EN 12297:1998
(Main)Biotechnology - Equipment - Guidance on testing procedures for sterilizability
Biotechnology - Equipment - Guidance on testing procedures for sterilizability
This European Standard gives guidance on general testing procedures to assess the sterilizability for microorganisms of equipment (components and units of equipment) used in biotechnological processes. This European Standard gives guidance on the assessment of the sterilizability of biotechnological equipment with respect to a release of process microorganisms that can affect the safety of the worker (occupational health) and/or that can have adverse effects to the environment.
Biotechnik - Geräte und Ausrüstungen - Leitfaden für Verfahren zur Prüfung der Sterilisierbarkeit
Diese Europäische Norm gibt eine Anleitung für allgemeine Prüfverfahren zum Nachweis der Sterilisierbarkeit von in biotechnischen Verfahren verwendeten Geräten und Ausrüstungen (Bauteile und Apparateeinheiten) gegenüber Mikroorganismen. Diese Europäische Norm gibt eine Anleitung zur Bewertung der Sterilisierbarkeit biotechnischer Geräte und Ausrüstungen im Hinblick auf ein Entweichen von im Verfahren eingesetzten Mikroorganismen, die die Sicherheit der Beschäftigten gefährden können (arbeitsmedizinischer Aspekt) und/oder die nachteilige Wirkungen auf die Umwelt ausüben können.
Biotechnologie - Equipement - Guide des procédures d'essai pour le contrôle de la capacité à la stérilisation
La présente norme européenne donne des indications sur les procédures d'essai permettant d'évaluer la capacité à la stérilisation de microorganismes dans des équipements (composants individuels et unités d'équipement) mis en oeuvre dans les procédés biotechnologiques. La présente norme européenne donne des indications pour l'évaluation de la capacité à la stérilisation des équipements biotechnologiques vis-à-vis du rejet de microorganismes d'intérêt industriel susceptibles de porter atteinte à la sécurité des travailleurs (santé au travail) et/ou d'avoir des effets néfastes sur l'environnement.
Biotehnologija – Oprema - Navodilo o preskusnih postopkih za ugotavljanje sterilnosti
General Information
- Status
- Published
- Publication Date
- 17-Mar-1998
- Technical Committee
- CEN/TC 233 - Biotechnology
- Drafting Committee
- CEN/TC 233/WG 4 - Equipment
- Current Stage
- 9093 - Decision to confirm - Review Enquiry
- Start Date
- 11-Apr-2022
- Completion Date
- 14-Apr-2025
Overview
EN 12297:1998 - published by CEN - is a European Standard titled Biotechnology - Equipment - Guidance on testing procedures for sterilizability. It provides guidance on general testing procedures to assess the sterilizability of equipment, components and units used in biotechnological processes. The standard focuses on evaluating the potential release of process microorganisms that could affect occupational health or cause adverse environmental impacts.
Key topics and requirements
- Scope of assessment: Guidance applies to equipment and components used in biotech processes where microorganism release is a concern.
- General testing procedures: Describes principles for planning and conducting sterilizability tests (sampling strategy, test execution and interpretation) rather than prescribing a single prescriptive method.
- Microorganism release assessment: Focus on detecting and limiting release of process microorganisms that may endanger workers or the environment.
- Validation and documentation: Emphasises establishing reproducible test procedures and documenting results as part of equipment qualification and safety assessments.
- Risk-based approach: Encourages assessment of equipment design, points of potential release, and operational conditions that influence sterilizability.
Note: EN 12297:1998 provides guidance rather than specific numeric parameters or single test protocols; users adapt its principles to their process risks and regulatory context.
Applications
- Design verification: Evaluate whether new or modified equipment can be effectively sterilized to minimise microorganism release.
- Commissioning & qualification: Support sterilizability testing during equipment commissioning and routine requalification.
- Process safety & environmental protection: Assess and control risks of process microorganism escape that could affect worker safety or local ecosystems.
- Supplier assessment & procurement: Inform technical specifications and supplier testing requirements for bioprocess equipment.
- Troubleshooting: Help identify design or operational weaknesses leading to sterilization failures or contamination risk.
Who uses this standard
- Equipment manufacturers and designers in the biotechnology and bioprocessing sectors
- Validation and QA / QC engineers performing sterilizability testing and documentation
- Bioprocess facility managers, occupational health & safety officers, and environmental compliance teams
- Regulatory and conformity assessment bodies assessing safety controls related to microorganism release
Related standards
- Complementary CEN/ISO guidance on sterilization, validation, cleanroom practice and risk assessment should be consulted alongside EN 12297:1998 to form a complete sterilization and biosafety strategy.
Keywords: EN 12297:1998, sterilizability testing, biotechnology equipment, CEN standard, sterilization validation, occupational health, environmental safety.
Frequently Asked Questions
EN 12297:1998 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Equipment - Guidance on testing procedures for sterilizability". This standard covers: This European Standard gives guidance on general testing procedures to assess the sterilizability for microorganisms of equipment (components and units of equipment) used in biotechnological processes. This European Standard gives guidance on the assessment of the sterilizability of biotechnological equipment with respect to a release of process microorganisms that can affect the safety of the worker (occupational health) and/or that can have adverse effects to the environment.
This European Standard gives guidance on general testing procedures to assess the sterilizability for microorganisms of equipment (components and units of equipment) used in biotechnological processes. This European Standard gives guidance on the assessment of the sterilizability of biotechnological equipment with respect to a release of process microorganisms that can affect the safety of the worker (occupational health) and/or that can have adverse effects to the environment.
EN 12297:1998 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology; 07.100.01 - Microbiology in general. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12297:1998 is associated with the following European legislation: EU Directives/Regulations: 90/219/EEC, 90/220/EEC, 90/679/EEC; Standardization Mandates: M/BC/CEN/91/19. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotehnologija – Oprema - Navodilo o preskusnih postopkih za ugotavljanje sterilnostiBiotechnik - Geräte und Ausrüstungen - Leitfaden für Verfahren zur Prüfung der SterilisierbarkeitBiotechnologie - Equipement - Guide des procédures d'essai pour le contrôle de la capacité a la stérilisationBiotechnology - Equipment - Guidance on testing procedures for sterilizability07.080Biologija. Botanika. ZoologijaBiolo
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기사 제목: EN 12297:1998 - 생명공학 - 장비 - 살균 테스트 절차에 대한 지침 기사 내용: 이 유럽 표준은 생명공학 공정에서 사용되는 장비(구성 요소 및 장비 단위)의 미생물의 살균 가능성을 평가하기 위한 일반적인 테스트 절차에 대한 지침을 제공합니다. 이 유럽 표준은 작업자의 안전(직업 건강)에 영향을 줄 수 있는 생산 미생물의 방출 및 환경에 부정적인 영향을 줄 수 있는 생명공학 장비의 살균 가능성에 대한 평가에 대한 지침을 제공합니다.
記事タイトル：EN 12297:1998 - バイオテクノロジー - 機器 - ウィルス性能のテスト手順に関するガイダンス 記事内容：このヨーロッパ規格では、バイオテクノロジー過程で使用される機器（構成要素および機器のユニット）のウィルス性能を評価するための一般的なテスト手順に関するガイダンスを提供しています。このヨーロッパ規格では、作業者の安全性（職業衛生）に影響を与える可能性のあるプロセスウイルスの放出や、環境への負の影響を持つ可能性のあるバイオテクノロジー機器のウィルス性能評価に関するガイダンスを提供しています。
EN 12297:1998 is a European Standard that provides guidance on testing procedures for sterilizability of equipment used in biotechnological processes. It outlines the assessment of equipment's ability to eliminate microorganisms that could pose a risk to worker safety or have negative effects on the environment.
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