|
US$209.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY 0839-2011: Microwave hyperthermia equipment
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY 0839-2011 | English | 209 |
Add to Cart
|
3 days [Need to translate]
|
Microwave hyperthermia equipment
| Valid |
YY 0839-2011
|
PDF similar to YY 0839-2011
Basic data | Standard ID | YY 0839-2011 (YY0839-2011) | | Description (Translated English) | Microwave hyperthermia equipment | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C42 | | Classification of International Standard | 11.040.60 | | Word Count Estimation | 9,997 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | GB/T 191-2008; GB 9706.1-2007; GB 9706.6-2007; GB 9706.15-2008; GB/T 14710-2009; YY 0505-2005; GB/T 16886.10; GB/T 16886.11; GB/T 16886.1; GB/T 16886.12; GB/T 16886.13; GB/T 16886.14; GB/T 16886.15; GB/T 16886.16; GB/T 16886.17; GB/T 16886.18; GB/T 16886.19; GB/T 16886.2; GB/T 16886.3; GB/T 16886.4; GB/T 16886.5; GB/T 16886.6; GB/T 16886.7; GB/T 16886.9 | | Adopted Standard | GB 9706.6-2007, MOD | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the terms and microwave hyperthermia device definition, classification and composition requirements, test methods, inspection rules, marking, packaging, transportation and storage. 3. 1 This standard applies to the definition of microwave hyperthermia equipment (hereinafter referred to as hyperthermia equipment), the hyperthermia device has a control wet function, suitable for clinical tumor adjuvant therapy. | YY 0839-2011: Microwave hyperthermia 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.
Microwave hyperthermia equipment
ICS 11.040.60
C42
People's Republic of China pharmaceutical industry standards
Microwave hyperthermia equipment
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Microwave hyperthermia equipment is a use of microwave heating of the tissue penetration of hyperthermia equipment. In order to standardize the technology and special products
, To ensure safety and efficacy, formulated industry standards, as a basis for production and quality control of products.
The standard safety requirements for full implementation of the GB 9706.1-2007 "Medical Electrical Equipment Part 1. General requirements for safety," the
Provisions.
This revised standard adopts GB 9706.6-2007 "Medical electrical equipment Part 2. requirements for the safety of microwave therapy equipment," the
Provisions.
The standards for electromagnetic compatibility requirements in accordance with YY 0505-2005 "Medical electrical equipment - Part 1-2. General requirements for safety tie
Standard. EMC requirements and tests "to run concurrently.
Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents.
If the requested material or structure in the form of equipment or components used in connection with the standards required by different, but if they can prove that it reaches the same
Requirements, which should be recognized.
This standard was proposed by the State Food and Drug Administration.
This standard by the national standardization of physical therapy equipment Medical Electrical Technical Committee of Standardization Technical Committee (SAC/TC10/SC4)
Centralized.
This standard was drafted. Tianjin, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, Xuzhou LEVANTINA medical equipment
Limited.
The main drafters of this standard. Yang Juan, Qili Jing, Han desert, Liu Bo, Wu Gang.
Microwave hyperthermia equipment
1 Scope
This standard specifies the terms and definitions microwave hyperthermia equipment, classification and composition requirements, test methods, inspection rules, marking, packaging, transport
Transport and storage.
3.1 This standard applies to the definition of microwave hyperthermia device (hereinafter referred to as hyperthermia equipment), the hyperthermia device has a temperature measurement and control functions for
Clinical tumor adjuvant therapy.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 191-2008 Packaging - Pictorial signs
GB 9706.1-2007 Medical electrical equipment - Part 1. General requirements for safety
GB 9706.6-2007 Medical electrical equipment Part 2. requirements for the safety of microwave therapy equipment
GB 9706.15-2008 Medical electrical equipment - Part 1-1. General requirements for safety Collateral standard. medical electrical systems security
Claim
GB/T 14710-2009 medical electrical environmental requirements and test methods
Biological evaluation of GB/T 16886 (all parts) Medical Devices
YY 0505-2005 Medical electrical equipment - Part 1-2. General requirements for safety Collateral standard. Electromagnetic compatibility requirements and tests
3 Terms and Definitions
GB 9706.1-2007 and GB 9706.6-2007 defined in the following terms and definitions apply to this document.
3.1
Use the operating frequency of 0.3GHz ~ 30GHz microwave source, the microwave energy propagation through the radiator and having a temperature measurement and control functions for
Therapy equipment neoplastic disease.
4 Classification and composition
4.1 Classification
Divided by the temperature measurement methods. continuous and intermittent temperature shutdown temperature. Intervention by temperature divided into. lossy and lossless temperature measurement temperature. Press temperature
Divided into. start/stop temperature control and adaptive power output temperature.
4.2 Composition
Hyperthermia equipment from the microwave source, radiators, couch (if applicable), temperature measurement and control system and other control system functions.
|