SMMMS/SSMMS FOR SURGICAL GOWN & SURGICAL DRAPE APPLICATION
SMMMS/SSMMS用于手术衣和手术铺单
布料用途
必得福生产的SSMMS/SMMMS无纺布可用于制作手术洞巾、手术衣、洁净服等医用产品,适用于蒸汽或EO(环氧乙烷)灭菌,并与产品标签和灭菌指示标签相兼容。
EN 13795/ YY 0506
必得福生产的SSMMS/SMMMS医用无纺布符合EN13795:2011和YY 0506:2009标准的性能要求。
AAMI
必得福生产的SSMMS/SMMMS无纺布符ANSI/AAMI PB70: 2003标准的要求。
生物相容性
必得福生产的SSMMS/SMMMS无纺布经生物相容性测试证明为无毒、不刺激皮肤、不致敏的无纺布产品。
Application
SSMMS/SMMMS nonwoven fabric has been successfully used in surgical drapes, surgical gowns and clean air suit applications. Beautiful Nonwoven's SSMMS/SMMMS nonwoven fabric is suitable for use with Steam, and EO sterilization. Each packaged product has been clearly labeled and identified for its sterilized status.
EN 13795/YY 0506
Our SMMMS/SSMMS nonwoven fabric complies with EN13795:2011 and YY 0506:2009 standards for surgical drapes, surgical gowns and clean air suits.
AAMI
SSMMS/SMMMS nonwoven fabric complies with ANSI/AAMI PB70:2003 standards - liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
Biocompatibility Information
SSMMS/SMMMS nonwoven fabric has been thoroughly evaluated and tested for biocompatibility and the fabric shows no toxicity and no skin irritation and does not cause any allergic reaction.
手术衣和铺单典型材料物理性能数据表
Physical Properties of Nonwoven Fabrics for Surgical Gown/Drape Application
Technical Data Sheet
Product Code: H050102-TA1
Description: 35gsm SMMMS Medical Blue Alcohol Repellent+Anti-static
Test results according to guidelines of EN13795: 2011 standard performance
Physical Properties | Properties | Unit | Target | Test Result | Test Method |
Basis Weight | gsm | ±5% (33.3-36.8) | 34.7 | EN ISO 536: 1996 |
Bursting Strength (Dry) | kpa | ≥40 | 117 | ENISO 13938-1: 1999 |
Bursting Strength (Wet) | kpa | ≥40 | 104 | ENISO 13938-1: 1999 |
Tensile Strength MD (Dry) | N | ≥20 | 70.3 | ENISO 20973-1: 1992 |
Tensile Strength CD (Dry) | N | ≥20 | 44.9 | ENISO 20973-1: 1992 |
Tensile Strength MD (Wet) | N | ≥20 | 78.5 | ENISO 20973-1: 1992 |
Tensile Strength MD (Wet) | N | ≥20 | 45.8 | ENISO 20973-1: 1992 |
Resistance to Liquid Penetration 1 | CM H2O | ≥20 | 38 | EN 20811: 1992 |
Microbial Barrier | Resistance to microbial penetration (Dry) | log10 CFU | ≤2a,c | 1.0 | ENISO 22612 |
Resistance to microbial penetration (Wet) | IB | ≥2.8b | 4.7 | ENISO 22610: 2006 |
Cleanliness-microbial | CFU/100cm2 | ≤300 | 140 | EN 11737-1:2006 |
Cleanliness-particulate matter 2 | IPM | ≤3.5 | 2-3 | EN ISO 9073-10: 2003 |
Linting 3 | log10 (lint count) | ≤4.0 | 2.7 | EN ISO 9073-10: 2003 |
1.Test condititons: 60cm H2O/min, temperature of the water: 20℃
2.Size of particles counted: 3μm-25μm.
3.Size of particles counted: 3μm-25μm.
a.Test conditions: challenge concentration 108 CFU/g talc. and 30 min vibration time.
b.The Least Significant Difference (LSD) for lB when estimated using EN ISO 22610, was found to be 0.98 at the 95% confidence level. This is the minimum difference needed to distinguish between two materials thought to be different. Thus materials varying by more than 0.98 lB probably are different. (98% confidence levels means that an observer would be correct 19 times
out of 20 to accept these alternatives.)
c.For the purpose of EN13795 standard, log10CFU 2 means maximum 300CFU.