YY/T 1846-2022Endoscopic surgical instruments-Reusable abdominal suction and irrigation tubes (English PDF)
内窥镜手术器械 重复性使用腹部冲吸器
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
May 18, 2022
Implementation date
June 1, 2023
Scope
YY/T 1846-2022 is the English-translated version of 内窥镜手术器械 重复性使用腹部冲吸器.
YY/T 1846-2022 is the Chinese pharmaceutical industry standard for the reusable abdominal suction and irrigation instrument used in laparoscopic surgery to wash the field and remove the waste fluid.
It sets the structure and the materials, the requirements and the test methods, the type inspection rules, and the labels, instructions, packaging, transport and storage, covering the tubes and the handle, the flow of irrigation and suction, the tightness and strength of the connections, the corrosion resistance and the ability of the instrument to be cleaned and sterilized repeatedly. Issued on 18 May 2022, it has applied since 1 June 2023.
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Document preview — YY/T 1846-2022
National Standard of the People's Republic of China
- Classification
- C 31
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Structure and materials
Foreword
This 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.
1 Scope
This document specifies the structure, materials, requirements, test methods, type inspection, Labels, instructions, packaging, transportation and storage.
This document is suitable for lavage and suction (waste fluid) in laparoscopic surgery to ensure a clear surgical field and a clean cavity.
2 Normative references
The 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 16886 (all parts) Biological evaluation of medical devices
YY/T 0149-2006 Test method for corrosion resistance of stainless steel medical devices
YY/T 0294.1-2016 Metal Materials for Surgical Instruments Part 1: Stainless Steel
3 Terms and Definitions
There are no terms and definitions that need to be defined in this document.
4 Structure and materials
4.1 Structure and Identification
4.1.1 The insufflator usually consists of an insufflation tube and a handle. The handle usually has a handle type and a button type, and the main components of the handle type handle are connected.
Head, valve body, water outlet and water inlet; the main components of the button handle are water inlet valve, water outlet valve, valve body, water outlet and water inlet.
See Figure 1, Figure 2 and Table 1, Table 2 for the structure type, specifications and basic dimensions of the suction device. Index number description. 1---Rinse the straw; 2---connector; 3--- valve body; 4---water outlet; 5---water inlet;
6 --- side hole; Phi --- the outer diameter of the straw; L --- the working length of the straw; D1---outer diameter of water inlet interface; D2---Outer diameter of water outlet.
Figure 1 Schematic diagram of the structure of the handle-type aspirator
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.10-2024 — Biological evaluation of medical devices - Part 10: Tests for skin sensitization
GB/T 16886.11-2021 — Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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