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 |
|
basic care, standard hospital medical unit |
| 2 | AATCC 42:2007 AATCC 127:2008 |
≤1.0g ≥20cm |
|
Blood draw from a vein, Suturing, Intensive care unit, Pathology lab |
| 3 | AATCC 42:2007 AATCC 127:2008 |
≤1.0g ≥50cm |
|
Arterial blood draw, Inserting an IV, Emergency Room, Trauma |
| 4 | STM F1671:2007 | Pass |
|
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 |
