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Henan Tongwei Medical Equipment Co., LtdCall us : +86 − −19139704654 // Email us : [email protected]
Henan Tongwei Medical Equipment Co., LtdCall us : +86 − −19139704654 // Email us : [email protected]
1 2 The AAMI has established a classification system for minimum requirements for healthcare protective apparel and drapes based on their liquid barrier performance in their standard 1 2 Surgical gowns with a level 1 classification provide the lowest level of protection and level 4 provide the highest level of protection 2 Some
ISO 11138 - Sterilization of Health care Products Package ISO 11138-1 ISO 11138-2 ISO 11138-3 ISO 11138-4 and ISO 11138-5 ISO 11138 - Sterilization of Health care Products Package provides methods for testing systems containing viable microorganisms providing a defined resistance to a specified sterilization process
2 3 1 Confidence 4 In Sterilization with the Core Four (2) If a test BI is positive all items from that load and all items from loads processed since the last load with a negative BI result should be 3 • Conforms to ANSI/AAMI/ISO 11140-1:2005 Class 5 Integrating Indicator
The level of bacteria and endotoxin that should be met is the same as that of the water system AAMI bacteria and endotoxin recommendations for dialysate 200 CFU/ml Action limit of 50 CFU/ml 2 EU/ml Action limit of 1 EU/ml The AAMI committee felt that these limits were reasonable and obtainable by most facilities in the United States
The Association for the Advancement of Medical Instrumentation (AAMI) is a professional organization in which committees are composed of representatives that include health care professionals patients medical device manufacturers and representatives of federal agencies These committees have developed voluntary guidelines for medical products and procedures
1 Meets ASTM F1671 in the critical zones (ties fabric sleeve seams) per AAMI PB70:2012 Level 4 2 Meets AAMI Level 4 AAMI PB70:2012 EN13795 High Performance 3 ASTM F1671 MOCON and cup crush testing 4 ISO 22610 (wet) ISO 22612 (dry) ASTM F1671 and ASTM F1670 Hydrohead-20811 5 Per ISO 11810 6 Per EN Resistance to Linting and
Scissors 4 1/2 and larger use a ____ test material and scissors 4 or smaller use _____ material to check blades for sharpness 1 Insulin- reduces the level of sugar in the blood stream 2 Glucagon- increases the blood sugar level such as AAMI AORN Association of Operating Room Nurses Dedicated to providing optimal care to the
1 Precleaned at the point of use 2 Transported to the endoscopy processing room 3 Leak Test 4 Manual cleaning 5 Rinse 6 Dry 7 Visual inspection 8 high-level disinfection (critical water) or sterilization 9 Rinse flush critical water 10 alcohol flush and drying 11 Storage Pre-clean Leak-test Manual clean Visual inspection
There are several differences between ANSI/AAMI PB70 and EN 13795 surgical gown classifications Because the test methods and performance requirements cannot be compared directly it is difficult to assign equivalency between surgical gowns classified according to ANSI/AAMI PB70 (see Table 3) and EN 13795 (see Table 4)
The level of the impressed current should not exceed 100 V1p-p V2p-p 1M Result Unit Standard Roscoe Electrode VitalStim Electrode Result # 1 3 kΩ 0 29 kΩ 3 05 kΩ Pass* (considering equipment tolerance) # 2 3 kΩ 0 27 kΩ 1 82 kΩ Pass 2 DC offset Test Report Test Standard Reference: Standard ANSI/AAMI EC12-1991 Testing Date: 2014
1 Precleaned at the point of use 2 Transported to the endoscopy processing room 3 Leak Test 4 Manual cleaning 5 Rinse 6 Dry 7 Visual inspection 8 high-level disinfection (critical water) or sterilization 9 Rinse flush critical water 10 alcohol flush and drying 11 Storage Pre-clean Leak-test Manual clean Visual inspection
1 2 The AAMI has established a classification system for minimum requirements for healthcare protective apparel and drapes based on their liquid barrier performance in their standard 1 2 Surgical gowns with a level 1 classification provide the lowest level of protection and level 4 provide the highest level of protection 2 Some
Nov 07 2008"For example KC100 isolation gowns meet AAMI level one KC200 isolation gowns meet AAMI level two and KC300 isolation gowns meet AAMI level three To assist HCWs in recognizing what AAMI level of protection they will need for the types of procedures they perform we identified specific procedures as reference points for each category level
The level of the impressed current should not exceed 100 V1p-p V2p-p 1M Result Unit Standard Roscoe Electrode VitalStim Electrode Result # 1 3 kΩ 0 29 kΩ 3 05 kΩ Pass* (considering equipment tolerance) # 2 3 kΩ 0 27 kΩ 1 82 kΩ Pass 2 DC offset Test Report Test Standard Reference: Standard ANSI/AAMI EC12-1991 Testing Date: 2014
Nov 09 20177 6 4 5 and 13 2 Cleaning verification of Mechanical processes is now daily and should be documented Section 7 6 4 4 1 Ultrasonic cleaning equipment (item d) states "performed with fresh cleaning solution solution should be changed after each use (a "use" should be defined in the health care facility's policies and procedures) "
China surgical gowns catalog of Disposable Eo Sterile SMS Surgical Gown for Hospital Operation Use AAMI Level 2/3 with High Quality Smmms Liquid Blood Flammability Resistance Protective Gown Reinforce Disposable Eo Sterile SMS Surgical Gown Smmms AAMI Level 3 High Level Fluid Blood Flammability Resistance Protection Surgeon Operation Use Manafucture provided by China
of Medical Instrumentation (AAMI) The chart below describes the criteria for AAMI Levels 1 2 and 3 Each level is assigned a different color Choose the right gown by matching the color on the neck binding to the AAMI level on the chart Levels of Barrier Protection–AAMI PB70:20121 LEVEL 1 LEVEL 2 LEVEL 3 Test AATCC 42:2000 AATCC 42:2000 AATCC
Association for the Advancement of Medical Instrumentation ： ： AAMI； ； 1 AAMI 7198-1998 (R 2004) CARDIOVASCULAR IMPLANTS - TUBUAL VASCULAR PROSTHESES-FDA RECOGNIZED 2 AAMI 10993-1-2003 Biological evaluation of medical devices - Part 1: Evaluation and testing-FDA RECOGNIZED 3 AAMI 10993-2-2006 Biological
No Always look for the AAMI Level rating on the surgical gown packaging to determine the AAMI Level rating ? If a surgical gown isn't rated AAMI Level 4 then it is an AAMI Level 3 surgical gown correct? No Surgical gowns can be rated AAMI Level 1 AAMI Level 2 AAMI Level 3 or AAMI Level 4
AAMI PB70 AAMI PB70 provides basic tests to evaluate the barrier effectiveness of gown Based on the results of these standardized tests 4 barrier performance levels are specified with the lowest level of protection being Level 1 and the highest level of protection being Level 4 Level 1: Minimal level of fluid barrier protection Level 2:
There are several differences between ANSI/AAMI PB70 and EN 13795 surgical gown classifications Because the test methods and performance requirements cannot be compared directly it is difficult to assign equivalency between surgical gowns classified according to ANSI/AAMI PB70 (see Table 3) and EN 13795 (see Table 4)
Microbiological Level Previous Standards New Standards Previous Action Level New Action Level Colony Forming Units 200 CFU/mL 100 CFU/mL ≥ 50 CFU/mL ≥ 50 CFU/mL Endotoxin Units 2 EU/mL 0 25 EU/mL ≥ 1 EU/mL ≥ 0 125 EU/mL AAMI Microbiological Standards for Dialysis Water ANSI/AAMI 13959:2014
Note 2: ANSI/AAMI PB70 evaluates the barrier properties of surgical gown fabrics using water only in Levels 1 2 and 3 Since surgical gowns are exposed to blood and other fluids with different surface tensions the performance of additional testing to identify the barrier levels to simulated biological fluids is required for a Level 4 gown
AAMI Level Level 1 Level 2 Level 3 Performance Requirements at 4% AQL Spray impact penetration 4 5g Spray impact penetration 1 0g Hydrostatic pressure 20cm Spray impact penetration 1 0g Hydrostatic pressure 50cm Anticipated Risk of Exposure to Fluid: Low: Between low and moderate: Moderate: Gown Characteristics (Weight) Lightweight SMS
Level 4: 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
Based on the results of these standardized tests four levels of barrier performance are defined with Level 1 being the lowest level of protection and Level 4 being the highest level of protection Table 3 summarizes the requirements of ANSI/AAMI PB70:2012 regarding the classification of barrier performance of surgical gowns isolation gowns
Association for the Advancement of Medical Instrumentation ： ： AAMI； ； 1 AAMI 7198-1998 (R 2004) CARDIOVASCULAR IMPLANTS - TUBUAL VASCULAR PROSTHESES-FDA RECOGNIZED 2 AAMI 10993-1-2003 Biological evaluation of medical devices - Part 1: Evaluation and testing-FDA RECOGNIZED 3 AAMI 10993-2-2006 Biological
in the laboratory test ASTM F1671 Figure 2 – AAMI Levels of Barrier Performance Table 2 – Barrier Performance of Surgical Gowns Level Test Criterion Acceptable Quality Level Rejectable Quality Level 1 AATCC 42:2007 ≤4 5 g 4% 20% 2 AATCC 42:2007 AATCC 127:2008 ≤1 0 g ≥20 cm 4% 4% 20% 3 AATCC 42:2007 AATCC 127:2008 ≤1 0 g ≥50 cm 4%
Full text of IS ISO 13485 Medical Devices-Quality
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