YY 0068.4-2009/XG1-2023 Medical electrical equipment―Part 1:General requirements for basic safety and essential performance, includes Amendment 1 (English Version)
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
Standard
YY 0068.4-2009/XG1-2023 Medical electrical equipment―Part 1:General requirements for basic safety and essential performance, includes Amendment 1 (English Version)
Standard No.
YY 0068.4-2009/XG1-2023
Status
valid
Language
English
File Format
PDF
Word Count
5000 words
Price(USD)
150.0
Implemented on
2023-5-1
Delivery
via email in 1 business day
Detail of YY 0068.4-2009/XG1-2023
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
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)
Contents of YY 0068.4-2009/XG1-2023
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
