Standard No.:	YY 0068.1-2008
English Name:	Medical Endoscopes—Rigid Endoscope—Part 1:Optical properties and test methods
Chinese Name:	医用内窥镜 硬性内窥镜 第1部分：光学性能及测试方法
Chinese Classification:	C40    Medical optical instrument and endoscope
Professional Classification:	YY    Professional Standard - Pharmaceutics
Issued by:	China Food and Drug Administration
Issued on:	2008-04-25
Implemented on:	2009-12-1
Status:	valid
Superseding:	YY 0068-1992 General specification for medical rigid endoscopes
Language:	English
File Format:	PDF
Word Count:	10000 words
Price(USD):	150.0
Delivery:	via email in 1 business day

1 Scope This part of YY 0068 specifies the optical property requirements and test methods of rigid endoscope. This part is applicable to the medical rigid endoscope. 2 Normative References The following normative documents contain provisions which, through reference in this part of YY 0068, constitute provisions of this part. For dated references, subsequent amendments to (excluding corrections to), or revisions of, any of these publications do not apply. However, all parties coming to an agreement according to this part are encouraged to study whether the latest editions of these documents apply. For undated reference, the latest edition of the normative documents referred to applies. GB/T 5702 Methods of Measuring the Color of Light Sources GB 10810 Spectacles Lenses GB 11244-2005 General Requirements for the Medical Endoscope and Endoscope accessories JB/T 7403-1994 Illuminometer JB/T 9328-1999 Resolving Power Test Target ISO 10526:1999 CIE S 005 CIE Standard Illuminants for Colorimetry CIE 13.3-1995 Method of Measuring and Specifying Colour Rendering Properties of Light Sources CIE 15:2004 Colorimetry 3 Terms and Definitions For the purposes of this Part of YY 0068, the following terms and definitions apply. 3.1 endoscope medical instrument having viewing means, introduced into a body cavity through natural or surgically-created body opening 3.2 rigid endoscope endoscope whose insertion portion is intended to be unyielding to natural or surgically-created body opening or other instrument channels

Foreword II Introduction IV 1 Scope 2 Normative References 3 Terms and Definitions 4 Requirements 5 Test methods Annex A (Normative) Determination of Field of View and Direction of View Annex B (Normative) Determination of Angular Resolution Annex C (Normative) Determination of Color Resolution and Color Reducibility Annex D (Normative) Determination of Synthetical Relative Self-effect Annex E (Normative) Determination of Unit Relative Distortion Take the arithmetic mean value of the 3 measured consistency differences as the final result. Annex F (Informative) Typical Values of Shape Parameter of the Evaluated Field-of-view Plane