YY 0068.3-2008Medical endoscopes - Rigid endoscopes - Part 3: Marking and instructions for use (English PDF)
医用内窥镜 硬性内窥镜 第3部分：标签和随附资料
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Issued by
NMPA
Level / Type
Industry · Mandatory
Issue date
October 17, 2008
Implementation date
June 1, 2010
Scope
YY 0068.3-2008 is the English-translated version of 医用内窥镜 硬性内窥镜 第3部分：标签和随附资料.
YY 0068.3-2008 is the Chinese pharmaceutical industry standard that sets the requirements for the marking and the instruction manual of the rigid endoscope.
It is the third part of the YY 0068 series and fixes what must be marked on the instrument and on its package and what the manufacturer must tell the user: the identification of the device and its optical data, the intended use, the instructions for handling, cleaning, disinfection and sterilization, the compatible accessories and light sources, the warnings and the service information.
An informative annex gives examples of an instruction manual. Issued on 17 October 2008, it has applied since 1 June 2010.
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Document preview — YY 0068.3-2008
National Standard of the People's Republic of China
- Replacing
- YY 0068-1992
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative references4
- 3 Requirements4
- Appendix A (Informative) Examples of instruction manual7
Foreword
YY 0068 "Medical endoscopes - Rigid endoscope" is divided into four parts.
- Part 1: Optical properties and test methods;
- Part 2: Mechanical properties and test methods - Part 3: Marking and instruction manual;
- Part 4: Fundamental requirement. This part is part 3 of YY 0068.
This part corresponds to the ISO 8600-1:2005 "Optics and photonics - Medical endoscopes and endotherapy devices - Part 1: General requirements", AND its consistency with ISO 8600-1:2005 is non-equivalent. Appendix A of this part is an informative appendix.
This part was approved by the China Food and Drug Administration.
1 Scope
This part of YY 0068 specifies the requirements for the marking and instruction manual of rigid endoscope.
2 Normative references
The provisions in following documents become the provisions of this part through reference in this part of YY 0068. 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 9706.19 Medical electrical equipment - Part 2: Particular requirements for the safety of endoscopic equipment (GB 9706.19-2000, idt IEC 60601-2-18:1996)
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
ISO 10526:1999 CIE S 005 CIE Standard illuminants for colorimetry
3 Requirements
3.1 Marking
3.1.1 Minimum marking
Each endoscope shall have at least the following markings.
3.1.2 Marking clarity
When the endoscope is used, cleaned, disinfected, sterilized and stored in accordance with the manufacturer's instructions, the markings must be legible.
3.1.3 Marking exceptions
If it is not possible to mark the endoscope due to dimensional or structural reasons, the marking required by 3.1.1 shall be given in the instruction manual.
3.2 Instruction manual
The manufacturer of the endoscope shall provide the user's instruction manual, which shall contain at least the following information.
Appendix A (Informative) Examples of instruction manual
A.1 Please read the entire contents of this manual thoroughly before using the XXX endoscope manufactured by the XXX Endoscope Co., Ltd. Failure to follow the instructions and warnings in this manual can have serious consequences for the patient.
A.2 Endoscopes shall only be used by practicing physicians and trained medical professionals.
A.3 This endoscope is used for XXX surgery and diagnosis and treatment in the surgery. A.10.2.2.1 PLACE the endoscope on a sterile tray.
A.10.2.2.2 Pre-evacuation or high-vacuum sterilization
Pre-evacuation or high-vacuum sterilization consists of four basic stages. preparation, treatment, degassing and drying. The preparation stage is to remove the air in the room by vacuuming, and to inject the steam in the room to preheat the equipment. When the temperature reaches 134 °C and the pressure value is 200 kPa, it enters into the second stage, that is, the treatment stage. The treatment duration in the pre-evacuated vacuuming sterilizer is 4 min. The degassing stage is to remove all the steam from the room. Finally MAKE vacuuming again and LET the equipment be dried in the vacuum for about 20 min.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.
Referenced standards
Normative references
- GB 9706.19Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment
- YY 0068.1Medical Endoscopes—Rigid Endoscope - Part 1: Optical properties and test methods
- YY 0068.2Medical endoscopes—Rigid endoscope - Part 2: Mechanical properties and test methods
ISO 10526:1999
Similar standards
Editions of YY 0068.3
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY 0068.3-2008 | Medical endoscopes - Rigid endoscopes - Part 3: Marking and instructions for use | current edition | Current |
| YY 0068-1992 | Medical endoscopes - Rigid endoscopes - Part 3: Marking and instructions for use | previous edition | Superseded |
This page sells the current edition, YY 0068.3-2008. Earlier editions are listed for reference only.
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Related Standards
GB 9706.19-2000 — Medical electrical equipment. Part 2: Particular requirements for the safety of endoscopic equipment
YY 0068.1-2008 — Medical Endoscopes—Rigid Endoscope - Part 1: Optical properties and test methods
YY 0068.2-2008 — Medical endoscopes—Rigid endoscope - Part 2: Mechanical properties and test methods
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YY 0068.3-2008
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