FAQs PPE – Technical Compliance – Isolation Or Surgical Gowns

FAQs PPE – Technical Compliance To Relevant Performance Standards – Isolation Or Surgical Gowns

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Standard Test TitleReference StandardMinimum acceptable performance levelCompliant  Claimed performance (Class, Type, or measured)Year/Version of standardReference document (.pdf)
Test report origin
ILAC accredited labISO 17025Compliant               
National Notifying BodyISO 17025Compliant               
Local, non-accreditedISO 17025Compliant               
Whole gown performance, surgical
Liquid barrier performanceAAMI PB70Level 1               
Liquid barrier performanceAAMI PB70Level 2               
Liquid barrier performanceAAMI PB70Level 3               
Liquid barrier performanceAAMI PB70Level 4               
Surgical clothing and drapesEN 13795Standard Performance               
Surgical clothing and drapesEN 13795High Performance               
Protective clothing against liquid chemicalsEN 13034CompliantHydrostatic head pressure:      cm of H2O          
Surgical gownsYY/T 0506Compliant               
Sterilization of medical devicesEN 556Compliant (sterile)               
Whole gown performance, isolation
Isolation gownsASTM F3352Compliant               
Protective clothing against liquid chemicalsEN 13034Compliant               
Material performance
Water resistance (impact penetration)AATCC 42<4.5 g (AAMI Level 1) AQL 4%, RQL=20%               
≤ 1.0 g (AAMI Level 2) AQL 4%, RQL=20%               
Water resistance (hydrostatic pressure)AATCC 127≥ 20 cm (AAMI Level 2) AQL 4%, RQL=20%               
≥ 20 cm (AAMI Level 3) AQL 4%, RQL=20%               
Viral penetrationASTM F1671Pass (AQL 4%, RQL=20% (AAMI Level 4)               
Clothing for protection against contact with blood and body fluidsISO 16604Class 5               
Resistance to wet bacterial penetrationISO 22610≥ 2.8 IB (critical area, std performance)               
≥ 6.0 IB (critical area, std performance)               
Resistance to dry microbial penetrationISO 22612≤ 300 CFU               
Cleanliness microbial / BioburdenEN ISO 11737-1≤ 300 CFU/ 100 cm2               
Particle releaseEN ISO 9073-10≤ 4.0 log10 (lint count)               
Liquid penetrationEN ISO 811≥ 20 cm H2O (critical area, std performance)               
≥ 10 cm H2O (less critical area, std performance)               
≥ 100 cm H2O (critical area, high performance)               
≥ 10 cm H2O (less critical area, high performance)               
Physical performance/characteristics
Seam type N/AStitched, welded, taped               
Bursting strength (Wet)EN ISO 13938-1≥ 40 kPa (critical area)               
Tensile strength (Dry)EN 29073-3≥ 20 N (critical  and less critical areas)               
Tensile strength (Wet)EN 29073-3≥ 20 N (critical area)               
Basis weighASTM D3776 –               
Shelf life  5 years               
Quality compliance
General quality management systemISO 9001Compliant                
Medical device quality managementISO 13485Compliant               
Sampling procedures for inspection by attribute, post shipmentISO 2859Compliant                
Regulatory clearance 
EU PPE Regulation 2016/425 Valid, issued <5 years               
EN MD Directive 93/42/EEC Valid, issued <5 years               
US FDA 510(k) Valid, issued <5 years               
NMPA, export clearance Valid, issued <5 years               
NMPA, internal use Valid, issued <5 years               
Other: Valid, issued <5 years