YY/T 1707-2020 English PDFUS$149.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1707-2020: Implants for surgery--Differential scanning calorimetry of poly ether ketone (PEEK)polymers and compounds for use in implantable medical devices Status: Valid
Basic dataStandard ID: YY/T 1707-2020 (YY/T1707-2020)Description (Translated English): Implants for surgery--Differential scanning calorimetry of poly ether ketone (PEEK)polymers and compounds for use in implantable medical devices Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C35 Classification of International Standard: 11.040.40 Word Count Estimation: 8,850 Date of Issue: 2020 Date of Implementation: 2021-01-01 Issuing agency(ies): State Drug Administration Summary: This standard specifies a method for thermal analysis of polyetheretherketone (PEEK) and its composites for the manufacture of implantable medical devices using differential scanning calorimetry (DSC). This standard is applicable to the determination of glass transition temperature (Tg), melting temperature (Tm) and cooling crystallization temperature (Tc) of PEEK and its composites for the manufacture of implanted medical devices. YY/T 1707-2020: Implants for surgery--Differential scanning calorimetry of poly ether ketone (PEEK)polymers and compounds for use in implantable 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. Implants for surgery--Differential scanning calorimetry of poly ether ether ketone (PEEK)polymers and compounds for use in implantable medical devices ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Polyetheretherketone for surgical implants implanted in medical devices Differential scanning calorimetry of polymers and their composites 2020-02-21 released 2021-01-01 implementation Issued by the State Drug Administration ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. This standard uses the redrafting method to amend and adopt ISO 15309.2013 Polyetheretherketone Polymer for Surgical Implants and Medical Devices Differential scanning calorimetry of its complexes. Compared with ISO 15309.2013, except for editorial changes, the main technical changes of this standard are as follows. ---Regarding normative reference documents, this standard has made adjustments with technical differences to adapt to my country's technical conditions and adjustments. The situation is collectively reflected in Chapter 2 "Normative Reference Documents", and the specific adjustments are as follows. ● Replace ISO 11357-1.2009 with GB/T 19466.1 equivalent to the international standard; ● Replace ISO 11357-2 with GB/T 19466.2 which is equivalent to the international standard; ● Replace ISO 11357-3 with GB/T 19466.3 which is equivalent to adopting international standards; Please note that certain contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Standardization Technical Committee for Surgical Implants and Orthopedic Devices (SAC/TC110). Drafting organizations of this standard. Tianjin Medical Device Quality Supervision and Inspection Center, Evonik Specialty Chemicals (Shanghai) Co., Ltd., National Drug Administration Supervision Administration Medical Device Technology Evaluation Center, Medtronic (Shanghai) Management Co., Ltd., Beijing Fuller Technology Development Co., Ltd. The main drafters of this standard. Jing Ming, Ma Chunbao, Zhang Hong, Zhen Zhen, Zhang Yidan, Geng Fang, Yin Anyuan, Bai Yunsheng, Xu Bingzhi. Polyetheretherketone for surgical implants implanted in medical devices Differential scanning calorimetry of polymers and their composites1 ScopeThis standard specifies the use of differential scanning calorimetry (DSC) for the manufacture of polyetheretherketone (PEEK) polymers for implanted medical devices and their complexes. The method of thermal analysis of the compound. This standard is applicable to the glass transition temperature (Tg), melting temperature (Tm) and cold temperature of PEEK and its composites used in the manufacture of implanted medical devices. The crystallization temperature (Tc) and other transformation temperatures are measured.2 Normative referencesThe following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 19466.1 Plastic Differential Scanning Calorimetry (DSC) Part 1.General (GB/T 19466.1-2004, ISO 11357-1.1997, IDT) GB/T 19466.2 Plastic Differential Scanning Calorimetry (DSC) Part 2.Determination of Glass Transition Temperature (GB/T 19466.2- 2004, ISO 11357-2.1999, IDT) GB/T 19466.3 Differential Scanning Calorimetry (DSC) for Plastics Part 3.Determination of Melting and Crystallization Temperature and Enthalpy (GB/T 19466.3-2004, ISO 11357-3.1999, IDT)3 Terms and definitionsThe following terms and definitions defined in GB/T 19466.1 apply to this document. 3.1 Glass transition The amorphous regions in amorphous polymers or semi-crystalline polymers change from (or to) viscous fluid state, rubbery state to (or from) hard, relatively brittle glass A reversible change in the glass state is shown by a step change in heat flow during heating. 3.2 Extrapolated onset temperature of glass transition The temperature corresponding to the intersection of the tangent at the inflection point of the curve is extrapolated from the initial baseline on the low temperature side of the curve. 3.3 Midpoint temperature of glass transition The temperature corresponding to the intersection point of a line with the same distance from the two extrapolated baselines and the curve. 3.4 Melting temperature The temperature at which a fully crystalline or semi-crystalline polymer changes from a solid state to a liquid state with different viscosities is shown as an endothermic curve in the DSC curve The peak temperature. see picture 1. Note. The DSC curve does not include transitions other than those listed in Table 1. Figure 1 Typical DSC curve of PEEK heating curve 3.5 Crystallization temperature crystalization Tc The temperature at which the amorphous liquid state of the polymer transforms to a completely crystalline or semi-crystalline solid state, which is expressed in the differential scanning calorimetry (DSC) curve Is the peak temperature of the exothermic peak.4 Equipment and materials4.1 Differential Scanning Calorimeter (DSC) The main features of the instrument should meet the requirements of GB/T 19466.1. 4.2 Sample crucible The sample crucible and the reference crucible required for the test material should be made of the same material and have the same size and quality. Material of the sample crucible The material should be physically and chemically inert relative to PEEK within 500°C. Example. aluminum. 4.3 Balance The balance should be able to measure the mass of samples, sample crucibles and reference crucibles with an accuracy of ±0.01 mg. 4.4 Reference materials At least two certified reference materials covering the temperature range to be measured are required. 4.5 Air source Inert gas should be used (for example. nitrogen with a purity of 99.99% or higher).5 Test samplesNote. PEEK is a hard semi-crystalline polymer. Care should be taken during the cutting operation to avoid damage. The test sample of PEEK polymer can be powder, granule or fine particle shape, or it can be injection molded or extruded polymer sample Pieces cut from the top. When cutting samples, avoid generating heat or causing polymer reorientation to affect its characteristics. Ideally, you should use Sharp scalpel, scissors or microtome.6 Test conditions and sample state adjustment6.1 Test conditions The test should be performed under laboratory environmental conditions. The DSC should be turned on at least 1h before the start of the test in order to balance the electronic components and temperature. 6.2 Sample status adjustment The sample should be adjusted at a constant temperature of 18℃~28℃ for at least 4h.7 Instrument calibration7.1 Temperature calibration Measure the transition temperature of two standard materials and measure the extrapolated starting temperature of the glass transition according to GB/T 19466.1.Nominal value Compare with actual measured value. The temperature calibration repeatability should not exceed 2%. 7.2 Energy calibration Determine the heat of fusion of the two standard materials and compare these values with the nominal values. Repeatability should not exceed 2%.8 steps8.1 Baseline measurement Place two empty sample crucibles with the same mass on the sample holder. Adjust to the actual measurement conditions. On request Within the temperature range, the DSC curve (ie the instrument baseline) should be close to a straight line. If a significant baseline curvature change is observed, check the sample support Whether the holder is contaminated. Note. The computer-controlled instrument can be used to correct the excess curvature changes by subtracting the instrument baseline from the DSC curve. When the ideal straight line cannot be obtained, record the DSC curve after confirming its repeatability. 8.2 Sample preparation At least two samples should be prepared for each batch or sample to be checked. Follow the steps below, and the following weighing is accurate to 0.1mg. ---Weigh and record the quality of the sample crucible and lid; ---Put the PEEK sample into the sample crucible. Adjust the sample quality to be between 5mg~15mg, and record the sample quality; --- Use the lid to seal the sample crucible according to the steps recommended by the manufacturer; ---Weigh the sealed sample crucible again and record the quality; --- Weigh and record the quality of the reference crucible. Use the lid to seal the reference crucible according to the procedure recommended by the manufacturer; ---Weigh the sealed reference crucible again and record the mass. 8.3 Place the sample crucible Use appropriate equipment (such as tweezers) to put the sample and reference crucible into the corresponding DSC furnace. Ensure that the bottom of the crucible and the heating furnace Good, close contact between. Close the instrument cover. 8.4 Temperature scan program The following temperature program should be used. a) Heat the sample from 30°C to 400°C at a heating rate of 20°C/min; b) Maintain a constant temperature at 400°C for 5 minutes; c) Cooling from 400°C to 30°C at a cooling rate of 20°C/min; d) Reheat from 30°C to 400°C at a heating rate of 20°C/min. 8.5 Sample inspection Remove the sample crucible from the instrument and check whether the crucible is overflowing or deformed. If overflow or deformation occurs, separate the crucible and lid, and observe Check the remaining sample for signs of volatilization or reaction. Due to the stability of the PEEK and PEEK compound, there should be no sample crucible overflow and/or deformation. If any signs of volatilization or reaction are observed in a batch of PEEK or PEEK compound, the test result should be discarded. 8.6 Data analysis 8.6.1 General The data should be processed according to the instrument manufacturer's instructions. 8.6.2 Melting temperature The melting temperature Tm shall be determined and recorded according to GB/T 19466.3. 8.6.3 Crystallization temperature The crystallization temperature Tc during the cooling process shall be determined and recorded in accordance with GB/T 19466.3. 8.6.4 Glass transition temperature The glass transition temperature should be measured from the second heating cycle according to GB/T 19466.2.Record vitrification in Teig or Tmg Transition temperature Tg.9 Test report and typical performanceIn addition to the information required by GB/T 19466.1, the test report should include the batch number or sample model. Typical transformation temperature during transformation The range is given in Table 1. If any transition temperature is outside the expected range, then the batch of PEEK polymer or PEEK composite may not be suitable Surgical implant applications. references [1] YY/T 0660 Standard Specification for Polyetheretherketone (PEEK) Polymer for Surgical Implants ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1707-2020_English be delivered?Answer: Upon your order, we will start to translate YY/T 1707-2020_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 1707-2020_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1707-2020_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. 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