YY/T 1498-2016 English PDF (YYT1498-2016)

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YY/T 1498-2016: Guideline for evaluation of selection and use of medical protective clothing
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...