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YY/T 1409-2016 English PDF

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YY/T 1409-2016: Plasma surgical equipment
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YY/T 1409-2016English179 Add to Cart 3 days [Need to translate] Plasma surgical equipment Valid YY/T 1409-2016

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Basic data

Standard ID YY/T 1409-2016 (YY/T1409-2016)
Description (Translated English) Plasma surgical equipment
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C42
Classification of International Standard 11.040.60
Word Count Estimation 9,934
Date of Issue 2016-03-23
Date of Implementation 2017-01-01
Regulation (derived from) Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies) State Food and Drug Administration

YY/T 1409-2016: Plasma surgical equipment

---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.
Plasma surgical equipment ICS 11.040.60 C42 People's Republic of China Pharmaceutical Industry Standard Plasma surgical equipment 2016-03-23 release 2017-01-01 Implementation State Food and Drug Administration issued Directory Preface I 1 Scope 1 2 normative reference document 1 3 Terms and definitions 1 4 Composition 1 5 request 2 6 Test Method 3 7 Inspection rules 4 8 logo, instruction manual 5 9 Packaging, transportation, storage 6

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Electrical Apparatus Standardization Technical Committee of Physiotherapy Equipment Subcommittee (SAC/TC10/SC4) centralized. The drafting unit. the State Food and Drug Administration Tianjin Medical Equipment Quality Supervision and Inspection Center, Fang Run medical equipment technology (Shanghai) Co., Ltd., Chengdu, a US Electronic Technology Co., Ltd. The main drafters of this standard. Liu Bo, Yang Guoyuan, mountain, Han desert, Qi Lijing. Plasma surgical equipment

1 Scope

This standard specifies the terms and definitions, composition, requirements, test methods, inspection rules, marking, packaging, transportation and Storage. This standard applies to the plasma surgical equipment (hereinafter referred to as "equipment") as defined in 3.1. For a multi-functional device, this standard Is only applicable to the plasma operation of the device and other functions of the device shall comply with the requirements of other relevant standards.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 191-2008 Packaging and storage icon (ISO 780..1997, MOD) GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety (IEC 60601-1. 1988, IDT) Medical electrical equipment - Part 2-2. Particular requirements for the safety of high - frequency surgical equipment (IEC 60601-2-2. 2006, IDT) GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety - Side standard. Medical electrical system safety (IEC 60601-1-1..2000, IDT) Environmental requirements and test methods for medical appliances GB/T 14710-2009 GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing in risk management (ISO 10993-1. 2009, IDT) Medical devices - Symbols for labeling, marking and providing information on medical devices - Part 1. Generic requirements for medical devices YY/T 0466.1-2009 (ISO 15223-1..2007, IDT) YY 0505-2012 Medical electrical equipment - Part 1-2. General requirements for safety - Parallel standards. Electromagnetic compatibility requirements and tests (IEC 60601-1-2..2004, IDT) General technical conditions for medical foot switch YY 91057

3 terms and definitions

GB 9706.1-2007 and GB 9706.4-2009 and the following terms and definitions apply to this document. 3.1 Including medical equipment, including related accessories. In the case of saline or Ringer's solution as perfusate, the device passes through the bipolar Electrode to the surgical site to release energy, the use of perfusion discharge of the plasma formed by the organization of cutting and solidification.

4 composition

The plasma surgical equipment consists of a host and an accessory, and the related accessories usually include. surgical accessory, foot switch and associated accessory equipment.

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