YY/T 0506.4-2016 (YY/T0506.4-2016, YYT 0506.4-2016, YYT0506.4-2016)
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Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment--Part 4: Test method for linting in the dry state
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YY/T 0506.4-2016
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Standards related to: YY/T 0506.4-2016
| Standard ID | YY/T 0506.4-2016 (YY/T0506.4-2016) | | Description (Translated English) | Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment -- Part 4: Test method for linting in the dry state | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C46 | | Classification of International Standard | 11.140 | | Word Count Estimation | 10,180 | | Date of Issue | 2016-07-29 | | Date of Implementation | 2017-06-01 | | Older Standard (superseded by this standard) | YY/T 0506.4-2005 | | Drafting Organization | Shandong Hang Shun Detection Technology Development Center, robust Industrial (Shenzhen) Co., Ltd. | | Administrative Organization | State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center | | Regulation (derived from) | State Food and Drug Administration Notice 2016 (No.129) | | Issuing agency(ies) | State Administration of Food and Drug Administration | YY/T 0506.4-2016
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.140
C 46
Replacing 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
(ISO 9073-10:2003, NEQ)
ISSUED ON: JULY 29, 2016
IMPLEMENTED ON: JUNE 01, 2017
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Principle ... 5
5 Instruments ... 5
6 Procedures ... 8
7 Calculation ... 9
8 Test Report ... 10
Appendix A (Informative) General Information on Reproducibility ... 12
Appendix B (Informative) Test Example of the Total Lining of Sample X ... 13
Surgical Drapes, Gowns and Clean Air Suits for
Patients, Clinical Staff and Equipment -
Part 4: Test Method for Linting in the Dry State
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.
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.
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.
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.
NOTE: Scrub with a wet clean cloth in a clean room, and dry the box for the next test.
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).
7 Calculation
7.1 Background correction
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.
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