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GB 9706.4-2009 English PDF

GB 9706.4-2009 English PDF

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GB 9706.4-2009: Medical electrical equipment -- Part 2-2: Particular requirements for the safety 0f high frequency surgical equipment

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Scope

This clause of the General Standard applies except as follows.
A requirement of this Particular Standard, replacing or modifying requirements of the
General Standard or Collateral Standards, takes precedence over the corresponding
General Requirement(s).

Basic Data

Standard ID GB 9706.4-2009 (GB9706.4-2009)
Description (Translated English) Medical electrical equipment -- Part 2-2: Particular requirements for the safety 0f high frequency surgical equipment
Sector / Industry National Standard
Classification of Chinese Standard C41
Classification of International Standard 11.040.30
Word Count Estimation 56,568
Date of Issue 2009-05-06
Date of Implementation 2010-03-01
Older Standard (superseded by this standard) GB 9706.4-1999
Adopted Standard IEC 60601-2-2-2006, IDT
Regulation (derived from) Announcement of Newly Approved National Standards No. 4, 2009 (No. 144 overall)
Issuing agency(ies) General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China
Summary This Chinese standard specifies the dedicated high-frequency surgical equipment and high frequency medical attachment security requirements, such equipment and accessories hereinafter referred to as high-frequency surgical equipment. Rated output power not exceeding 50 W high-frequency surgical equipment (such as micro- coagulation device, or for dental or ophthalmic devices) are excluded from some of the specific standard requirements, these exclusions specified in the relevant requirements.


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