YY/T 1814-2022 English PDFUS$219.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1814-2022: Implants for surgery - Synthetic non-absorbable patch - Hernia repair patch Status: Valid
Basic dataStandard ID: YY/T 1814-2022 (YY/T1814-2022)Description (Translated English): Implants for surgery - Synthetic non-absorbable patch - Hernia repair patch Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C35 Word Count Estimation: 10,121 Issuing agency(ies): State Drug Administration YY/T 1814-2022: Implants for surgery - Synthetic non-absorbable patch - Hernia repair patch---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 - Synthetic non-absorbable patch - Hernia repair patch ICS 11.040.40 CCSC35 People's Republic of China Pharmaceutical Industry Standard Synthetic Nonabsorbable Patches for Surgical Implants hernia repair patch Published on 2022-05-18 2023-06-01 Implementation Released by the State Drug Administration directory Preface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Technical requirements 1 5 Inspection method 3 6 Identification requirements6 7 Packaging, transport and storage 6 Reference 7 forewordThis document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" drafted. Please note that some content of this document may be patented. The issuing agency of this document assumes no responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Technical Committee on Standardization of Surgical Implants and Orthopedic Devices (SAC/TC110). This document is drafted by. China National Institute for Food and Drug Control. The main drafters of this document. Wang Jian, Liu Li, Tang Jinglong, Feng Xiaoming, Shi Qi, Wang Chunren. Synthetic Nonabsorbable Patches for Surgical Implants hernia repair patch1 ScopeThis document specifies terms and definitions, requirements, test methods, packaging, marking, transportation and storage requirements for hernia repair mesh products. This document applies to hernia repair meshes processed from synthetic non-absorbable materials (eg. polypropylene, polyester, polyvinylidene fluoride, etc.).2 Normative referencesThe contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document. GB/T 3917.2 Tear properties of textile fabrics - Part 2.Determination of tear strength of trouser-shaped specimens (single seam) GB/T 3923.1 Tensile properties of textile fabrics - Part 1.Determination of breaking strength and elongation at break (strip method) GB/T 14233.1-2008 Test methods for medical infusion, blood transfusion and injection equipment - Part 1.Chemical analysis methods GB/T 14233.2-2005 Test methods for medical infusion, blood transfusion and injection equipment - Part 2.Biological test methods GB/T 16886 (all parts) Biological evaluation of medical devices YY/T 0313 Requirements for medical polymer product packaging and information provided by manufacturers YY/T 0500-2021 Cardiovascular Implants, Vascular Prostheses, Tubular Vascular Grafts and Vascular Patches Pharmacopoeia of the People's Republic of China (2020 Edition)3 Terms and Definitions3.1 hernia Any organ or tissue that leaves its original location through a normal or abnormal congenital or acquired weakness, defect or hole in the human body into another area. 3.2 synthetic material hernia repair herniarepair Synthetic material is used as a patch to strengthen the weak point or defect and porosity of the hernia, which overcomes the traditional surgery (that is, no need to repair the hernia). The suture repair method of the slice) interferes with the normal tissue anatomical structure, and the layers are distinct. 3.3 non-absorbablematerial Materials that are not absorbed by the human body after implantation (currently commonly used clinically polypropylene, polyester, polyvinylidene fluoride, etc.).4 Technical requirements4.1 Physical Properties 4.1.1 Appearance There should be no stains or foreign matter, no tear marks, abrasions, particles. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1814-2022_English be delivered?Answer: Upon your order, we will start to translate YY/T 1814-2022_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 1814-2022_English with my colleagues?Answer: Yes. 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