YY/T 1106-2008Electrically powered operating table (English PDF)

Foreword

This standard is a recommended standard. This standard replaces YY 91106-1999 "Electrically powered operating table".

The main differences between this standard and YY 91106-1999 "Electrically powered operating table" are as follows.

- MODIFY the safety requirements to be carried out in accordance with GB 9706.1-2007 "Medical electrical equipment - Part 1: General requirements for safety";

- Special requirements for safety shall be implemented in accordance with YY 0570-2005 "Medical electrical equipment - Part 2-46.Particular requirements for the safety of operating tables";

- MODIFY the environmental test requirements to be implemented in accordance with GB/T 14710-1993 "The environmental requirements and test methods for medical electrical equipment";

- DELETE the non-technical contents 4.7, 4.12, 4.13 of the technical requirements from the original standard;

- UPDATE the outdated reference standards.

1 Scope

This standard specifies the classification, requirements, test methods, inspection rules and markings, instructions for use, packaging, transport, storage requirements for electrically powered operating table (hereinafter referred to as operating table).

This standard applies to electrically powered operating table. This product is used for general surgery for thoracic and abdominal surgery, ophthalmology, otolaryngology, gynecology, obstetrics, and urology.

2 Normative references

The provisions in following documents become the provisions of this standard through reference in this standard. For the dated references, the subsequent amendments (excluding corrections) or revisions do not apply to this standard; however, parties who reach an agreement based on this standard 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/T 191-2008 Packaging - Pictorial marking for handling of goods

GB 9706.1-2007 Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988, IDT)

GB 9969.1-1998 General principles for preparation of instructions for use of industrial products

GB/T 14710-1993 The environmental requirements and test methods for medical electrical equipment

YY 0570-2005 Medical electrical equipment - Part 2-46.Particular requirements for the safety of operating tables (IEC 60601-2-46:1998, IDT)

3 Classification and basic size

3.1 The type of operating table is electrically powered. hydraulic and/or pneumatic and/or mechanical.

3.2 The basic size of the operating table shall comply with the requirements of […]

4 Requirements

4.8 The special requirements for the safety of the operating table shall comply with the provisions of YY 0570-2005.

4.9 The environmental test shall be in accordance with the provisions of the climatic environment test group II and the transport test in GB/T 14710-1993.

4.10 The of operating table shall be flat in appearance, uniform in color, free of defects such as scratches.

5 Test methods

5.1 Basic parameters. It is measured by the use a universal measuring tool. The results shall comply with the provisions of 4.1.

5.2 Leakage. The operating table shall be tested in accordance with 5.2.1 ~ 5.2.3 at 20 °C ± 5 °C. The results shall comply with the provisions of 4.2.

5.2.1 As shown in Figure 2, raise the table top to the highest position and keep it horizontally. Align the center of the column on the table top's hip board, apply a 100 kg static load. After maintaining the hydraulic pressure for 5 h (or 1 h for pneumatic system), measure the falling distance.

5.2.2 As shown in Figure 3, lower the table top to a minimum and horizontal position, hang a 25 kg static load at the middle position of 100 mm from the end of leg board. After maintaining the hydraulic pressure for 5 h (or 1 h for pneumatic system), measure the falling distance.

5.2.3 As shown in Figure 4, lower the table top to the lowest position. Upward fold the back board to form an angle of 125° to the hip board. Hang a 50 kg static load at the middle of the top of the back board. After maintaining the hydraulic pressure for 5 h (or 1 h for pneumatic system), measure the falling distance.

5.6 The table top and the selected table mat shall be visually inspected through

X-ray (50 kV) or X-ray fluoroscopy (70 kV), it shall be free from shadow and comply with the requirements of 4.6.

5.7 General requirements for safety shall be tested in accordance with the method as specified in GB 9706.1, to verify whether it complies with the requirements.

5.8 Special requirements for safety shall be tested in accordance with the method as specified in YY 0570, to verify whether it complies with the requirements.

5.9 Environmental test requirements shall be tested in accordance with the method as specified in GB/T 14710, to verify whether it complies with the requirements.

5.10 Make visual observation. The results shall comply with the provisions of 4.10.

6 Inspection rules

7 Markings, instructions for use, packaging, transport, storage