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

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
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.
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 mo...
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