ASTM F2101 - Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus
The standard method ASTM F2101 specifies a test for determining Bacterial Filtration Efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.
For additional information:
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus (astm.org)
ASTM F2299 - Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
This test method establishes procedures for measuring the initial particle filtration efficiency of materials used in medical facemasks using monodispersed aerosols.
For additional information:
Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres (astm.org)
IEST-RP-CC003.4: Garment System Considerations for Cleanrooms and Other Controlled Environments (Helmke Drum)
This Recommended Practice (RP), IEST-RP-CC003.4, is published by the Institute of Environmental Sciences and Technology to advance the technical and engineering sciences. It addresses the gowning of personnel as a critical aspect of cleanroom contamination control. Specification and use of an appropriate gowning system is essential in limiting human-generated contamination from reaching and affecting product or processes in the cleanroom. IEST-RP-CC003.4 provides nonmandatory guidance for the selection, specification, maintenance, and testing of garments or apparel and accessories appropriate for use in non-aseptic and aseptic environments
This RP is intended to assist the end user, system designer, supplier, and processor in defining required performance criteria, test methods, and procedures for gowning system use and maintenance, as well as in developing a quality control plan for the apparel and accessories that may be included in the system.
For additional information:
IEST-RP-CC003: Garment System Considerations for Cleanrooms and Other Controlled Environments
ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package
The ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package provides the requirements for developing, validating and routinely controlling the sterilization process of medical devices. In addition to providing the requirements for the sterilization process of medical devices, this package also considers the products' environment, personnel and their hygiene, packaging / storage, sterilization doses and more to inactivate microbiological contaminants on medical devices.
For additional information:
ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package
ISO 11737 – Sterilization of Health Care Products – Microbiological Methods
A sterile health care product is one that is free of viable microorganisms. International Standards that specify requirements for the validation and routine control of sterilization processes require, when it is necessary to supply a sterile health care product, that adventitious microbiological contamination of a health care product prior to sterilization be minimized. Such products are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile products into sterile ones.
For additional information:
ISO 11737-1:2018(en), Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
Bacterial & Viral Filtration Efficiency (BFE/VFE)
The Bacterial Filtration Efficiency (BFE) test is performed on filtration materials and devices that are designed to provide protection against biological aerosols, such as garments, face masks, surgical gowns, caps, and air filters.
The Viral Filtration Efficiency (VFE) test is similar to the BFE test, however tests against a distinct virus used in aerosol form instead of bacteria. Specifically, the testing conditions remain the same between the Viral Filtration Efficiency Test and the Bacterial Filtration Efficiency Test but bacteriophage phiX174 is used in the place of bacterial particles.
For additional information:
Bacterial & Viral Filtration Efficiency Tests | Nelson Labs
Certificates of Conformance (COC) verify that a specific product lot conforms to all specifications before the lot is released. Physical characteristics are tested in accordance with ASTM standards. Particles and extractables are tested in accordance with IEST standards.
Certificates of Irradiation (COI) document the minimum and maximum dosage of irradiation that a product received, and are available for all sterile products. Sterilization validation documentation confirms that the doses have been verified, the loading patterns are sufficient, and that the process is audited on a regular basis.
The standard method ASTM F2101 specifies a test for determining Bacterial Filtration Efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials.
For additional information:
Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus (astm.org)
ASTM F2299 - Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
This test method establishes procedures for measuring the initial particle filtration efficiency of materials used in medical facemasks using monodispersed aerosols.
For additional information:
Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres (astm.org)
IEST-RP-CC003.4: Garment System Considerations for Cleanrooms and Other Controlled Environments (Helmke Drum)
This Recommended Practice (RP), IEST-RP-CC003.4, is published by the Institute of Environmental Sciences and Technology to advance the technical and engineering sciences. It addresses the gowning of personnel as a critical aspect of cleanroom contamination control. Specification and use of an appropriate gowning system is essential in limiting human-generated contamination from reaching and affecting product or processes in the cleanroom. IEST-RP-CC003.4 provides nonmandatory guidance for the selection, specification, maintenance, and testing of garments or apparel and accessories appropriate for use in non-aseptic and aseptic environments
This RP is intended to assist the end user, system designer, supplier, and processor in defining required performance criteria, test methods, and procedures for gowning system use and maintenance, as well as in developing a quality control plan for the apparel and accessories that may be included in the system.
For additional information:
IEST-RP-CC003: Garment System Considerations for Cleanrooms and Other Controlled Environments
ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package
The ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package provides the requirements for developing, validating and routinely controlling the sterilization process of medical devices. In addition to providing the requirements for the sterilization process of medical devices, this package also considers the products' environment, personnel and their hygiene, packaging / storage, sterilization doses and more to inactivate microbiological contaminants on medical devices.
For additional information:
ANSI/AAMI/ISO 11137 - Sterilization of Health Care Products Package
ISO 11737 – Sterilization of Health Care Products – Microbiological Methods
A sterile health care product is one that is free of viable microorganisms. International Standards that specify requirements for the validation and routine control of sterilization processes require, when it is necessary to supply a sterile health care product, that adventitious microbiological contamination of a health care product prior to sterilization be minimized. Such products are non-sterile. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the non-sterile products into sterile ones.
For additional information:
ISO 11737-1:2018(en), Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products
Bacterial & Viral Filtration Efficiency (BFE/VFE)
The Bacterial Filtration Efficiency (BFE) test is performed on filtration materials and devices that are designed to provide protection against biological aerosols, such as garments, face masks, surgical gowns, caps, and air filters.
The Viral Filtration Efficiency (VFE) test is similar to the BFE test, however tests against a distinct virus used in aerosol form instead of bacteria. Specifically, the testing conditions remain the same between the Viral Filtration Efficiency Test and the Bacterial Filtration Efficiency Test but bacteriophage phiX174 is used in the place of bacterial particles.
For additional information:
Bacterial & Viral Filtration Efficiency Tests | Nelson Labs
Certificates of Conformance (COC) verify that a specific product lot conforms to all specifications before the lot is released. Physical characteristics are tested in accordance with ASTM standards. Particles and extractables are tested in accordance with IEST standards.
Certificates of Irradiation (COI) document the minimum and maximum dosage of irradiation that a product received, and are available for all sterile products. Sterilization validation documentation confirms that the doses have been verified, the loading patterns are sufficient, and that the process is audited on a regular basis.