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YY/T 1498-2016 (YY/T1498-2016)

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YY/T 1498-2016: PDF in English (YYT 1498-2016)
YY/T 1498-2016
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.120
C 48
Guideline for Evaluation of Selection and Use of
Medical Protective Clothing
ISSUED ON: JULY 29, 2016
IMPLEMENTED ON: JUNE 1, 2017
Issued by: China Food and Drug Administration
Table of Contents
Foreword ... 3 
Introduction ... 4 
1 Scope ... 5 
2 Normative References ... 5 
3 Terms and Definitions ... 6 
4 Types of Protective Clothing Materials ... 8 
5 Safety and Performance Indicators ... 11 
6 Evaluation and Selection of Protective Clothing Products ... 25 
7 Guiding Principle for Selection of Protection Levels under Specific Medical
Procedures ... 28 
Bibliography ... 33 
Guideline for Evaluation of Selection and Use of
Medical Protective Clothing
1 Scope
This Standard provides information on the types, safety and performance indicators of
protective clothing materials; evaluation and selection of protective clothing products;
guiding principles for the selection of protection levels based on specific medical
procedures; guidelines for the maintenance and handling of protective clothing.
It is impossible for this Standard to cover all the technical information necessary for
medical institutions to select protective clothing products. Moreover, it should not be
used as an evaluation standard for medical protective clothing products.
2 Normative References
The following documents are indispensable to the application of this document. In
terms of references with a specified date, only versions with a specified date are
applicable to this document. In terms of references without a specified date, the latest
version (including all the modifications) is applicable to this document.
GB/T 4744-2013 Textiles - Testing and Evaluation for Water Resistance - Hydrostatic
Pressure Method
GB/T 5455-2014 Textiles - Burning Behavior - Determination of Damaged Length,
Afterglow Time and After-flame Time of Vertically Oriented Specimens
GB/T 16886 (all parts) Biological Evaluation of Medical Devices
GB 19082-2009 Technical Requirements for Single-use Protective Clothing for Medical
Use
YY/T 0689-2008 Clothing for Protection against Contact with Blood and Body Fluids -
Determination of Resistance of Protective Clothing Materials to Penetration by Blood-
borne Pathogens - Test Method Using Phi-X174 Bacteriophage
YY/T 0700-2008 Clothing for Protection against Contact with Blood and Body Fluids -
Determination of the Resistance of Protective Clothing Materials to Penetration by
Blood and Body Fluids - Test Method Using Synthetic Blood
YY/T 1499-2016 Liquid Barrier Performance and Classification of Protective Apparel
Intended for Use in Health Care Facilities
during the usage.
3.9 Microbial Model
Microbial model refers to the simulation of a specific pathogenic microorganism to the
human body in size, shape and concentration. It is used to test the microbial barrier
properties of protective clothing.
3.10 Nonwoven Fabrics
Nonwoven fabrics refers to fabrics that do not require spinning or weaving. Textile
staple fibers and filaments are simply oriented or randomly arranged to form a web
structure, then, strengthened and formed through mechanical, thermal bonding or
chemical methods.
3.11 Other Potentially Infectious Materials
OPIM
Other potentially infectious materials refer to substances that carry blood-borne
pathogens or infectious disease-related substances, except from blood or body fluids.
3.12 Particle
Particle refers to solid, liquid or solid-liquid-mixed particulate substances suspended in
the air, such as: microorganisms, dust, smoke and mist, etc.
3.13 Penetration
Penetration refers to the phenomenon that substances pass through the breathable
fabrics or placket, seams and defects (for example, pinholes) of protective clothing at
the non-molecular level.
3.14 Ply
Ply refers to separable layer or sheet on material.
3.15 Reinforced Area
Reinforced area refers to an area, in which one or two layers of the same or different
materials as the product itself are added onto protective clothing to enhance or improve
the product’s performance.
3.16 Strike-through
Strike-through refers to the process, in which microbial-bearing fluids pass through
barrier material (including seams or joints on the material).
3.17 Surface Tension
This is the first reusable, waterproof finished fabric. When it is used for the
first time, this material has good water resistance. However, after repeated
washing, drying, sterilization and use, its water resistance will deteriorate.
4.1.3 Recent reusable materials
At present, the most commonly used materials for reusable protective clothing are:
a) Polyester fabric: it is made by spinning polyester filaments into yarns, and
then, weaving. After chemical treatment or calendering (to minimize the pore
size and make it denser), it may obtain stronger fluid barrier properties. This
fabric may also be woven with microfibers;
b) Composite fabric: by laminating various types of films or coatings on the
surface of knitted fabrics or woven fabrics, its performance can be enhanced
in certain aspects (for example, resistance to liquid penetration).
4.2 Single-use Materials
Generally speaking, single-use protective clothing is made of nonwoven fabrics (other
types of materials may also be used). Nonwoven fabrics may be used alone, or,
composite materials of nonwoven fabrics and materials (for example, plastic films) that
can enhance product’s resistance to liquid penetration may be used.
Nonwoven fabric is an engineering material that relies on fiber bonding technology
(heat-sealing, chemical or mechanical means) to provide the integrity and strength of
the material, rather than relying on geometric interlocking like woven or knitted
materials. The basic raw materials for the production of nonwoven fabrics are various
types of natural fibers (such as: wood pulp and cotton) or synthetic fibers (such as:
polyester and polyolefin). By adopting specific types of fibers, specific bonding
procedures and finishing processes, nonwoven fabrics with specific properties can be
produced.
The most commonly used nonwoven materials for the production of single-use
protective clothing are as follows:
a) Spunlace cloth: usually take wood pulp and polyester fibers as the raw
materials; through high-speed water flow, the fibers are bonded together;
through chemical treatment, the material’s resistance to liquid penetration is
enhanced;
b) SMS nonwoven fabrics (spunbond and melt-blown nonwoven fabric): this
material is produced by a combination of two processes: spunbond and melt-
blown. Typical medical materials are made of polypropylene and treated to
improve the material’s resistance to water penetration. Spunbond nonwoven
fabrics are made of continuous filaments. Melt-blown nonwoven fabrics are
made of ultra-fine fiber structures with small fiber diameter; or, they may be
c) Coating method: coating is a semi-liquid material, for example, carbamic acid
ester or organic silicon resin, which is usually applied on one side of the fabric.
Different performance parameters (such as: types of coating materials,
coating thickness) of the coating materials would lead to different barrier
levels to microorganisms and liquid penetration.
5 Safety and Performance Indicators
5.1 Barrier Properties
5.1.1 Barrier against penetration of liquids and microorganisms
For the purpose of protecting patients’ wounds from infection and protecting medical
personnel from infection due to blood-borne pathogens or other microorganisms,
medical protective clothing must be able to provide effective barrier properties to
prevent the spread of microorganisms. When medical personal implement isolation
and protection for patients, they usually wear protective clothing to prevent their own
clothing from causing contamination to the environment. The liquid barrier level of
medical protective clothing is shown in YY/T 1499-2016.
There are two types of protective materials: one type relies on protective coatings
(waterproof coatings) and / or product structure; the other type reinforces product
through film-laminating. Even with the same product, the resistance to liquid
penetration in some areas would be stronger than other areas. For example, the front
of protective clothing is usually reinforced through certain means, so that it can be
more resistant to liquid penetration than other parts.
It has been reported in literature that when microorganism-containing liquid passes
through protective material, the microorganisms contained in it would also pass
through, and in the absence of visible liquid, the microorganisms can also pass through
the reinforced protective material. Traditionally speaking, users often assume that
without visible penetration, no microorganisms would pass through the protective
material. This has been proved to be unrealistic.
In medical activities, liquid is often considered as an important carrier for microbial
transfer. Other possible carriers include: air, aerosol, hair, linting and dander. Under
mechanical action, dry-state microorganisms can pass through the porous material of
protective clothing. Effective microbial barrier must prevent the penetration of dry-state
and wet-state microorganisms.
The two basic types of liquid contamination that occur in medical activities are:
spraying and splashing, or liquid penetration due to pressure and contact. During
medical activities, at least one of the above-mentioned types of liquid contamination
would occur; in many cases, a combination of the two types would occur. Based on
different usage environments, the most suitable test method shall be selected to more
is limited. Since the test method adopts low-end pressure values in the range
of pressure, the test pressure often cannot represent the pressure applied to
the liquid in actual medical activities. (during medical treatment, the pressure
generated on the protective clothing by squeezing and contacting ranges from
less than 6.895 kPa to larger than 413.7 kPa; in medical activities, the
representative pressure value of abdominal pressure is 1.72 kPa ~ 13.79 kPa)
During compression and contact, the pressure applied to the protective
material and the pressure actually applied to the liquid are not the same. That
is because unless the liquid is completely wrapped, otherwise, it will be
squeezed away towards the direction with least resistance. In medical
activities, the pressure applied to the liquid has not been accurately quantified;
d) Most liquid challenge test methods have specific time-pressure procedures,
and the time is often shorter than the expected actual time. In accordance
with the final use of protective clothing, the time of liquid challenge test shall
be representative and practical. It is generally believed that it is necessary to
adopt a higher liquid pressure and a shorter time to achieve a specific test
result;
e) In liquid challenge test, the conditions of protective clothing are quite
important. Before the test, the adverse effect of physical, chemical or thermal
methods on product material’s quality will lead to erroneous evaluation of the
actual performance of the product. The final purpose of protective product is
to form effective barrier to the penetration of liquids and microorganisms
throughout the medical process. In the medical process, the impact of
physical, chemical and thermal means, and the impact of reprocessing on
product for multiple repeated uses shall all be evaluated. Physical technical
parameters include: stretching, relaxation, mechanical bending and wear
(wet-state and dry-state). Chemical effect includes: exposure to various
clinical solutions, skin disinfectants and human lubricants, irrigation fluids,
perspiration and sebum. Thermal effect includes: direct contact with hot
equipment and direct contact with high-energy output equipment;
f) YY/T 0689-2008 mainly focuses on a model organism, which is relatively
small and easily detected through analytical means---Phi-X174 bacteriophage.
However, the transmission mode of many viruses is not completely clear. The
test mode in YY/T 0689-2008 cannot be universally used in all virus exposure
situations. Therefore, manufacturers shall not issue a blocking statement
against all viruses, even if their products have passed the test of YY/T 0689-
2008. In terms of products that have passed the test of YY/T 0689-2008,
products may be marked as “(product name) has passed the test of YY/T
0689-2008 and satisfies the requirements of the standard, YY/T 0689-2008
Clothing for Protection against Contact with Blood and Body Fluids -
Determination of Resistance of Protective Clothing Materials to Penetration
by Blood-borne Pathogens - Test Method Using Phi-X174 Bacteriophage”.
c) Inflatable bladder test method: in this test, an inflatable bladder is used to test
textiles’ anti-wear performance under controllable conditions and wet
conditions.
5.4 Strength
5.4.1 Overview
Barrier material shall have sufficient mechanical strength; under controllable conditions
and wet conditions, it shall be able to withstand the high strength generated by normal
use. Both tearing and perforation can cause threats to sterile areas and lead to liquid
penetration. A material shall be tested for its breaking strength, tear strength and
puncture resistance. The following methods (5.4.2, 5.4.3 and 5.4.4) can be used to
determine these properties.
5.4.2 Breaking strength
The commonly used test methods for breaking strength are as follows:
a) Grab method: in terms of an initial material without any cracks, this test
method applies a gradually increasing tensile force to test the material’s
tensile strength. In the test, the greater the force required to cause the sample
to break is, the greater the strength of the product is;
b) Strip method: this test method applies a gradually increasing tensile force to
a strip sample with a certain width and without any cracks to test the tensile
strength of a material. In the test, the greater the force required to cause the
sample to break is, the greater the strength of the product is;
c) Bursting strength method: this test method applies a gradually increasing
pressure to test sample’s anti-bursting strength. The greater the pressure
required to cause the sample to burst is, the greater the strength of the sample
is.
5.4.3 Tear strength
Firstly, make an initial tear on the sample. The test of tear strength is to determine the
force required to extend the tear. The three most commonly used test methods for the
determination of tear strength are as follows:
a) Elmendorf tear strength method: when there is already an initial tear on the
material, under the effect of controllable force, test material’s resistance to
tear. The greater the required force is, the greater the tear resistance of the
material is;
b) Trapezoidal tear strength method: under the condition of applying a gradually
increasing force perpendicular to the tearing direction, test the material’s
breathability can be used as a predictable evaluation parameter. However, film-
reinforced protective clothing does not allow gas to pass through. Hence, in the test of
the discomfort caused by thermal stress on protective clothing, moisture permeability
test is generally selected as a parameter to compare all the protective materials
(including breathable materials and non-breathable materials). To sum up, comfort
level can be affected by a lot of factors. Although it is inapplicable to all types of
protective clothing, breathability and water vapor permeability can be used as two
objective testing parameters of textile materials.
Protective clothing is usually made of a variety of materials, which may vary greatly in
the two parameters: breathability and water vapor permeability. The whole or part of
protective clothing may allow perspiration and water vapor of the body surface to
penetrate into the environment, and thus, assisting the body temperature regulation
and balance. Protective clothing made entirely or partially of materials with high-air
permeability or high-water vapor permeability usually has a wider range of comfort, or,
is tolerant to higher temperature, relative humidity and higher workload. Protective
clothing that cannot allow permeation of perspiration or breathing vapors would break
the balance of internal and external exchanges, which often results in discomfort.
The test methods for air permeability, water vapor permeability and thermal resistance
are as follows.
5.5.1 Air permeability
Under the condition of a certain pressure difference, test the sample’s capability of
allowing gas to pass through. The test result shall be expressed in gas volume / area
/ time. The larger the tested value is, the better the material’s permeability is. When
the result is less than 30.5 cm3/(cm2min), other test methods shall be adopted.
5.5.2 Moisture permeability
Water vapor permeability refers to the capability of water vapor to pass through a
material. This property has significant influence on comfort level, because materials
that are impermeable to water vapor often cause discomfort. There are many test
methods for the measurement of water vapor permeability. When comparing the
results of different test methods, the comparability of the methods needs to be carefully
considered.
5.5.3 Thermal resistance and moisture resistance
Under steady-state conditions, use perspiration protection hot plate (also known as
skin model, because it simulates the thermal regulation mode of human skin) to test
material’s resistance to dry heat loss and water vapor heat loss. This device simulates
the transfer of heat and mass that occurs on two dry and sweaty human skins. When
using different environmental conditions to simulate different environmental conditions,
the tests of protective clothing’s resistance to dry heat and water vapor heat loss may
b) Electrostatic attenuation: the sample is in equilibrium at a certain temperature
and relative humidity. Then, the sample is suspended between the two
electrodes; use 5,000 V of electrostatic voltage to charge it; record the time
of discharging to 500 V. In GB 19082-2009, the described acceptable
attenuation time does not exceed 0.5 s.
c) Surface resistivity: in this test method, the sample is in equilibrium at a certain
temperature and relative humidity, then, use a resistance meter to test the
sample’s resistivity.
5.8 Flame Retardancy
There are many potential fire sources in modern medical activities, including surgical
lasers, electrosurgical units, fiber optic endoscopes and other high-energy electric
medical equipment. If a high-intensity heat source (for example, surgical lasers or other
surgical electric equipment) acts on any material in the medical activity environment, it
will cause burning, especially when the oxygen content increases in the environment.
Different materials have different flame-retardant properties under different
environmental conditions.
In accordance with the test method specified in GB/T 5455-1997, test the flame-
retardant properties of protective clothing products. Combine the requirements for
flame retardant properties in GB 19082-2009, determine if the product’s flame-
retardant properties can meet the requirements.
5.9 Particles and Linting
During the wear process, most materials (fabrics and nonwoven fabrics) would
generate and release thread particles to a certain extent. In addition, records indicate
that some materials can generate more particles than others. At present, a generally
accepted viewpoint is that the more linting and particles, the greater the probability of
infection due to microbial transmission or foreign body reaction is. Eventually, the
generated linting can form particles in the ducts of the air treatment system, or on the
top of the closet or storage shelf, which may potentially reduce the efficiency of the
purification circulation system and increase the workload of cleaning and maintaining
the medical environment. Therefore, protective clothing shall be designed to generate
no linting. The following test methods may be used to evaluate whether protective
clothing materials would easily generate particles or visible linting:
a) Air deflection test: the sample is deflexed in a clean test chamber; the air in
the test chamber is drawn out. Use an optical particle counter to count the
particles in the air.
b) Water oscillation test: place protective clothing material in a container that
contains ultrapure water; oscillate the container, so that the particles are
released into the water. Pump out the water; use a water-based optical
sterilized products shall have correct documentation and operating instructions
provided by the manufacturer, so as to ensure the effectiveness of on-site sterilization.
In terms of sterilization of protective clothing, the sterilization dose must be guaranteed;
the sterilant residue must be effectively removed. Other important variable factors
include: recommended folding method, packaging configuration, restrictions on
contents and density of package, and restrictions on the capacity of sterilization
container.
5.13 Functional Performance
Under normal conditions of use, and within the period of validity, for each medical
procedure, protective clothing shall be able to provide effective barriers to blood and
other potential sources of infection. Due to different operating procedures and tasks
being undertaken, the requirements for the conditions and the time of the use of the
products are also obviously different, which requires products to provide different levels
of protection (see Chapter 6). The influence on product functions shall be carefully
considered, such as: strength (breaking strength, puncture strength and tear strength);
abrasive resistance (loss to protective properties); flexibility; anti-contamination
property; flame retardancy. If protective clothing is required to be sterile during the use,
then, the effectiveness of the sterile effect and the storage time of reusable products
and single-use products shall all be evaluated. Furthermore, in terms of reusable
products, the cleaning and disinfection procedures shall also be evaluated.
In terms of reusable products, an effective system can ensure that the products are
removed in time at the end of their service life. Consult with the manufacturer of
protective clothing about the expected service life of the products and the mode of use
for the service life. If the work is all outsourced, medical institutions must ensure that
these contractors meet the above-mentioned requirements in operations, such as: dry-
cleaning, re-packaging and aseptic packaging, etc.
Medical institutions are required to have a system that can timely repair or replace
personal protective equipment, so as to ensure the effectiveness of barrier. This
system can timely examine, inspect, repair and update personal protective facilities,
which is essential to ensure the correct maintenance and continuous integrity of
protective products. In addition, the above-mentioned services shall completely be
completed by the manufacturer or the supplier. End-users shall establish and improve
a standard system for the accepted products (including product type, product location,
packaging quantity, maintenance and contamination control, etc.). It is the
responsibility of medical institutions to implement effective and scientific quality
management of products that they use.
Once the priority of a performance parameter is set, then, it shall be
applicable to all the products being evaluated;
c) In accordance with the selected method, conduct the test. Then, in
accordance with the test results, grade the product performance. The grading
shall be based on medical institutions’ inspection scheme or the literature
provided by the manufacturer. The following may be used as a reference for
setting the grading scheme:
1) Inferior (lower than the standard requirements);
2) Lower than the average value;
3) Average value (conformant with the standard requirements);
4) Higher than the average value;
5) Excellent (above the standard requirements).
In terms of all the products to be evaluated, adopt the above-mentioned
scoring grades to compare the actual test results. All the grading systems
shall adopt this format, and meanwhile, all the products shall adopt the
same test method;
d) Multiply the priority by the grading level; fill the obtained value into the result
column;
e) Add the values in the result column to calculate the total score of each product.
All the products have a score for each evaluated performance. This is quite
important.
In accordance with medical institution’s special requirements, sort the total score of the
overall physical properties of all the products; comprehensively consider the cost and
quality assurance of the products. Take this as a basis for the selection of protective
clothing.
6.5 Periodic Evaluation
In consideration of the continuous updating of optional products and changes in the
specifications of medical diagnosis and treatment procedures, it is recommended to
re-evaluate at least every two years.
when the conditions allow, products with a higher protection level shall be selected as
a substitute. In addition, long-term clinical experience may be used to select a suitable
level of barrier properties for specific medical procedures, and this selection may be
different from what is recommended in Table 4. Medical procedure is constituted of
several parts, and the exposure risk of each part differs. Hence, user shall in
accordance with the requirements of the pre-determined procedure, select the highest
protection level. As the initial consideration of the decision-making procedure, Table 3
may be considered as a general criterion.
7.5 Special Considerations of Protective Clothing
If patients’ secretions, excreta or other contaminations might contaminate medical
personnel’s clothing, standard precautions require the medical personnel to wear
protective clothing when performing medical care. When medical personnel care for
patients who might have a specific infectious disease, the use of protective clothing
shall consider the mode of transmission of the infectious disease. Whether standard
precautions or isolation precautions are implemented, the selection of protective
clothing shall comprehensively consider the risk and the nature of expected exposure,
and the protection level that protective clothing can provide.
The selection of protective clothing shall base on the following considerations:
a) The nature of disease shall be considered. The most important is whether the
etiology and the mode of transmission of the disease are already known. If
the mode of transmission is already known, then, it is quite easy to select
suitable protective clothing and other personal protective equipment. When
an unknown infectious disease outbreaks, it would be extremely difficult to
correctly select suitable protective clothing and personal protective equipment.
The severe acute respiratory syndrome (SARS) that appeared in 2003
approves this. At first, the pathogen and the main transmission mode of this
infectious disease were unknown, and the Center for Disease Control and the
World Health Organization became extremely worried about the number of
medical personnel infected with the disease. Therefore, the two organizations
recommended the medical personnel to adopt the highest level of personal
protective equipment.
b) The possibility of exposure to body fluids shall be considered. When patients
undergo projectile vomiting or have severe diarrhea, this possibility is
extremely high. Under this circumstance, a higher barrier protection level is
indispensable. In particular, due to the intervention of intubation, a large
amount of body fluid is generated, and the operation of the medical procedure
is also of great importance.
c) Protective clothing has two functions: one is to protect medical personnel from
infection by patients; the other is to protect patients from infection by medical
personnel. In the initial stage of infectious diseases (for example, SARS),
......
 
(Above excerpt was released on 2020-04-11, modified on 2021-06-07, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/YYT1498-2016