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YY/T 0842-2011 English PDF

YY/T 0842-2011_English: PDF (YY/T0842-2011)
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YY/T 0842-2011English150 Add to Cart 0--9 seconds. Auto-delivery Medical endoscopes - Endoscope accessories - Sheaths Valid YY/T 0842-2011


BASIC DATA
Standard ID YY/T 0842-2011 (YY/T0842-2011)
Description (Translated English) Medical endoscopes - Endoscope accessories - Sheaths
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C40
Classification of International Standard 11.040.99
Word Count Estimation 8,847
Date of Issue 2011-12-31
Date of Implementation 2013-06-01
Quoted Standard GB/T 16886.1; YY/T 0419-2066
Adopted Standard ISO 8600-1-2005, NEQ
Drafting Organization Hangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center
Administrative Organization National Standardization Technical Committee of Medical optics and instruments
Regulation (derived from) State Food and Drug Administration Notice No. 106 of 2011
Proposing organization State Food and Drug Administration
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the mirror tip of the requirements, test methods. This standard applies to medical purposes for human use an endoscope sheath mirror.


YY/T 0842-2011 YY ICS 11.040.99 C 40 PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE'S REPUBLIC OF CHINA Medical endoscopes – Endoscope accessories - Sheaths (ISO 8600-1.2005, Optics and photonics - Medical endoscopes and endotherapy devices - Part 1. General requirements; ISO 8600-4.1997, Optics and optical instruments - Medical endoscopes and certain accessories - Part 4. Determination of maximum width of insertion portion, NEQ) ISSUED ON. DECEMBER 31, 2011 IMPLEMENTED ON. JUNE 01, 2013 Issued by. China Food and Drug Administration Table of Contents Foreword ... 3  1 Scope ... 4  2 Normative references ... 4  3 Terms and definitions ... 4  4 Requirements... 5  5 Test methods ... 8  6 Inspection rules ... 10  Foreword This Standard is drafted in accordance with the rules given in GB/T 1.1-2009. The Standard is established under the title of “Medical endoscopes - Endoscope accessories”. This Standard not-equivalently adopts the international standards ISO 8600-1.2005 “Optics and photonics - Medical endoscopes and endotherapy devices - Part 1. General requirements” and ISO 8600-4.1997 “Optics and optical instruments - Medical endoscopes and certain accessories - Part 4. Determination of maximum width of insertion portion”. Please note that some of the content of this document may involve patents. The issuing agency of this document does not undertake the responsibility for the identification of these patents. This Standard was proposed by the China Food and Drug Administration. The Standard shall be under the jurisdiction of the National Standardization Technical Committee on Medical Optical Instruments (SAC/TC 103/SC 1). Drafting organizations of this Standard. Hangzhou Quality Supervision and Inspection Center on Medical Device under State Food and Drug Administration, Zhejiang Institute for the Control of Medical Device. Main drafters of this Standard. Yan Qinglai, Jia Xiaohang, Zhang Xinyuan. Medical endoscopes – Endoscope accessories – Sheaths 1 Scope This Standard specifies the requirements and test methods of sheaths. This Standard applies to sheaths for the insertion of medical endoscopes. 2 Normative references The following documents are essential for the application of this document. For all dated reference documents, only the dated versions are applicable to this document. For all undated reference documents, the latest versions (including all modifications) are applicable to this document. GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing within a risk management process (ISO 10993-1.2009, IDT) YY/T 0149-2006 Medical instruments of stainless steel - Test methods of corrosion resistance (ISO 13402.1995, MOD) 3 Terms and definitions The following terms and definitions apply to this document. 3.1 Endoscope accessory Optional accessories that are necessary and/or suitable to be used with endoscopes, to achieve the intended use of endoscopes, or to provide convenience for the intended use of endoscopes, or to improve the intended use of endoscopes, or to increase the additional use of endoscopes. 3.2 Sheath External inserting pipes for guiding endoscopes or endotherapy devices. 3.3 Main channel A part of sheaths. Endoscopes or endotherapy devices are required to be inserted through this part. 3.4 Minimum main channel width Minimum internal width of the channel of endoscopes or endotherapy devices. 3.5 Insertion portion A part of sheaths, which can be inserted into natural channels or surgical incisions of human bodies. 3.5.1 Working length Maximum length of sheath's insertion portion. 4 Requirements 4.1 Materials 4.1.1 Chemical composition of metal materials Manufacturers of the metal materials that directly or indirectly contact with patients shall explicitly indicate in any possible form, wherein the metal materials shall be marked with grades and/or code as well as the requirements for materials' chemical composition. The chemical composition of metal materials shall be verified by tests. 4.1.2 Biological compatibility Materials that directly or indirectly contact with patients shall be conducted with biological safety evaluation in accordance with the principles and requirements in GB/T Sheaths and endoscopes or scope mounts or obturators shall meet the following requirements after mounting. a) the positioning shall be reliable and has no loosening after full insertion; b) except for no sealing requirement claimed by the manufacturer, the sealing after full insertion shall be in a good condition. The water seeped shall not exceed more than 5 drops within 1 min when performing water permeability test. 4.4 Connection Every connecting portion involving sheaths shall be connected by tight mounting method, the mounting area shall be no visible cracks; if it is connected by welding, the welding seam shall be no unevenness, loose weld, bead weld or apparent pitting; if it is connected by gluing, the gluing area shall be no effusion or apparent heaping glue, other parts shall be no flow trance of glue. 4.5 Outer surface quality of insertion portion Except for special purpose, there shall be nothing that may cause injury on the insertion portion. 4.6 Water-passing and/or air-passing functions 4.6.1 Water-passing and/or air-passing ducts If the sheath has water-passing and/or air-passing functions, there shall be no impurities in water-passing and/or air-passing ducts, and water-passing and/or air- passing processes shall be smooth. 4.6.2 Water-passing and/or air-passing connectors If the sheath has water-passing and/or air-passing functions, the manufacturer shall provide the specification of water-passing and/or air-passing connectors. Water- passing and/or air-passing connectors of sheath shall meet the requirements of this specification or relevant standards applicable for this specification. 4.7 Tolerance (applicable for non-disposable products) After the following tolerance tests, the sheath shall still be able to meet the requirements of 4.3. a) High-pressure and high-temperature resistance Sheaths with high-pressure and high-temperature resistance shall be able to 5.6 Water-passing and/or air-passing functions 5.6.1 Water-passing and/or air-passing ducts VERIFY by visual observation and water-passing and air-passing operations. 5.6.2 Water-passing and/or air-passing connectors MEASURE according to the method specified in the relevant standards applicable for connector specification. 5.7 Tolerance test 5.7.1 High-temperature and high-pressure resistance test After performing 20 times of high-temperature and high-pressure resistance test (the test conditions are in accordance with the specification in manufacturer's instruction manual), the result shall still meet the requirements of 4.3. 5.7.2 Corrosion resistance test The portion uses stainless steel material shall be tested according to the boiling water test method in YY/T 0149-2006, the result shall meet the requirements of 4.7 b). Other materials shall be processed according to the sterilization method specified by the manufacturer in the instruction manual, there shall be no corrosion, and the result shall still meet the requirements of 4.3. 6 Inspection rules Inspection rules are made by the manufacturer according to product features. ......

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