EN 12462:1998
(Main)Biotechnology - Performance criteria for pumps
Biotechnology - Performance criteria for pumps
This European Standard specifies performance criteria for pumps used in biotechnological processes, in which the release of microorganisms should be limited or prevented for reasons of safety. This standard applies if the intended use of the pump includes hazardous or potentially hazardous microorganisms. This standard applies to pumps with no auxiliary equipment, bordered by the connections on the unit of equipment. It also applies to pump systems equipped with all necessary auxiliary equipment necessary for operation of pumps and to accomplish cleaning and sterilization.
Biotechnik - Leistungskriterien für Pumpen
Die vorliegende Europäische Norm legt Leistungskriterien für Pumpen fest, die bei biotechnischen Verfahren angewendet werden, bei denen der Austritt von Mikroorganismen aus Sicherheitsgründen zu begrenzen oder zu verhindern ist. Diese Norm gilt, sobald die vorgesehene Anwendung der Pumpe den Gebrauch gefährlicher oder potentiell gefährlicher Mikroorganismen einschließt. Diese Norm gilt für Pumpen ohne Hilfseinrichtungen, wobei die Anschlüsse die Grenze der Apparateeinheit darstellen.
Biotechnologie - Critères de performance pour les pompes
La présente norme européenne spécifie les critères de performance applicables aux pompes utilisées dans des procédés biotechnologiques et pour lesquelles il convient pour des raisons de sécurité, de limiter ou d'empêcher la dissémination de microorganismes. La présente norme s'applique lorsque la pompe est conçue pour un usage faisant intervenir des microorganismes dangereux ou potentiellement dangereux. La présente norme s'applique aux pompes ne comprenant aucun équipement auxiliaire, limitées par les raccordements à l'unité d'équipement.
Biotehnologija - Merila za delovanje za črpalke
General Information
- Status
- Published
- Publication Date
- 21-Jul-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
- 01-Oct-2025
- Completion Date
- 08-Oct-2025
Overview
EN 12462:1998 - Biotechnology: Performance criteria for pumps is a European Standard published by CEN that specifies performance and safety criteria for pumps used in biotechnological processes where the release of microorganisms must be limited or prevented. The standard covers pumps intended for use with hazardous or potentially hazardous microorganisms and applies both to standalone pump units (bounded by their connections) and to pump systems equipped with the auxiliary equipment needed for operation, cleaning and sterilization. EN 12462 has been adopted by national bodies (e.g., SIST EN 12462:1999).
Key Topics
The standard focuses on practical performance and containment considerations relevant to biotechnology pumps and typically addresses the following technical topics and requirements:
- Containment and leakage control - requirements to limit or prevent release of microorganisms during normal operation.
- Cleanability and sterilizability - design features that enable effective cleaning-in-place (CIP) and sterilization-in-place (SIP).
- Materials and surface finish - selection of materials compatible with bioprocess media and sterilization methods.
- Seals and connections - design of seals, flanges and process connections to minimize contamination risk.
- Operational performance - criteria for reliable flow, pressure handling and durability in biotechnology environments.
- Validation and testing - requirements for demonstrating that pumps meet containment and sterilization performance objectives (functional testing, inspection, documentation).
(Note: EN 12462 sets performance criteria and scope rather than prescribing specific test values; manufacturers and users must validate compliance per the standard’s principles.)
Applications
EN 12462 is applicable wherever pumps handle hazardous or potentially hazardous microorganisms and containment is required:
- Sterile transfer and circulation in bioprocessing and fermentation
- Aseptic sampling, media handling and downstream processing
- Pilot plants and production-scale bioreactors
- Pharmaceutical and biotech manufacturing facilities requiring validated sterilization and containment
Who Uses This Standard
- Pump manufacturers and equipment designers developing bioprocess pumps
- Process engineers specifying pumps for sterile and containment-critical systems
- Quality assurance, validation and safety teams ensuring compliance and risk control
- System integrators and OEMs of bioprocess equipment
- Regulatory and conformity assessment bodies assessing equipment suitability
Related Standards
EN 12462 complements standards and guidance on hygienic design, aseptic processing, equipment validation, sterilization protocols and pressure/construction codes. Users should apply EN 12462 alongside relevant hygienic and regulatory standards for a complete compliance and validation strategy.
Keywords: EN 12462, biotechnology pumps, pump performance criteria, bioprocessing pumps, containment, sterilization, hygienic design, microorganism release prevention.
Frequently Asked Questions
EN 12462:1998 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Performance criteria for pumps". This standard covers: This European Standard specifies performance criteria for pumps used in biotechnological processes, in which the release of microorganisms should be limited or prevented for reasons of safety. This standard applies if the intended use of the pump includes hazardous or potentially hazardous microorganisms. This standard applies to pumps with no auxiliary equipment, bordered by the connections on the unit of equipment. It also applies to pump systems equipped with all necessary auxiliary equipment necessary for operation of pumps and to accomplish cleaning and sterilization.
This European Standard specifies performance criteria for pumps used in biotechnological processes, in which the release of microorganisms should be limited or prevented for reasons of safety. This standard applies if the intended use of the pump includes hazardous or potentially hazardous microorganisms. This standard applies to pumps with no auxiliary equipment, bordered by the connections on the unit of equipment. It also applies to pump systems equipped with all necessary auxiliary equipment necessary for operation of pumps and to accomplish cleaning and sterilization.
EN 12462:1998 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology; 23.080 - Pumps. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12462:1998 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.Biotechnik - Leistungskriterien für PumpenBiotechnologie - Criteres de performance pour les pompesBiotechnology - Performance criteria for pumps23.080ýUSDONHPumps07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta slovenski standard je istoveten z:EN 12462:19
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이 기사는 유해 또는 잠재적으로 유해한 미생물이 포함된 공정에서 사용되는 펌프에 대한 성능 기준인 유럽 표준 EN 12462:1998에 대해 다룹니다. 이 표준은 펌프의 사용 목적이 안전상의 이유로 미생물의 높은 방출을 제한하거나 예방하는 경우에 적용됩니다. 이 표준은 부가 장비가 없는 펌프뿐만 아니라, 펌프 작동, 청소 및 살균을 위해 필요한 모든 부속 장비가 설치된 펌프 시스템에도 적용됩니다.
この記事は、バイオテクノロジーのプロセスで使用されるポンプに対する性能基準であるEN 12462:1998の内容について述べています。この基準は、危険または潜在的に危険な微生物が含まれる場合にポンプの使用が意図されている場合に適用されます。安全上の理由から、微生物の放出を制限または防止することを目的としています。この基準は、ユニットの接続によって区切られた補助装置のないポンプに適用されます。また、ポンプの運転および清掃・滅菌を実行するために必要なすべての補助装置が設置されたポンプシステムにも適用されます。
The article discusses the European Standard EN 12462:1998, which outlines the performance criteria for pumps used in biotechnological processes. The standard is applicable if the pump is used with hazardous or potentially hazardous microorganisms and aims to limit or prevent their release for safety purposes. The standard covers pumps without any additional equipment, as well as pump systems with all necessary auxiliary equipment required for pump operation, cleaning, and sterilization.
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