with HEALTH, with CARE

안전한 수술환경을 만드는 ㈜세종헬스케어

가운과 드레이프의 Critical Zone

AAMI PB70 (미국규격)

  • AAMI PB70은 미국의 의료기기 협회인 AAMI(Association for the Advancement for Medical Instrumentation)에 의해 제정된 “가운 및 드레이프에 대한 액체 방어력 가이드라인"입니다.
  • AAMI의 Protection Level은 1~4단계로 되어 있으며 수치가 높을 수록 높은 방어력을 제공합니다.

Barrier Performance

Level Test Criterion Description Applicability
1 AATCC 42:2007 ≤4.5g
  • Used for MINIMAL risk situations
  • Provides a slight barrier to small amounts of fluid penetration
  • Single test of water impacting the surface of the gown material is conducted to assess barrier protection performance.
basic care, standard hospital medical unit
2 AATCC 42:2007
AATCC 127:2008
≤1.0g ≥20cm
  • Used in LOW risk situationss
  • Provides a barrier to larger amounts of fluid penetration through splatter and some fluid exposure through soaking
  • Two tests are conducted to assess barrier protection performance:
  • - Water impacting the surface of the gown material
  • - Pressurizing the material
Blood draw from a vein, Suturing, Intensive care unit, Pathology lab
3 AATCC 42:2007
AATCC 127:2008
≤1.0g ≥50cm
  • Used in MODERATE risk situations
  • Provides a barrier to larger amounts of fluid penetration through splatter and more fluid exposure through soaking than Level 2
  • Two tests are conducted to test barrier protection performance:
  • - Water impacting the surface of the gown material
  • - Pressurizing the material/li>
Arterial blood draw, Inserting an  IV, Emergency Room, Trauma
4 STM F1671:2007 Pass
  • Used in HIGH risk situations
  • Prevents all fluid penetration for up to 1 hour
  • May prevent VIRUS penetration for up to 1 hour
  • In addition to the other tests conducted under levels 1-3, barrier level performance is tested with a simulated blood containing a virus. If no virus is found at the end of the test, the gown passes.
Pathogen resistance, Infectious diseases (non-airborne), Large amounts of fluid exposure over long periods
  • AATCC 42-2007. Water Resistance: Impact Penetration Test.
  • AATCC 127-2008. Water Resistance: Hydrostatic Pressure Test.
  • ASTM F1671-13. Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System.

EN13795는 가운 및 드레이프 성능에 대한 유럽 기준 규격으로 미생물침투방어력, 액체방어력, 파열강도, 인장강도, 청정도, Linting(직조) 수준 등 의료진 및 환자의 안전과 감염방지를 위한 최소한의 기준을 제시합니다.

Performance requirements for Surgical Drapes

Characteristic Test method Unit Standard Performance High Performance
Critical product area Less critical product area Critical product area Less critical product area
Resistance to microbial penetration - dry ENISO 22612 CFU N/A ≤ 300 a N/A ≤ 300 a
Resistance to microbial penetration - wet ENISO 22610 IB ≥ 2,8 b N/A 6,0 b c N/A
Cleanliness - microbial ENISO 11737-1 CFU/100 cm2 ≤ 300 ≤ 300 ≤ 300 ≤ 300
Cleanliness - particulate matter ENISO 9073-10 IPM ≤ 3,5 ≤ 3,5 ≤ 3,5 ≤ 3,5
Linting ENISO 9073-10 log 10 (lint count) ≤ 4,0 ≤ 4,0 ≤ 4,0 ≤ 4,0
Resistance to liquid penetration EN 20811 cm H20 ≥ 20 ≥ 10 ≥ 100 ≥ 10
Bursting strength - dry ENISO 13938-1 kPa ≥ 40 ≥ 40 ≥ 40 ≥ 40
Bursting strength - wet ENISO 13938-1 kPa N/A ≥ 40 ≥ 40 N/A
Tensile strength - dry ENISO 29073-3 N ≥ 20 ≥ 20 ≥ 20 ≥ 20
Tensile strength - wet ENISO 29073-3 N N/A ≥ 20 ≥ 20 N/A

Performance requirements for Surgical Gowns

Characteristic Test method Unit Standard Performance High Performance
Critical product area Less critical product area Critical product area Less critical product area
Resistance to microbial penetration - dry ENISO 22612 CFU N/A ≤ 300 a N/A ≤ 300 a
Resistance to microbial penetration - wet ENISO 22610 IB ≥ 2,8 b N/A 6,0 b c N/A
Cleanliness - microbial ENISO 11737-1 CFU/100 cm2 ≤ 300 ≤ 300 ≤ 300 ≤ 300
Cleanliness - particulate matter ENISO 9073-10 IPM ≤ 3,5 ≤ 3,5 ≤ 3,5 ≤ 3,5
Linting ENISO 9073-10 log 10 (lint count) ≤ 4,0 ≤ 4,0 ≤ 4,0 ≤ 4,0
Resistance to liquid penetration EN 20811 cm H20 ≥ 20 ≥ 10 ≥ 100 ≥ 10
Bursting strength - dry ENISO 13938-1 kPa ≥ 40 ≥ 40 ≥ 40 ≥ 40
Bursting strength - wet ENISO 13938-1 kPa N/A ≥ 40 ≥ 40 N/A
Tensile strength - dry ENISO 29073-3 N ≥ 20 ≥ 20 ≥ 20 ≥ 20
Tensile strength - wet ENISO 29073-3 N N/A ≥ 20 ≥ 20 N/A