EN 12690:1999
(Main)Biotechnology - Performance criteria for shaft seals
Biotechnology - Performance criteria for shaft seals
This European Standard specifies performance criteria for shaft seals in equipment used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment.
Biotechnik - Leistungskriterien für Wellendichtungen
Die vorliegende Europäische Norm legt die Leistungskriterien für Wellendichtungen, die bei biotechnischen Verfahren angewendet werden, im Hinblick auf die potentiellen Risiken durch die verwendeten Mikroorganismen für die Beschäftigten oder die Umwelt fest.
Biotechnologie - Critères de performance pour les dispositifs d'étanchéité dynamique d'arbre
La présente norme européenne spécifie les critères de performance applicables aux dispositifs d'étanchéité dynamique d'arbre présents dans des équipements utilisés dans des procédés biotechnologiques compte tenu des risques potentiels, pour les opérateurs et l'environnement, liés aux microorganismes utilisés.
Biotehnologija – Merila za delovanje tesnil za gredi
General Information
- Status
- Published
- Publication Date
- 16-Feb-1999
- Withdrawal Date
- 30-Aug-1999
- Technical Committee
- CEN/TC 233 - Biotechnology
- Drafting Committee
- CEN/TC 233/WG 4 - Equipment
- Current Stage
- 9093 - Decision to confirm - Review Enquiry
- Start Date
- 01-Oct-2025
- Completion Date
- 08-Oct-2025
Overview
EN 12690:1999 - published by CEN - defines performance criteria for shaft seals used in equipment for biotechnological processes. The standard focuses on the potential risks posed by microorganisms in process fluids and specifies how shaft sealing systems should perform to protect workers and the environment from microbial release during operation.
Key topics and requirements
While the full text provides the definitive requirements, EN 12690:1999 centers on practical performance attributes rather than prescribing particular designs. Core technical topics typically addressed include:
- Containment performance: criteria for preventing release of microorganisms along rotating shafts and gland areas.
- Material compatibility: suitability of sealing materials for contact with biological agents, process media, and cleaning/sterilization agents.
- Operational reliability: durability and performance under expected process conditions (temperature, pressure, speed, chemical exposure).
- Leakage and monitoring: requirements for minimizing leakage and for methods to detect or manage seal failure to limit biological risk.
- Maintenance and serviceability: guidance on inspection intervals, replacement procedures and safe handling to reduce occupational exposure.
- Design considerations: features that reduce aerosolization, cross-contamination and environmental discharge during normal and fault conditions.
(EN 12690:1999 is concerned with performance outcomes and risk control; it does not mandate a single type of seal or proprietary solution.)
Applications
EN 12690:1999 is directly applicable to bioprocess and biotechnology equipment where rotating shafts penetrate process enclosures, including:
- Bioreactors and fermenters
- Mixers, agitators and homogenizers used in biological production
- Centrifuges and downstream processing equipment with rotating seals
Typical users of this standard:
- Equipment manufacturers and seal designers seeking to demonstrate compliance with industry expectations
- Process and mechanical engineers specifying seals for bioprocess lines
- Quality, EHS and compliance teams assessing biological containment and worker safety
- Procurement professionals selecting components for pharmaceutical and biotech production lines
Related standards
EN 12690:1999 is part of a broader framework of European and international standards addressing seals, machine components and biosafety in industrial processes. Users often reference this standard alongside other CEN/ISO standards for mechanical sealing, material compatibility and bioprocess safety to develop comprehensive specifications.
Keywords: EN 12690, shaft seals, biotechnology, bioprocess seals, containment, sealing performance, microorganism risk, biotech equipment, sterilizable seals.
Frequently Asked Questions
EN 12690:1999 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Performance criteria for shaft seals". This standard covers: This European Standard specifies performance criteria for shaft seals in equipment used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment.
This European Standard specifies performance criteria for shaft seals in equipment used in biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment.
EN 12690:1999 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 12690:1999 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 – Merila za delovanje tesnil za grediBiotechnik - Leistungskriterien für WellendichtungenBiotechnologie - Criteres de performance pour les dispositifs d'étanchéité dynamique d'arbreBiotechnology - Performance criteria for shaft seals21.140Tesnilke, mašilkeSeals, glands07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta sloven
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記事のタイトル：EN 12690:1999 - バイオテクノロジー - シャフトシールの性能基準 記事の内容：この欧州標準は、生物工学プロセスで使用される機器のシャフトシールに関する性能基準を定めています。この基準は、作業者や環境に対する潜在的な微生物のリスクに関連しています。
The article discusses European Standard EN 12690:1999, which outlines performance criteria for shaft seals in biotechnological equipment. The standard aims to address any potential risks of microorganisms present in the equipment that could pose a threat to workers or the environment.
기사 제목: EN 12690:1999 - 생물공학 - 샤프트 실의 성능 기준 기사 내용: 이 유럽 표준은 생물공학 과정에서 사용되는 장비의 샤프트 실에 대한 성능 기준을 명시한다. 이 기준은 작업자나 환경에 대한 잠재적인 미생물의 위험성과 관련하여 작동한다.
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