GB/T 25440.2-2021 English PDFUS$459.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 25440.2-2021: Retrieval and analysis of surgical implants - Part 2: Analysis of retrieved surgical implants Status: Valid GB/T 25440.2: Historical versions
Basic dataStandard ID: GB/T 25440.2-2021 (GB/T25440.2-2021)Description (Translated English): Retrieval and analysis of surgical implants - Part 2: Analysis of retrieved surgical implants Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C45 Word Count Estimation: 25,269 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 25440.2-2021: Retrieval and analysis of surgical implants - Part 2: Analysis of retrieved surgical implants---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. Retrieval and analysis of surgical implants - Part 2.Analysis of retrieved surgical implants ICS 11.040.40 C45 National Standards of People's Republic of China Replace GB/T 25440.2-2010, GB/T 25440.3-2010, GB/T 25440.4-2010 Removal and analysis of surgical implants Part 2.Analysis of removal of surgical implants (ISO 12891-2.2020, MOD) Released on 2021-11-26 2022-12-01 implementation State Administration for Market Regulation Issued by the National Standardization Management Committee Table of contentsForeword Ⅲ Introduction Ⅳ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Take-out, handling and packaging procedures 1 5 Implant interface analysis 2 6 Implant analysis 2 7 Implant performance 5 Appendix A (Normative Appendix) Standard format for the analysis of removal of surgical implants 6 Appendix B (informative appendix) International standards applicable to material evaluation 14 Reference 18ForewordGB/T 25440 "Removal and Analysis of Surgical Implants" is divided into two parts. ---Part 1.Take out and handle; ---Part 2.Analysis of the removal of surgical implants. This part is Part 2 of GB/T 25440. This part was drafted in accordance with the rules given in GB/T 1.1-2009. This part replaces GB/T 25440.2-2010 "Removal and Analysis of Surgical Implants Part 2.Removal of Metal Surgical Implants" Analysis", GB/T 25440.3-2010 "Removal and Analysis of Surgical Implants Part 3.Analysis of Removal of Polymer Surgical Implants" and GB/T 25440.4-2010 "Removal and Analysis of Surgical Implants Part 4.Analysis of Removal of Ceramic Surgical Implants", and GB/T Compared with 25440.2-2010, in addition to editorial changes, the main technical changes are as follows. ---Added the performance test about taking out polymer and ceramic implants (see 6.5.2.3, 6.5.2.4, A.3 and A.4); --- Modified the scope of application, adding "This section also applies to other materials, such as animal-derived implants" (see Chapter 1). This part uses the redrafting method to modify and adopt ISO 12891-2.2020 ``Removal and Analysis of Surgical Implants Part 2.Removal Analysis of Surgical Implants. This section has made the following editorial changes. ---Delete the references to laws and regulations in the scope (see Chapter 1 in ISO 12891-2.2020) to comply with the compilation of Chinese standards Write rules; --- Modify the scope of "Analysis is divided into three stages based on the increase in the degree of damage to the removal of surgical implants" to the form of "Note"; ---Adjust the content of 6.1 Note 1 in ISO 12891-2.2020 to the main text. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying these patents. This part was proposed by the State Drug Administration. This part is under the jurisdiction of the National Standardization Technical Committee for Surgical Implants and Orthopaedic Devices (SAC/TC110). Drafting organizations of this section. Tianjin Medical Device Quality Supervision and Inspection Center, Medical Device Technology Review under the State Drug Administration Xin, Beijing Natong Medical Science and Technology Research Institute Co., Ltd., Trauson Medical Devices (China) Co., Ltd. The main drafters of this section. Li Yuan, Zhang Chen, Min Yue, Dong Lihua, Dong Xiang, Li Mei, Chen Changsheng, Yang Qun. The previous releases of the standards replaced by this part are as follows. ---GB/T 25440.2-2010; ---GB/T 25440.3-2010; ---GB/T 25440.4-2010.IntroductionThe study of removing surgical implants and adjacent tissues has diagnostic value for clinical complications, and can deepen the performance and safety of clinical implants. A comprehensive understanding to improve the understanding of the interaction between implants and the human body, thereby promoting the development of implants with better biocompatibility. High service life. This section stipulates that surgical implants and related samples taken from the patient’s body should be taken during revision surgery or autopsy. Methods of output, processing and analysis. The purpose is to provide a guideline to avoid unclear research results due to sample damage, and Provide guidance on collecting data at the right time and environment. GB/T 25440.1-2021 involves taking out and handling. This section deals with specific materials Analysis of implants, and report programs including data collection. For special research projects, more detailed plans need to be attached. If make With special analysis techniques, it is important to specify the steps. This section specifies the analytical methods for removing surgical implants to ensure that the implants are not damaged, and to determine typical research methods. The source of the research results are compared. These methods may be suitable for removal and analysis of animals. This section provides comprehensive inspection items for all aspects of surgical implants. But in most cases only a small part of these inspection items The points are applicable to the research of specific surgical implants. GB/T 25440.1-2021 specifies the method of removal and disposal, and is applied to this section. Appendix to GB/T 25440.1-2021 A and Appendix C include sample reports of data related to the retrieval process. These examples are not repeated in this section. According to the removed surgical implant Entry, attachment and accompanying biological materials, as well as the purpose of removal and analysis, can be deleted and added. Removal and analysis of surgical implants Part 2.Analysis of removal of surgical implants1 ScopeThis part of GB/T 25440 specifies the analytical method for removing surgical implants. This section applies to the analysis of metal, polymer and ceramic implants taken out. Note. The analysis is divided into three stages based on the increase in the degree of damage to the removal of surgical implants. This section also applies to other materials, such as animal-derived implants.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 reference documents, the latest version (including all amendments) is applicable to this document. GB/T 25440.1-2021 Removal and analysis of surgical implants Part 1.Removal and handling (ISO 12891-1.2015, IDT)3 Terms and definitionsThe following terms and definitions apply to this document. ISO and IEC provide a database of terminology used in the standard at the following websites. 3.1 Surgical implant Implant Medical devices that are expected to be implanted into the human body with surgical techniques. Note 1.Hereinafter referred to as "implant". Note 2.The implant can be a single component or multiple components. 4 Unloading, handling and packaging procedures The procedures for removal, handling, packaging and related personnel protection shall be in accordance with GB/T 25440.1-2021. As a preventive measure, the removed implant should be sterilized by an appropriate method, which should not adversely affect the implant and the anticipated research. ring. For appropriate measures, see 3.8 in GB/T 25440.1-2021. During the removal process of the implant, any difficulties and the description of the damage caused during the removal process should be included in the report. In the report. The cleaning solution (see Table 1 in GB/T 25440.1-2021) may react with the material, such as corrosion or dissolution, the choice of solution should be Minimize this risk. If possible, take pictures of the surgical area before removing the implant. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 25440.2-2021_English be delivered?Answer: Upon your order, we will start to translate GB/T 25440.2-2021_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 GB/T 25440.2-2021_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 25440.2-2021_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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