YY/T 0283-2007 English PDF (YYT0283-2007)

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YY/T 0283-2007: Large intestine fiber endoscope
YY/T 0283-2007
Large intestine fiber endoscope
ICS 11.040.70
C40
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0283-1995
Fiber colonoscopy
Posted 2007-07-02
2008-03-01 implementation
State Food and Drug Administration issued
Foreword
This standard is YY/T 0283-1995 "fiber colonoscopy" amendments.
This standard YY/T 0283-1995 the main differences.
--- The standard name of the specification;
--- Added by waterproof product classification;
--- Increase the number of broken wires indicators;
--- Increased the illumination source and the observation field of view coincides with the requirements;
--- Modify the product marking requirements;
--- Increased waterproof product requirements;
--- Increase biocompatibility requirements;
--- Revised test methods for viewing angle;
--- Cancel the original standard sealing performance requirements;
--- Added Appendix A (normative).
Electrical connection fully implement the GB 9706.1-1995 "Medical electrical equipment Part 1. General requirements for safety", GB 9706.4-
1999 "Medical electrical equipment - Part 2. requirements for the safety of high frequency surgical equipment" and GB 9706.19-2000 "Medical Electrical Equipment
Part 2. requirements for the safety of endoscopic equipment "requirements, the specific content of Appendix A (normative) given in the form.
This standard Annex A, Annex B is normative appendix Appendix C are informative appendices.
From the date of implementation of this standard, instead of YY/T 0283-1995.
This standard is approved by the State Food and Drug Administration.
This standard by the national medical and optical instruments Standardization Technical Committee and centralized.
This standard was drafted. Shanghai Medical Devices Co., Ltd. Medical Optical Instrument Factory.
The main drafters of this standard. Li Yafen, Sun Qi, Shen dawn.
This standard was first released in November 1995.
Fiber colonoscopy
1 Scope
This standard specifies the fiber colonoscopy classification and marking requirements, test methods, inspection rules, signs, instructions and packaging,
Transportation and storage.
This standard applies to fiber colonoscopy (hereinafter referred to as fiber colonoscopy). The product is used in human colon lumen examination, diagnosis with
Co-operation related to the system can be treated.
2 Normative references
The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent
Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research
Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.
GB/T 191-2000 Packaging - Pictorial signs
GB/T 2829-2002 periodic inspection Sampling procedures and tables (suitable for process stability test)
GB 9706.1-1995 Medical electrical equipment Part 1. General requirements for safety (idt IEC 601-1. 1988)
GB 9706.4-1999 Medical electrical equipment - Part 2. requirements for the safety of high frequency surgical equipment (idt IEC 60601-2-2.
1991)
GB 9706.19-2000 Medical electrical equipment - Part 2. Particular requirements for the safety of endoscopic equipment (idt IEC 60601-2-18.
1996)
GB 11244-2005 General requirements for medical endoscopes and accessories
GB/T 14710-1993 Medical electrical equipment environmental requirements and test methods
GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and testing (idt ISO 10993-1.1997)
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests (ISO 10993-5.1999,
IDT)
GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test
(ISO 10993-10.2002, IDT)
YY 0466-2003 medical equipment used with medical device labels, signs and symbols provide information (ISO 15223.2000, IDT)
People's Republic of China Pharmacopoeia 2005 Edition
Medical equipment manuals, labeling and packaging labeling regulations (State Food and Drug Administration Decree No. 10)
Category 3
3.1 fibers include sigmoidoscopy and colonoscopy colonoscopy.
3.2 fiber colonoscopy the type of forward-looking type.
3.3 fiber colonoscopy press after using a cleaning were divided into. ordinary type, water type.
4 Requirements
4.1 Working conditions
Fiber colonoscopy normal working conditions.
a) Ambient temperature range. 5 ℃ ~ 40 ℃;
b) Relative humidity range. 30% to 80%;