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YY 0677-2008

Search Result of Chinese Standard: 'YY 0677-2008'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY 0677-2008English179 Add to Cart Days<=3 Liquid nitrogen cryosurgical equipment Valid YY 0677-2008
YY 0677-2008Chinese14 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]

   
Detail Information of YY 0677-2008; YY0677-2008
Description (Translated English): Liquid nitrogen cryosurgical equipment
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C37
Classification of International Standard: 11.040.60
Word Count Estimation: 9,912
Date of Issue: 2008-10-17
Date of Implementation: 2010-06-01
Quoted Standard: GB 9706.1; GB/T 14710-1993; GB/T 16886.1; YY 0466-2003; YY 0678
Drafting Organization: Zhejiang Institute of Medical Devices
Administrative Organization: Hangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center
Regulation (derived from): SFDA [2008] No. 605
Proposing organization: State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center
Issuing agency(ies): China Food and Drug Administration
Summary: This standard specifies the liquid nitrogen cryosurgery therapy equipment scope, definitions and terminology, requirements, test methods, inspection rules and signs, labels, and packaging requirements. This standard applies to refrigerant liquid nitrogen, using its latent heat of vaporization of refrigerant, and the memory capacity of more than 1L of liquid nitrogen cryosurgery therapy equipment (hereinafter referred to as therapy equipment). Therapy equipment mainly produce cryogenic target tissue for freezing necrosis, frozen block, inflammatory response and frozen with adhesions.


YY 0677-2008
Liquid nitrogen cryosurgical equipment
ICS 11.040.60
C37
People's Republic of China pharmaceutical industry standards
Surgical treatment of liquid nitrogen refrigeration equipment
Posted 2008-10-17
2010-06-01 implementation
State Food and Drug Administration issued
Foreword
This standard and GB 9706.1 "Medical Electrical Equipment Part 1: General requirements for safety" and GB/T 14710-1993 "Medical Electrical
Environmental Equipment requirements and test methods "complementary used together.
This standard is proposed and managed by the State Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center.
This section drafted by: Institute of Medical Devices Zhejiang Province, Zhejiang Medical Device Testing.
The main drafters of this standard: Lv Weimin, Yinjian Bing, Turnbull, Sun Yu, Zhang Zhong Min, Mary.
Surgical treatment of liquid nitrogen refrigeration equipment
1 Scope
This standard specifies the range of liquid nitrogen cryosurgery therapy equipment, terminology and definitions, requirements, test methods, inspection rules and signs, labels,
Packaging requirements.
This standard applies to the refrigerant is liquid nitrogen, using its latent heat of vaporization cooling, and liquid nitrogen is greater than the memory capacity of cryosurgery treatment 1L
Spa equipment (hereinafter referred to as therapy equipment). Treatment equipment, mainly produce low temperature of the target tissue, necrosis for freezing, frozen block, and inflammation
Frozen with adhesions.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB 9706.1 Medical Electrical Equipment Part 1: General requirements for safety (GB 9706.1-2007, IEC 60601-1: 1988,
IDT)
GB/T 14710-1993 Medical electrical equipment environmental requirements and test methods
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing (GB/T 16886.1-2001,
idt ISO 10993-1:1997)
YY 0466-2003 medical equipment used with medical device labels, signs and symbols provide information (YY 0466-2003,
ISO 15223:2000, IDT)
YY 0678 medical treatment cryosurgery equipment performance and safety
Medical Devices brochures, packaging and labeling management and labeling provisions of the State Food and Drug Administration Decree No. 10
3 Terms and Definitions
YY 0678 established and the following terms and definitions apply to this standard.
3.1
Liquid into a gas absorption heat.
3.2
Pipeline transportation of liquid nitrogen.
3.3
Liquid nitrogen container treatment device storage.
3.4
Contact with body tissues cryotherapy probe.
3.5
Specially designed liquid nitrogen directly to the target tissue means.
Related standard:   YY 0678-2008  YY/T 0466.1-2016
   
 
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