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YY 0069-2009 PDF English

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YY 0069-2009: Particular requirements for rigid bronchoscopes
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Status: Obsolete

YY 0069: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YY 0069-2009English145 Add to Cart 0-9 seconds. Auto-delivery Particular requirements for rigid bronchoscopes Obsolete
YY 0069-1992English239 Add to Cart 2 days Trachea endoscope Obsolete

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YY 0069-2009: Particular requirements for rigid bronchoscopes

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YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040 C 40 Replacing YY 0069-92 Particular requirements for rigid bronchoscopes (ISO 8600-2:2002 Optics and optical instruments - Medical endoscopes and endoscopic accessories - Part 2: Particular requirements for rigid bronchoscopes, IDT) ISSUED ON: DECEMBER 30, 2009 IMPLEMENTED ON: JUNE 01, 2011 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... 6 5 Test methods ... 10 6 Marking ... 13 7 Accompanying documentation ... 14 Annex A (Informative) Rationale ... 16

Foreword

This Standard is identical to ISO 8600-2:2002 “Optics and optical instruments - Medical endoscopes and endoscopic accessories - Part 2: Particular requirements for rigid bronchoscopes” (English version). This Standard replace YY 0069-92 “Bronchoscopes”. Form the date of implementation of this Standard, YY 0069-92 abolished at the same time. Annex A of this Standard is an information annex. This Standard is approved by China Food and Drug Administration. This Standard was proposed by and shall be under the jurisdiction of National Technical Sub-committee on Medical Optics and Instruments of Standardization Administration of China (SAC/TC 103/SC 1). Drafting organization of this Standard: Zhejiang Institute of Medical Device Testing. Main drafters of this Standard: Mao Xinxin, Yan Qinglai, Jia Xiaohang, Ma Jun, Ma Li. Particular requirements for rigid bronchoscopes

1 Scope

This Standard specifies scope, terms and definitions, requirements, test methods, markings, instruction manual and packaging of rigid bronchoscopes. This Standard applies to rigid bronchoscopes. The product is used for the examination and diagnosis of the human tracheobronchial internal lumen, and may be used for treatment in conjunction with the relevant surgical system.

2 Normative references

The following documents contain the provisions which, through reference in this Standard, become the provisions of this Standard. For dated references, their subsequent amendments (excluding corrigendum) or revisions do not apply to this Standard. However, the parties who enter into agreement based on this Standard are encouraged to investigate whether the latest versions of these documents are applicable. For undated reference documents, the latest versions apply to this Standard. GB/T 191-2000 Packaging - Pictorial marking for handling of goods YY 0068.1-2008 Medical endoscopes - Rigid endoscope - Part 1: Optical properties and test methods YY 0068.2-2008 Medical endoscopes - Rigid endoscope - Part 2: Mechanical properties and test methods YY 0068.3-2008 Medical endoscopes - Rigid endoscope - Part 3: Marking and instruction manual YY 0068.4-2009 Medical endoscopes - Rigid endoscopes - Part 4: Fundamental requirement YY 1040.1-2003 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets

3 Terms and definitions

3.1 ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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