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YY 0068.4-2009 PDF in English

YY 0068.4-2009 (YY0068.4-2009) PDF English
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YY 0068.4-2009: PDF in English

YY 0068.4-2009
ICS 11.040
C 40
Medical endoscopes – Rigid endoscope –
Part 4. Fundamental requirement
Issued by. China Food and Drug Administration
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Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Terms and definitions ... 5 
4 General provisions ... 5 
5 Optical and mechanical properties ... 6 
6 Electrical safety ... 6 
7 Biocompatibility ... 7 
8 Interface security ... 7 
9 Manufacturing ... 8 
10 Disinfection and sterilization ... 8 
11 Packaging ... 9 
12 Marking and instruction manual ... 9 
13 Documentation ... 9 
Medical endoscopes – Rigid endoscope –
Part 4. Fundamental requirement
1 Scope
This part of YY 0068 specifies the fundamental requirements for the rigid
endoscope for medical purposes.
2 Normative references
The provisions in following documents become the provisions of this part
through reference in this part. For the dated references, the subsequent
amendments (excluding corrections) or revisions do not apply to this part;
however, parties who reach an agreement based on this part are encouraged
to study if the latest versions of these documents are applicable. For undated
references, the latest edition of the referenced document 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 - Part 2. Particular requirements
for the safety of endoscopic equipment (GB 9706.19-2000, idt IEC
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 - Requirement for validation
and routine control - Radiation sterilization (GB 18280-2000, idt ISO
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)
YY 0068.1 Medical Endoscopes - Rigid Endoscope - Part 1. Optical
properties and test methods
YY 0068.2 Medical endoscopes - Rigid endoscope - Part 2. Mechanical
properties and test methods
YY 0068.3 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, idt ISO 13485.2003)
YY/T 0297 Clinical investigation of medical devices (YY/T 0297-1997, idt
ISO 14155.1996)
YY/T 0316 Medical devices - Application of risk management to medical
devices (YY/T 0316-2008, idt ISO 14971.2007)
People's Republic of China Pharmacopoeia, 2005 version, two volumes
3 Terms and definitions
The terms and definitions in the other parts of YY 0068 apply to this part.
4 General provisions
The safety and performance of rigid endoscopes shall be subjected to both
preclinical and clinical evaluations, including appropriate risk analysis in
accordance with YY/T 0316.
In accordance with the relevant provisions of YY/T 0297, MAKE clinical
evaluation against the rigid endoscope, AND it shall be able to certify that the
endoscope is clinically safe and effective.
9 Manufacturing
Endoscopes shall be produced in a manner that guarantees design
The quality system shall comply with the requirements of YY/T 0287 and/or
related laws and regulations.
10 Disinfection and sterilization
10.1 Endurance of repeatable disinfection or sterilization product
For rigid endoscopes that can be repeatedly disinfected or sterilized, the
method of disinfection or sterilization shall neither impair the functioning of the
product NOR cause corrosion.
The test can be made by repeating 20 times of disinfection or sterilization as
specified in the instruction manual. For the soaking disinfection method, it may
also use the duration 20 times the soaking duration as specified in the
instruction manual.
10.2 Sterile provision of products
For sterile products, the sterile process shall be effective and controlled.
Products shall be indicated as “sterile”, AND the sterilization assurance level
(SAL) shall not exceed 10-6.
If other sterilization assurance levels are used, the manufacturer shall provide
a risk assessment document to prove it.
If using the ethylene oxide sterilization, it shall meet the requirements of GB
If using the radiation sterilization, it shall be consistent with the requirements of
GB 18280.
If using the industrial damp heat sterilization, it shall be consistent with the
requirements of GB 18278.
As for the sterile inspection, it may use the test method in People’s Republic of
China Pharmacopoeia (2005 version), two volumes.
For ethylene oxide sterilized products, ethylene oxide residues shall not
exceed the limits given in GB/T 16886.7.
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.