.2 Determine the assurance level Specify a level of test strength. This level shall be one of three predetermined assurance levels. 8.3 Determine acceptance criteria Acceptance criteria are related to the expected state of the product and packaging at the end of the distribution cycle. See Chapter 7. 8.4 Select the distribution cycle For sterile medical devices, use the distribution cycle in Table 1. 8.6 Select the test sample See Chapter 5. 8.7 Sample conditioning See Chapter 6. 8.8 Perform the test Perform the test according to the test method standards that are specified in each test schedule and the changes that are given in the special instructions of each method. 8.9 Evaluate the results Evaluate the results, so as to determine whether the shipping unit meets the acceptance criteria. See Chapter 7. 8.10 Document the test results Document the test results by reporting each step. See Chapter 16.

9 Test schedule corresponding to the hazard

The test schedule corresponding to the hazard is shown in Table 2. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
Image 1     Image 2     Image 3     

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of English version of YY/T 0681.15-2019 be delivered?Answer: The full copy PDF of English version of YY/T 0681.15-2019 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.

Question 2: Can I share the purchased PDF of YY/T 0681.15-2019_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0681.15-2019_English will be deemed to be sold to your employer/organization who actually paid 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. www.ChineseStandard.us -- YY/T 0681.15-2019 -- Click this link and select your country/currency to pay, the exact amount in your currency will be printed on the invoice. Full PDF will also be downloaded/emailed in 9 seconds.

How to buy and download a true PDF of English version of YY/T 0681.15-2019?

A step-by-step guide to download PDF of YY/T 0681.15-2019_EnglishStep 1: Visit website https://www.ChineseStandard.net (Pay in USD), or https://www.ChineseStandard.us (Pay in any currencies such as Euro, KRW, JPY, AUD).
Step 2: Search keyword "YY/T 0681.15-2019".
Step 3: Click "Add to Cart". If multiple PDFs are required, repeat steps 2 and 3 to add up to 12 PDFs to cart.
Step 4: Select payment option (Via payment agents Stripe or PayPal).
Step 5: Customize Tax Invoice -- Fill up your email etc.
Step 6: Click "Checkout".
Step 7: Make payment by credit card, PayPal, Google Pay etc. After the payment is completed and in 9 seconds, you will receive 2 emails attached with the purchased PDFs and PDF-invoice, respectively.
Step 8: Optional -- Go to download PDF.
Step 9: Optional -- Click Open/Download PDF to download PDFs and invoice.
See screenshots for above steps: Steps 1~3    Steps 4~6    Step 7    Step 8    Step 9