FORM 1:
PROPOSAL FOR A NEW FIELD OF TECHNICAL ACTIVITY
Circulation date2019-09-28

Reference number: TS/P 283(to be given by ISO Central Secretariat)

Closing date for voting
2019-12-21
Proposer
AFNOR

ISO/TS/P 283

A proposal for a new field of technical activity shall be submitted to the ISO Central Secretariat,
which will assign it a reference number and process the proposal in accordance with the ISO/IEC
Directives Part 1, Clause 1.5. The proposer may be a member body of ISO, a technical committee,
subcommittee or project committee, the Technical Management Board or a General Assemblycommittee, the Secretary-General, a body responsible for managing a certification system
operating under the auspices of ISO, or another international organization with national bodymembership. Guidelines for proposing and justifying a new field of technical activity are given in
the ISO/IEC Directives Part 1, Annex C.

Proposal (to be completed by the proposer)
Title of the proposed new committee (The title shall indicate clearly yet concisely the new
field of technical activity which the proposal is intended to cover).
Surfaces with biocidal and antimicrobial properties
Scope statement of the proposed new committee (The scope shall precisely define thelimits of the field of activity. Scopes shall not repeat general aims and principles
governing the work of the organization but shall indicate the specific area concerned).
Standardization of test methods used to assess the biocidal performance and efficacy of any
surfaces with antimicrobial activities, including their compatibility with different families of
disinfectants and cleaning agents. Such methods aim at evaluating the biocidal activity (i.e. thatwhich irreversibly inactivates microorganism) and at differentiating it from the biostatic activity(i.e. the inhibition of the growth of microorganisms).
The field of covers the assessment of surfaces displaying intrinsic biocidal properties and of
surfaces processed by any means so as to deliver biocidal properties.
Areas of interest include medical and veterinary applications, aerospace, agriculture, foodhygiene and other industrial fields, institutional and domestic applications.
Excluded: Toxicological and ecotoxicological surface testing methods, antimicrobial activities oftextile products.

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Form 1: Proposal for a new field of technical activity
Page 2☒The proposer has checked whether the proposed scope of the new committee
overlaps with the scope of any existing ISO committee☐

If an overlap or the potential for overlap is identified, the affected committee has been
informed and consultation has taken place between proposer and committee on
i. modification/restriction of the scope of the proposal to eliminate the overlap,
ii. potential modification/restriction of the scope of the existing committee toeliminate the overlap.

☐

If agreement with the existing committee has not been reached, arguments arepresented in this proposal (under question 7) as to why it should be approved.

Proposed initial programme of work. (The proposed programme of work shall correspondto and clearly reflect the aims of the standardization activities and shall, therefore, show
the relationship between the subject proposed. Each item on the programme of work shallbe defined by both the subject aspect(s) to be standardized (for products, for example,
the items would be the types of products, characteristics, other requirements, data to besupplied, test methods, etc.). Supplementary justification may be combined withparticular items in the programme of work. The proposed programme of work shall alsosuggest priorities and target dates.)
The proposed work programme is the following:
1) Standards to evaluate the basic biocidal activity of surfaces
Such standards will help evaluating the biocidal efficacy of surfaces, close to general ambientconditions, but without developing variations taking into account each specific set of use
conditions. They will also provide tools to demonstrate the biocidal activity (i.e. that which
irreversibly inactivates microorganisms) of surfaces, while providing disambiguation regarding
biostatic activity (i.e. inhibition of the growth of microorganisms).
2) Standards to evaluate the biocidal activity of surfaces in various areas of application,
integrating the effect of interfering substances, of specific microorganisms, of log reduction incorrelation with field’s and user's needs, including the ability to sustain the level of performanceover time;3) Any guidance documents that the TC would deem needed in support to the use of thestandards envisaged here above. This may include guidance for performing hygiene withbiocidal surfaces or publish round-robin tests results conducted in support of the standards.
Indication(s) of the preferred type or types of deliverable(s) to be produced under the
proposal (This may be combined with the "Proposed initial programme of work" if moreconvenient).
Test method standards
Technical specifications
Guidance documents
Technical reports

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Form 1: Proposal for a new field of technical activity
Page 3A listing of relevant existing documents at the international, regional and national levels.
(Any known relevant document (such as standards and regulations) shall be listed,regardless of their source and should be accompanied by an indication of theirsignificance.)•

ISO 22196 “Measurement of antibacterial activity on plastics and other non-porous
surfaces”

National standards identified:• NF S90-700 “Surfaces with biocidal properties - Method for the evaluation of basic
bactericidal activity of a non-porous surface”• ABNT NBR 16316 (2014-11) “Antimicrobial copper surfaces - Requirements and test
methods”• SANS 5730:2009*SABS SM 730:2009 “Antibacterial efficacy of solid and semi-solid
antiseptics”
Other reference documents:• ASTM E 2180 “Standard Test Method for Determining the Activity of Incorporated
Antimicrobial Agent(s) In Polymeric or Hydrophobic Materials”• OECD Guidance Document on Quantitative Methods for Evaluating the Activity ofMicrobicides used on Hard Non-Porous Surfaces. ENV.JM.MONO(2014)18

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Form 1: Proposal for a new field of technical activity
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A statement from the proposer as to how the proposed work may relate to or impact on
existing work, especially existing ISO and IEC deliverables. (The proposer should explain
how the work differs from apparently similar work, or explain how duplication and conflict
will be minimized. If seemingly similar or related work is already in the scope of othercommittees of the organization or in other organizations, the proposed scope shalldistinguish between the proposed work and the other work. The proposer shall indicate
whether his or her proposal could be dealt with by widening the scope of an existingcommittee or by establishing a new committee.)
The proposed work programme is the following-Standards to evaluate the basic activity of the surfaces and to differentiate the biocidal
from the biostatic activity
Standards or technical specifications to evaluate the activity of the surfaces in different
areas, their related conditions of use and performance retention ability
Guidance documents for performing day-to-day hygiene with biocidal surfaces

None of these items are covered by an existing ISO TC or SC. No transversal methods has been
set in order to support and clarify end user choices for identifying surfaces with efficacy criteria
in correlation with areas risks. Such lack of transversal standards leads to the impossibility tocompare efficacy of different type of surfaces with antimicrobial and biocidal properties making
those surfaces less used than their potentials for reducing contamination could ensure. There isno intend to developed materials specific standards.
It should be noted that ISO subcommittee 6 Ageing, chemical and environmental on plastics andother non-porous surfaces, which is related to the scope of the propose resistance of ISO/TC 61
Plastics has developed ISO 22196 Measurement of antibacterial activity d TC. However thisstandard is a test method mostly designed for a specific type of product, without possible
distinction between biocidal and biostatic activities. Furthermore, the laboratory test conditionsof the method are very far from generic ambient use conditions.
This standard so as other material specific’s methods (eg: pr ISO 17721-1 and -2…) will betaken into account in the work.
International market already propose a wide range of products claiming to have antimicrobial
properties (copper, ceramic, chemical treated surfaces, nanomaterials, silver…).The real added
value of this new ISO TC will be to develop a holistic and global approach for evaluating theeffectiveness of any type of biocidal surfaces (porous and non-porous) independently of the
product compounds and for also taking into account the needs of different sectors.
In order to ensure consistency of ISO standards collection and to take into account needs fromvarious sector and cooperation with technical committees wishing to apply standards formaterials or product within their scopes, several liaisons are expected to be needed.
A listing of relevant countries where the subject of the proposal is important to theirnational commercial interests.
This standardization endeavor is intended to involve all countries, considering the numerous
sectors concerned by this topic

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Form 1: Proposal for a new field of technical activity
Page 5A listing of relevant external international organizations or internal parties (other ISO
and/or IEC committees) to be engaged as liaisons in the development of thedeliverable(s). (In order to avoid conflict with, or duplication of efforts of, other bodies, it
is important to indicate all points of possible conflict or overlap. The result of any
communication with other interested bodies shall also be included.)
To have feedbacks and cooperation with hygiene experts from various area:
ISO/TC 84 Devices for administration of medicinal products and catheters
ISO/TC 194 Biological and clinical evaluation of medical devices
ISO/TC 198 Sterilization of health care products
ISO/TC 209 Cleanrooms and associated controlled environments
ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
ISO/TC 217 CosmeticsU

CEN/TC 205 Non-active medical devices
CEN/TC 216 Chemical antiseptics and disinfectants

To avoid conflict with sector-specific methods and to ensure cooperation with product specificbodies:
ISO/TC 26 Copper and copper alloys
ISO/TC 34 Food products
ISO/TC 35 Paints and varnishes
ISO/TC 38 Textiles
ISO/TC 45 Rubber and rubber products
ISO/TC 61 Plastics
ISO/TC 91 Surface active agents
ISO/TC 102 Iron ore and direct reduced iron
ISO/TC 107 Metallic and other inorganic coatings
ISO/TC 153 Valves
ISO/TC 189 Ceramic tile
ISO/TC 201 Surface chemical analysis
ISO/TC 206 Fine Ceramics
ISO/TC 229 Nanotechnologies
ISO/TC 261 Additive manufacturingU

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A simple and concise statement identifying and describing relevant affected stakeholder
categories (including small and medium sized enterprises) and how they will each benefit
from or be impacted by the proposed deliverable(s).
Prior proposing this committee to ISO members, AFNOR get confirmation from a wide range ofstakeholders that such work would be of interest:- SMEs, and more generally all manufacturers will benefit from ISO standards supportingand guiding their R&D and market assertions.
- Laboratories and testing houses will have clear testing methods to apply to assess the
biocidal efficacy of surfaces.
- Product users will have a clear tools to recognize, compare and identify products thatmeet their expectations and needs- Hygienists (governments, healthcare professionals, cleanrooms owners and users…)
from a number of areas and sectors, for instance …, …and …, will benefit from these
new standards that will clarify and increase their trust in the marketing claims andfacilitate product’s benchmarks.
- Regulatory authorities can also use the standard to control product claims.
An expression of commitment from the proposer to provide the committee secretariat if
the proposal succeeds.
If the proposal is accepted, AFNOR is willing to undertake the work of secretariat of the newTC, and is committed to providing all resources to successfully run the secretariat.

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Purpose and justification for the proposal. (The purpose and justification for the creationof a new technical committee shall be made clear and the need for standardization in thisfieldshall be justified. Clause C.4.13.3 of Annex C of the ISO/IEC Directives, Part 1
contains a menu of suggestions or ideas for possible documentation to support andpurpose and justification of proposals. Proposers should consider these suggestions,but they are not limited to them, nor are they required to comply strictly with them. Whatis most important is that proposers develop and provide purpose and justification
information that is most relevant to their proposals and that makes a substantial businesscase for the market relevance and the need for their proposals. Thorough, well-developed
and robust purpose and justification documentation will lead to more informed
consideration of proposals and ultimately their possible success in the ISO IEC system.)
The worldwide community agrees that infection or biological contamination prevention is still oneof its biggest challenges of the next century. Based on the various existing products on themarket and scientific researches since at least 20 years, biocidal surfaces have clearly a keyrole to play to reinforce current programs for fighting infections and the spread of pathogens. To
achieve this objective, standardization of transversal testing methods to assess biocidal activityof any surfaces is necessary to ensure that we have reliable and performant surfaces.
Addressing antimicrobial and biocidal efficacies of surfaces independently of the productcompounds is innovative and addresses a worldwide need of the market that is to evaluatebiocidal efficacy of surfaces in order to reinforce available tools against pathogen
microorganisms and reliability on the surfaces efficacy in use conditions.
48T

48T

Various sectors have to ensure contamination control such as:- The medical sector:
Indeed, according to the World Health Organization (WHO):• 1 in 10 patients catch an infection while receiving care,• Effective infection prevention and control reduces healthcare associated infections by atleast 30%.
Moreover, the colonization of undesired microorganisms on surfaces and on devices used inbiomedical and clinical applications has become a persistent problem1:
P

•
•
•
•

Donskey CJ et al. Beyond high-touch surfaces: Portable equipment and floors as potential sources oftransmission of health care-associated pathogens, Am J Infect Control. 2019
Kramer A. How long do nosocomial pathogens persist on inanimate surfaces? A systematic review BMC
Infect Dis. 2006
Boyle MA et al. Off the rails': hospital bed rail design, contamination, and the evaluation of their microbial
ecology. J Hosp Infect. 2019
Russotto V et al. Bacterial contamination of inanimate surfaces and equipment in the intensive care unit. J
Intensive Care. 2015

- The food sector: food safety management, reduction of chemical preservative agent, heat
method vs nutrition…
- The farming sector: reduction of pathogens microorganism, antibiotic resistance- and also the pharmaceutical, cosmetics or transportation sectors
International standardized test methods are necessary not only for safety reasons but also for
economic ones to facilitate the best choice for each use.
Several studies have underlined (non-exhaustive list) how surface cleaning could varied and therole of biocidal surfaces for reducing microorganism.
•

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Muller MP et al. Antimicrobial surfaces to prevent healthcare-associated infections: a systematic
review. J Hosp Infect. 2016

Form 1: Proposal for a new field of technical activity
Page 8••••B.C Eckstein et al, Reduction of Clostridium Difficile and vancomycin-resistant Enterococcus
contamination of environmental surfaces after an intervention to improve cleaning methods 2007
Weber DJ et al. The role of the surface environment in healthcare-associated infections. Curr
Opin Infect Dis. 2013
Vincent M et al. Contact killing and antimicrobial properties of copper. J Appl Microbiol. 2018
Francolini I et al. Antifouling and antimicrobial biomaterials: an overview APMIS. 2017

Effect of biocidal surfaces in a contamination control context, is alone, not sufficient to ensure
safety but in combination with other safety devices/practices (Training, hand hygiene, surfaces
disinfection and cleaning, air contamination control, water… ), it is part of a global system thathighly reduces risks of infections. Creating such ISO committee and placing hygiene as thestarting point of the creation of horizontal standards to evaluate antimicrobial and biocidal
efficacy will support this objective.
Signature of the proposer

Alain COSTES,
AFNOR Standardisation Director
Further information to assist with understanding the requirements for the items above can befound in the Directives, Part 1, Annex C.

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