SIST EN 16616:2022/kFprA1:2025
(Amendment)Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)
Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)
This document specifies a test method and the minimum requirements for the microbicidal activity of a specified disinfection process for the treatment of contaminated textile. This procedure is carried out by using a washing machine as specified in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers' instructions are expected to be sufficient if they content the process parameters identified in the test (e.g. dosing disinfectant in whatever washing phase e.g. main wash, rinsing, disinfecting at 40 °C).
This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example:
- in hospitals, in community medical facilities, and in dental institutions;
- in clinics of schools, of kindergartens, and of nursing homes;
and could occur in the workplace and in the home.
It could also include services such as laundries and kitchens supplying products directly for the patients.
The method described is intended to determine the activity of a product or product combination under the conditions in which they are used. This is a phase 2, step 2 laboratory test that simulates the conditions of application of the product.
EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
Chemische Desinfektionsmittel und Antiseptika - Chemothermische Wäschedesinfektion - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Désinfectants chimiques et antiseptiques - Désinfection thermochimique du textile - Méthode d’essai et exigences (phase 2, étape 2)
Kemična razkužila in antiseptiki - Termokemično razkuževanje tekstila - Preskusna metoda in zahteve (faza 2, stopnja 2) - Dopolnilo A1
General Information
Relations
Overview
EN 16616:2022/FprA1 - Chemical disinfectants and antiseptics: Chemical‑thermal textile disinfection - Test method and requirements (phase 2, step 2) is a CEN standard that defines a laboratory test method and minimum requirements for the microbicidal activity of chemical‑thermal disinfection processes applied to contaminated textiles. The procedure is a phase 2, step 2 test that simulates practical use conditions using a specified washing machine and addresses the disinfection step without prewash. The scope covers all textile types where disinfection is medically indicated (e.g., hospitals, community medical facilities, dental clinics, schools, nursing homes) and related services (laundries, kitchens).
Key topics and requirements
- Test objective: Determine the activity of a product or product combination under realistic application conditions (temperature, contact time, liquor ratio, dosing, interfering substances).
- Test platform: A washing machine specified in clause 5.3.2.18 is used to simulate in‑use conditions.
- Temperature ranges: Clarified to include processes at temperatures < 60 °C and processes ≥ 60 °C up to 70 °C; reference procedures for ≥ 60 °C to 70 °C are specified at 60 °C.
- Process parameters: Contact times, temperature(s), disinfectant concentration, liquor ratio, ballast load and dosing phase (main wash, rinse, etc.) must be specified and reported.
- Validation runs: Demonstration of efficacy requires multiple valid runs (e.g., three valid runs for specified temperature ranges) and comparison against defined reference procedures.
- Microbial controls and reporting: Requirements for non‑treated carriers per batch/test day, mean values for reductions, and expanded test report content (ballast composition, load weight, liquor ratio) are mandated.
- Amendment highlights (prA1): Several procedural and reporting updates-e.g., maximum time change in 5.3.2.18 (≤ 10 min), additions to test report items, clarification of drying times and table formats in Annexes.
Practical applications and users
- Who uses it:
- Manufacturers of chemical disinfectants and antiseptic laundry products (to substantiate claims)
- Independent testing and certification labs (to perform standardized validation)
- Central and hospital laundries, textile service providers (to validate in‑house processes)
- Infection prevention and control teams in healthcare, long‑term care and communal settings
- Regulatory bodies and procurement teams requiring evidence of textile disinfection performance
- Practical value:
- Provides a repeatable, standardized method to compare products and processes
- Supports product labeling and “use recommendations” when combined with EN 14885 guidance
- Helps ensure that textile disinfection meets clinical hygiene needs and regulatory expectations
Related standards
- EN 14885 - Relationship of disinfectant tests and “use recommendations” (referenced for contextual linkage and interpretation)
- CEN/TC 216 publications - other methods for chemical disinfectants and antiseptics
Keywords: EN 16616, chemical‑thermal textile disinfection, chemical disinfectants, antiseptics, phase 2 step 2 test, washing machine validation, microbicidal activity, healthcare laundry.
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 16616:2022/oprA1:2024
01-julij-2024
Kemična razkužila in antiseptiki - Termokemično razkuževanje tekstila - Preskusna
metoda in zahteve (faza 2, stopnja 2) - Dopolnilo A1
Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test
method and requirements (phase 2, step 2)
Chemische Desinfektionsmittel und Antiseptika - Chemothermische Wäschedesinfektion
- Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Désinfectants chimiques et antiseptiques - Désinfection thermochimique du textile -
Méthode d’essai et exigences (phase 2, étape 2)
Ta slovenski standard je istoveten z: EN 16616:2022/prA1
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
71.100.35 Kemikalije za dezinfekcijo v Chemicals for industrial and
industriji in doma domestic disinfection
purposes
SIST EN 16616:2022/oprA1:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN 16616:2022/oprA1:2024
SIST EN 16616:2022/oprA1:2024
DRAFT
EUROPEAN STANDARD
EN 16616:2022
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
May 2024
ICS
English Version
Chemical disinfectants and antiseptics - Chemical-thermal
textile disinfection - Test method and requirements (phase
2, step 2)
Désinfectants chimiques et antiseptiques - Désinfection Chemische Desinfektionsmittel und Antiseptika -
thermochimique du textile - Méthode d'essai et Chemothermische Wäschedesinfektion - Prüfverfahren
exigences (phase 2, étape 2) und Anforderungen (Phase 2, Stufe 2)
This draft amendment is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 216.
This draft amendment A1, if approved, will modify the European Standard EN 16616:2022. If this draft becomes an amendment,
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration.
This draft amendment was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 16616:2022/prA1:2024 E
worldwide for CEN national Members.
SIST EN 16616:2022/oprA1:2024
EN 16616:2022/prA1:2024 (E)
Contents Page
European foreword . 3
1 Modification to 3.2 . 4
2 Modification to clause 4 . 4
3 Modification to 5.1 . 4
4 Modification to 5.3.2.18 a) . 4
5 Modification to 5.5.2.2 c) . 4
6 Modification to 5.5.2.3 . 4
7 Modification to 5.6.2.4 b). 4
8 Modification to 5.9.2.1 . 5
9 Modification to 5.9.2.2 . 5
10 Modification to 5.10 e) . 5
11 Modification to Annex
...
Frequently Asked Questions
SIST EN 16616:2022/kFprA1:2025 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection - Test method and requirements (phase 2, step 2)". This standard covers: This document specifies a test method and the minimum requirements for the microbicidal activity of a specified disinfection process for the treatment of contaminated textile. This procedure is carried out by using a washing machine as specified in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers' instructions are expected to be sufficient if they content the process parameters identified in the test (e.g. dosing disinfectant in whatever washing phase e.g. main wash, rinsing, disinfecting at 40 °C). This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: - in hospitals, in community medical facilities, and in dental institutions; - in clinics of schools, of kindergartens, and of nursing homes; and could occur in the workplace and in the home. It could also include services such as laundries and kitchens supplying products directly for the patients. The method described is intended to determine the activity of a product or product combination under the conditions in which they are used. This is a phase 2, step 2 laboratory test that simulates the conditions of application of the product. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
This document specifies a test method and the minimum requirements for the microbicidal activity of a specified disinfection process for the treatment of contaminated textile. This procedure is carried out by using a washing machine as specified in 5.3.2.18 and refers to the disinfection step without prewash. This procedure is not limited to certain types of textile. The suppliers' instructions are expected to be sufficient if they content the process parameters identified in the test (e.g. dosing disinfectant in whatever washing phase e.g. main wash, rinsing, disinfecting at 40 °C). This document applies to areas and situations where disinfection is medically indicated. Such indications occur in patient care, for example: - in hospitals, in community medical facilities, and in dental institutions; - in clinics of schools, of kindergartens, and of nursing homes; and could occur in the workplace and in the home. It could also include services such as laundries and kitchens supplying products directly for the patients. The method described is intended to determine the activity of a product or product combination under the conditions in which they are used. This is a phase 2, step 2 laboratory test that simulates the conditions of application of the product. EN 14885 specifies in detail the relationship of the various tests to one another and to “use recommendations”.
SIST EN 16616:2022/kFprA1:2025 is classified under the following ICS (International Classification for Standards) categories: 11.080.20 - Disinfectants and antiseptics; 71.100.35 - Chemicals for industrial and domestic disinfection purposes. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 16616:2022/kFprA1:2025 has the following relationships with other standards: It is inter standard links to SIST EN 16616:2022+A1:2026, SIST EN 16616:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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