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YY 0068.4-2009 PDF English

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YY 0068.4-2009: Medical endoscopes. Rigid endoscopes. Part 4: Fundamental requirement
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YY 0068.4-2009: Medical endoscopes. Rigid endoscopes. Part 4: Fundamental requirement

---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YY0068.4-2009
YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040 C 40 Medical endoscopes – Rigid endoscope – Part 4.Fundamental requirement 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... 5 4 General provisions... 5 5 Optical and mechanical properties... 6 6 Electrical safety... 6 7 Biocompatibility... 7 8 Interface security... 7 9 Manufacturing... 8 10 Disinfection and sterilization... 8 11 Packaging... 9 12 Marking and instruction manual... 9 13 Documentation... 9

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 part 4 of YY 0068. This part non-equivalently adopts the ISO 8600-1.2005 “Optics and photonics - Medical endoscopes and endotherapy devices - Part 1.General requirements” (English version). YY 0068-1992 is abolished from the date of release of this part. This part was approved by the China Food and Drug Administration. This part was proposed by AND shall be under the jurisdiction of the National Optical and Optical Instrument Standardization Technical Committee Medical Optical and Instrument Technical Committee (SAC/TC 103 /SC 1). The drafting organizations of this part. China Food and Drug Administration Hangzhou Medical Device Quality Supervision and Inspection Center. The main drafters of this part. Jia Xiaohang, Yan Qinglai, He Tao, Qi Weiming, Zhang Qinyuan. Medical endoscopes – Rigid endoscope – Part 4.Fundamental requirement

1 Scope

This part of YY 0068 specifies the fundamental requirements for the rigid endoscope for medical purposes.

2 Normative references

The provisions in following documents become the provisions of this part through reference in this part. For the dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this part; however, parties who reach an agreement based on this part are encouraged to study if the latest versions of these documents are applicable. For undated references, the latest edition of the referenced document applies. GB 9706.1-2007 Medical electrical equipment - Part 1.General requirements for safety (IEC 60601-1.1988, IDT) GB 9706.19 Medical electrical equipment - Part 2.Particular requirements for the safety of endoscopic equipment (GB 9706.19-2000, idt IEC 60601-2-18.1996) GB 11244-2005 General requirements for the medical endoscope and endoscope accessories GB 18278 Sterilization of health care products - Requirements for validation and routine control - Industrial moist heat sterilization (GB 18278-2000, idt ISO 11134.1994) GB 18279 Medical devices - Validation and routine control of ethylene oxide sterilization (GB 18279-2000, idt ISO 11135.1994) GB 18280 Sterilization of health care products - Requirement for validation and routine control - Radiation sterilization (GB 18280-2000, idt ISO 11137.1995)

3 Terms and definitions

The terms and definitions in the other parts of YY 0068 apply to this part.

4 General provisions

The safety and performance of rigid endoscopes shall be subjected to both preclinical and clinical evaluations, including appropriate risk analysis in accordance with YY/T 0316.

5 Optical and mechanical properties

The manufacturer shall ensure that the rigid endoscope meets the requirements of YY 0068.1 and 0068.2.If the endoscope also has other properties, the manufacturer shall provide the requirements AND provide the appropriate test methods for the intended purpose of the performance.

6 Electrical safety

Hard endoscopes shall comply with the applicable requirements of GB 9706.19. For endoscope with eyepiece cover, if its eyepiece cover is claimed to be electrically isolated from the insertion part, the dielectric strength of the isolated part shall pass a test at a sinusoidal voltage of 50 Hz with a maximum current not exceeding 0.03 mA at 1500 V. Test method shall be as specified in 20.4 of GB 9706.1-2007.

7 Biocompatibility

Materials of the part of the rigid endoscope inserted into the human body shall be subject to the biosafety assessment in accordance with the principles and requirements of GB/T 16886.1 to demonstrate good biocompatibility.

8 Interface security

As for the rigid endoscope with a cable interface for illumination, particularly an endoscope with multiple interfaces other than an optical cable interface, in view of the possibility of other interfaces being incorrectly connected to the endoscope interface, the endoscope manufacturers shall implement the risk management procedures in accordance with YY/T 0316, in order to evaluate the physical possibility of incorrect connection to the endoscope interface, the likelihood of the operation occurring, and the severity of the potential harm to the patient.

9 Manufacturing

Endoscopes shall be produced in a manner that guarantees design characteristics.

10 Disinfection and sterilization

10.1 Endurance of repeatable disinfection or sterilization product For rigid endoscopes that can be repeatedly disinfected or sterilized, the method of disinfection or sterilization shall neither impair the functioning of the product NOR cause corrosion.

11 Packaging

Endoscopic packaging shall protect the endoscope from the effects of adverse storage and shipping conditions.

12 Marking and instruction manual

Rigid endoscope product markings and instruction manual shall comply with the provisions of other parts of YY 0068.

13 Documentation

The manufacturer collects and maintains all relevant technical documents as required. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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