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YY/T 0068.3-2008Medical endoscopes - Rigid endoscopes - Part 3: Marking and instruction manual (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 · Recommended

Issue date

October 17, 2008

Implementation date

June 1, 2010

Scope

YY/T 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/T 0068.3-2008 is the Chinese standard "Medical endoscopes - Rigid endoscopes - Part 3: Marking and instruction manual". Its scope clause reads: This part of YY 0068 specifies the requirements for the marking and instruction manual of rigid endoscope. Its clauses include requirements.

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Document preview — YY/T 0068.3-2008

National Standard of the People's Republic of China

Issued by: National Medical Products Administration

Foreword3
1 Scope4
2 Normative references4
3 Requirements4
Appendix A (Informative) Examples of instruction manual7

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

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 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.

YY 0069-2009 | YY 0068.4-2009 | YY 0068.1-2008 | YY 0068.2-2008 | YY/T 0071-2018 | […]

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.

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