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

 
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

 
ASTM F2101 (IHAM)

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:

ASTM F2101-19 - Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of <emph type="ital" >Staphylococcus aureus</emph> (ansi.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 (IHAM)

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)

 
ASTM D737 - Standard Test Method for Air Permeability of Textile Fabrics

This test method covers the measurement of the air permeability of textile fabrics. This test method applies to most fabrics including woven fabrics, nonwoven fabrics, air bag fabrics, blankets, napped fabrics, knitted fabrics, layered fabrics, and pile fabrics. The fabrics may be untreated, heavily sized, coated, resin-treated, or otherwise treated.

For additional information:

ASTM D737-18 - Standard Test Method for Air Permeability of Textile Fabrics (ansi.org)

ISO 6530:2005:  Protective Clothing - Protection Against Liquid Chemicals - Test Method For Resistance Of Materials To Penetration By Liquids

ISO 6530:2005 specifies a test method for the measurement of indices of penetration, absorption and repellency for protective clothing materials against liquid chemicals, mainly chemicals of low volatility.

For additional information:

ISO 6530:2005 - Protective clothing - Protection against liquid chemicals - Test method for resistance of materials to penetration by liquids (ansi.org)

 
ASTM D5034-21 - Standard Test Method For Breaking Strength And Elongation Of Textile Fabrics (Grab Test)

This test method covers the grab and modified grab test procedures for determining the breaking strength and elongation of most textile fabrics. Provisions are made for wet testing. The grab test procedure is applicable to woven, nonwoven, and felted fabrics, while the modified grab test procedure is used primarily for woven fabrics.

For additional information: 

ASTM D5034-21 - Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) (ansi.org)

 
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

 
PPE Chemical Permeation, Degradation & Penetration

Ideally, the chosen material(s) must resist permeation, degradation, and penetration by the respective chemicals.

Permeation is the process by which a chemical dissolves in or moves through a material on a molecular basis. In most cases, there will be no visible evidence of chemicals permeating a material.

Permeation breakthrough time is the most common result used to assess material chemical compatibility. The rate of permeation is a function of several factors such as chemical concentration, material thickness, humidity, temperature, and pressure. Most material testing is done with 100% chemical over an extended exposure period. The time it takes chemical to permeate through the material is the breakthrough time. An acceptable material is one where the breakthrough time exceeds the expected period of PPE use.  However, temperature and pressure effects may enhance permeation and reduce the magnitude of this safety factor. For example, small increases in ambient temperature can significantly reduce breakthrough time and the protective barrier properties of a protective PPE material.

Degradation involves physical changes in a material as the result of a chemical exposure, use, or ambient conditions (e.g. sunlight). The most common observations of material degradation are discoloration, swelling, loss of physical strength, or deterioration.

Penetration is the movement of chemicals through zippers, seams, or imperfections in a protective clothing material. 

It is important to note that no material protects against all chemicals and combinations of chemicals, and that no currently available material is an effective barrier to any prolonged chemical exposure.

For additional information:

OSHA Technical Manual (OTM) - Section VIII: Chapter 1 | Occupational Safety and Health Administration

 
USP 800

USP General Chapter <800> describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation. These standards apply to all healthcare personnel who receive, prepare, administer, transport or otherwise come in contact with hazardous drugs and all the environments in which they are handled.

For additional information:

USP 800 | USP

USP_FAQs_on_GC_800.pdf

800-know-your-exposure-to-hazardous-drugs.pdf (usp.org)

 
Sterilization for Medical Devices

Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide).

For additional information:

Sterilization for Medical Devices | FDA

Sterilization | Disinfection & Sterilization Guidelines | Guidelines Library | Infection Control | CDC


PDA EU Annex 1 Revision

https://www.pda.org/topic-areas/eu-annex-1-revision