YY 0069-2009 PDF in English
YY 0069-2009 (YY0069-2009) PDF English
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| YY 0069-2009 | English | 145 |
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Particular requirements for rigid bronchoscopes
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| YY 0069-1992 | English | 239 |
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Trachea endoscope
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Standards related to (historical): YY 0069-2009
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YY 0069-2009: PDF in English YY 0069-2009
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 PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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