Legislation

Our objective is to help our valued clients achieve seamless protection in every process and situation – and this includes regulatory protection. In order to achieve this we not only provide a range of high-quality compliant products but we also look for opportunities to share our advice, insights and support to help your applications and facilities keep pace with current legislation.

On this page we have collected a variety of information and resources on three important areas of regulatory compliance that relate to our product portfolio.

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.

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

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

ASTM D6978-05 - Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

This practice covers a protocol for the assessment of resistance of medical glove materials to permeation by potentially hazardous cancer chemotherapy drugs under conditions of continuous contact. An assessment is made based on the permeation (breakthrough) of nine chemotherapy drugs through the glove material over a certain period of time.

For additional information:

PPE-Info - Standard Details (cdc.gov)

Certificate of Irradiation

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.

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 imperfections in PPE material including pinholes and tears.

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

Pyrogen and Endotoxins Testing

The USP now recognizes two tests - The Pyrogen Test conducted with rabbits and the Bacterial Endotoxins Test, also termed the Limulus Amebocyte Lysate (LAL) Test. Additionally, the agency has approved the use of the Bacterial Endotoxins Test for many drug and device products.

For additional information:

Bacterial Endotoxins/Pyrogens | FDA

Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers | FDA

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)

Food Contact Compliance – 21 CFR

The formulations of the following Kimberly-Clark™ Scientific Gloves have been tested and the ingredients have been found to comply with the Federal Food, Drug and Cosmetic Act requirements for food contact materials as stated in the following regulations:

• 21 CFR 177.2600, “Rubber articles intended for repeated use.”
• 21 CFR 178, “Indirect Food Additives: Adjuvants, Production Aids and Sanitizers.”
• 21 CFR 178.3297, “Colorants for Polymers.”
• 21 CFR 177.2600(e), An extraction test was performed to confirm that the product complies with the regulation.

For additional information:

eCFR :: 21 CFR Chapter I Subchapter B -- Food for Human Consumption

Certificate of Analysis

The CGMP regulations require either testing or use of a certificate of analysis (COA) plus an identity analysis (§ 211.84) for the release of materials for manufacturing. In the preamble to the CGMP regulations, these requirements were explicitly interpreted. The preamble states that reliability can be validated by conducting tests or examinations and comparing the results to the supplier’s COA.

For additional information:

Guidance for Industry (fda.gov)

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

Gamma Irradiation Processing:

Gamma Irradiation Sterilization Process & Services | STERIS AST (steris-ast.com)

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

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