GB 9706.6-2007 English PDF

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GB 9706.6-2007: Medical electrical equipment -- Part 2: Particular requirements for the safety of microwave therapy equipment
Status: Obsolete

GB 9706.6: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB 9706.6-2007	599	Add to Cart	3 days	Medical electrical equipment -- Part 2: Particular requirements for the safety of microwave therapy equipment	Obsolete
GB 9706.6-1992	359	Add to Cart	3 days	Particular requirements for the safety of microwave therapy equipment	Obsolete

Similar standards

GB 9706.203   YY/T 1095   YY 0950   GB 9706.204   GB 9706.222   GB 9706.255   

Basic data

Standard ID: GB 9706.6-2007 (GB9706.6-2007)
Description (Translated English): Medical electrical equipment -- Part 2: Particular requirements for the safety of microwave therapy equipment
Sector / Industry: National Standard
Classification of Chinese Standard: C42
Classification of International Standard: 11.040.60
Word Count Estimation: 15,174
Date of Issue: 2007-07-02
Date of Implementation: 2008-07-01
Older Standard (superseded by this standard): GB 9706.6-1992
Adopted Standard: IEC 60601-2-6-1984, MOD
Regulation (derived from): China Announcement of Newly Approved National Standards No. 8, 2007 (No. 108 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 microwave therapy equipment requirements for the safety. This standard does not apply heat with special equipment.

GB 9706.6-2007: Medical electrical equipment -- Part 2: Particular requirements for the safety of microwave therapy 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.
Medical electrical equipment Part 2. Particular requirements for the safety of microwave therapy equipment ICS 11.040.60 C42 National Standards of People's Republic of China Replacing GB 9706.6-1992 Medical electrical equipment - Part II. requirements for the safety of microwave therapy equipment (IEC 60601-2-6. 1984, MOD) Posted 2007-07-02 2008-07-01 implementation Administration of Quality Supervision, Inspection and Quarantine of People's Republic of China Standardization Administration of China released

Table of Contents

Preface Ⅰ The first chapter Overview 1 1. Scope and purpose 1 2 Terms and definitions 1 3 2 General requirements 4 2 General test requirements 5 Category 2 6 Identification, marking and documents 2 7 Input Power 3 The second safety requirements 3 Third of the risk of electric shock protection 3 13 Overview 3 Requirements concerning classification of 14 3 15 voltage and (or) current limit 3 16 housing and shield 3 19 Continuous leakage currents and patient auxiliary current 4 20 Dielectric strength 4 Title IV of the mechanical hazards Protection 4 The fifth chapter of unwanted or excessive radiation hazard protection 4 29 X-ray radiation 4 30 α, β, γ, neutron radiation and other particle radiation 4 31 microwave radiation 4 36 Electromagnetic Compatibility 5 Title VI of the room within the medical risk of explosion protection 5 Title VII of the over-temperature fire and other hazards (such as human error) protection 5 42 overtemperature 5 Part VIII of the accuracy of the data and work on preventing incorrect output 6 The accuracy of the data work 50 6 51 pairs to prevent incorrect output of 6 Chapter 9. fault condition caused by overheating and (or) mechanical damage and environmental testing 6 Tenth Canto structural requirements 7 54 Overview 7 Housing 55 and cover 7 Appendix B manufacturing and testing (or) when installed 8 Appendix L of this portion of the IEC 60601-2-6. 1984 technical differences and their causes 9 Appendix AA Fundamentals 10

Foreword

Medical electrical equipment standard series of standards, the series of standards has two main parts. --- Part I. General requirements for safety of medical electrical equipment; --- Part II. medical electrical equipment requirements for the safety. The specific standard revise the International Electrotechnical Commission IEC 60601-2-6. 1984 "Medical electrical equipment --- Part 2. Microwave treatment Equipment requirements for the safety. " The main content modification includes the following two aspects, and identified in the text by a vertical line. Rated output power of microwave therapy equipment --- 51.2 shall not exceed 250W. Added "at the treatment site with temperature control equipment Unlimited. " --- 51.4 If the radiation is in direct contact with an area of 20cm2 or less, the microwave power can not exceed 25W. Added "for Tissue coagulation device is not so limited. " The specific standard replaces GB 9706.6-1992 "Medical electrical equipment requirements for the safety of microwave therapy equipment." The amendments and additions to the specific standard GB 9706.1-1995 "Medical electrical equipment Part 1. General requirements for safety" (hereinafter referred to as Common Criteria). The specific standard should apply in GB 9706.1-1995 "Medical electrical equipment Part 1. General requirements for safety" Supporting together. The specific requirements of the standard should take precedence over generic standards. No common standards consistent with this specific standard clauses and. General Standard for the increase reg numbered starting from 101. Appendix increased upper-case letters AA, BB and so on. The increased entry crown Lowercase letters aa), bb) and the like. Article corresponding principle stated in article number after the mark "". The specific standard Chapter 36 Electromagnetic compatibility and YY0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard electromagnetic compatibility requirements and tests "earlier implementation. Appendix B of this specific standard normative appendix; this specific standard Appendix L, Appendix AA are informative appendices. The specific criteria proposed by the State Food and Drug Administration. The specific standard is under the jurisdiction of the National Technical Committee of Standardization for medical appliances. The specific standard drafted by the State Food and Drug Administration of Tianjin Medical Device Quality Supervision and Inspection Center. The main drafters of this specific standard. Wu Gang, Duan Chuan Ying, Yang Juan, Yang Jian, Han desert. Medical electrical equipment - Part II. requirements for the safety of microwave therapy equipment The first chapter outlines This part of the GB 9706 modified using the International Electrotechnical Commission IEC 601-2-6. 1984 "Medical electrical equipment --- Part 2. Micro Wave therapy equipment requirements for the safety. "

1 Scope and purpose

Except for the following "common standards" in this chapter apply. 1.1 Scope increase. This standard specifies the special 2.1.101 defined microwave therapy equipment (hereinafter referred to as equipment) requirements for the safety. This standard does not apply to special heating equipment used.

2 Terms and definitions

Except for the following "common standards" in this chapter apply. 2.1.5 increase. Accessible part of the radiator and connected thereto cable or waveguide and their connectors. Increase definition. 2.1.101 Utilization frequency of the microwave radiation energy 0.3GHz ~ 30GHz treatment apparatus diseases. 2.1.102 Radiation is a directional antenna. For example, a two-electrode with a reflector, dipole or monopole antenna horn vibrator, etc. for suffering By topical application of microwave energy. 2.1.103 Model simulation apparatus for testing a patient. 2.12.101 1s obtained by averaging at least matches the load fed to the maximum power value. 2.12.102 Radiation to the patient and the treatment of space in Central Africa with microwave energy. 2.12.103 Usually divided into 50Ω and 75Ω matched load, when it replaced the radiator so that the radiator connecting cables or waveguides voltage standing wave ratio ......

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