EN 12885:1999
(Main)Biotechnology - Performance criteria for cell disrupters
Biotechnology - Performance criteria for cell disrupters
This European Standard specifies performance criteria for cell disrupters used in the biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment. This European Standard applies where the intended use of the cell disrupter includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
Biotechnik - Leistungskriterien für Zellaufschlußgeräte
Die vorliegende Europäische Norm legt Leistungskriterien für Zellaufschlußgeräte, die bei biotechnischen Verfahren angewendet werden, im Hinblick auf die potentiellen Risiken durch die verwendeten Mikroorganismen fürdie Beschäftigten oder die Umwelt fest. Diese Europäische Norm gilt, sobald die vorgesehene Anwendung der Zellaufschlußgerätes den Gebrauch gefährlicher oder potentiell gefärlicher Mikroorganismen in biotechnischen Prozessen einschließt, und/oder wenn die Exposition des Beschäftigten oder der Umwelt gegenüber solchen Mikroorganismen aus Sicherheitsgründen eingeschränkt wird.
Biotechnologie - Critères de performance pour les broyeurs de cellules
La présente norme européenne spécifie les critères de performance applicables aux broyeurs de cellules utilisés dans des procédés biotechnologiques compte tenu des risques potentiels, pour l'opérateur et l'environnement, liés aux microorganismes utilisés. La présente norme européenne s'applique lorsqu'il est prévu que le broyeur de cellules implique l'utilisation de microorganismes dangereux ou potentiellement dangereux dans des procédés biotechnologiques, et/ou lorsque l'exposition de l'opérateur ou de l'environnement à de tels microorganismes est limitée pour des raisons de sécurité.
Biotehnologija - Merila za delovanje celičnih razbijalcev
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 12885:1999 - published by CEN and adopted by national bodies (e.g., SIST EN 12885:1999) - defines performance criteria for cell disrupters used in biotechnology when the process involves hazardous or potentially hazardous microorganisms. The standard addresses the risks these organisms pose to worker safety and environmental protection, and applies where exposure is controlled or restricted for safety reasons.
Key Topics
The standard focuses on performance and safety aspects relevant to cell disruption equipment. Typical technical topics and requirements you can expect to find or assess under EN 12885:1999 include:
- Containment and design: requirements for sealed housings, leak prevention and interfaces to upstream/downstream systems to minimise release of microorganisms.
- Decontamination and cleaning: performance expectations for cleaning-in-place (CIP), sterilization compatibility and effective decontamination procedures to reduce biological risk.
- Validation and testing: protocols for verifying that a cell disrupter meets containment and decontamination criteria before and after use.
- Operational safety features: interlocks, safe access for maintenance, emergency shutdowns and measures to protect operators during routine and exceptional operations.
- Risk assessment considerations: guidance for assessing potential worker and environmental exposure related to the intended use with hazardous microbes.
- Documentation and labeling: requirements for user instructions, maintenance records and traceability to support safe operation and compliance.
(EN 12885:1999 is a performance-oriented standard - it specifies what must be achieved rather than prescribing one single technical solution.)
Applications
Who uses EN 12885:1999 and where it’s applied:
- Biotechnology companies and laboratories that perform cell disruption on hazardous or potentially hazardous microorganisms.
- Equipment manufacturers and suppliers of mechanical, acoustic or chemical cell disrupters who must demonstrate that their products meet biosafety performance expectations.
- Facilities that operate process-scale disruption for research, bioprocessing, vaccine production or biodefense-related work where operator and environmental protection is mandatory.
- Health & safety officers, validation engineers and regulatory compliance teams preparing risk assessments, commissioning and acceptance testing.
Related Standards
For full compliance and best practice, EN 12885:1999 is typically used together with other European and international standards and local biosafety regulations covering:
- laboratory and process biosafety principles,
- equipment validation and qualification,
- machinery safety and electrical/equipment directives,
- national occupational health and environmental regulations.
Keywords: EN 12885:1999, cell disrupters, cell disruption, biotechnology, biosafety, performance criteria, microorganisms, worker safety, environmental protection, containment, decontamination, validation.
Frequently Asked Questions
EN 12885:1999 is a standard published by the European Committee for Standardization (CEN). Its full title is "Biotechnology - Performance criteria for cell disrupters". This standard covers: This European Standard specifies performance criteria for cell disrupters used in the biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment. This European Standard applies where the intended use of the cell disrupter includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
This European Standard specifies performance criteria for cell disrupters used in the biotechnological processes with respect to the potential risks of microorganisms in use for the worker or the environment. This European Standard applies where the intended use of the cell disrupter includes hazardous or potentially hazardous microorganisms used in biotechnological processes and/or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
EN 12885:1999 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 12885:1999 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.Biotechnik - Leistungskriterien für ZellaufschlußgeräteBiotechnologie - Criteres de performance pour les broyeurs de cellulesBiotechnology - Performance criteria for cell disrupters07.100.01Mikrobiologija na splošnoMicrobiology in general07.080Biologija. Botanika. ZoologijaBiology. Botany. ZoologyICS:Ta slovens
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기사 제목: EN 12885:1999 - 생명공학 - 세포 파괴기의 성능 기준 기사 내용: 이 유럽 표준은 생명공학 프로세스에서 사용되는 세포 파괴기의 성능 기준을 명시한다. 이 유럽 표준은 작업자나 환경에 대한 사용 중인 미생물의 잠재적인 위험과 관련된 사항에 적용된다. 이 유럽 표준은 세포 파괴기의 의도된 사용이 안전상의 이유로 위험하거나 잠재적으로 위험한 미생물을 사용하는 생명공학 프로세스 및 작업자나 환경이 이러한 미생물에 노출되어야 하는 경우에 적용된다.
The article discusses EN 12885:1999, a European Standard that outlines performance criteria for cell disrupters used in biotechnological processes. The purpose of this standard is to address the potential risks associated with using microorganisms in these processes. It applies specifically to cell disrupters that handle hazardous or potentially hazardous microorganisms, and when there is a need to restrict exposure to these microorganisms for safety reasons.
記事のタイトル：EN 12885:1999 - バイオテクノロジー - セル破砕装置の性能基準 記事内容：この欧州規格は、バイオテクノロジーにおけるセル破砕装置の性能基準を定めています。この欧州規格は、作業者または環境への使用している微生物の潜在的なリスクに関連する事項に適用されます。この欧州規格は、セル破砕装置の意図された使用が安全上の理由で危険または潜在的に危険な微生物を使用するバイオテクノロジーのプロセスである場合や、作業者または環境がこれらの微生物に曝露する必要がある場合に適用されます。
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