1 Scope
This part of YY 0068 specifies the fundamental requirements of rigid endoscope for medical purpose.
2 Normative References
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY 0068. For dated references, subsequent amendments (excluding corrections), or revisions, of any of these publications do not apply to this part. However parties to agreements based on this part 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 referred to 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 — Rigid Endoscope — 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 — Requirements for Validation and Routine Control — Radiation Sterilization (GB 18280-2000, idt ISO 11137:1995)
GB/T 16886.1 Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing (ISO 10993-1:1997, IDT)
GB/T 16886.7 Biological Evaluation of Medical Devices — Part 7: Ethylene Oxide Sterilization Residuals (GB/T 16886.7-2001, idt ISO 10993-7: 1995)
GB/T 19000 Quality Management Systems — Fundamentals and Vocabulary (GB/T 19000-2008, idt ISO 9000:2005)
GB/T 19633-2005 Packaging for Terminally Sterilized Medical Devices (ISO 11607:2003, IDT)
Foreword II
1 Scope
2 Normative References
3 Terms and Definitions
4 General
5 Optical and Mechanical Properties
6 Electrical Safety
7 Biocompatibility
8 Interface Safety
9 Manufacturing
10 Disinfection and Sterilization
11 Packaging
12 Marking and Instruction Manual
13 Documentation
