YY/T 0855.2-2011Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 2: Secondary ignition (English PDF)

Foreword

YY/T 0855 "surgical drapes and (or) patient protective covering anti-laser test methods and classification", consists of the following components.

--- Part 1. Primary ignition and penetration --- Part 2. Secondary ignition This section YY/T Section 20855 of.

YY/T 0855 This section is based on GB/T 1.1-2009 given rule drafting.

YY/T 0855 is identical with this part of ISO 11810-2:2007 "Lasers and laser-related equipment surgical drapes and (or) patient protection Covering anti-laser test methods and classification - Part 2. Secondary ignition. "

This standard by the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.

This part mainly drafted by. Shandong Province Medical Devices Product Quality Inspection Center, Shandong Hengxin detection technology development center.

Introduction

Certain medical surgical laser applications in laser surgery may require anti-single and (or) other patient protective covering. In the sterile surgical too Process, surgical drapes and (or) other patient protective covering is necessary, while protecting the surrounding areas are not subject to liquid, and accidental discharge laser Radiation. Conventional surgical drapes and/or other protective covering patients do not have to have anti-laser resistance, only specific surgical requirements with a single before Anti-laser resistance.

Laser-induced risk include. ignition, flammable, melting, penetration, heat transfer and reflection. Providing a laser barrier fabric and non-woven surgical Single material may also have other risks. In the operating room often have more than one potential cause ignition device (for example. fiber optic lighting systems, electronic surgical device Home, hot wire ignition device), this test method is only for laser-induced ignition source. YY/T 0855 for this part of the expected nominal single anti-laser surgery And/or patient trial was covered.

CO2 laser offers the most challenging conditions for all medical laser. Burning/flammability test and the penetration test may find more Challenging laser wavelengths and laser delivery models, Q- exchange such as within nanosecond range. YY/T 0855 this part of the choice of 20W CO2 laser (continuous wave) laser as a test. For surgical drapes and/or patient protective covering other laser-induced secondary ignition, the wind Risk depends on the size of the power at a given spot. In addition, the composition or design of products in different regions of the material may vary. The manufacturing Nominal or end-user's requirements, all nominal anti-laser areas may need to experiment.

YY/T 0855 This section applies to the secondary ignition and provides YY/T test and report on the results of its outside 0855.1 His message. The goal is to simulate the secondary ignition surgical drapes and/or other patient protective covering with the lid on top of other materials. With a Cotton gauze simulate another material, YY/T 0855 this part of the gauze determined whether other patients combustion ignite surgical drapes and (or)

Protective cover, if the removal of the burning of gauze, surgical drapes and (or) other patients whether protective coverings will continue to burn. Also measured surgery Single and (or) other patient protective covering over the burn.

When used in combination rather than alone, a single anti-laser surgery and (or) the performance of other patient protective coverings may vary reduce.

1 Scope

YY/T 0855 This section applies to a nominal one-time use of anti-laser and repetitive use of surgical drapes and other patient protective cover It was the nonwoven and woven materials.

YY/T 0855 This section of the surgical drapes and (or) other patient protective covering for the harm caused by the laser provides a standard Testing and classification methods, and the corresponding classification system. YY/T 0855 does not include this part of the general fire safety regulations. Headquarters Only minutes to ignition test according to I1 YY/T 0855.1 classification or secondary I2 grade material.

All materials will reflect a portion of the beam, the user must decide whether specular reflection will bring harm, but in YY/T 0855 to the present Part not involved.

Results YY/T 0855 in this section do not apply to other wavelengths and time format.

YY/T 0855 this part of the choice of 20W CO2 laser (continuous wave) laser as a test.

Note: The use of this test method should be careful, because the surgical drapes and (or) other patient protective covering of anti-laser wavelength is very sensitive, and surgical drapes and (or)

Other patients protective covering should be used in its intended wavelength test, if the other wavelength, power settings, and delivery models should be clearly stated.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 15313-2008 Laser term

YY/T 0855.1 surgical drapes and (or) patient protective covers test methods for anti-laser and classification - Part 1. Primary ignition and penetrate

ISO 11146-1 Lasers and laser equipment laser beam width, beam divergence angle and beam propagation ratio test methods - Part 1. No image Scattered beam and simple astigmatic beams

3 Terms and Definitions

GB/T 15313-2008, YY/T 0855.1 and define the following terms and definitions apply to this document.