Foreword
Codeofchina Inc. is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
This standard is a revision of YY 91028-1999 Upper gastro intestinal fiberscope based on GB 11244-2005 General requirements for the medical endoscope and endoscope accessories.
This standard replaces YY 91028-1999 Upper gastro intestinal fiberscope.
The following changes have been made with respect to YY 91028-1999: The biocompatibility requirements of human contact have been added.
The electrical safety of this standard is enforced by GB 9706.1-2007 Medical electrical equipment — Part 1: General requirements for safety and GB 9706.19-2000 Medical electrical equipment — Part 2: Particular requirements for the safety of endoscopic equipment.
The environmental test of this standard shall follow GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment.
Annex A to this standard is normative.
This standard was proposed by and is under the jurisdiction of the Subcommittee on Medical Optics and Optic Instruments of the National Technical Committee on Optics and Optic Instruments of Standardization Administration of China (SAC/TC 103/SC 1).
This standard is drafted by Hangzhou Medical Apparatus Supervision and Inspection Center of the National Medical Products Administration.
Upper gastro intestinal fiberscope
1 Scope
This standard specifies the requirements of classification, basic parameters, technical specifications, test methods, inspection rules, marking, packaging, transportation and storage of upper gastro intestinal fiberscope.
This standard is applicable to the series product of upper gastro intestinal fiberscopes, which are used for examination, diagnosis or treatment of esophagus, stomach and duodenum.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this standard. For dated references, subsequent amendments (excluding corrections) to, or revisions, of any of these publications do not apply to this standard. However parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document applies.
GB/T 191-2008 Packaging — Pictorial marking for handling of goods (ISO 780:1997, MOD)
GB 9706.1-2007 Medical electrical equipment — Part 1: General requirements for safety (IEC 60601-1:1988, IDT)
GB 9706.19-2000 Medical electrical equipment — Part 2: Particular requirements for the safety of endoscopic equipment (IEC 60601-2-18:1996, IDT)
GB/T 16886.5-2003 Biological evaluation of medical devices — Part 5: Test for in vitro cytotoxicity (ISO 10993-5:1999, IDT)
GB/T 16886.10-2005 Biological evaluation of medical devices — Part 10: Tests for irritation and delayed-type hypersensitivity (ISO 10993-10:2002, IDT)
GB/T 14233.1-1998 Test methods for infusion transfusion injection equipments for medical use — Part 1: Chemical analysis methods
GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment
3 Product classification
3.1 Upper gastro intestinal fiberscopes are classified into three types: forward-viewing endoscopes, oblique-viewing endoscope and side-viewing endoscopes.
3.2 Main parameters and overall dimensions of upper gastro intestinal fiberscope shall be in accordance with those specified in Table 1.
Foreword i
1 Scope
2 Normative references
3 Product classification
4 Requirements
5 Test methods
6 Inspection rules
7 Labels, marking and instruction manual
8 Packaging, transportation and storage
