YY 0672.1-2008Endoscopic Instruments - Part 1: Trocars for Laparoscope Use (English PDF)
内镜器械 第1部分：腹腔镜用穿刺器
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
October 17, 2008
Implementation date
June 1, 2010
Scope
YY 0672.1-2008 is the English-translated version of 内镜器械 第1部分：腹腔镜用穿刺器.
YY 0672.1-2008 is the Chinese pharmaceutical industry standard for the trocar used in laparoscopy, the puncture instrument through which instruments enter the abdominal cavity.
It is the first part of the YY 0672 series on endoscopic instruments and specifies the classification and nomenclature, the requirements, the test methods, the inspection rules, the marking, the instructions for use and the rules for packaging, transport and storage, covering the dimensions of the cannula and the obturator, the sharpness of the point, the sealing valve and the gas tightness under pneumoperitoneum pressure, the corrosion resistance and the biological evaluation. Issued on 17 October 2008, it has applied since 1 June 2010.
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Document preview — YY 0672.1-2008
National Standard of the People's Republic of China
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Classification and nomenclature5
- 4 Requirements6
- 5 Test method7
- 6 Inspection rules9
- 7 Signs and instruction manual10
- 8 Packaging, transportation, storage11
- 9 Others11
- References12
1 Scope
This 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 references
The 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 Requirements
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 method
5.1 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 Signs and instruction manual
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, storage
8.1 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 Others
After 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.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 230.1-2004Metallic materials - Rockwell hardness test - Part 1: Test method
- GB/T 1220-2007Stainless steel bars
- GB/T 2828.1-2003Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
- GB/T 2829-2002Sampling procedures and tables for periodic inspection by attributes
- GB/T 4340.1-1999Metallic materials - Vickers hardness test - Part 1: Test method
- GB/T 16886.5-2003Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
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