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YY 0068.1-2008 English PDF (YY0068.1-2008)

YY 0068.1-2008 English PDF (YY0068.1-2008)

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YY 0068.1-2008: Medical Endoscopes. Rigid Endoscope. Part 1: Optical properties and test methods

This Part of YY 0068 specifies the optical property requirements and test methods of the rigid endoscopes. This Part applies to the rigid endoscopes for medical purposes.
YY 0068.1-2008
YY
ICS 11.040
C 40
Pharmaceutical Industry Standard
of the PEOPLE Republic of China
Partially replacing YY 0068-1992
Medical endoscopes ?€? Rigid endoscope ?€?
Part 1. Optical properties and test methods
ISSUED ON. APRIL 25, 2008
IMPLEMENTED ON. DECEMBER 1, 2009
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
Introduction ... 5
1 Scope ... 8
2 Normative references ... 8
3 Terms and definitions ... 8
4 Requirements ... 17
5 Test methods ... 22
Appendix A ... 28
Appendix B ... 31
Appendix C ... 33
Appendix D ... 37
Appendix E ... 40
Appendix F ... 43
Foreword
YY 0068 Medical endoscopes ?€? Rigid endoscope is divided into four parts. ?€? Part 1. Optical properties and test methods;
?€? Part 2. Mechanical properties and test methods;
?€? Part 3. Marking and instruction manual;
?€? Part 4. Fundamental requirement.
This Part is the Part 1 of YY 0068.
This Part is not equivalent to the international standards ISO 8600-1.2005 Optics and photonics ?€? Medical endoscopes and endotherapy devices ?€? Part 1. General requirements (English), ISO 8600-3.1997 Optics and optical
instruments ?€? Medical endoscopes and endoscopic accessories ?€? Part 3.
Determination of field of view and direction of view of endoscopes with optics (English), ISO 8600-5.2005 Optics and photonics ?€? Medical endoscopes and endotherapy devices ?€? Part 5. Determination of optical resolution of rigid endoscopes with optics (English), and ISO 8600-6.2005 Optics and photonics ?€? Medical endoscopes and endotherapy devices ?€? Part 6. Vocabulary (English). The differences between this Part and the above-mentioned parts of the ISO 8600 are as follows.
?€? DIVIDE the parts of the standard according to the characteristics of rigid endoscopes described in this Standard;
?€? SUPPLEMENT the definitions of object pupil field angle, image pupil field angle, color rendering properties, rigid optical endoscope, rigid optical observation endoscope, axis of view, relative effect of edge light
luminosity, shape parameter, relative effect of lambert edge light
luminosity, relative self-effect of illumination light luminosity, relative self- effect of imaging light energy, synthetical relative effect of light energy, unit relative distortion, and color rendering index;
?€? SPLIT the definition of the field of view;
?€? MODIFY the definition of the maximum image height;
?€? AMEND the definition of the angular resolution;
?€? SUPPLEMENT the requirements and test methods for the effective depth
of field, field quality, chromatic aberration resolution, color reducibility, Introduction
This Part is a specific standard established under the general heading of ?€?Medical endoscopes ?€? Rigid endoscope?€?, which is released for the first time. The optical property requirements and test methods of rigid endoscopes are first integrated in this Part for the ease of use and subsequent amendments. This Part is formulated for two purposes. ESTABLISH the fundamental
requirements that can ensure the clinical safety and effective application of the endoscopic products, so as to synchronize with the current understanding of the safety and efficiency of the products; gradually IMPROVE the standard system under the heading framework of medical endoscopes by starting with this Part.
With the growing popularity of the minimally invasive surgeries via endoscopes, the safety and efficiency understanding of the clinical application of the endoscopic products has also been gradually developed and deepened. For security reasons, the property indexes of the products, especially the optical properties, are directly or indirectly involved in patient safety. Therefore, we have every reason to attach importance to the property indexes of the products. Since the progress in the existing national standards, industry standards and ISO standards is too slow, and relevant standards are not systematic, it is very necessary to establish the standards applicable to the product safety and effectiveness evaluation, and to improve the standard system needed for the product development.
On the basis of covering all the optical requirements specified in the ISO 8600 Optics and photonics ?€? Medical endoscopes and endotherapy devices series of standards, this Part supplements multiple contents, for instance, chromatic aberration resolution, relative effect of edge light luminosity, depth of field, distortion, etc. The supplements are mainly made based on the following considerations.
The rigid endoscopes are applied to non-invasive or minimally invasive
diagnosis, auxiliary examination, or non-open intracavitary surgeries in clinical application. This kind of medical environment is far more complicated than the open medical conditions, and has high degree of risk. In case of careless treatment or surgeries, there will be severe consequences. ISO 8600 series of international standards only involve in basic optical characteristics of the endoscopic field of view, field of direction, and resolution. However, these index requirements are far from enough. For instance, the human tissues in the cavities have similar colors and subtle changes, if the chromatic aberration resolution of the endoscopes is not good enough, there will be great risk of misdiagnosis or surgical errors. Therefore, the chromatic aberration resolution and color reduction level of the endoscopes are very important. The
surrounding human tissues of the cavities have complicated environment. For the endoscopic system with large field of view, multiple cosine effects will reduce the luminosity on the edges of the field of view in image space. Considering the light reflection in the center of the field of view, it is likely to occur the following circumstances. it is unable to learn the information of the tissues on the inner edges of the cavities; light saturation in the center of the field of view; and visual deprivation in the medical central area. Therefore, we cannot ignore the control of the relative self-effect of edge light luminosity of endoscopes. The human tissues in the cavities have distinctive structures, and some parts have big gradient changes in the clinical application. Therefore, the indexes of the depth of field are also meaningful. From the aspect of distortion, the operations under endoscopes rely on experience instead of stereoscopic sensation. Since the shapes in the cavities of the human bodies are similar, and it is difficult to identify the orientation, the excessive deformation of edges will easily lead to orientation confusion, visual errors, experience loss, and diagnostic or surgical uncertainty. Furthermore, the excessive deformation may also exert psychological effects, cause irritability or lose patience. Therefore, it is necessary to put forward the distortion requirements.
This Part has also fully considered the contents applicable to the YY 0068-1992 Medical rigid endoscopes ?€? General technical conditions standard during the formation. The optical requirements specified in the YY 0068-1992 are reserved or continue to be used after modification and correction according to the principle of applicability. For instance, the serial number 5 ?€?illumination requirements?€? specified in Table 2 of the Section 4.4 of YY 0068-1992 is modified into the ?€?light energy transfer efficiency?€?.
One of the remarkable features of this Part is to put forward explicit
requirements for the optical property indexes of the endoscopes, so as to embody the explicit principle of security and effectiveness, which is also the most basic purpose of this Standard. Considering the different types and functions of the rigid endoscopes, and the current situation of the domestic industry level, it is inappropriate to specify all the required limit values in this Part. However, the manufacturers have the obligations and responsibilities to express the actual values or controlled quantity and meanings of these indexes to the users in the accompanying files.
It is certainly necessary to make more comprehensive requirements proceeding from the medical safety of endoscopes and effective purposes. In the aspect of the over-temperature control, the requirements specified in this Part have been stipulated in the GB 9706.19 standard, while other aspects, such as the requirements for the image-quality MTF, are still under consideration.
This Part is formulated for the purpose of the safety and effectiveness of the Medical endoscopes ?€? Rigid endoscope ?€?
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