标准编号:	YY 0068.4-2009
中文名称:	医用内窥镜 硬性内窥镜 第4部分：基本要求
英文名称:	Medical endoscopes Rigid endoscopes - Part 4: Fundamental requirement
行业分类:	YY    医药行业标准
发布机构:	国家食品药品监督管理局
发布日期:	2009-12-30
实施日期:	2011-6-1
标准状态:	superseded
被新标准替代:	YY 0068-1992 医用硬管内窥镜通用技术条件 YY 0068.4-2009/XG1-2023 《医用内窥镜 硬性内窥镜 第4部分：基本要求》第1号修改单
被替代日期:	2023-5-1
替代旧标准:	YY 0068-1992 医用硬管内窥镜通用技术条件
翻译语言:	英文
文件格式:	PDF
中文字符数:	6000 字
翻译价格(元):	240.0
交付时间:	付款后 1 个工作日

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