YY/T 0855.1-2011Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 1: Primary ignition and penetration (English PDF)
手术单和/或病人防护覆盖物抗激光试验方法和分类 第1部分:初级点燃和穿透
This is a limited preview
Buy now to download the full PDF (15 pages)
Need quotation for your management?
Get a formal quotation for YY/T 0855.1-2011 in 30 minutes.
Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 31, 2011
Implementation date
June 1, 2013
Scope
YY/T 0855.1-2011 is the English-translated version of 手术单和/或病人防护覆盖物抗激光试验方法和分类 第1部分:初级点燃和穿透.
YY/T 0855.1-2011 is the Chinese pharmaceutical industry standard that gives the test method and the classification for the primary ignition and penetration of surgical drapes and other patient protective covers exposed to laser radiation.
It is the first part of the YY/T 0855 series and applies to the nonwoven and woven materials of such products, whether single-use or reusable, setting out the laser and the exposure, the observation of ignition and of penetration and the classes into which a material falls. Issued on 31 December 2011, it has applied since 1 June 2013.
Found what you need?
Document preview — YY/T 0855.1-2011
National Standard of the People's Republic of China
- ICS
- 11.040.20
- Classification
- C 48
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
Foreword
YY/T 0855 "surgical drapes and/or patient protective covers anti-laser test methods and classification" is divided into two parts.
--- Part 1. Primary ignition and penetration;
--- Part 2. Secondary ignition. This section YY/T Section 10855 of. This section drafted in accordance with GB/T 1.1-2009 given rules.
The partial modification of the use of ISO 11810-1:2005 "Lasers and laser-related equipment surgical drapes and/or patient protective covers anti-laser test Test methods and classification - Part 1. Primary ignition and penetration. " The main changes are.
--- Of relevant terms by a footnote;
--- Modify the ISO 11810-1:2005 Table 1 error.
Introduction
Certain medical surgical laser applications in laser surgery may require anti-mono- 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 discharge and laser radiation accident Shot effect. Conventional surgical drapes and/or other protective covering patients do not have to have anti-laser resistance, only dedicated only requires a single surgery Laser anti-sex.
Laser-induced risks include, ignite, 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. In addition, the area of this product may have different materials or design. According to the manufacturer's nominal or End-user requirements, all nominal anti-laser areas may need to experiment.
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 selection 20W CO2 laser (continuous wave) laser as a test.
Users of this test method should pay attention to, surgical drapes and/or other patient protective covering of anti-laser wavelength dependent, surgical drapes and / Or other protective covering patient should be tested at a wavelength of intended use. If the experiment using other wavelengths, power setting and delivery team Law, need to be explained.
YY /test results in this section T 0855 should not be used for other wavelengths and temporal patterns.
When used in combination than when used alone, a single anti-laser surgery patients or other protective covering performance might change.
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.
This section surgical drapes and other patient protective covering for the harm caused by the laser provides a standard test methods and classification, and It gives the corresponding classification system. This section does not include a general fire safety specification. Also, this section includes neither caused by other sources of ignition, do not Including laser-induced secondary ignition cover.
All materials will reflect a portion of the beam, the user must decide whether specular reflection may bring harm, but not in this section It involved.
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 terminology (ISO 11145:2006, MOD)
ISO 11146-1 Test methods for laser and laser-related equipment associated laser beam parameters - beam width, divergence angle and beam radiation factor Part 1. no astigmatism and simple astigmatic beams (Lasersandlaser-relatedequipment-Testmethodsforlaserbeam widths, divergenceanglesandbeam propagationratios-Part 1. Stigmaticandsimpleastigmatic beams)
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1 I fired afterflame
Under test conditions, after the ignition source is removed continue burning material.
3.2 I burn time afterflametime
Under test conditions, the length of time after the ignition source is removed continue burning material.
3.3 Afterglow
Under test conditions, after cessation of flaming or after the ignition source is removed continue burning without emitting material occurs.
3.4 Afterglow time
Under test conditions, the material after cessation of flaming or after the ignition source is removed without combustion occurring duration of light emission length of time.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Similar standards
How to Download YY/T 0855.1-2011
- 1
Add to cart
Click "Download PDF" on this page and choose "Buy this standard". You can add more standards before checkout.
- 2
Checkout
Enter your email and billing details. Payment is processed securely by Stripe (cards or bank transfer). Prefer bank details? Request a quotation (min. order $300).
- 3
Instant delivery (0–9 sec)
Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4
Invoice included
A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB/T 15313-2008 — Terminology for laser
YY/T 0855.2-2011 — Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Part 2: Secondary ignition
YY/T 0297-2026 — General requirements for clinical investigation of medical devices
Secure payment via Stripe
Payments accepted
YY/T 0855.1-2011
$195.00