EN 16438:2014
(Main)Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation in hard water or in the case of ready-to-use products with water.
This European Standard applies to products for use in the veterinary area i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry.
EN 14885 specifies in detail the relationship of the various tests to one another and to use recommendations.
NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.
NOTE 2 This method corresponds to a Phase 2 Step 2 test.
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur Bestimmung der fungiziden oder levuroziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich auf nicht-porösen Oberflächen ohne mechanische Wirkung - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)
Diese Europäische Norm legt ein Prüfverfahren und die Mindestanforderungen an die fungizide oder levurozide Wirkung von chemischen Desinfektionsmitteln und Antiseptika fest, die in Wasser standardisierter Härte oder - im Fall gebrauchsfertiger Produkte - mit Wasser eine homogene, physikalisch stabile Zubereitung bilden.
Diese Europäische Norm gilt für Produkte für die Anwendung im Veterinärbereich, d. h. bei der Aufzucht, Haltung, Produktion und beim Transport von Tieren sowie bei der Tierkörperbeseitigung, außer wenn die Tiere nach der Tötung durch Zuführung in die weiterverarbeitende Industrie in die Nahrungsmittelkette eintreten.
EN 14885 legt im Einzelnen die Beziehung der verschiedenen Prüfungen untereinander sowie zu den 'Anwendungsempfehlungen' fest.
ANMERKUNG 1 Das beschriebene Verfahren ist für die Bestimmung der Wirkung von handelsüblichen Zubereitungen oder Wirkstoffen unter den Bedingungen, unter denen sie verwendet werden, bestimmt.
ANMERKUNG 2 Dieses Verfahren entspricht einer Prüfung der Phase 2, Stufe 2.
Antiseptiques et désinfectants chimiques - Essai quantitatif de surface pour l'évaluation de l'activité fongicide ou levuricide des antiseptiques et des désinfectants chimiques utilisés dans le domaine vétérinaire sur des surfaces non poreuses sans action mécanique - Méthode d'essai et prescriptions (phase 2, étape 2)
La présente Norme européenne spécifie une méthode d’essai et les prescriptions minimales relatives à l’activité fongicide ou levuricide des produits antiseptiques et désinfectants chimiques qui forment une préparation homogène, physiquement stable, lorsqu’ils sont dilués dans l’eau dure ou —dans le cas de produits prêts à l’emploi— dans l’eau.
La présente Norme européenne s'applique aux produits destinés à être utilisés dans le domaine vétérinaire, à savoir la reproduction, l'élevage, la production, le transport et l’abattage de tous les animaux, sauf au cours de la chaîne alimentaire qui suit l’abattage et l’entrée dans l’industrie de transformation.
L'EN 14885 spécifie en détail la relation entre les différents essais et les « recommandations d'emploi ».
NOTE 1 La méthode décrite vise à déterminer l’activité des formulations commerciales ou des substances actives dans les conditions dans lesquelles elles sont utilisées.
NOTE 2 Cette méthode correspond à un essai de phase 2, étape 2.
Kemična razkužila in antiseptiki - Kvantitativni preskus na neporoznih površinah brez mehanskega delovanja za vrednotenje fungicidnega delovanja ali delovanja kemičnih razkužil in antiseptikov na kvasovke v veterini - Preskusna metoda in zahteve (faza 2, stopnja 2)
EN 16438 določa preskusno metodo in minimalne zahteve za fungicidno delovanje ali delovanje kemičnih razkužil in antiseptikov na kvasovke, ki tvorijo homogen, fizikalno stabilen pripravek, če so razredčeni s trdo vodo oziroma, pri proizvodih, ki so pripravljeni za uporabo, z vodo. Ta evropski standard se uporablja za izdelke v veterini, tj. pri vzreji, živinoreji, proizvodnji, prevozu in odstranjevanju vseh živali, razen če so v prehrambeni verigi po smrti in so del predelovalne industrije. EN 14885 podrobno določa razmerje med različnimi preskusi in priporočili za uporabo.
General Information
Overview
EN 16438:2014 is a CEN European Standard that defines a quantitative surface test to evaluate the fungicidal and yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area. It covers products that form a homogeneous, physically stable preparation in hard water or ready‑to‑use products diluted with water. The method is a Phase 2, Step 2 laboratory surface test on non‑porous surfaces without mechanical action, designed to reflect practical use conditions (contact time, temperature, interfering substances) and to allow inter‑laboratory comparison.
Key topics and requirements
- Test organisms
- Fungicidal: Aspergillus brasiliensis (conidiospores) and Candida albicans (vegetative cells)
- Yeasticidal: Candida albicans (vegetative cells)
- Obligatory test conditions
- Surface type: non‑porous, without mechanical action
- Test temperature: 10 °C ± 1 °C (additional temperatures may be used)
- Contact time: 60 min ± 10 s (additional contact times optional)
- Interfering substances (soiling): low level (3.0 g/l bovine albumin) and high level (10 g/l yeast extract + 10 g/l bovine albumin)
- Minimum performance requirement
- At least a 3 log10 reduction (99.9%) compared with a water control under the specified conditions
- Method principle
- Inoculum with interfering substance is dried on a non‑porous surface, treated with the product, neutralised at the end of contact time (dilution‑neutralisation method), and surviving organisms are quantitatively recovered and counted
- Reporting and validation
- Includes requirements for controls, neutraliser validation, incubation conditions, and test reporting; Annexes provide strain references and example neutralisers
Applications and users
EN 16438:2014 is applicable for:
- Manufacturers of veterinary disinfectants and antiseptics validating label claims for fungicidal/yeasticidal activity
- Independent testing laboratories performing standardized efficacy testing (Phase 2 / Step 2 surface tests)
- Regulatory bodies and certification agencies assessing product performance for veterinary use (breeding, husbandry, transport, disposal of animals, excluding carcass processing in the food chain)
- Quality assurance teams in veterinary facilities and animal production enterprises specifying effective surface disinfectants
Related standards
- EN 14885 - Application of European Standards for chemical disinfectants and antiseptics (relationship between tests and use recommendations)
- EN 12353 - Preservation of test organisms used in disinfectant efficacy testing
- ISO 4793 - Laboratory sintered (fritted) filters - porosity grading
Keywords: EN 16438:2014, chemical disinfectants, antiseptics, fungicidal, yeasticidal, veterinary surface test, non‑porous surfaces, Phase 2 Step 2, contact time, interfering substances.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur Bestimmung der fungiziden oder levuroziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich auf nicht-porösen Oberflächen ohne mechanische Wirkung - Prüfverfahren und Anforderungen (Phase 2, Stufe 2)Antiseptiques et désinfectants chimiques - Essai quantitatif de surface pour l'évaluation de l'activité fongicide ou levuricide des antiseptiques et des désinfectants chimiques utilisés dans le domaine vétérinaire sur des surfaces non poreuses sans action mécanique (phase 2, étape 2)Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step2)71.100.35Kemikalije za dezinfekcijo v industriji in domaChemicals for industrial and domestic disinfection purposes11.220VeterinarstvoVeterinary medicineICS:Ta slovenski standard je istoveten z:EN 16438:2014SIST EN 16438:2014en,fr,de01-julij-2014SIST EN 16438:2014SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 16438
February 2014 ICS 71.100.35 English Version
Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)
Antiseptiques et désinfectants chimiques - Essai quantitatif de surface pour l'évaluation de l'activité fongicide ou levuricide des antiseptiques et des désinfectants chimiques utilisés dans le domaine vétérinaire sur des surfaces non poreuses sans action mécanique - Méthode d'essai et prescriptions (phase 2, étape 2)
Chemische Desinfektionsmittel und Antiseptika - Quantitativer Oberflächenversuch zur Bestimmung der fungiziden oder levuroziden Wirkung chemischer Desinfektionsmittel und Antiseptika für den Veterinärbereich auf nicht-porösen Oberflächen ohne mechanische Wirkung - Prüfverfahren und Anforderungen (Phase 2, Stufe 2) This European Standard was approved by CEN on 30 November 2013.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.
This European Standard exists 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 16438:2014 ESIST EN 16438:2014
................................................................................. 10 5.4 Preparation of test organism suspensions and product test solutions ....................................... 11 5.4.1 Test organism suspension (test and validation suspension) ........................................................ 11 5.4.2 Product test solutions ........................................................................................................................ 15 5.5 Procedure for assessing the fungicidal or yeasticidal activity of the product ............................ 16 5.5.1 General ................................................................................................................................................. 16 5.5.2 Test procedure (Dilution-neutralisation method) ............................................................................ 17 5.5.3 Observation of the test surface agar ................................................................................................ 20 5.6 Experimental data and calculation.................................................................................................... 20 5.6.1 Explanation of terms and abbreviations .......................................................................................... 20 5.6.2 Calculation ........................................................................................................................................... 21 5.7 Verification of methodology .............................................................................................................. 24 5.7.1 General ................................................................................................................................................. 24 5.7.2 Control of weighted mean counts ..................................................................................................... 24 5.7.3 Basic limits .......................................................................................................................................... 24 5.7.4 Microscopic observation ................................................................................................................... 24 5.8 Expression of results and precision ................................................................................................. 24 5.8.1 Reduction ............................................................................................................................................ 24 5.8.2 Control of active and non-active product test solution (5.4.2) ...................................................... 25 5.8.3 Fungicidal or yeasticidal concentration ........................................................................................... 25 5.8.4 Precision, repetitions ......................................................................................................................... 25 5.9 Interpretation of results - conclusion ............................................................................................... 25 5.9.1 General ................................................................................................................................................. 25 5.9.2 Fungicidal or yeasticidal activity for general purposes ................................................................. 26 5.9.3 Qualification for certain fields of application .................................................................................. 26 5.10 Test report ........................................................................................................................................... 26 Annex A (informative)
Referenced strains of national collections . 28 Annex B (informative)
Examples of neutralisers of the residual antimicrobial activity of chemical disinfectants and antiseptics . 29 Annex C (informative)
Graphical representations of dilution-neutralisation method . 31 Annex D (informative)
Example of a typical test report . 35 Bibliography . 39 SIST EN 16438:2014
Foreword This document (EN 16438:2014) has been prepared by Technical Committee CEN/TC 216 “Chemical disinfectants and antiseptics”, the secretariat of which is held by AFNOR. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by August 2014 and conflicting national standards shall be withdrawn at the latest by August 2014. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. SIST EN 16438:2014
Fungicidal or yeasticidal activity on non-porous surfaces without mechanical action in the veterinary area Test organism Fungicidal activity a) obligatory Aspergillus brasiliensis (conidiospores) and Candida albicans (vegetative cells) Test organism Yeasticidal activity a) obligatory Candida albicans (vegetative cells) b) additional any relevant test organism Test temperature a) obligatory 10 °C ± 1 °C b) additional 4 °C ± 1 °C; 20 °C ± 1 °C; 40 °C ± 1 °C Contact time a) obligatory 60 min ± 10 s b) additional* 5 min ± 10 s; 30 min ± 10 s; 120 min ± 10 s Interfering substance a) obligatory low level soiling high level soiling 3,0 g/l bovine albumin 10 g/l yeast extract plus 10 g/l bovine albumin b) additional any relevant substance The obligatory contact times for surface disinfectants stated in Table 1 were chosen to enable comparison of standard conditions. *The recommended contact time for the use of the product is within the responsibility of the manufacturer. NOTE For the additional conditions, the concentration defined as a result can be lower than the one obtained under the obligatory test conditions. Any additional specific fungicidal activity shall be determined in accordance with 5.2.1 and 5.5.1.1 in order to take into account intended specific use conditions. 5 Test method 5.1 Principle A test suspension of fungal conidiospores or yeast and interfering substance is inoculated onto the test surface and dried. After a drying time, an aliquot of the product under test is transferred to the surface, in a manner which covers the dried film. The surface is maintained at a specified temperature for a defined period of time specified in Clause 4 and 5.5.1.1. At the end of that contact time the surface is transferred to a neutraliser so that the action of the disinfectant is immediately neutralised. The numbers of surviving organisms which can be recovered from the surface is determined quantitatively. The number of fungi or yeast on a surface treated with water in place of the disinfectant is also determined and the reduction is calculated. The test is performed using the conidiospores of Aspergillus brasiliensis (formerly niger) and the vegetative cells of Candida albicans (fungicidal activity) or only the vegetative cells of Candida albicans (yeasticidal SIST EN 16438:2014
1) The ATCC numbers are the collection numbers of strains supplied by the American Type Culture Collection (ATCC). This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of the product named. SIST EN 16438:2014
2) This information is given for the convenience of users of this European Standard and does not constitute an endorsement by CEN of the product named. Equivalent products may be used if they can be shown to lead to the same results. SIST EN 16438:2014
3) Decon concentrate is obtained from Decon Laboratories Ltd, Conway Street, Hove, East Sussex, BN3 3LY, UK Tel. 01273 756598. Studies have shown that this method of cleaning is satisfactory. A suitable ‘Generic’ will be specified at a later stage. 4) Disposable sterile equipment is an acceptable alternative to reusable glassware. SIST EN 16438:2014
5) Vortex ® is an example of a suitable product available commercially. This information is given for the convenience of users of this standard and does not constitute an endorsement by CEN of this product. SIST EN 16438:2014
Figure 1 — A. brasiliensis ATCC 16404 after 7 days of incubation at 30°C (correct appearance)
Figure 2 — A. brasiliensis ATCC 16404 after 7 days of incubation at 30°C (incorrect appearance) SIST EN 16438:2014
6) cfu/ml = colony forming unit(s) per millilitre SIST EN 16438:2014
Figure 3 — Observation of conidiospores under light microscope: presence of smooth (a) and spiny (b) spores (insufficient spiny spores)
Figure 4 — Observation of conidiospores under light microscope: High concentration of characteristic mature spores with spiny aspect (sufficient spiny spores) c) Adjust the number of conidiospores in the suspension to 1,5 × 108 cfu/ml to 5,0 × 108 cfu/ml using the diluent (5.2.2.4), estimating the number of cfu by any suitable means. Use the suspension within 48 h. It can be stored up to 2 days in the refrigerator and shall then be checked just before the test for absence of germinated conidiospores [see b)]. In any case, adjust the temperature according to 5.5.1.4 only immediately before the start of the test (5.5.2). SIST EN 16438:2014
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Frequently Asked Questions
EN 16438:2014 is a standard published by the European Committee for Standardization (CEN). Its full title is "Chemical disinfectants and antiseptics - Quantitative surface test for the evaluation of fungicidal or yeasticidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2)". This standard covers: This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation in hard water or in the case of ready-to-use products with water. This European Standard applies to products for use in the veterinary area i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry. EN 14885 specifies in detail the relationship of the various tests to one another and to use recommendations. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. NOTE 2 This method corresponds to a Phase 2 Step 2 test.
This European Standard specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous physically stable preparation in hard water or in the case of ready-to-use products with water. This European Standard applies to products for use in the veterinary area i.e. in the breeding, husbandry, production, transport and disposal of all animals except when in the food chain following death and entry to the processing industry. EN 14885 specifies in detail the relationship of the various tests to one another and to use recommendations. NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used. NOTE 2 This method corresponds to a Phase 2 Step 2 test.
EN 16438:2014 is classified under the following ICS (International Classification for Standards) categories: 71.100.35 - Chemicals for industrial and domestic disinfection purposes. The ICS classification helps identify the subject area and facilitates finding related standards.
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표준 EN 16438:2014는 비틀거리지 않는 표면에서 사용되는 화학적 소독제와 안티세프틱의 공업용 및 완성제품의 곰팡이 살균 또는 효모 살균 활동을 평가하기 위한 정량적인 표면 시험 방법과 최소 요구 사항을 명시하고 있다. 이러한 유럽 표준은 동물 사육, 양식, 생산, 운송 및 처분과 같은 수의사 분야에서 사용되는 제품을 대상으로 한다. EN 14885는 다양한 시험 간의 관계와 사용 권장에 대한 구체적인 내용을 제시하고 있는데, 상업적 제품 또는 활성 물질의 실제 사용 조건에서의 효능을 판단하기 위한 방법을 설명하고 있다. 이 방법은 제2 단계 2단계 테스트에 해당하며, 제품의 효능을 실제 조건에서 평가하기 위한 것이다.
本記事は、EN 16438:2014について述べています。このヨーロッパ標準は、硬水または使用済みの製品の場合は水を含む均一な物理的に安定した調製品における、獣医領域で使用される化学的な殺菌剤および抗菌剤の殺真菌または殺酵母活性の評価のための試験方法と最小要件を規定しています。この標準は、食品連鎖における死後および処理工場への入り口を除く、動物の飼育、飼育、生産、輸送、廃棄物処理に使用される製品に適用されます。EN 14885では、さまざまなテスト間の関係と使用推奨事項について詳細に規定されています。説明されている方法は、実際の使用条件下で商業的な製剤または有効成分の効果を判断するための第2段階のテストに対応しています。
The article discusses EN 16438:2014, a European standard that establishes a test method and minimum requirements for evaluating the fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products used in the veterinary field. The standard applies to products used in the breeding, husbandry, production, transport, and disposal of animals, excluding those in the food chain. This method is intended to determine the activity of commercial formulations or active substances as they are used. It corresponds to a Phase 2 Step 2 test according to EN 14885.
記事のタイトル：EN 16438:2014- 動物医療分野における非多孔質表面上における機械的作用なしで使用される化学薬品消毒剤および抗菌剤の真菌または酵母消毒作用の定量的表面試験方法および要件（フェーズ2、ステップ2） 記事内容：このヨーロッパ標準は、硬水または使用準備ができた製品の場合、化学薬品消毒剤および抗菌剤の真菌または酵母消毒効果の試験方法と最低要件を規定しています。 このヨーロッパ標準は、動物の繁殖、飼育、生産、輸送、廃棄物処理など、動物医療分野で使用される製品に適用されますが、食品チェーンにおける死後の処理工程では適用されません。 EN 14885では、各テスト間および使用推奨事項との関係が詳細に規定されています。 注1 ：この方法は、商業製剤または活性物質の使用条件下での活性を決定するためのものです。 注2：この方法は、フェーズ2ステップ2の試験に対応しています。
The article discusses EN 16438:2014, a European Standard that establishes a test method and minimum requirements for the fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products used in the veterinary industry. The standard applies to products used in the breeding, husbandry, production, transport, and disposal of animals, excluding those in the food chain. EN 14885 provides details on the relationship between different tests and their recommended use. The described method corresponds to a Phase 2 Step 2 test, and it aims to determine the effectiveness of commercial formulations or active substances under real-world conditions.
제목: EN 16438:2014 - 화학 소독제와 항균제 - 비구조적 표면에서 기계 조작 없이 수의학 분야에서 사용되는 화학 소독제와 항균제의 곰팡이 살균 또는 효모 살균 작용을 평가하기 위한 정량적 표면 시험 방법과 요구 사항 (단계 2, 단계 2) 기사 내용: 이 유럽 표준은 공기 혼합 한정되어 있는 경수 또는 사용 준비 상태의 제품인 경우 경수에서의 곰팡이 살균 또는 효모 살균 작용에 대한 시험 방법과 최소 요구 사항을 명시합니다. 이 유럽 표준은 동물의 번식, 사육, 생산, 운반 및 처분을 포함한 수의학 분야에서 사용되는 제품에 적용됩니다. 단, 동물이 사망하고 가공 산업에 입장한 경우에는 적용되지 않습니다. EN 14885는 각각의 시험과 사용 권장 사항 사이의 관계를 상세하게 규정합니다. 참고 1: 설명된 방법은 상용 제형 또는 활성 물질이 사용되는 조건에서의 활동을 결정하기 위한 것입니다. 참고 2: 이 방법은 단계 2, 단계 2 시험에 해당합니다.
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