General Information

Abstract

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.

Status
Published
Publication Date
31-Dec-2001
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

Buy Documents

Standard

SIST EN 13312-6:2002

English language (8 pages)
Preview
Preview
e-Library read for
×1 day

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.

Relations

Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026
Effective Date
28-Jan-2026

Buy Documents

Standard

SIST EN 13312-6:2002

English language (8 pages)
Preview
Preview
e-Library read for
×1 day

Get Certified

Connect with accredited certification bodies for this standard

Institut za varilstvo d.o.o. (Welding Institute)

Slovenia's leading welding institute since 1952. ISO 3834, EN 1090, pressure equipment certification, NDT personnel, welder qualification. Only IIW Au

SA Slovenia Verified

Sponsored listings

Frequently Asked Questions

SIST EN 13312-6:2002 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Biotechnology - Performance criteria for piping and instrumentation - Part 6: Equipment probes". This standard covers: 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.

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.

SIST EN 13312-6:2002 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology; 23.040.01 - Pipeline components and pipelines in general. The ICS classification helps identify the subject area and facilitates finding related standards.

SIST EN 13312-6:2002 has the following relationships with other standards: It is inter standard links to SIST EN 13312-1:2002, SIST EN 16682:2017, SIST EN 1430:2009, SIST EN 12850:2009, SIST EN 12594:2007, SIST EN ISO 8041:2005, SIST EN ISO 14815:2005, SIST EN 1429:2009, SIST EN 1428:2012, SIST EN 12592:2014, SIST EN 12592:2007. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

SIST EN 13312-6:2002 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 13312-6:2002 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 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
...