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YY/T 1498-2016: Guideline for Evaluation of Selection and Use of Medical Protective Clothing
YY/T 1498-2016
Guideline for evaluation of selection and use of medical protective clothing
ICS 11.120
C48
People's Republic of China Pharmaceutical Industry Standard
Guidelines for the selection and evaluation of medical protective clothing
2016-07-29 release
2017-06-01 Implementation
Published by the State Food and Drug Administration
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some elements of this standard may involve patents. Publication of this standard
The agency is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the State Food and Drug Administration Beijing Medical Device Quality Supervision and Inspection Center.
This standard was drafted. Beijing Medical Device Inspection Institute.
The main drafters of this standard. Jin Guosheng, Liu Simin, Jiang Hongxia, Huang Yongfu, Yue Weihua, Hu Guangyong.
introduction
Given that blood-borne pathogens such as HIV, Hepatitis B virus and Hepatitis C virus
The protection of medical personnel has become an important issue.
Medical protective clothing is made of reusable or single-use materials, each of which has advantages and disadvantages. In optional materials
Within the range of types, product design and performance parameters can vary widely.This difference is the product's economics, comfort, and specific protection.
As a result of a trade-off between needs, the diversity of this difference allows medical personnel to choose the right protective clothing product or level of performance
Face complex decision-making procedures.
The purpose of this standard is to help medical personnel choose medical protective clothing products approved for marketing as medical devices.It can provide professional medical personnel with
Technical support, they can learn about medical protective clothing products (hereinafter referred to as protective clothing) from manufacturers according to specific medical procedures according to this standard
Performance indicators to select suitable medical protective clothing products.
Guidelines for the selection and evaluation of medical protective clothing
1 Scope
This standard gives information on the types of protective clothing materials, safety and performance indicators, evaluation and selection of protective clothing products,
Guidelines for selecting the degree of protection for protective procedures and guidelines for the maintenance and handling of protective clothing.
This standard cannot cover all the technical information necessary for medical institutions to choose protective clothing products, and should not be used as medical protective clothing.
Product evaluation criteria.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 4744-2013 Testing and Evaluation of Textile Waterproofing Performance
GB/T 5455-2014 Determination of vertical burning length, smoldering and afterglow time of burning behavior of textiles
GB/T 16886 (all parts) Biological evaluation of medical devices
GB 19082-2009 technical requirements for medical disposable protective clothing
YY/T 0689-2008 Blood and body fluid protection equipment Protective clothing material Anti-blood-transmitted pathogen penetration performance test Phi-
X174 bacteriophage test method
YY/T 0700-2008 Blood and body fluid protection equipment Protective clothing material Anti-blood and body fluid penetration performance test Synthetic blood test
method
YY/T 1499-2016 liquid barrier performance and classification of medical protective clothing
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Barrier properties
Refers to the ability of protective products to prevent the penetration of liquids and microorganisms in liquids.
3.2
Blood
Refers to human blood, human blood components, and human blood products.
3.3
Bodyfluid
All fluids produced (secreted or excreted) by the body.
Note. The body fluids in this standard include those that may be infected by blood-borne pathogens, including but not limited to. blood, semen, vaginal secretions, cerebrospinal fluid,
Synovial fluid, peritoneal fluid, amniotic fluid, saliva, and other body fluids that are obviously contaminated with blood, and body fluid mixtures when they cannot be distinguished and distinguished.
3.4
Contaminated
It refers to the state of actual or potential contact with microorganisms.
Note. Contamination can be interpreted as direct contact with blood or other potentially infectious materials, whether or not known to contain microorganisms.
3.5
Protectiveclothing'scriticalarea
Protective clothing left and right front, left and right arms and back position.
3.6
Hydrostatic pressure
Force applied by a still liquid.
3.7
Protectiveclothing
A class of specially designed and manufactured clothing used to isolate all or part of the human body from potential dangers, or to isolate the wearer from
Source of contamination on clothing.
3.8
Linting
Fibers, debris, or other particles that fall from protective clothing materials during use.
3.9
Microbial model strain
It simulates a specific human pathogenic microorganism in size, shape and concentration, and is used to test the microbial barrier performance of protective clothing.
3.10
Non-woven fabrics
Fabrics that do not require spinning and weaving, just align or randomly arrange textile short fibers or filaments to form a web structure.
It is then reinforced by mechanical, thermal bonding or chemical methods.
3.11
Otherpotentialyinfectiousmaterials
OPIM
In addition to blood or body fluids, it carries blood-borne pathogens or substances related to the transmission of infectious diseases.
3.12
Particles
Solid, liquid or particulate matter mixed with solid and liquid suspended in air, such as microorganisms, dust, smoke and mist.
3.13
Penetration
At the non-molecular level, it refers to the phenomenon that substances pass through the breathable fabric or placket, seams, and defects (such as pinholes) of protective clothing.
3.14
Ply
Separable layer or separable sheet of material.
3.15
Reinforced area
An area in which one or two layers of the same or different materials as the product itself are added to the protective clothing to enhance or improve the performance of the product.
3.16
Strike-through
The process by which a liquid carrying microorganisms passes through a barrier material, including a seam or joint on the material.
3.17
Surface tension
It is caused by the imbalance of the intermolecular forces between the liquid surface layer and the force acting on any boundary line along the liquid surface. Surface tension energy
It can affect the wetting ability of the liquid (for example, the smaller the surface tension, the easier it is for the liquid to wet the surface of the material).
3.18
Wovenfabric
A textile made by interweaving two yarns or similar materials with each other at the right angle.
3.19
Breaking strength
The maximum force recorded during the tensile test under the specified conditions during the tensile test.
3.20
Tear strength
The maximum force required to extend a crack in a material during a tear test under specified conditions.
4 Types of protective clothing materials
4.1 Reusable materials
4.1.1 Overview
The basic commonality of reusable materials is that they can be reused and reused.
4.1.2 Early reusable materials
The early protective clothing textile materials are some easily available textile fabrics.The three most common materials and their advantages and disadvantages are as follows.
a) 100% cotton muslin (warp and weft density 140). a loose fabric with softness, strong water absorption, good drape and air permeability. Because its
It is very easy to penetrate, so this material does not have any waterproof performance. In addition, this material is extremely easy to wear and easy to produce
Thread
b) Blended high-weaving cotton (flat cloth) (warp and weft density 180). a polyester and cotton blended fabric with good durability and pressure resistance
Yes, it also has all the characteristics of cotton;
c) T280 barrier sheet (warp and weft densities are. 280, 270, 272, and 175 textile materials). a dense woven cotton or cotton/polyester
Ester blend fabric. This is the first reusable, waterproof finished fabric. This material has good
Water resistance, but after repeated washing, drying, sterilization and use, its water resistance will decrease.
4.1.3 Recently reusable materials
Currently the most commonly used materials for reusable protective clothing are.
a) Polyester fabric. polyester filaments are spun into yarn and then weaved, after chemical treatment or calendering finishing (to minimize the aperture, more
Dense) to obtain stronger liquid barrier properties. This fabric can 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, the performance of one aspect of the fabric can be obtained.
Enhancement (such as resistance to liquid penetration).
4.2 Single-use materials
Disposable protective clothing is usually made of nonwovens (other types of materials can also be used). Non-woven fabric can be used alone,
Or use a composite material of non-woven fabric and materials (such as plastic film) that can enhance the resistance of the product to liquid penetration.
Nonwoven is an engineering material that relies on fiber bonding technology (heat-sealing, chemical or mechanical means) to provide material integrity and strength
Rather than relying on geometric interlocks like weaving or knitting materials. The basic raw materials for producing nonwovens are various types
Natural fibers (such as wood pulp, cotton) or synthetic fibers (such as polyester, polyolefin). By using specific types of fibers and specific bonding processes,
After finishing process, non-woven fabrics with specific properties can be produced.
The most commonly used nonwoven materials for the production of disposable protective clothing are as follows.
a) Spunlace cloth. usually using wood pulp and polyester fibers as raw materials, the fibers are bonded together by high-speed water flow, and after chemical treatment
To improve the material's resistance to liquid penetration;
b) SMS nonwovens (spunbond and meltblown composite nonwovens). These materials are produced by a combination of spunbond and meltblown processes.
Typical medical materials are made of polypropylene and treated to improve the material's water resistance. Spunbond Nonwoven
Made of continuous filament. Meltblown nonwovens have ultra-fine fiber structure and small fiber diameter, and can also be made of short fibers;
c) Wet nonwovens. This nonwoven is made of wood pulp or polyester/wood pulp fibers. The fibrous material is suspended in an aqueous solution and
A homogeneous suspension is formed, then the water is filtered through a strainer, and the fibers are more firmly bonded together with a chemical binder, while at the same time
Improve the waterproof performance of the material;
d) Composite material. It is made of non-woven fabric and film by laminating or laminating process. This composite material not only retains the original constituent materials
Material performance has been enhanced.
4.3 Improvements in single-use products and reusable products
Both single-use products and reusable products are often modified to enhance or improve their performance indicators.
For example, a single layer of protective clothing may not provide adequate barrier protection in some cases. In this case, you can add additional layers, coatings,
Strengthen or laminate (integral or partial) and other means to improve the product, giving the product a higher barrier protection ability. In addition, the manufacturer will
Anticipate user needs to enhance or increase product characteristics, such as giving the product absorbent properties, anti-slip properties, extra strength, or other beneficial
characteristic.
The most commonly used enhancements are as follows.
a) Multi-layer processing method. It is processed by using two or more layers of materials to improve the barrier performance or strength of the product;
b) Lamination method. a variety of films can be combined with other materials through lamination to protect textile materials in protective clothing
use. Microporous film, monolayer film and bicomponent film are the three most commonly used coating materials at present.
1) Microporous membrane. The small holes in the microporous membrane can allow water vapor to pass through, depending on the technology used, targeting liquids and microorganisms
Can provide different levels of barrier protection;
2) Monolayer film. Monolayer film is a non-porous film. Depending on the technology used, the ability to prevent water vapor from passing through is different. It is a barrier liquid.
Typical products penetrated by organisms and microorganisms;
3) Two-component film. Two-component film usually consists of a microporous film and a breathable polymer, which can block the penetration of liquids and microorganisms.
c) Coating method. Coating is a semi-liquid material, such as urethane or silicone resin, which is usually applied to a fabric
Surface. The performance parameters of the coating material (e.g., coating material type, coating thickness) are different
The barrier levels offered are also different.
5 Safety and performance indicators
5.1 Barrier performance
5.1.1 Resistance to liquid and microbial penetration
For the purpose of protecting patient wounds from infection and protecting medical personnel from blood-borne pathogens or other microorganisms, medical
Protective clothing must provide effective barrier properties to prevent the spread of microorganisms. When medical staff protect patients, they often wear
Protective clothing to protect the e...