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YY/T 0506.2-2016 (YYT0506.2-2016)

YY/T 0506.2-2016_English: PDF (YYT 0506.2-2016, YYT0506.2-2016)
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YY/T 0506.2-2016English135 Add to Cart 0--9 seconds. Auto-delivery Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment. Part 2: Performance requirements and test methods Valid YY/T 0506.2-2016

BASIC DATA
Standard ID YY/T 0506.2-2016 (YY/T0506.2-2016)
Description (Translated English) Surgical drapes, gowns and clean air suits for patients, clinical staff and equipment. Part 2: Performance requirements and test methods
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C46
Classification of International Standard 11.040
Word Count Estimation 11,123
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Older Standard (superseded by this standard) YY/T 0506.2-2009; YY/T 0506.3-2005
Quoted Standard GB/T 4744; GB/T 6529; GB/T 7742.1; GB/T 24218.3; YY/T 0506.1; YY/T 0506.4; YY/T 0506.5; YY/T 0506.6; YY/T 0506.7
Drafting Organization Shandong Province medical equipment product quality inspection center
Administrative Organization State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Administration of Food and Drug Administration
Summary This standard specifies the performance requirements and test methods for surgical procedures, surgical clothing and clean clothing.

Standards related to: YY/T 0506.2-2016

YY/T 0506.2-2016
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
C 46
Replacing YY/T 0506.2-2009, YY/T 0506.3-2005
Surgical drapes, gowns and clean air suits for
patients, clinical staff and equipment - Part 2:
Performance requirements and test methods
ISSUED ON: JANUARY 26, 2016
IMPLEMENTED ON: JANUARY 01, 2017
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3 
Introduction ... 5 
1 Scope ... 6 
2 Normative references ... 6 
3 Terms and definitions ... 7 
4 Performance requirements ... 8 
Appendix A (Normative) Test method ... 11 
Appendix B (Informative) Optional test method ... 14 
References ... 16 
Surgical drapes, gowns and clean air suits for
patients, clinical staff and equipment - Part 2:
Performance requirements and test methods
1 Scope
This part of YY/T 0506 specifies the performance requirements and test
methods of surgical drapes, surgical gowns and clean air suits.
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 standard.
GB/T 4744 Textile fabrics - Determination of resistance to water penetration
- Hydrostatic pressure test
GB/T 6529 Textiles - Standard atmospheres for conditioning and testing
GB/T 7742.1 Textiles. Bursting properties of fabrics - Part 1: Hydraulic
method for determination of bursting strength and bursting distension
GB/T 24218.3 Textiles - Test methods for nonwovens - Part 3: Determination
of tensile strength and elongation (strip method)
YY/T 0506.1 Surgical drapes, gowns and clean air suits for patients, clinical
staff and equipment - Part 1: General requirements for manufacturers
processors and products
YY/T 0506.4 Surgical drapes, gowns and clean air suits for patients, clinical
staff and equipment - Part 4: Test method for linting in the dry state
YY/T 0506.5 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 0506.6 Surgical drapes, gowns and clean air suits for patients, clinical
staff and equipment - Part 6: Test method to determine the resistance to wet
bacterial penetration
Classification of various characteristics of products used as medical devices
as minimum performance requirements during traumatic surgery.
3.3.2
High performance
Classification of various characteristics of products used as medical devices
as stricter performance requirements during traumatic surgery.
Note: Examples of surgical procedures that shall be considered to improve the
performance level are those that are excessively exposed to fluids, mechanical
stress, or longer surgical procedures.
3.4
Product
Surgical gowns, surgical drapes and clean air suits.
Note: For surgical kits, each surgical gown or drape is considered a product.
3.5
Sterile field
The area covered by the sterile surgical drape for aseptic procedures.
Note: The sterile area can be located, such as the instrument table.
4 Performance requirements
The product must comply with the YY/T 0506 series of standards. When tested
according to this standard, it shall meet the requirements specified in Table 1,
Table 2 or Table 3. See Appendix A for detailed information on the
corresponding test method and its application.
If the medical device is intended to be used in a sterile area, then the surgical
drape and instrument drape shall meet the requirements of Table 2.
Note 1: YY/T 0506.1 gives manufacturers, processors and products, information to be
provided and general requirements for production, processing and testing.
Note 2: Performance requirements are as specified in accordance with product area
and performance level. However, the performance requirements of some features will
apply to all performance levels of medical devices and product areas of medical
devices.
Appendix A
(Normative)
Test method
A.1 General
Unless otherwise specified, the atmosphere for pre-conditioning, conditioning
and testing shall be carried out in accordance with GB/T 6529. Before the test,
the sample shall be state-conditioned without restrictions.
A.2 Cleanliness-microbial evaluation test method
It shall follow the test method given in YY/T 0506.7 to evaluate the cleanliness-
microbial.
A.3 Test method for the evaluation of cleanliness-particulate matter
It shall follow the test method given in YY/T 0506.4 to estimate the cleanliness-
particulate matter.
Note: YY/T 0506.4 allows the test to be carried out in a laminar flow hood. If the
instruments required for the test are placed in the hood, it is necessary to confirm the
occurrence of laminar flow.
In order to estimate the cleanliness-particulate matter, the following changes
apply to this document.
a) It shall calculate the particle count in the range of 3 μm ~ 25 μm.
Note: Particles in this specification range are considered to carry microbial.
b) Add the particulate matter counts obtained from the first three time points
30s, 60s and 90s according to the following formula to calculate the
particulate matter (PM):
PM = C30 + C60 + C90
The test results shall be reported in terms of the index of particulate
matter (IPM), which is usually expressed in logarithmic values for
particulate matter: IPM = log10 PM.
Note: This test procedure cannot distinguish between particulate matter and lint
in this period of time, so these two parts are included.
A.4 Test method for evaluation of lint
Appendix B
(Informative)
Optional test method
B.1 Test method for evaluation of liquid control
If the manufacturer claims that the liquid control of the product depends on its
absorption to achieve its purpose, it is recommended to evaluate it according
to GB/T 24218.11 and make the following modifications:
a) Distilled water or deionized water is used as the test liquid;
b) It shall use the overflow percentage (w) to calculate the liquid retention
percentage as follows:
Percentage of fluid retention = 1 - w
The percentage of liquid retention is the amount of liquid absorbed by the
material.
Note: Other tests to evaluate absorption such as GB/T 24218.6 or GB/T 24218.12.
B.2 Test method for evaluation of breathability
It is recommended to evaluate the breathability of the product according to the
test of GB/T 5453.
The applicable test parameters are:
a) Test area: 20 cm2;
b) Pressure drop: 100 Pa.
Note: Breathability is an important aspect of evaluating the comfort of surgical gowns
and surgical drapes (see also Appendix A of YY/T 0506.1), which is a contradiction
between protective performance.
B.3 Laser resistance
It may use the test method as specified in the YY/T 0855 series of standards to
give the primary ignition level, penetration level, secondary ignition level of the
surgical drapes, so that the doctor can take appropriate protective measures.
B.4 Drapability
It may follow GB/T 23329 to evaluate the drapability of the surgical gowns and
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