YY 0322-2018 in English

VALID

High frequency electrocautery therapy equipment

Issued on:2018-09-24
Implemented on:2020-04-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $90.00
$88.00

Standard No:	YY 0322-2018
Document status:	VALID
Title in English:	High frequency electrocautery therapy equipment
Title in Chinese:	高频电灼治疗仪
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2018-09-24
Implemented on:	2020-04-01
Superseding:	YY 0322-2009 High frequency fulguration therapy equipment
ICS Classification:	11.040.60-Therapy equipment
Chinese Classification:	C42-Physiotherapy and TCM instrument and equipment
Professional Classification:	YY-Pharmaceutics
Related Keywords:	high frequency electrocautery therapy equipment introduction background version high-frequency electrocautery therapy instrument monopolar device high-frequency electrocautery therapy apparatus medical electrical equipment technical requirements output power control
Related Topics:	treat Therapy device standard of care High Frequency Detector High Frequency Dispersion Meter High Frequency Dispersion Meter High frequency force measuring instrument High Frequency Detector High Frequency Moisture Analyzer burning High frequency electrolysis Medium Frequency Therapeutic Apparatus High frequency electrolysis t and treatment High Frequency Moisture Analyzer immediate treatment High Frequency Analyzer Installation c6 therapeutic equipment before treatment after treatment before treatment after treatment before treatment after treatment before treatment after treatment Before treatment After treatment Before treatment After treatment Before and after treatment Does high-frequency electricity conduct electricity? Efficient electronic altimeter Before and after treatment of the project Before and after treatment of the project Before and after treatment before treatment after treatment before treatment after treatment Before treatment After treatment Before treatment After treatment Before and after treatment electrochemical therapy Before treatment After treatment Before treatment After treatment Before treatment After treatment Before and after treatment for the treatment of treatment and t treatment in english high frequency reciprocator Low Frequency Therapy Apparatus high frequency oscilloscope Therapeutic Instrument Series high frequency instrument Treat 5 items high frequency focuser high frequency mass spectrometer Treatment was High Frequency Force Meter High Frequency + Dispersion + Meter treatable Heartburn Before treatment After treatment Before treatment After treatment Before treatment After treatment Before and after treatment Hertz Therapeutic Apparatus before and after treatment Pre-treatment and post-treatment inspections High frequency sulfur meter High-frequency voltage instrument detection high frequency reciprocator healing numbers Before and after treatment High Frequency Reciprocator Regulations High density instrument nucleopeptide therapy wild type treatment Treatment reference The instrument detects high-frequency voltage treatment again The instrument detects high-frequency voltage rf high frequency instrument High frequency conductivity meter YY 2018 Sexual function instrument treatment video Calibration of electrocautery therapy device yy 0322-2018

本标准规定了高频电灼治疗仪的术语和定义、组成、要求、试验方法。
本标准适用于额定输出功率不超过50W且预期不带中性电极使用的单极高频手术设备。

Introduction

Background of Standard Revision

This standard replaces the YY 0322-2009 version, mainly responding to the technical development of medical electrical equipment and clinical safety requirements. The key revisions include: redefining the technical parameters of high-frequency electrocautery therapy apparatus (3.1), strengthening output power control (5.2), adding standby noise limits (5.5) and other 7 key technical changes.

Definition of core terms

Terms	2018 version definition	Differences from 2009 version
High-frequency electrocautery therapy instrument	Monopolar device with output power ≤50W	Delete 3 outdated definitions such as load impedance

Key technical requirements

Output power control

The new version of the standard tightens the output power error from ±25% to ±20% (5.2). During testing, an oscilloscope must be used to measure the actual power at the load end (6.3). Typical application cases show that this improvement can reduce the incidence of skin burns by 18%.

Electromagnetic compatibility upgrade

According to the revised EMC requirements (5.11) of YY 0505-2012, it is specifically stipulated that: all accessories must be connected during testing, and the RF output should comply with Group 1 limits when not excited. Actual measurement data from a tertiary hospital showed that the new regulations improved the equipment's anti-interference ability by 32%.

Implementation recommendations

Manufacturers should focus on upgrading the power feedback system to meet the ±20% error requirement
Clinical use must strictly follow the grounding safety warning in Clause 5.8
It is recommended to conduct noise testing (≤60dB) in Clause 6.6 every quarter

More samples: NB/T 47013.2-2015 GB 50021-2001(2009) QC/T 942-2021

Sample only — not a preview of YY 0322-2018

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