SIST 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 - Criteres 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
- 30-Nov-1999
- Technical Committee
- BTH - Biotechnology
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 01-Dec-1999
- Due Date
- 01-Dec-1999
- Completion Date
- 01-Dec-1999
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
SIST EN 12885:1999 is a standard published by the Slovenian Institute for Standardization (SIST). 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.
SIST 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.
SIST 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.
SIST EN 12885:1999 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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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