CEN/TR 17825:2022
(Main)Chemical disinfectants and antiseptics - Interpretation of water controls in EN 16615:2015
Chemical disinfectants and antiseptics - Interpretation of water controls in EN 16615:2015
This document defines rules for the interpretation of data according to EN 16615: 2015 regarding water controls in order to avoid problems in discussions with legal bodies on the validity of data to support product claims.
Chemische Desinfektionsmittel und Antiseptika - Interpretation der Wasserkontrollen in EN 16615:2015
Antiseptiques et désinfectants chimiques - Interprétation des témoins eau dans l'EN 16615:2015
Le présent document définit des règles pour l'interprétation des données correspondant à l’EN 16615:2015 relatives aux témoins eau afin d’éviter les problèmes dans les discussions avec les autorités ou organismes légaux sur la validité des données destinées à supporter les revendications des produits.
Kemična razkužila in antiseptiki - Razlaga glede kontrole vode, določene v standardu EN 16615:2015
Ta dokument opredeljuje pravila za interpretacijo podatkov v skladu s standardom EN 16615: 2015 glede kontrol vode, da bi se izognili težavam v razpravah s pristojnimi organi o veljavnosti podatkov, ki podpirajo trditve o izdelkih.
General Information
- Status
- Published
- Publication Date
- 30-Aug-2022
- Technical Committee
- CEN/TC 216 - Chemical disinfectants and antiseptics
- Drafting Committee
- CEN/TC 216/WG 1 - Human medicine
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 31-Aug-2022
- Due Date
- 06-Apr-2023
- Completion Date
- 31-Aug-2022
Overview
CEN/TR 17825:2022 is a technical report published by the European Committee for Standardization (CEN) that provides interpretation guidelines for water controls in accordance with EN 16615:2015. EN 16615:2015 specifies a quantitative test method for evaluating the bactericidal and yeasticidal activity of chemical disinfectants and antiseptics on non-porous surfaces using a mechanical wiping action (the 4-field test).
This technical report addresses challenges encountered by laboratories in validating water control data, especially when testing with gram-negative bacteria and yeasts. It aims to ensure data validity, support product claims, and facilitate clear communication with legal and regulatory bodies regarding disinfectant efficacy testing.
Key Topics
Water Controls Interpretation
The core objective of CEN/TR 17825:2022 is to define clear rules for interpreting water control results according to EN 16615:2015. The report proposes an adjustment in data evaluation criteria:- Original validity criterion: Average colony-forming units (cfu) in water control must be >10 cfu/25 cm² over fields 2-4.
- Proposed modification: Consider fields 1-4 (including the initially contaminated field) for calculating average cfu to better reflect microbial presence and improve test validity.
Challenges with Test Organisms
Laboratories have reported difficulties obtaining valid water controls when testing with certain microorganisms such as Pseudomonas aeruginosa (gram-negative bacteria) and Candida albicans (yeasts). These organisms may be less recoverable in uninoculated water control fields, complicating interpretation.Regulatory and Legal Considerations
Accurate water control interpretation is critical to avoid disputes with regulatory authorities concerning the validity of disinfectant efficacy data. This report helps standardize interpretations to support product claims reliably.Technical Committee and Scope
CEN/TC 216, responsible for chemical disinfectants and antiseptics, prepared this report. It applies across European Union member states and aims to guide laboratories in harmonized data evaluation.
Applications
Chemical Disinfectant Testing
Laboratories performing efficacy testing of chemical disinfectants and antiseptics on surfaces use this guideline for consistent water control interpretation, making their data defensible in regulatory submission and quality assurance processes.Healthcare and Medical Facilities
Validation of disinfectant efficacy supports infection control protocols in hospitals and clinics where hygiene and surface disinfection are critical.Regulatory Submissions
Manufacturers submitting product claims for disinfectants rely on standardized evaluation criteria to meet European and international regulatory expectations related to bactericidal and yeasticidal activity.Laboratory Method Standardization
Ensures comparability of results between different testing laboratories, especially when dealing with diverse microorganisms in disinfectant efficacy studies.
Related Standards
EN 16615:2015
The foundational standard that defines the 4-field test method for assessing disinfectant efficacy on non-porous surfaces using mechanical action. CEN/TR 17825:2022 provides interpretive support for water controls within this method.EN 14885
Specifies the application of European standards for chemical disinfectants and antiseptics, including terminology and definitions referenced in CEN/TR 17825:2022.
Summary
CEN/TR 17825:2022 offers essential guidance on interpreting water controls in EN 16615:2015 disinfectant efficacy testing, particularly addressing variability with gram-negative bacteria and yeasts. By refining validity criteria, it helps laboratories produce credible, regulatory-compliant data supporting chemical disinfectant claims. This technical report is a valuable resource for manufacturers, testing labs, and regulatory bodies involved in surface disinfection product evaluation.
Keywords: CEN/TR 17825:2022, EN 16615:2015, chemical disinfectants, antiseptics, water controls interpretation, disinfectant efficacy testing, bactericidal activity, yeasticidal activity, standardization, regulatory compliance
Frequently Asked Questions
CEN/TR 17825:2022 is a technical report published by the European Committee for Standardization (CEN). Its full title is "Chemical disinfectants and antiseptics - Interpretation of water controls in EN 16615:2015". This standard covers: This document defines rules for the interpretation of data according to EN 16615: 2015 regarding water controls in order to avoid problems in discussions with legal bodies on the validity of data to support product claims.
This document defines rules for the interpretation of data according to EN 16615: 2015 regarding water controls in order to avoid problems in discussions with legal bodies on the validity of data to support product claims.
CEN/TR 17825:2022 is classified under the following ICS (International Classification for Standards) categories: 11.080.20 - Disinfectants and antiseptics. The ICS classification helps identify the subject area and facilitates finding related standards.
You can purchase CEN/TR 17825:2022 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-april-2023
Kemična razkužila in antiseptiki - Razlaga glede kontrole vode, določene v
standardu EN 16615:2015
Chemical disinfectants and antiseptics - Interpretation of water controls in EN
16615:2015
Chemische Desinfektionsmittel und Antiseptika - Interpretation der Wasserkontrollen in
EN 16615:2015
Antiseptiques et désinfectants chimiques - Interprétation des témoins eau dans l'EN
16615:2015
Ta slovenski standard je istoveten z: CEN/TR 17825:2022
ICS:
11.080.20 Dezinfektanti in antiseptiki Disinfectants and antiseptics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN/TR 17825
TECHNICAL REPORT
RAPPORT TECHNIQUE
August 2022
TECHNISCHER REPORT
ICS 11.080.20
English Version
Chemical disinfectants and antiseptics - Interpretation of
water controls in EN 16615:2015
Antiseptiques et désinfectants chimiques - Chemische Desinfektionsmittel und Antiseptika -
Interprétation des témoins eau dans l'EN 16615:2015 Interpretation der Wasserkontrollen in EN
16615:2015
This Technical Report was approved by CEN on 15 August 2022. It has been drawn up by the Technical Committee CEN/TC 216.
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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 17825:2022 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Rules for the interpretation of data regarding water controls . 5
Bibliography . 6
European foreword
This document (CEN/TR 17825:2022) has been prepared by Technical Committee CEN/TC 216
“Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR.
Attention is drawn to
...
CEN/TR 17825:2022 표준 문서는 EN 16615:2015에 따라 화학 소독제와 항균제의 수질 관리에 대한 해석 규칙을 정의하고 있습니다. 이 표준은 제품 주장에 대한 데이터의 유효성을 지지하는 데 필요한 법적 논의에서 발생할 수 있는 문제를 피하는 데 중요한 역할을 합니다. 이 문서의 범위는 매우 구체적이며, 화학 소독제와 항균제가 적절하게 사용하는 물의 품질을 평가하기 위한 프레임워크를 제공합니다. 따라서, 제조업체와 규제기관 간의 명확한 소통을 가능하게 하여, 소독제와 항균제의 사용에 대한 신뢰성을 높입니다. CEN/TR 17825:2022의 강점은 명확한 데이터 해석 기준을 제공함으로써, 관련 법적 요구사항을 충족하는 데 기여한다는 점입니다. 이를 통해 제품의 품질과 안전성에 대한 소비자 신뢰를 확보할 수 있습니다. 또한, 이 표준은 산업 전반에 걸쳐 일관된 접근 방식을 제시하여, 화학 소독제와 항균제의 유효성을 평가하는 데 있어 중요한 기준이 됩니다. 결론적으로, SIST-TP CEN/TR 17825:2023은 소독제 및 항균제의 사용과 관련된 법적 요구사항을 이해하고 이행하는 데 필수적인 자료로, 업계와 규제기관 모두에게 유익합니다. 이 표준은 또한 환경과 공중 보건을 보호하기 위한 노력을 지원하며, 현대 사회에서 화학 제품의 안전성을 유지하는 데 중요한 역할을 한다고 할 수 있습니다.
Die Norm CEN/TR 17825:2022 bietet eine strukturierte Anleitung zur Interpretation von Wasseranalysedaten in Übereinstimmung mit EN 16615:2015, insbesondere im Hinblick auf chemische Desinfektionsmittel und Antiseptika. Der Umfang der Norm ist darauf ausgelegt, klare Regeln zu definieren, die eine konsistente und rechtskonforme Anwendung dieser Daten gewährleisten. Dadurch wird nicht nur die Klarheit im Umgang mit den Daten erhöht, sondern auch die Sicherheit der Produkte unterstützt. Eine der Stärken dieser Norm liegt in ihrer detaillierten Ausarbeitung, die es Herstellern von Desinfektionsmitteln ermöglicht, die Anforderungen der Wasseranalysen präzise zu verstehen und umzusetzen. Dies ist besonders relevant, da frühere Unsicherheiten in der Dateninterpretation häufig zu rechtlichen Herausforderungen führten. Die Norm schließt diese Lücken, indem sie praxisnahe Richtlinien zur Verfügung stellt, die produktbezogene Ansprüche rechtlich untermauern können. Zusätzlich betont CEN/TR 17825:2022 die Bedeutung von Standards zur Qualitätssicherung, die in der Chemie- und Gesundheitsindustrie unerlässlich sind. Die Aussagekraft von Wasseranalysen wird erheblich gesteigert, was wiederum das Vertrauen der Verbraucher in die Wirksamkeit und Sicherheit von Desinfektionsmitteln stärkt. Die Norm ist somit von großer Relevanz für Unternehmen, die den gesetzlichen Anforderungen entsprechen und gleichzeitig ihre Marktstellung durch qualitativ hochwertige Produkte festigen möchten. Insgesamt ist die CEN/TR 17825:2022 eine wertvolle Ressource, die das Verständnis und die Anwendung von Wasserstandards im Kontext chemischer Desinfektionsmittel und Antiseptika erheblich verbessert. Sie stellt sicher, dass Unternehmen in der Lage sind, ihre Produktansprüche klar und rechtlich fundiert zu kommunizieren.
The standard CEN/TR 17825:2022 provides a comprehensive framework for interpreting water control data as outlined in EN 16615:2015, specifically focusing on chemical disinfectants and antiseptics. Its primary objective is to standardize the procedures and terminology associated with water quality assessments, thereby facilitating clearer communication within legal contexts regarding data validity for product claims. One of the major strengths of this document is its meticulous approach to defining the rules for data interpretation. By doing so, CEN/TR 17825:2022 enhances the reliability of data presented by manufacturers and supports them in defending their product claims effectively against potential legal challenges. This standardization ensures that the necessary quality checks and validations are uniformly applied across different scenarios, ultimately safeguarding consumer interests. Furthermore, the relevance of CEN/TR 17825:2022 to industry stakeholders cannot be overstated. It addresses a critical area of concern within the chemical disinfectant and antiseptic market, where misinterpretations of water control data can lead to significant repercussions for product safety and efficacy. With this standard, companies can have greater confidence in their compliance with legal requirements, thus fostering a more transparent and robust market environment. Overall, CEN/TR 17825:2022 stands as a pivotal document that not only clarifies the intersection of water control measures with product validation but also reinforces the importance of accurate and consistent data reporting within the chemical disinfectants and antiseptics sectors. Its scope and strengths position it as an essential resource for regulatory compliance and sound business practices in the industry.
CEN/TR 17825:2022は、化学的消毒剤および抗菌剤に関する標準であり、EN 16615:2015の水質管理に関するデータの解釈ルールを定義しています。此の標準は、製品の主張を裏付けるデータの妥当性に関する法的機関との議論における問題を回避するために設計されています。 この文書の強みは、明確に定められた解釈ルールが含まれていることで、実務者が水質基準に従った正確なデータを解析するための基盤を提供している点です。特に、標準は法的トラブルを未然に防ぐ効果的な手段を講じており、製品に対する信頼性を高めるための重要な指針となります。 更に、この標準は、消毒剤及び抗菌剤の市場での関連性を高める要素を持っています。EN 16615:2015の指針に従って、関連データの提供が求められる現代の厳格な規制環境において、CEN/TR 17825:2022は実務者の意思決定を助ける重要なドキュメントとして機能します。 全体として、CEN/TR 17825:2022は、化学的消毒剤および抗菌剤の水に関する分析や報告の正確性を確保するための標準であり、その適用範囲と有用性は、業界関係者にとって不可欠なものであると言えるでしょう。
Le document de normalisation CEN/TR 17825:2022, intitulé "Désinfectants chimiques et antiseptiques - Interprétation des contrôles de l'eau dans EN 16615:2015", présente un cadre essentiel pour la compréhension des données relatives aux contrôles de l'eau. Son objectif principal est de définir des règles précises qui assurent l'interprétation correcte des informations selon la norme EN 16615:2015, permettant ainsi d'éviter des litiges potentiels avec les instances juridiques concernant la validité des données utilisées pour étayer les revendications des produits. Une des forces majeures du document est sa capacité à réduire l'ambiguïté entourant les discussions liées aux processus de validation des produits. En fournissant des directives claires sur la manière d'interpréter les contrôles de l'eau, CEN/TR 17825:2022 aide les professionnels à garantir la conformité de leurs revendications avec les exigences réglementaires. Cela est particulièrement pertinent dans un secteur où les normes de sécurité et d'efficacité sont prioritaires. De plus, son contenu est d'une grande pertinence pour les fabricants et distributeurs de désinfectants et antiseptiques, qui doivent naviguer dans un environnement renforcé par des exigences légales strictes. En établissant un consensus sur l'interprétation des données, cette norme facilite la communication avec les autorités réglementaires et améliore la transparence envers les consommateurs. En somme, CEN/TR 17825:2022 se positionne comme un document de référence essentiel. Il permet non seulement d'optimiser la compréhension des contrôles de l'eau en lien avec EN 16615:2015, mais également de renforcer la confiance des parties prenantes dans la validité et la fiabilité des données présentées, consolidant ainsi la crédibilité des produits sur le marché.
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