YY 0068.1-2008 (YY0068.1-2008) & related versions
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Medical Endoscopes. Rigid Endoscope. Part 1: Optical properties and test methods
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YY 0068.1-2008: PDF in English
YY 0068.1-2008
YY
ICS 11.040
C 40
Pharmaceutical Industry Standard
of the People’s 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 –
Part...
......
| Standard ID | YY 0068.1-2008 (YY0068.1-2008) | | Description (Translated English) | Medical Endoscopes. Rigid Endoscope. Part 1: Optical properties and test methods | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040 | | Word Count Estimation | 27,219 | | Date of Issue | 2008-04-25 | | Date of Implementation | 2009-12-01 | | Older Standard (superseded by this standard) | YY 0068-1992 | | Quoted Standard | GB/T 5702; GB 10810; GB 11244-2005; JB/T 7403; JB/T 9328-1999; ISO 10526-1999 CIE S005; CIE 13.3-1995; CIE 15-2004 | | Adopted Standard | ISO 8600-1-2005, NEQ; ISO 8600-3-1997, NEQ; ISO 8600-5-2005, NEQ; ISO 8600-6-2005, NEQ | | Drafting Organization | Hangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National Standardization Technical Committee of Medical optics and instruments | | Regulation (derived from) | SFDA [2008] No. 192 | | Proposing organization | National medical optical instruments Standardization Technical Committee (SAC/TC 103/SC 1) | | Issuing agency(ies) | China Food and Drug Administration | | Summary | This standard specifies the rigid endoscope optical performance requirements, test methods. This standard applies to medical purposes rigid endoscopes. |
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