YY/T 0681.1-2018 PDF EnglishUS$205.00 · In stock · Download in 9 seconds
YY/T 0681.1-2018: Test methods for sterile medical device package - Part 1: Test guide for accelerated aging Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Valid YY/T 0681.1: Historical versions
Similar standardsYY/T 0681.1-2018: Test methods for sterile medical device package - Part 1: Test guide for accelerated aging---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/YYT0681.1-2018 MEDICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.080.040 C 31 Replacing YY/T 0681.1-2009 Test methods for sterile medical device package - Part 1.Test guide for accelerated aging Issued on. DECEMBER 20, 2018 Implemented on. JANUARY 01, 2020 Issued by. National Medical Products Administration Table of ContentsForeword... 3 1 Scope... 6 2 Normative references... 6 3 Terms and definitions... 7 4 Meaning and application... 8 5 Instruments... 9 6 Accelerated aging theory... 9 7 Accelerated aging plan... 10 8 Post-aging test guide... 13 9 Report... 14 Annex A (normative) Accelerated aging of polymers... 15 Annex B (informative) Example of shelf life test plan for sterile barrier system ... 16 Annex C (informative) Relative humidity used in aging solution... 18 Bibliography... 20ForewordYY/T 0681 “Test methods for sterile medical device package” consists of the following 16 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.Breathable packaging materials for wet and dry microbial barrier tests; - Part 15.Performance test of transport containers and systems; - Part 16.Packaging system climate strain capability test. This is Part 1 of YY/T 0681. This Part was drafted in accordance with the rules given in GB/T 1.1-2009. This Part replaces YY/T 0681.1-2009 “Test methods for sterile medical device package - Part 1.Test guide for accelerated aging”. Compared with YY/T 0681.1-2009, in addition to editorial modifications, the main technical changes are as follows. - for sterile package, used the term “sterile barrier system” to replace the term “package”; - uniformly modified “actual-time aging” as “real-time aging”; - in “Meaning and application”, modified sub-clause 4.2 as “the packaging system shall...”; - in “Meaning and application”, added sub-clause 4.5; - required the thermometer “be able to record” in 5.4 of “Instruments”; - added sub-clause 6.5 in “accelerated aging theory”; - in sub-clause 7.2.3 of “Accelerated aging plan”, deleted “for example, the temperature chosen shall be at least 10°C lower than the Tg of the material”; - in sub-clause 7.2.3 of “Accelerated aging plan”, added NOTE 3, NOTE 4; - in “Accelerated aging plan”, added sub-clause 7.4.5; - in “Accelerated aging plan”, added sub-clause 7.5; - revised “8 Post-aging test guide”; - deleted Figure B.1 from Annex B; - deleted “Where appropriate, in accordance with ASTM D 4169...” from Annex B.5; - modified the note in Annex B.6 as “the effect of humidity can be used as a packaging system design...” - added Annex C (informative) “Relative humidity used in aging solutions”. Attention is drawn to the possibility that some of the elements of this Standard may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights. This Part was proposed by National Medical Products Administration. This Part shall be under the jurisdiction of National Technical Committee on Medical Infusion Device of Standardization Administration of China (SAC/TC 116). The drafting organizations of this Part. Shandong Medical Device Product Quality Inspection Center, DuPont (China) R&D Management Co., Ltd., Shandong Weigao Group Medical Polymer Products Co., Ltd., Medico (Shanghai) Packaging Materials Co., Ltd. Main drafters of this Part. Zhang Jing, Qian Jun, Yu Haichao, Gong Yaoren. This Part replaces YY/T 0681.1-2009. Test methods for sterile medical device package - Part 1.Test guide for accelerated aging1 ScopeThis Part of YY/T 0681 specifies the guide for designed accelerated aging solutions. This Part applies to the rapid determination of the sterile integrity of the sterile barrier system specified in GB/T 19633.1-2015 and the effects that physical properties of its packaging material components are affected by the elapsed time. NOTE 1.Use the information in this Part of YY/T 0681 to support the expiration date of the medical device sterile barrier system (i.e. shelf life). This Part is not applicable to real-time aging solution. NOTE 2.Accelerated aging test involves sterile barrier system with or without instruments. This Part does not address the compatibility of sterile barrier system materials with instrument interactions required during new product development or evaluation. NOTE 3.Real-time aging test is a basic aging study used to determine the results of accelerated aging tests. NOTE 4.This Part does not address methods for confirmation of sterile barrier system, including effects on mechanical processing, sterilization processes, circulation, handling and transport. The ability of the sterile barrier system to resist transport challenges is given in YY/T 0681.15. NOTE 5.This Part does not address the effects of extreme weather conditions that may be experienced in a simulated transport environment. For the climatic strain capacity test of the sterile barrier system, see YY/T 0681.16.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 4857.2, Packaging - Transport packages - Temperature and humidity conditioning GB/T 19633.1-2015, Packaging for terminally sterilized medical devices - Part 1.Requirements for materials, sterile barrier systems and packaging systems3 Terms and definitionsFor the purposes of this document, the terms and definitions defined in GB/t 19633.1-2015 as well as the followings apply. 3.1 accelerated aging store samples at a higher temperature to reduce time to simulate real-time aging 3.2 accelerated aging factor an estimated or calculated time ratio of physical performance changes to the same level as the package stored in real-time conditions NOTE. The aging factor (Q10) at which the temperature increases or decreases by 10°C is a conservatively estimated accelerated aging factor. 3.3 accelerated aging temperature a higher temperature that enters aging study; it is calculated based on the estimated storage temperature, the estimated operating temperature, or both 3.4 accelerated aging time duration of accelerated aging test 3.5 ambient temperature storage temperature of the sample representing the actual aging time of the storage conditions 3.6 sterile barrier system shelf life the expected storage time of the sterile barrier system to maintain its key performance parameters under ambient conditions or under specified storage conditions4 Meaning and application4.1 Degradation of physical properties of materials over time and degradation of materials at bonding or heat sealing over time and dynamic events during subsequent transport and handling, may lead to loss of integrity of the sterile barrier system. 4.2 The packaging system shall provide protection and maintain the integrity of the sterile barrier system. 4.3 Real-time aging procedures provide the best data to ensure that sterile barrier system materials and sterile barrier system integrity do not degrade over time. 4.4 If there is a lack of understanding of the material of the sterile barrier system being evaluated, a conservative accelerated aging factor shall be used. More realistic accelerated aging factors can be used. 4.5 When accelerating the aging process to establish a nominal shelf life, it shall be recognized that the data obtained from the study is based on a simulation of the aging effect of the material.5 Instruments5.1 A room (or box). its size may allow the sample to be independently exposed to the selected temperature and relative humidity of the circulating air. 5.2 Control instrument. keep the room (box) within the limits of the required atmospheric conditions. 5.4 Thermometer. a measuring device capable of recording and displaying temperature with an accuracy of 0.1°C can be used.6 Accelerated aging theory6.1 Accelerated aging of materials refers to accelerated changes in material properties associated with the safety and functionality of materials or sterile barrier system over time. 6.2 In aging study, material or sterile barrier system are subjected to harsher or more frequent external strains than usual in a relatively short period of time. 6.3 Accelerated aging technology is based on this assumption. 6.4 The determination method for Q10 is to test each material at various temperatures and define the difference in reaction rate between materials for every 10°C change in temperature. 6.5 The accelerated aging time in the accelerated aging scheme does not use the humidity factor. However, extreme temperature and humidity conditions that are inconsistent with actual conditions may affect the performance of the entire sterile barrier system.7 Accelerated aging plan7.1 Material characterization Accelerated aging theory and its application are directly related to the composition of packaging materials. Material properties that may affect the results of accelerated aging study include. 7.2 Design guide for accelerated aging plan 7.2.3 Select accelerated aging temperature based on material characterization. The higher the accelerated aging temperature, the greater the accelerated aging factor, and the shorter the time to accelerate aging. It shall be noted that the accelerated aging temperature cannot be reduced in an uncontrolled manner to shorten the time for accelerated aging. 7.3 Determination of accelerated aging factor 7.4 Accelerated aging plan steps 7.4.1 Select Q10 value. 7.4.2 Determine the shelf life of the desired sterile barrier system based on market demand, product demand, etc. 7.4.3 Determine the time interval for the aging test, including zero time. 7.4.4 Determine test conditions, ambient temperature and accelerated aging temperature. 7.4.5 Determine whether humidity conditions are used in aging studies. If used, determine the relative humidity (RH) target value and allowable deviation. 7.4.6 Use Q10, TRT, and TAA to calculate test duration time. 7.4.10 Evaluate whether the sterile barrier system meets its original design requirements after real-time aging.8 Post-aging test guide8.1 Evaluate physical properties and integrity of sterile barrier systems after aging (e.g., accelerated aging and real-time aging). 8.2 The test selected for evaluation shall be able to challenge the most critical function of the material or package or the function that is most likely to fail due to aging. 8.5 If the packaging system has documented acceptable limits for performance such as seal strength, puncture or impact resistance that meet the requirements of the intended packaging system, then the specified physical test data shall be complete. 8.6 Sometimes, packaging performance test can be performed on an aged packaging system so as to evaluate the performance of the packaging system during simulated flow, handling, and storage. 8.7 Establish acceptance criteria before all aging tests.9 ReportThe accelerated aging test report shall have the following information. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY/T 0681.1-2018 be delivered?Answer: The full copy PDF of English version of YY/T 0681.1-2018 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 0681.1-2018_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0681.1-2018_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+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. www.ChineseStandard.us -- YY/T 0681.1-2018 -- 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.Question 5: Should I purchase the latest version YY/T 0681.1-2018?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0681.1-2018 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically.How to buy and download a true PDF of English version of YY/T 0681.1-2018?A step-by-step guide to download PDF of YY/T 0681.1-2018_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 0681.1-2018". 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 |
