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
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.
Contents of YY 1028-2008
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
