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YY/T 1409-2016Plasma surgical equipment (English PDF)

等离子手术设备

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

March 23, 2016

Implementation date

January 1, 2017

Scope

YY/T 1409-2016 is the English-translated version of 等离子手术设备.

YY/T 1409-2016 is the Chinese pharmaceutical industry standard for plasma surgical equipment, the generator and handpieces that cut and coagulate tissue with a plasma arc.

It gives the terms and definitions, the composition of the equipment, the requirements, the test methods, the inspection rules, the marking and the rules for packaging, transport and storage, covering the output power and its accuracy, the gas flow, the electrodes and the handpiece, the alarms and interlocks, and the electrical safety and electromagnetic compatibility by reference to the general standards. Issued on 23 March 2016, it has applied since 1 January 2017.

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Document preview — YY/T 1409-2016

National Standard of the People's Republic of China

ICS: 11.040.60
Classification: C 42

Issued by: National Medical Products Administration of the People's Republic of China

Preface
1 Scope
2 normative reference document
3 Terms and definitions
4 Composition
5 request
6 Test Method
7 Inspection rules
8 logo, instruction manual
9 Packaging, transportation, storage

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

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 document. 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 Plasma surgical equipment

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.

Referenced standards

Normative references

Similar standards

YY/T 1706.1-2020

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