YY 0068.3-2008 PDF EnglishUS$145.00 · In stock · Download in 9 seconds
YY 0068.3-2008: Medical endoscopes. Rigid endoscope. Part 3: Marking and instruction manual Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedure Status: Obsolete
YY 0068.3-2008: Medical endoscopes. Rigid endoscope. Part 3: Marking and instruction manual---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/YY0068.3-2008YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040 C 40 Medical endoscopes – Rigid endoscope – Part 3.Marking and instruction manual Issued on. OCTOBER 17, 2008 Implemented on. JUNE 01, 2010 Issued by. China Food and Drug Administration Table of ContentsForeword... 3 1 Scope... 4 2 Normative references... 4 3 Requirements... 4 Appendix A (Informative) Examples of instruction manual... 7ForewordYY 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 3 of YY 0068. This part corresponds to the ISO 8600-1.2005 “Optics and photonics - Medical endoscopes and endotherapy devices - Part 1.General requirements”, AND its consistency with ISO 8600-1.2005 is non-equivalent. Appendix A of this part is an informative appendix. 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. Yan Qinglai, Mao Xinxin, Jia Xiaohang, He Tao, Qi Weiming. Medical endoscopes – Rigid endoscope – Part 3.Marking and instruction manual1 ScopeThis part of YY 0068 specifies the requirements for the marking and instruction manual of rigid endoscope.2 Normative referencesThe provisions in following documents become the provisions of this part through reference in this part of YY 0068.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 9706.19 Medical electrical equipment - Part 2.Particular requirements for the safety of endoscopic equipment (GB 9706.19-2000, idt IEC 60601-2-18.1996) YY 0068.1 Medical Endoscopes - Rigid Endoscope - Part 1.Optical properties and test methods YY 0068.2 Medical endoscopes - Rigid endoscope - Part 2.Mechanical properties and test methods ISO 10526.1999 CIE S 005 CIE Standard illuminants for colorimetry3 Requirements3.1 Marking 3.1.1 Minimum marking Each endoscope shall have at least the following markings. 3.1.2 Marking clarity When the endoscope is used, cleaned, disinfected, sterilized and stored in accordance with the manufacturer's instructions, the markings must be legible. 3.1.3 Marking exceptions If it is not possible to mark the endoscope due to dimensional or structural reasons, the marking required by 3.1.1 shall be given in the instruction manual. 3.2 Instruction manual The manufacturer of the endoscope shall provide the user's instruction manual, which shall contain at least the following information.Appendix A(Informative) Examples of instruction manual Instruction manual A.1 Please read the entire contents of this manual thoroughly before using the XXX endoscope manufactured by the XXX Endoscope Co., Ltd. Failure to follow the instructions and warnings in this manual can have serious consequences for the patient. A.2 Endoscopes shall only be used by practicing physicians and trained medical professionals. A.3 This endoscope is used for XXX surgery and diagnosis and treatment in the surgery. A.10.2.2.1 PLACE the endoscope on a sterile tray. A.10.2.2.2 Pre-evacuation or high-vacuum sterilization consists of four basic stages. preparation, treatment, degassing and drying. The preparation stage is to remove the air in the room by vacuuming, and to inject the steam in the room to preheat the equipment. When the temperature reaches 134 °C and the pressure value is 200 kPa, it enters into the second stage, that is, the treatment stage. The treatment duration in the pre-evacuated vacuuming sterilizer is 4 min. The degassing stage is to remove all the steam from the room. Finally MAKE vacuuming again and LET the equipment be dried in the vacuum for about 20 min. ......Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al. Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of English version of YY 0068.3-2008 be delivered?Answer: The full copy PDF of English version of YY 0068.3-2008 can be downloaded in 9 seconds, and it will also be emailed to you in 9 seconds (double mechanisms to ensure the delivery reliably), with PDF-invoice.Question 2: Can I share the purchased PDF of YY 0068.3-2008_English with my colleagues?Answer: Yes. The purchased PDF of YY 0068.3-2008_English will be deemed to be sold to your employer/organization who actually paid for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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