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

YY/T 1558.3-2017 English PDF

US$299.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1558.3-2017: Implants for surgery—Calcium phosphates—Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 1558.3-2017299 Add to Cart 3 days Implants for surgery—Calcium phosphates—Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes Valid

Similar standards

YY/T 1860.1   YY/T 1748   YY/T 1653   YY/T 1559   YY/T 1552   

Basic data

Standard ID: YY/T 1558.3-2017 (YY/T1558.3-2017)
Description (Translated English): Implants for surgery��Calcium phosphates��Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C35
Classification of International Standard: 11.040.40
Word Count Estimation: 15,139
Date of Issue: 2017-09-25
Date of Implementation: 2018-10-01
Regulation (derived from): China Food & Drug Administration Announcement 2017 No. 118
Issuing agency(ies): State Food and Drug Administration

YY/T 1558.3-2017: Implants for surgery—Calcium phosphates—Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes


---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-Calcium phosphates-Part 3. Hydroxyapatite and beta-tricalcium phosphate bone substitutes ICS 11.040.40 C35 People's Republic of China Pharmaceutical Industry Standard Surgical implant calcium phosphate Part 3. Hydroxyapatite and beta-tricalcium phosphate substitute Implantsforsurgery-Calciumphosphates-Part 3.Hydroxyapatiteand (ISO 13175-3.2012, IDT) Published on.2017-09-25 2018-10-01 implementation State Food and Drug Administration issued

Content

Foreword I Introduction II 1 Scope 1 2 Normative references 1 3 Terms, definitions and symbols 1 4 Requirements 3 Reference 10

Foreword

YY/T 1558 "Surgical Implant Calcium Phosphate" is expected to be divided into three parts. --- Part 1. Hydroxyapatite powder; --- Part 2. (reserved); --- Part 3. Hydroxyapatite and beta-tricalcium phosphate substitutes. This part is the third part of YY/T 1558. This part is drafted in accordance with the rules given in GB/T 1.1-2009. This section uses the translation method equivalent to ISO 13175-3.2012 "Surgical Implants Calcium Phosphate Part 3. Hydroxyapatite and Beta-tricalcium phosphate substitute. The documents of our country that have a consistent correspondence with the international documents referenced in this part are as follows. --- GB/T 16886.1-2011 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (ISO 10993-1.2009, IDT) GB/T 19077.1-2008 Part 1 . General rules for laser diffraction - Part 1 . General rules (ISO 13320-1..1999) --- GB 23101.3-2010 Surgical implants - Hydroxyapatite - Part 3. Chemical analysis and table of crystallinity and phase purity Expropriation (ISO 13779-3.2008, IDT) --- GB/T 21650.1-2008 Determination of pore size distribution and porosity of solid materials by mercury intrusion and gas adsorption - Part 1 Mercury method (ISO 15901-1.2005, IDT) 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 is proposed by the State Food and Drug Administration. This part is under the jurisdiction of the National Technical Committee for Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110). This section drafted by. Tianjin Medical Device Quality Supervision and Inspection Center, Shanghai Beiao Road Biomaterials Co., Ltd., South China Institute of Technology School of Materials Science and Engineering. The main drafters of this section. Lu Jianxi, Lu Wei, Yao Weiwei, Lin Kaili, Ma Chunbao, Jiang Xi, Wang Yingjun, Ren Li.

Introduction

Synthetic hydroxyapatite and beta-tricalcium phosphate substitutes are currently recognized as autologous bone and allogeneic bone graft substitutes. Synthetic material It can prevent infectious diseases from being transmitted to the affected patients. Moreover, hydroxyapatite and β-tricalcium phosphate materials show bone conduction at the bone implantation site. Use to promote bone healing on the surface of the material. Numerous studies have shown that hydroxyapatite and beta-tricalcium phosphate materials are biocompatible. This section covers three types of materials. single-phase hydroxyapatite, single-phase β-tricalcium phosphate and two-phase hydroxyapatite/β-tricalcium phosphate Substance. The ratio of hydroxyapatite/β-tricalcium phosphate affects the degradation rate of the material. The higher the content of β-tricalcium phosphate, the greater the degree of material degradation. The healing process of this type of bone substitute is not only related to the osteoconductivity of the material, but also to the porous structure of the material. Must be big enough The holes and internal connections allow the new bone to grow into the entire implant. Porosity also affects the absorption rate of the ceramic. The more the amount of micropores, the dissolution rate The higher. This type of bone substitute is not used for load bearing parts and mechanical strength is not necessary. However, most of the blocks need to be reshaped by the surgeon. The shape is adapted to the shape of the bone defect cavity, so the mechanical strength of the processing demand should be met. Surgical implant calcium phosphate Part 3. Hydroxyapatite and beta-tricalcium phosphate substitute

1 Scope

This part of YY/T 1558 specifies single-phase hydroxyapatite, single-phase β-tricalcium phosphate and two-phase hydroxyapatite/β-tricalcium phosphate blocks. Requirements for morphological and granular bone substitutes. This section does not apply to cell bone fillers, calcium phosphate cement or other bone fillings without hydroxyapatite and beta-tricalcium phosphate. material.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article. Pieces. For undated references, the latest edition (including all amendments) applies to this document. ISO 2591-1 -- Part 1 . screening test method using woven wire mesh and perforated metal sheets sieving-Part 1. Methodsusingtestsievesofwovenwireclothandperforatedmetalplate) ISO 10993-1 Biological evaluation of medical devices - Part 1. Evaluation and testing in the process of risk management (Biologicalevalu- ationofmedicaldevices-Part 1.Evaluationandtestingwithinariskmanagementprocess) ISO 13320 particle size analysis laser diffraction method (Particlesize analysis-Laserdiffractionmethods) ISO 13383-1 Fine ceramics (advanced ceramics, advanced process ceramics) - Microstructures - Part 1 . Grain size and particle size Determination of cloth [Fineceramics (advancedceramics, advancedtechnicalceramics)-Microstructuralcharacter- ization-Part 1.Determinationofgrainsizeandsizedistribution] ISO 13779-3 - Surgical implants - Hydroxyapatite - Part 3. Chemical analysis and characterization of crystallinity and phase purity (Implantsforsurgery-Hydroxyapatite-Part 3. Chemicalanalysisand characterizationofcrystalinity Andphasepurity) Determination of pore size distribution and porosity of solid materials by mercury intrusion and gas adsorption - Part 1 sizedistributionandporosityofsolidmaterialsbymercuryporosimetryandgasadsorption-Part 1. Mercuryporosimetry) ISO 80000-1 Quantity and Units Part 1. General (Quantitiesandunits-Part 1. General) 3 terms, definitions and symbols 3.1 Terms and definitions The following terms and definitions apply to this document. 3.1.1 Alpha-tricalcium phosphate α-TCP The crystal structure of the compound is in accordance with the International Diffraction Center Powder Diffraction Database (ICDD) PDF card 09-0348. Note. Its chemical formula is Ca3(PO4)2. 3.1.2 --tricalcium phosphate betatricalciumphosphate β-TCP The crystal structure of the compound conforms to the ICDD PDF card 09-0169. Note. Its chemical formula is Ca3(PO4)2. 3.1.3 Bone substitute bonesubstitute It is intended to fill products that cause bone defects caused by trauma or surgery. 3.1.4 Hydroxyapatite hydroxyapatite HA The crystal structure of the compound is consistent with the ICDD PDF card 09-0432 or 72-1243. Note. Its chemical formula is Ca10(PO4)6(OH)2. 3.1.5 Connecting hole interconnectedpore A hole that communicates with one or more holes. 3.1.6 Macro hole macropore A pore having a pore diameter greater than 10 μm. 3.1.7 Microporous micropore A hole having a pore diameter of not more than 10 μm. 3.1.8 Porosity porosity The ratio of the total pore volume to the volume of the bulk or granular product. 3.1.9 Tetracalcium phosphate tetracalciumphosphate TTCP The crystal structure characteristics of the compounds conform to the ICDD PDF card 25-1137 or 70-1379. Note. Its chemical formula is Ca4(PO4)2O. 3.1.10 Osteoconductive material osteoconductivematerial A material that provides a scaffold for adhesion, migration, proliferation, and differentiation of bone cells. Note. Bone conduction is a passive feature. 3.1.11 Calcium oxide CaO The crystal structure of the compound is consistent with the ICDD PDF card 4-0777 or 82-1690. 3.1.12 Β-tricalcium phosphate density β-tricalciumphosphatedensity dβ-TCP The theoretical density of the dense β-tricalcium phosphate was 3.07 g/cm 3 . 3.1.13 Hydroxyapatite density hydroxyapatitedensity dHA The theoretical density of the dense hydroxyapatite is 3.15 g/cm3. 3.2 symbol Dr. density of synthetic bone substitutes. Dth. theoretical density of synthetic bone substitutes. m. the quality of the synthetic bone substitute. V. volume of synthetic bone substitute.

4 requirements

4.1 Trace elements Table 1 shows the limit content of specific trace elements of hydroxyapatite and beta-tricalcium phosphate substitutes. Table 1 Limit content of specific trace elements The highest content of the element name/(mg/kg) Arsenic (As) 3 Cadmium (Cd) 5 Mercury (Hg) 5 Lead (Pb) 30 Total heavy metal 50 Methods for measuring trace elements include inductively coupled plasma/atomic emission spectroscopy (ICP/AES), inductively coupled plasma/mass Spectrometry (ICP/MS) and atomic absorption spectroscopy (AAS), or the method of quantification of trace elements specified in ISO 13779-3. Should be marked as used method. The heavy metal inspection method in the fourth part of the Pharmacopoeia of the People's Republic of China (2015 edition) can be used. Can also be quantified using one of the above methods Determine the trace element content and determine the total amount of heavy metals, that is, the sum of lead, mercury, arsenic, antimony, tin, cadmium, antimony, silver, copper and molybdenum. Should be marked as used method. Any impurities in excess of 1000 mg/kg should be identified and quantified to assess their effects on bone healing and in accordance with ISO 10993-1 The impact of biocompatibility is determined and evaluated. Any additional additives should be identified and quantified to assess their impact on bone healing. Impact on biocompatibility according to ISO 10993-1 Make determinations and assessments. 4.2 Crystal phase qualitative and quantitative determination 4.2.1 General The composition and phase purity should be quantified by X-ray diffraction (XRD) according to ISO 13779-3. 4.2.2 Single-phase hydroxyapatite bone substitute The hydroxyapatite content should not be less than 95% of the crystalline phase. The content of calcium oxide should not be higher than 1%. The formula for calculating the content of hydroxyapatite is shown in formula (1). MFHA=100%-MFβ-TCP-MFα-TCP-MFTTCP-MFCaO (1) In the formula. MFHA ---HA content; MFβ-TCP---β-TCP content; MFα-TCP---α-TCP content; MFTTCP---TTCP content; MFCaO ---CaO content. If the above phase content is below the detection threshold, the content should be considered zero. 4.2.3 Biphasic bone substitute The absolute value of the crystal phase content of the ratio of hydroxyapatite to β-tricalcium phosphate should be ±5%. For example, a 60% HA and 40% TCP combination can be composed of 65% HA and 35% TCP to 55% HA and 45% TCP. Qualitative determination of other crystalline phase contents. If α-tricalcium phosphate (α-TCP) is found, it should be indicated in the report. 4.2.4 Single-phase β-tricalcium phosphate substitute The content of β-tricalcium phosphate should not be lower than 95% of the crystalline phase. The formula for calculating the content of β-tricalcium phosphate is shown in formula (2). MFβ-TCP=100%-MFHA (2) If the HA content is below the detection threshold, the HA content should be considered zero. Qualitative determination of other crystal phases. If α-tricalcium phosphate (α-TCP) is found, it should be indicated in the report. If other crystal phases are present, they should be determined by infrared spectroscopy (FTIR) in accordance with ISO 13779-3. 4.3 Shape and size The physical shape of the bone substitute, such as granules or lumps, should be indicated. Product size specifications should be determined as follows. ---Block size; ---Particle size. The particle size is determined according to the laser diffraction method of ISO 13320 or the screening method of ISO 2591-1. Laser should be marked Diffraction method parameters D10, D50, D90 or screening method for particle minimum and maximum size. The volume of the bone substitute should be indicated on the package. 4.4 Porosity 4.4.1 Total porosity The minimum and maximum porosity of the bone substitute should be indicated and calculated according to equation (3). P=100%- Dr Dth ·100% ÷ (3) In the formula. P --- porosity, %; Dr --- Use a minimum volume of 2cm3 of cuboid bone substitute to determine its size and quality. The balance accuracy of the measured mass is 0.02g, the caliper accuracy of the measured size is at least 0.02mm. Volume of bone substitute (V) according to measured size The result is calculated. The calculation of dr is shown in equation (4). Dr= (4) For the calculation of dth, see equation (5). Dth= MFHA dHA MFHA dHA MFβ-TCP dβ-TCP ·dHA MFβ-TCP dβ-TCP MFHA dHA MFβ-TCP dβ-TCP ·dβ-TCP (5) If the particles are made by massive pulverization, the porosity of the particles should be detected by the above method before the block pulverization. If the particles are not crushed by blocks When made, the porosity of the particles should be measured by mercury intrusion. 4.4.2 Micropore and Macropore Dimensions 4.4.2.1 Micropores In order to meet the metallographic cutting of the material, the material can be cut after resin embedding. Determining the micro-aperture should be one of the methods described in ISO 13383-1 for micropores only, ie scanning electron microscopy of a section of the material The diameter of the micropores was measured in the sheet. When the holes are in contact with each other, an imaginary hole boundary should be drawn and the size measured. 4.4.2.2 Macro hole 4.4.2.2.1 General Determining the macropore aperture can be measured using Method A or Method B. 4.4.2.2.2 Method A. Scanning Electron Microscopy (SEM) In order to meet the metallographic cutting of the material, the material can be cut after resin embedding. Determining the macro aperture should be one of the methods described in ISO 13383-1 for macro holes only, ie scanning electron microscopy of a section of the material The diameter of the hole is measured in the sheet. When the holes are in contact with each other, an imaginary hole boundary should be drawn and the size measured. 4.4.2.2.3 Method B. Micro-focus CT detection Micro-focus CT can visually display three-dimensional structures (hole shape, wall thickness, uniformity and homogeneity), porosity and pore size distribution. Porosity is measured by three-dimensional analysis and calculation by measuring micro-focus CT images of several fields of view (FOV, diameter 3mm and height 1.5mm). The average and standard deviation of the porosity are obtained. The pore size distribution map is plotted by calculating the number of holes in each set of aperture ranges. Recommended image resolution The sample size was 5 mm in diameter and 10 mm in height, which was 6 μm/pixel. 4.4.3 Internal connection The holes should basically be open and interoperable. The internal connection diameter between the holes shall be determined in accordance with the pressure mercury method of ISO 15901-1. The principle of the method is to pressurize the mercury into the pores of the sample by changing the pressure. When the pressure is low, the mercury will pass through the larger internal connection, while the high pressure mercury Will pass through a smaller internal connection. The amount of mercury infiltrated into the sample is the volume of the communicating hole in the sample, and the applied pressure is closely related to the inner connecting diameter. Related. The main peak of mercury infiltration can determine the internal connection diameter, and the amount of all pores with an internal diameter greater than 5 μm should be determined. Microfocus CT images include 2D and 3D reconstructed images, which provide complementary information, especially in materials with a connection diameter greater than 100 μm When the mercury intrusion method is limited. Other accepted test methods can also be used for testing the inner connecting diameter. Specimens with a porosity tolerance greater than ±2% should be tested for the lowest and highest porosity samples. 4.5 Dissolution and pH changes Although the mechanism of external dissolution of bone substitutes is different from that of in vivo degradation, in vitro dissolution rates are still used to compare the body of different bone substitutes. Absorptive capacity. Significant changes in pH after implantation can impair bone conduction on the surface of the bone substitute. The purpose of the following test is to measure bone replacement The in vitro dissolution rate of the substance and the pH of the dissolution medium. The dissolution and dissolution rate of the material should be checked. Three bone substitute samples were placed at (37 ± 1) ° C and pH = 7.3 ± 0.1 TRIS buffer In the liquid, the shaker was loaded at a speed of.200 r/min for 24 h, 48 h and 72 h, respectively. The dissolution rate should be between the initial material mass and the dissolved medium body. The ratio of the mass of the test material to the volume of the dissolved medium should be 0.1 mg/mL to 4.0 mg/mL as measured under a constant ratio. The pH was measured after soaking for 0, 24 h, 48 h and 72 h, and the pH change should not exceed 0.3 of the initial value. The calcium content of the solution should be determined by ICP/AES or AAS or ICP/MS or ion probe methods, and the concentration and time should be plotted. Relationship lines. 4.6 Material mechanical strength measurement 4.6.1 General The mechanical strength of the bulk bone substitute should be measured by the ball indentation test (see Figure 1) and/or the compressive strength test (see Figure 2). The mechanical strength measurement of bone substitutes with high porosity (porosity ≥ 40%) should be tested by ball indentation. Although the compressive strength test can replace the ball indentation test, the high porosity material ball indentation test is a highly repetitive cycle test method. Description. 1---pressurized column; 2---sphere; 3---sample; 4---Base. Figure 1 Schematic diagram of ball indentation test Description. 1---pressurized column; 2---sample; 3--- base. Figure 2 Schematic diagram of compressive strength test Low porosity (porosity < 40%) bone substitute should be measured by compressive strength test. 4.6.2 Instruments, sampling and samples 4.6.2.1 Instrument 4.6.2.1.1 Testing machine The testing machine shall ensure that the compression force acting on the specimen is constant and that the maximum load applied can be recorded with an accuracy of To 1%. 4.6.2.1.2 Sphere A steel ball having a diameter of 9.52 mm was used as the indenter. 4.6.2.1.3 Pressurized column The steel of the sample pressurization column has a hardness of 300 HV or higher (≥30HRC), a thickness of at least 10 mm, and a surface area of at least a sample cross section. 4 times the face. The Ra roughness of the contact surface between the pressurized column and the sample does not exceed 0.40 μm, and the parallelism does not exceed 0.01 mm. The pressurized column of the ball indentatio......
Image     

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1558.3-2017_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1558.3-2017_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 1558.3-2017_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1558.3-2017_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.