YY/T 0506.4-2016Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 4: Test method for linting in the dry state (English PDF)
病人、医护人员和器械用手术单、手术衣和洁净服第4部分：干态落絮试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
July 29, 2016
Implementation date
June 1, 2017
Scope
YY/T 0506.4-2016 is the English-translated version of 病人、医护人员和器械用手术单、手术衣和洁净服第4部分：干态落絮试验方法.
YY/T 0506.4-2016 is the Chinese pharmaceutical industry standard that gives the test method for measuring the linting of surgical drapes, gowns and clean air suits in the dry state, that is the release of loose fibres and particles that could fall into a wound or disturb clean air.
It is the fourth part of the YY/T 0506 series and can also be used for other medical textile materials.
The method covers the specimens and their conditioning, the apparatus that agitates the material and collects what comes off it, the counting or weighing of the released particles and how the result is expressed, so that materials can be compared on equal terms.
It replaces YY/T 0506.4-2005, was issued on 29 July 2016 and has applied since 1 June 2017.
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Document preview — YY/T 0506.4-2016
National Standard of the People's Republic of China
- Replacing
- YY/T 0506.4-2005
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword3
- 1 Scope4
- 2 Normative References4
- 3 Terms and Definitions4
- 4 Principle5
- 5 Instruments5
- 6 Procedures8
- 7 Calculation9
- 8 Test Report10
- Appendix A (Informative) General Information on Reproducibility12
- Appendix B (Informative) Test Example of the Total Lining of Sample X13
1 Scope
This part of YY/T0506 specifies the test method for measuring linting of surgical drapes, gowns, clean air suits and materials under dry state. This method is also applicable for other medical textile materials.
2 Normative References
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this document.
GB/T 25915.1 Cleanrooms and Associated Controlled Environments - Part 1: Classification of Air Cleanliness (GB/T 25915.1-2010, ISO 14644-1:1999, IDT)
ISO 554 Standard Atmospheres for Conditioning and/or Testing - Specifications
3 Terms and Definitions
For the purpose of this document, the following terms and definitions apply.
3.1 Lint
Fibers released during the using period.
3.2 Linting
The release of lint and other particles during operating period.
3.3 Coefficient of linting
The logarithm (lg) of the count of all or partial particles entering the measurement channel.
4 Principle
This method describes the improved Gelbo distortion method. In this method, the sample is subjected to a combined action of torsion and compression in the test chamber. During the torsion process, extract the air from the test chamber; use the particle counters to count and classify the particles in the air. See Appendix A for general information on reproducibility.
5 Instruments
5.1 Laminar flow hood
It is used to provide a clean test environment.
NOTE: It is also possible to use ISO Level-5 clean rooms in accordance with GB/T 25915.1. 1)
5.2 Torsion device (improved Gelbo torsion device)
It contains two discs with a diameter of 82.8mm, one of which is fixed, and the other is a motion disc fixed on a motion mechanism, so that it reciprocates toward the fixed disc at a frequency of 60 cycles per minute. During the reciprocating motion, it also rotates 180° clockwise and counterclockwise at the same time, see Figure 1.
The disc has 8 holes (12.5mm in diameter), 10mm from the outer edge of the disc, and is arranged equally.
The starting distance of the two discs is (188±2) mm, and the linear motion stroke is (120±2) mm.
Clamp for fixing the test piece to the disc in the form of a tube.
1) The cleanliness level specified in GB/T 25915.1 is equal to that in GB 50073-2001 Code for Design of Clean Room, of which Level-5 is the Level-100 cleanliness of traditional English system; that is, The number of the suspended particles with a particle size greater than or equal to 0.5µm per cubic foot does not exceed 100. For such cleanliness level, the number of suspended particles with a particle size greater than or equal to 0.1µm per cubic meter does not exceed 100,000, which is 5 after the common logarithm is adopted. At present, domestic particle counters generally cannot count particles of 0.1µm.
a) Open the rear panel (to allow clean air to flow into the empty box), the bending device stops running without a test piece; conduct two measurements; and confirm that there are less than 100 particles with particle size >=0.5µm within the 30s sampling time. If this requirement is not met, this procedure shall be repeated.
b) Count the particles as follows to get the background count (C0):
1) Close the rear panel.
2) Let the torsion device run without load to 10 count stabilization periods with 30s for each; and record the results.
3) Sum up these results; then get C0.
NOTE: Scrub with a wet clean cloth in a clean room, and dry the box for the next test.
6 Procedures
6.4 The test environment shall be kept clean (see 5.1). The torsional box shall be clean between each measurement and check the air quality in the box.
6.5 Roll the test piece into a cylindrical shape along the long size direction; and stick it by a suitable glue, the bonding width is 0.5cm (see Figure 4).
6.6 Adjust the discs to the starting position with interval of (188±2) mm.
6.7 Carefully install the test piece on the disc and fix it with a suitable clamp (such as rubber band). Touch shall be minimized.
6.8 The particle counter is set to 30s counting time and 1s recounting time (operation mode).
6.9 Close the torsional box.
6.10 Start the torsion device and start the particle counter at the same time until the completion of 10 consecutive 30s counts.
6.11 Stop the operation of torsion device and counter. Remove the test piece and clean the torsional box before testing the next test piece.
6.12 Record the particle count results of each size classification on the reading device.
6.13 Repeat this procedure for all 10 test pieces (5 test Side-A, 5 test Side-B).
Appendix A (Informative)
General Information on Reproducibility The counted particles during the test may be debris (dust) in the air or debris from fabrics, stitches or other process items. When this test is used to evaluate the lint produced by nonwoven fabrics or composites, the dust shall be kept to a minimum.
It has been found that many types of nonwoven fabrics made of different materials have similar particle generation characteristics. The particles are released during the twisting process and slowly diffuse to the sampling port of the counter. During the total test time of five minutes, this diffusion reached its maximum and then decayed. Such a five-minute test time is more suitable for evaluating the characteristics of the material.
Generally speaking, the torsion effect only causes partial particles in the releasable particles to be released, which will lead to a large difference between the results of test pieces taken from the same sample. But multiple sampling and testing may get a relatively ideal measurement of products, processes and potential linting.
Reproducibility is only for the median of each absolute number, but the ranking is very reproducible.
To calculate the 95% confidence interval of the coefficient of linting2), first calculate the standard deviation of the original particulate content; then use this statistical data to calculate the confidence interval; and then take the lg value and report.
2) The 95% confidence limit for the coefficient of linting = lg (total linting ± 1.96S), where S is the standard deviation.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 21 pages — is available in the English PDF.
Referenced standards
Similar standards
Editions of YY/T 0506.4
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0506.4-2016 | Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 4: Test method for linting in the dry state | current edition | Current |
| YY/T 0506.4-2005 | Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 4: Test method for linting in the dry state | previous edition | Superseded |
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Related Standards
GB/T 25915.1-2021 — Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
YY/T 0506.5-2009 — Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 5: Test method for resistance to dry microbial penetration
YY/T 0506.3-2005 — Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment - Part 3: test methods
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