YY 0069-2009Particular requirements for rigid bronchoscopes (English PDF)
硬性气管内窥镜专用要求
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY 0069-2009 is the English-translated version of 硬性气管内窥镜专用要求.
YY 0069-2009 is the Chinese standard "Particular requirements for rigid bronchoscopes". Its scope clause reads: 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. Its clauses include terms and definitions.
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Document preview — YY 0069-2009
National Standard of the People's Republic of China
- Replacing
- YY 0069-1992
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Terms and definitions4
- 4 Requirements6
- 5 Test methods10
- 6 Marking13
- 7 Accompanying documentation14
- Annex A (Informative) Rationale16
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
YY 0068.4-2009 | YY 0068.1-2008 | YY 0068.2-2008 | YY 0068.3-2008 | YY/T 0071-2018 | […]
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 191-2000Graphical symbols marking for handling and storage of packages
- YY 0068.1-2008Medical Endoscopes—Rigid Endoscope - Part 1: Optical properties and test methods
- YY 0068.2-2008Medical endoscopes—Rigid endoscope - Part 2: Mechanical properties and test methods
- YY 0068.3-2008Medical endoscopes - Rigid endoscopes - Part 3: Marking and instructions for use
- YY 0068.4-2009Medical endoscopes - Rigid endoscopes - Part 4: Fundamental requirements
- YY 1040.1-2003Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
Editions of YY 0069
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0069-2009 | Particular requirements for rigid bronchoscopes | current edition | Current |
| YY 0069-1992 | Particular requirements for rigid bronchoscopes | previous edition | Superseded |
This page sells the current edition, YY 0069-2009. Earlier editions are listed for reference only.
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Related Standards
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 endoscopes - Part 3: Marking and instructions for use
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YY 0069-2009
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