SIST EN 13312-6:2002

Biotechnology - Performance criteria for piping and instrumentation - Part 6: Equipment probes

This European Standard specifies performance criteria for equipment probes used in biotechnological processes with respect to the potential risks to the worker and the environment from microorganisms in use.  This European Standard applies where the intended use of the equipment probes includes hazardous or potentially hazardous microorganisms used in biotechnological processes or where exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.

Biotechnik - Leistungskriterien für Leitungssysteme und Instrumentierung - Teil 6: Gerätesonden

Diese Europäische Norm legt Leistungskriterien für bei biotechnischen Verfahren verwendete Gerätesonden im Hinblick auf potentielle Risiken für die Beschäftigten und die Umwelt fest, die von den im Verfahren verwendeten Mikroorganismen ausgehen. Diese Europäische Norm gilt, sobald die vorgesehene Anwendung der Gerätesonden den Gebrauch gefährlicher oder potentiell gefährlicher Mikroorganismen in biotechnischen Verfahren einschließt, oder wenn die Exposition der Beschäftigten oder der Umwelt gegenüber solchen Mikroorganismen aus Sicherheitsgründen eingeschränkt wird.

Biotechnologie - Criteres de performance pour tuyauteries et instrumentation - Partie 6: Sondes d'instrumentation

La présente norme européenne spécifie les critères de performance des sondes d'instrumentation utilisées dans les procédés biotechnologiques vis-à-vis des risques potentiels que les microorganismes utilisés représentent pour l'opérateur et pour l'environnement.  La présente norme européenne s'applique lorsqu'il est prévu que les sondes d'instrumentation impliquent l'utilisation de microorganismes dangereux ou potentiellement dangereux dans des procédés biotechnologiques 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 cevne napeljave in pripomočke - 6. del: Sonde

General Information

• Status: Published
• Publication Date: 31-Dec-2001
• ICS: 07.080 - Biology. Botany. Zoology
• ICS: 23.040.01 - Pipeline components and pipelines in general
• Technical Committee: BTH - Biotechnology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Jan-2002
• Due Date: 01-Jan-2002
• Completion Date: 01-Jan-2002
• Directive: 90/219/EEC - Contained use of genetically modified micro-organisms
• Directive: 90/220/EEC - Deliberate release into the environment of genetically modified organisms
• Directive: 90/679/EEC - Protection of workers from risks related to exposure to biological agents at work
• Mandate: M/BC/CEN/91/19 - Mandate for CEN on biotechnology
• Ref Project: EN 13312-6:2001 - Biotechnology - Performance criteria for piping and instrumentation - Part 6: Equipment probes

Overview

SIST EN 13312-6:2002 is a European Standard developed by CEN that defines performance criteria for equipment probes used in biotechnological processes. This standard addresses the risks posed to workers and the environment by microorganisms handled during these processes. It is specifically applicable where the equipment probes are exposed to hazardous or potentially hazardous microorganisms, or where strict safety requirements limit exposure to such microorganisms. By establishing clear safety and performance benchmarks for equipment probes, SIST EN 13312-6:2002 plays a critical role in ensuring safe biotechnological operations.

Key Topics

• Performance Criteria for Equipment Probes
  The standard specifies detailed requirements to ensure that equipment probes used in biotechnology applications operate reliably while minimizing the risk of microorganism release.

• Safety Measures for Hazardous Microorganisms
  SIST EN 13312-6:2002 emphasizes designing probes to prevent exposure to hazardous or potentially hazardous microorganisms, protecting workers and the environment from contamination.

• Risk Management and Containment
  The criteria ensure probes maintain containment integrity within piping and instrumentation systems to avoid accidental leaks or exposure.

• Suitability for Biotechnological Processes
  Equipment probes must meet functional and safety standards tailored for biotechnological applications where microorganism control is essential.

• Compliance and Testing
  The standard provides guidelines for assessing and verifying equipment probes’ compliance with performance and safety requirements.

Applications

• Biopharmaceutical Manufacturing
  Equipment probes complying with SIST EN 13312-6:2002 are crucial in pharmaceutical production environments, where controlling pathogenic or genetically modified microorganisms is mandatory.

• Industrial Biotechnology
  Used in fermentation, enzyme production, and other biotech processes involving microorganisms, ensuring that probes prevent contamination or exposure risks.

• Research Laboratories
  Implementation of the standard supports safe instrumentation in lab settings working with hazardous microorganisms, enhancing biosafety.

• Environmental Biotechnology
  Used where microbial treatments or bioremediation involve potentially harmful organisms, minimizing environmental release through secure probes.

• Waste Treatment Facilities
  Facilities processing biohazardous waste employing probes to monitor conditions under strict containment requirements.

Related Standards

• EN 13312 Series
  The broader series focuses on performance criteria for piping and instrumentation in biotechnology, with various parts addressing different equipment types.

• ISO Standards on Biosafety and Biotechnology Instrumentation
  Complementary international standards that cover biosafety measures, equipment design, and microbial containment.

• CEN Safety Standards
  European standards addressing workplace safety specific to biotechnology and microbiological risks, reinforcing the protection goals of SIST EN 13312-6:2002.

• Good Manufacturing Practice (GMP) Guidelines
  Standards that integrate equipment safety and microbial control in pharmaceutical and biotech production environments.

---

Keywords: SIST EN 13312-6:2002, biotechnology standards, equipment probes, performance criteria, microbial safety, hazardous microorganisms, biotechnological processes, containment, worker safety, environmental protection, CEN standards, piping and instrumentation, biosafety.

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Biotechnik - Leistungskriterien für Leitungssysteme und Instrumentierung - Teil 6: GerätesondenBiotechnologie - Criteres de performance pour tuyauteries et instrumentation - Partie 6: Sondes d'instrumentationBiotechnology - Performance criteria for piping and instrumentation - Part 6: Equipment probes23.040.01Deli cevovodov in cevovodi na splo
...