Certification and Registration
EN European Standard Antibacterial and Mold-Resistant Testing
Category:
Antibacterial And Mold
EP 10.0 5.1.3 Efficacy of antimicrobial preservation
If a pharmaceutical preparation itself does not possess sufficient antimicrobial activity, antimicrobial preservatives may be added, particularly in aqueous formulations, to prevent microbial proliferation or limit microbial contamination.
Under normal storage and usage conditions, especially for products packaged in multi-dose containers, microorganisms may be introduced into the product, potentially causing infection risks to patients and affecting product stability. The addition of antimicrobial preservatives helps minimize these risks.
BP 2021 appendix XVI C Efficacy of Antimicrobial Preservation
EP10.0 2.6.12 & 2.6.13 package Microbiological examination of non-sterile products
The tests described in EP 10.0 2.6.12 and 2.6.13 allow the quantitative enumeration of aerobic microorganisms, including bacteria and fungi capable of growing under aerobic conditions.
BP 2021 appendix XVI B package Microbiological Examination of Non-sterile Products
EN 1276:2019 Evaluation of bactericidal activity of chemical disinfectants and antiseptics
EN 1276 specifies a suspension test method for determining whether chemical disinfectants or antiseptics exhibit bactericidal activity.Bactericidal or antibacterial products are developed to control and reduce specific populations of pathogenic microorganisms.
EN 1276 applies to products intended for use in food, industrial, domestic, and institutional areas. It does not apply to products used in medical disinfection applications or products intended for use on living tissues, except for hand hygiene products used in food, industrial, domestic, and institutional environments (such as alcohol-based hand gels).
EN 1650:2019 Evaluation of fungicidal activity of chemical disinfectants and antiseptics
EN 1650 specifies a Phase 2 Step 1 suspension test method for evaluating the fungicidal activity of chemical disinfectants and antiseptics intended for use in food, industrial, domestic, and institutional areas.This test evaluates the effectiveness of products against fungi and yeasts.
ISO 16187:2013 Footwear and footwear components - Test method to assess antibacterial activity
ISO 16187 specifies quantitative test methods for evaluating the antibacterial activity of footwear and footwear components.
ISO 16187 applies to all types of footwear and footwear components treated with non-diffusing antibacterial agents.
EN ISO 20743-2013 Textiles—Determination of antibacterial activity of antibacterial finished products (Absorption method)
EN ISO 20743 specifies quantitative test methods for determining the antibacterial activity of all antibacterial textile products, including nonwoven materials.
EN ISO 20645:2004 Textile fabrics—Determination of antibacterial activity (Agar diffusion plate test)
EN ISO 20645 specifies methods for determining the effectiveness of antibacterial treatments applied to woven, knitted, and other planar textile materials.
EN ISO 20645 is applicable for evaluating antibacterial treatments applied to hydrophilic, breathable materials or antibacterial agents incorporated into fibers. In this procedure, diffusion of the antibacterial agent into the test agar is required.
EN ISO 20645 may also be applied to other materials with appropriate modifications.
ISO 22196-2011 Measurement of antibacterial activity on plastics and other non-porous surfaces
ISO 22196 specifies a method for evaluating the antibacterial activity of antibacterial-treated plastic surfaces and other non-porous products, including intermediate products.
EN 1104-2018 Paper and board intended to come into contact with foodstuffs-Determination of transfer of antimicrobic constituents
EN 1104 specifies a method for determining the transfer of antimicrobial constituents from paper and board materials and articles intended to come into contact with foodstuffs.
The application of EN 1104 may be required according to relevant legislation concerning paper and board materials intended for food contact.
EN 14119:2003 Testing of textiles—Evaluation of the action of micro fungi
EN 14119 specifies methods for determining the long-term resistance of textile materials against microorganisms and mixed cultures.
ISO 16869-2008 Plastics — Assessment of the effectiveness of fungistatic compounds in plastics formulations
ISO 16869 specifies a method for determining the effectiveness of fungistatic compounds in protecting susceptible components of plastic formulations, such as plasticizers and stabilizers.
This method can demonstrate whether plastic products are effectively protected against fungal attack.
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