YY 0672.1-2008 PDF EnglishUS$170.00 · In stock · Download in 9 seconds
YY 0672.1-2008: Endoscopic instruments. Part 1: Trocars for laparoscope use Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Obsolete
Similar standardsYY 0672.1-2008: Endoscopic instruments. Part 1: Trocars for laparoscope use---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/YY0672.1-2008YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.30 C 31 Endoscopic instruments - Part 1: Trocars for laparoscope use ISSUED ON: OCTOBER 17, 2008 IMPLEMENTED ON: JUNE 01, 2010 Issued by: China Food and Drug Administration Table of ContentsForeword ... 3 1 Scope ... 4 2 Normative references ... 4 3 Classification and nomenclature ... 5 4 Requirements ... 6 5 Test method ... 7 6 Inspection rules ... 9 7 Signs and instruction manual ... 10 8 Packaging, transportation, storage ... 11 9 Others ... 11 References ... 12 Endoscopic instruments - Part 1: Trocars for laparoscope use1 ScopeThis part of YY 0672 specifies the classification and nomenclature, requirements, test methods, inspection rules, signs, instructions for use, packaging, transportation, storage of endoscopic instruments - trocars for laparoscope use. This part applies to the trocars for laparoscopy (hereinafter referred to as the trocar), which is used in conjunction with endoscopes, to puncture human tissues and establish abdominal channels, during endoscopic surgery.2 Normative referencesThe provisions in following documents become the provisions of this Part of YY 0672 through reference in this Part. For the dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this Part; however, parties who reach an agreement based on this Part are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies. GB/T 230.1-2004 Metallic Rockwell hardness test - Part 1: Test method (scales A, B, C, D, E, F, G, H, K, N, T) (ISO 6508.1:1999, MOD) GB/T 1220-2007 Stainless steel bars GB/T 2828.1-2003 Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (ISO 2859.1:1999, IDT) GB/T 2829-2002 Sampling procedures and tables for periodic inspection by attributes (Apply to inspection of process stability) GB/T 4340.1-1999 Metallic materials - Vickers hardness test - Part 1: Test method GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity (ISO 10993-5:1999, IDT) GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10: 4.5.2 The air choke valve of the trocar shall have good air choke performance; less than 20 bubbles shall emerge under the pressure of 4 kPa. 4.6 Hardness The tip end of the puncture needle shall be heat-treated. The hardness of the blade is 330 HV0.2 ~ 420 HV0.2, when using 05Cr17Ni4Cu4Nb material; it is 40 HRC ~ 48 HRC, when using 20Cr13 material; it is 47 HRC ~ 53 HRC, when using 30Cr13 and 32Cr13Mo materials. 4.7 Surface roughness The surface of the trocar can be treated to be shiny or dull; the maximum surface roughness Ra shall be no greater than 0.4 μm, if having shiny surface; it shall be not greater than 0.8 μm, if having dull surface; it shall be not more than 6.3 μm in the unpolished part. 4.8 Corrosion resistance The corrosion resistance of the trocar shall comply with the requirements of grade 5.4b in YY/T 0149-2006. 4.9 Biocompatibility 4.9.1 The cytotoxicity of the trocar shall not be greater than grade 1. 4.9.2 The delayed hypersensitivity reaction (sensitization) of the trocar shall not be greater than grade 1. 4.9.3 The intradermal response score of the trocar shall not exceed 1.5 Test method5.1 Basic dimensions When testing with general-purpose measuring tools or special-purpose measuring tools, it shall comply with the provisions of 4.1. 5.2 Appearance When observed by eye and touched by hand, it shall meet the requirements of 4.2. 5.3 Flexibility When checked by hands feeling, through imitation of the use action, it shall comply with the provisions of 4.3. 5.4 Matching test 5.4.1 Insert and pull out the puncture needle in the cannula three times, by imitating the action of use. It shall meet the requirements of 4.4.1. 5.4.2 Use general-purpose measuring tools or special measuring tools for testing. It shall meet the requirements of 4.4.2. 5.4.3 When using visual observation, it shall meet the requirements of 4.4.3. 5.5 Tightness and gas barrier test 5.5.1 Close the air injection valve of the trocar. Block the air hole at the end of the puncture needle. Then apply a 4 kPa pressure gas from the head end of the trocar. Immerse the trocar in water for 1 min. It shall comply with the requirements of 4.5.1. 5.5.2 Close the air injection valve of the trocar. Block the air hole at the end of the puncture needle. Then apply a 4 kPa pressure gas, from the head end of the trocar. Immerse the trocar in water. Pull out the puncture needle. Hold for 1 min. It shall meet the provisions of 4.5.2. 5.6 Hardness test It is carried out according to the method specified in GB/T 230.1 or GB/T 4340.1. Measure three points on the heat-treated surface. Take the arithmetic mean of the three points, which shall meet the requirements of 4.6. 5.7 Surface roughness test Make measurement by sample block comparison or electrical measurement. It shall comply with the provisions of 4.7. The quality arbitration shall be carried out by electrical measurement. 5.8 Corrosion resistance It is carried out according to the boiling water test method in YY/T 0149. It shall meet the requirements of 4.8. 5.9 Biocompatibility 5.9.1 It is carried out according to the method of direct contact test in 8.3 of GB/T 16886.5-2003, which shall meet the requirements of 4.9.1. 5.9.2 It is carried out according to the maximum dose test method of 7.4 in GB/T 16886.10-2005, which shall meet the requirements of 4.9.2. 5.9.3 It is carried out according to the intradermal reaction test method in 7.1.1 Each set of trocars shall have the following marks, as specified in YY/T 1052: a) The name or trademark of the manufacturer; b) Product batch number or serial number. 7.1.2 The certificate of conformity shall comply with the provisions in 4.3 of YY/T 0171-2008. 7.1.3 The packaging box sign shall comply with the provisions in 4.1.1 of YY/T 0171-2008. 7.2 Instruction manual The contents of the instruction manual shall comply with the provisions in Chapter 5 of YY/T 0171-2008.8 Packaging, transportation, storage8.1 Packaging 8.1.1 Each set of trocars shall be put into a neutral plastic bag. The bag shall have an inspection certificate. Several trocars of the same type and specification shall be put into the packing box. 8.1.2 If there are any special requirements, it can be packaged according to the order contract. 8.2 Transportation Packing and transportation requirements are as specified in the order contract. 8.3 Storage The packaged trocar shall be stored in a clean and well-ventilated room, which has a relative humidity not exceeding 80% AND no corrosive gas.9 OthersAfter the trocar is packaged, it shall be guaranteed that it will not rust within one and a half years, under the condition that the storage rules are followed. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. 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