Chinese medical protective textiles Production .... Wangbaojun_EN_Medical Textiles.pdfmedical...

Chinese medical protective

textilesProduction, application

and standards

State quality inspection center for textile products

Chinese text i le tes t & cer t i f icat ion center

2010.10.20

1、General production situation of Chinese medical textiles

2、Usage of Chinese medical textiles

-- medical textiles mainly used in Chinese hospitals

-- market demands of medical textiles

-- actual purchase and usage situation of Chinese hospitals

3 、Standard situation of Chinese medical textiles

-- general situation of standards of medical textiles

-- introduction of several main standards

Content Summary

- Number of Production Corporations of all kinds of medical

materials and protective clothes in China reaches thousands

- Disposable medical protective clothes produced in China occupy

60% of the world production

- Operating coats produced per year reach about 50 million, mask

reach 1 billion

- China has been a production base of disposable protective

clothes in world

- PGI、K-C and so on these famous corporations have established

many factories in China

- Domestic corporations are mainly middle-small size

- Domestic products are mainly for export

General

1、 General production situation of

Chinese medical textiles

Registered production corporations in China for disposable operating coats

reach 300+, for masks reach 100+, for gloves reach 1000+.

Production distribution

河南, 14%

其他16省市,

30%

湖北, 14%

江苏, 13%

江西, 11%浙江, 11%

广东, 7%



- Daily medical protection clothes (white gown,

clothes for patients)

- Operating clothes

- Insulation clothes

- Emergency medical protective clothes

- Medical mask

- Medical gloves

- Eye protection glasses

Main type



Medical working clothes Operating clothes Insulation clothes Emergency medical protect



Main style of protective clothes

Mainly used

at emergency

treatment

room

Used for

normal

operation

Proper for

operation with

high amount

of bleeding

Proper for

long-time

operation with

high amount

of bleeding

Proper for

operation with

high amount

of bleeding

and of high

blood virus

infective





- Pure cotton, cotton/polyester fabrics

- PP spunbond fabrics（SS）

- PP spunbond fabrics + melt-blown fabric + PP spunbond fabrics （SMS、SMMS、SMMMS）

- wood pulp , polyester hydroentangling fabrics

- spunbond+film（PE）

- spunbond+ permeable film +spunbond（SFS）

- Woven fabric+film

- Woven fabric+film+knitted fabric

Main material



Material Service life

Reference

Price

(Y/P)

Grade of liquid insulation

（according to AAMI PB70）

Pure cotton operating clothes repeatable 50 Less than grade 1

spunbond disposable 6 Less than grade 1

Domestic produced SMS disposable 10 Grade 2

SMMS disposable 15 Grade 2、3

SMMMS disposable 20 Grade 3、4

wood pulp polyester

hydroentangling fabrics

disposable 30 Grade 2

spunbond+film disposable 8 Grade 4

spunbond+film compound

（domestic producted

permeable film ）


spunbond+ permeable film

+spunbond


Woven fabric+film+knitted fabric repeatable 200 Grade 4

Note: price in table is just for reference, it would change according to change of

price of raw material and finishing process and so on these elements.



- Population of China reach 1.3billion,

hospitals of different levels reach ten

thousands

- Usage level of medical protective products is

low

- Divisions using these products are few

Most divisions (including operating room) still use cotton coats

and gauze masks, parts of operating room, infectious disease

areas and Intensive Care rooms use disposable or emergency

protective clothes

Application of medical protective products in Chinese hospitals

2、Usage of Chinese medical

textiles in China

- Used amount of protective products in 3

grade hospitals（average number per person

per year）：

use amount of protective products：480yuan

gloves：disposable 250 pairs+latex110 pairs

mask：disposable 120+gauze12个+N95 mask 0.2

protective clothes： disposable 6pieces+cotton 2 pieces

eye protective glasses：0.5

face mask： 0.2


in China

- Chinese hygiene management departments process government

license rule for medicine

- Chinese hygiene management departments process “three

licenses” management for medical instruments

production corporation license

hygiene license

medical instruments register license

- Only products with “three licenses” register have qualification to

enter into hospitals

- Registration is carried out by hygiene departments and medical

instrument bureaus, and published by State medical supervision

bureau

Market demands of medical protective products in China


in China

- Masknormal gauze mask, traditional products, large use amount

disposable nonwoven mask, mainly used at surgery, operation

medical protective mask, mainly are N95, seldom used

- Ordinary medical protective working clothes

normal pure cotton, polyester/cotton gown, very large use

Main medical protective products used in Chinese hospitals


in China

- Operating clothesnormal pure cotton、polyester/cotton with water proof finishing,

most commonly used

disposable nonwoven fabrics, small use, not reaches 3%

- Emergency medical protective clotheswith water proof, blood penetration proof, alcohol proof, air

insulation and so on these functions

disposable：nonwoven and water proof film compound material,

mainly used at infectious disease areas

repeatable：woven and water proof film several layers

compounded, mainly used for P3、 P4 grade protection such as

high danger places and labs.


in China

- Gloves

latex gloves

checking gloves

- Eye protective glasses


in China

- China has not established protection system with

clear classification and direct rules.

- Hospitals have not established perfect protective

rules yet

- Hospitals buy protective goods by themselves

- Purchase departments do not have good link with

departments that use the PPE, demands of products

are not clear

- Only “three licenses” are checked when hospital

purchase, which could not mean quality for sure.

Purchase of medical protective products by Chinese hospitals


in China

- Basic standards for protective products have

been published

- Standards of medical protective products

have not been systemic enough

- There is urgency to publish them

- They try to be closer to standards and rules of

European/America

General situation

3、 Standard situation of Chinese

medical textiles

• GB15979-2002 Hygienic standard for disposable sanitary products

• GB15980-1995 Hygienic standard for disinfection for single use medical products

• GB19082-2003 Technical requirements for single use protective clothing for medical use

• GB19083-2003 Technical requirements for protective face masks for medical use

• GB19084-2003 Ordinary absorbent gauze masks

• YY0469-2004 Technical requirements for medical surgery masks

• YY0331-2002 Medical absorbent gauze

• YY0330-2002 Medical absorbent cotton

• YY/T 0506 Standard system《 Surgical drapes, gowns and clean air suits. Used as medical devices for patients, clinical staff and equipment 》

主要标准


medical textiles

Compare table of domestic and foreign standards

Class Foreign Domestic

Medical normal

textilesENV14237：2002 —

Operating textiles

EN 13795

ANSI/AAMI PB70

JIS L 1912-1997

YY/T 0506

Emergency

medical protectNFPA 1999 GB 19082

Medical mask

GB19083-2003

GB19084-2003

YY0469-2004


medical textiles

Introduction of several main standards

GB19082 Technical requirements for single use

protective clothing for medical use

Use range

disposable protective clothes supplying

insulation and protective functions for clinic

medical worker who contact blood, body

liquid and Secretion of potential infectious


medical textiles

Main demands

- Appearance structure：appearance、structure、size and specification

- Insulation of liquid：

anti water penetration≥1.67kPa

moisture permeability ≥2500g/m2.d

blood permeability≥1.75kPa

anti moisture of surface≥ grade 3


medical textiles

- Breaking force ≥45N

- Elongation at Breaking ≥30%

- Filter effective ≥70%

- Anti flame： B2级

- Anti static：electric amount ≤0.6μc

- Skin irritants：None

- Micro organism index：≤200cfu/g

- Residual of epoxyethane ：≤10μg/g


medical textiles

GB19083 Technical requirements for protective face

masks for medical use

Use scope

Filter medical protective masks which can

filter particles in air and insulate spray, blood,

body liquid and secretion.


medical textiles

Main demands- outer structure：appearance、structure、size

- filter efficiency：≥95%（particle filter）

- air retardant：≤35mmH2O

- insulation to blood penetration： ≥160mmHg no

penetration

- anti-wet surface ：≥ grade 3

- disinfection and sterilization

- epoxyethane residual：≤10μg/g

- flame retardant：burning keep time≤5s

- skin irritant：no irritant


medical textiles

GB 19084 Ordinary absorbent gauze masks

Use scope

ordinary absorbent gauze masks


medical textiles


gauze density： ≥9ends/cm，layer： ≥ 12

- solve in water： ≤ 0.3%

- pH value ：not become pink by adding phenolphthalein, not

become yellow by adding bromcresol purple

- starch and dextrin： not become blue, purple by adding iodine

- fluorescence materials ：only show light brown purple under

ultraviolet light, not show strong blue light

- Solve in aether： ≤0.5%

- Burn residual： ≤0.3%

- Microorganism index： bacterial colony number≤normal degree

200，disinfection degree 20cfu/g


medical textiles

YY 0469 Medical surgery masks

Use scope

Medical surgery masks used at processing

with wound by clinical medical workers, which

supply protection for patients and medical

workers, and prevent diffusion of blood, body

liquid and spay.


medical textiles


- insulation to blood penetration： ≥120mmHg no penetration

- anti-wet surface ：≥ grade 3

- filter efficient：bacterial filter≥95%，particle filter≥30%

- flame retardant ：burning keep time≤5s

- microorganism index：bacterial colony number ≤20cfu/g


- skin stimulus：no stimulus

- air change：exchange pressure, flow speed, breath retardent


medical textiles

YY 0331 Medical absorbent gauze

Use scope

use cotton plain fabric woven with mature

cotton without repeated processing, process

it by degreasing and bleaching, then make

gauze for medical usage, no other fiber and

additional materials included


medical textiles

Technical demands- White degree： ≥80

- Density deflection：±5%

- solve in water： ≤ 0.3%

- pH value ：not become pink by adding phenolphthalein, not

become yellow by adding bromcresol purple

- starch and dextrin： not become blue, purple by adding iodin

- water absorption time： ≤10s

- fluorescence materials：only show light brown purple under

ultraviolet light, not show strong blue light

- solve in ether： ≤0.5%

- burn residual： ≤0.3%


medical textiles

Technical demands

- weight loss after drying： ≤ 8%

- surface Reactive Materials ：

- tensile strength： ≥ density*k

- no bacterial



medical textiles

GB15979 Hygienic standard for disposable sanitary

products

Use scope

disposable hygiene products ： goods

discarded after using once, in direct or

indirect contact to body, used for purpose of

physiological hygiene and hygiene protection,

such as disposable gloves, tissue, wet tissue,

hat, mask, underwear, hygiene products for

women, diaper and so on


medical textiles

Main demands- skin irritant：not cause irritations or allergy to skin

- microorganism：

bacterial colony number≤20/200cfu/g

anti-bacterial products： anti-bacterial efficient≥50%

epoxyethane residual：≤250μg/g

- hygiene index of production surrounding： bacterial colony

number at workshop、work table、hands

- disinfection effective：

epoxyethane disinfection sterilization index≥103

ionization radiation disinfection sterilization index ≥103

pressured steam disinfection sterilization index ≥103


medical textiles

YY/T 0506 Surgical drapes, gowns and clean air

suits. Used as medical devices for patients,

clinical staff and equipment

This standard system refer to EN13795 (MOD)

Part1： general requirements for manufactures, processors and

products

Part2： requirements for properties and property level

Part3： test methods

Part4： test method of dry flow drops

Part5： test method for anti-penetration of dry micro organism

Part6： test method for anti-penetration of wet micro organism


medical textiles

Demands of standard EN 13795


medical textiles


medical textiles

Demands of standard EN 13795

Demands of American standard AAMI PB70

Grade Test method Property index

1 AATCC 42:2000 ≤4.5g

2AATCC 42:2000

AATCC 127:1998

≤1.0g

≥20 cmH2O

3AATCC 42:2000

AATCC 127:1998

≤1.0g

≥50 cmH2O

4

Operation clothes:

ASTM F1671: 2003

surgical ivio: ASTM F1670: 2003

No penetration

No penetration

Protection grade is determined by lowest grade of

standard scope

State quality inspection center for textile products

Thanks！Address：北京朝外延静里中街3号中国纺织科学研院内Zip：100025

Tel：0086-10 65004780， 65002813

Fax：0086-10 65003776， 65076599

Web: http//www.cta-cttc.com.cn

E-mail:[email protected]

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