Standard No.:	YY 0068.4-2009/XG1-2023
English Name:	Medical electrical equipment―Part 1:General requirements for basic safety and essential performance, includes Amendment 1
Chinese Name:	《医用内窥镜 硬性内窥镜 第4部分：基本要求》第1号修改单
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	SDA
Issued on:	2009-12-30
Implemented on:	2023-5-1
Status:	valid
Superseding:	YY 0068.4-2009 Medical endoscopes Rigid endoscopes - Part 4: Fundamental requirement
Target Language:	English
File Format:	PDF
Word Count:	5000 words
Translation Price(USD):	150.0
Delivery:	via email in 1 business day

YY 0068.4-2009/XG1-2023 Medical Endoscopes — Rigid Endoscope — Part 4: Fundamental Requirement 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 9706.1-2020 Medical electrical equipment — Part 1:General requirements for basic safety and essential performance GB 9706.218 Medical electrical equipment — Part 2-18:Particular requirements for the basic safety and essential performance of endoscopic equipment 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 Packaging for Terminally Sterilized Medical Devices (all parts) YY 0068.1 Medical Endoscopes — Rigid Endoscope — Part 1: Optical Properties and Test Methods YY 0068.2 Medical Endoscopes — Rigid Endoscope — Part 1: Mechanical Properties and Test Methods YY 0068.3-008 Medical Endoscopes — Rigid Endoscope — Part 3: Marking and Instruction Manual YY/T 0287 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes (YY/T 0287-2003, ISO 13485:2003, 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