SIST EN 12347:1999
(Main)Biotechnology - Performance criteria for steam sterilizers and autoclaves
Biotechnology - Performance criteria for steam sterilizers and autoclaves
This European Standard specifies performance criteria for steam sterilizer and autoclave used for the destruction and prevention of release of microorganisms used in biotechnological processes. This European Standard applies if the intended use of steam sterilizers or autoclaves includes hazardous or potentially hazardous microorganisms used in biotechological processes or if exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
Biotechnik - Leistungskriterien für Dampf-Sterilisatoren und Autoklaven
Diese Europäische Norm legt die Leistungskriterien für Dampf-Sterilisatoren und Autoklaven fest, die für die Abtötung und die Verhinderung des Austritts der bei biotechnischen Verfahren verwendeten Mikroorganismen eingesetzt werden. Diese Europäische Norm gilt, sobald die vorgesehene Anwendung von Dampf-Sterilisatoren und Autoklaven den Gebrauch gefährlicher oder potentiell gefährlicher Mikroorganismen in biotechnischen Verfahren einscließt, oder wenn die Exposition der Beschäftigung oder der Umwelt gegenüber solchen Mikroorganismen aus Sicherheitsgründen eingeschränkt wird.
Biotechnologie - Criteres de performance pour les stérilisateurs a la vapeur d'eau et les autoclaves
La présente norme spécifie les critères de performance des stérilisateurs à la vapeur d'eau et des autoclaves utilisés pour la destruction et la prévention de dissémination de microorganismes utilisés dans les procédés biotechnologiques. La présente norme s'applique s'il est prévu que les stérilisateurs à la vapeur d'eau ou les autoclaves l'emploi de microorganismes dangereux ou potentiellement dangereux, ou si l'exposition des opérateurs ou de l'environnement à de tels microorganismes est limité pour des raisons de sécurité.
Biotehnologija – Merila za delovanje parnih sterilizatorjev in avtoklavov
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 12347:1998 - published by CEN - defines performance criteria for steam sterilizers and autoclaves used in biotechnology. The standard applies when sterilizers/autoclaves are intended to destroy or prevent release of hazardous or potentially hazardous microorganisms, or when worker or environmental exposure to such microorganisms must be restricted for safety. EN 12347:1998 focuses on performance, containment and safe operation rather than prescriptive process parameters.
Key topics and requirements
EN 12347:1998 addresses technical and operational topics essential to biosafety and sterilization performance, including:
- Performance criteria for steam sterilizers and autoclaves used with biological materials, ensuring reliable inactivation and containment.
- Containment and release prevention, requirements that limit or eliminate the escape of microorganisms during processing and discharge.
- Validation and routine verification concepts for demonstrating that equipment meets intended performance (functional testing, indicators and records).
- Operational controls and monitoring, covering cycle control, process monitoring and documentation needed to verify sterilization performance.
- Safety and user protection, ensuring systems minimize exposure risk to operators and the environment during loading, operation and unloading.
- Design and construction considerations that affect sterilization efficacy and containment, such as chamber integrity, drainage and condensate management.
Note: The standard specifies performance-oriented requirements; it does not prescribe specific time/temperature cycles or biological indicator details in place of validation.
Applications
EN 12347:1998 is practical for any setting where steam sterilization must prevent environmental or worker exposure to biotechnology-derived microorganisms:
- Decontamination of biohazardous waste from laboratories and production sites
- Sterilization of equipment, containment vessels and process lines used in biotech manufacturing
- Facilities processing genetically modified organisms (GMOs) or infectious agents requiring controlled disposal
- Situations where regulatory compliance requires documented performance and containment of sterilization systems
Who uses this standard
Typical users include:
- Biotechnology and pharmaceutical manufacturers
- Research and diagnostic laboratories handling hazardous microorganisms
- Sterilizer and autoclave manufacturers and suppliers
- Validation engineers, biosafety officers, quality assurance and regulatory compliance teams
- Facility managers responsible for biosecurity and waste treatment
Related standards
EN 12347 complements other European, national and international standards on sterilization, sterilizer validation and biosafety. Organizations typically use it alongside broader sterilization validation guidance and local biosafety regulations to build a compliant sterilization program.
Keywords: EN 12347:1998, steam sterilizer performance, autoclave criteria, biotechnology sterilization, biosafety, sterilization validation, CEN standard.
Frequently Asked Questions
SIST EN 12347:1999 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Biotechnology - Performance criteria for steam sterilizers and autoclaves". This standard covers: This European Standard specifies performance criteria for steam sterilizer and autoclave used for the destruction and prevention of release of microorganisms used in biotechnological processes. This European Standard applies if the intended use of steam sterilizers or autoclaves includes hazardous or potentially hazardous microorganisms used in biotechological processes or if exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
This European Standard specifies performance criteria for steam sterilizer and autoclave used for the destruction and prevention of release of microorganisms used in biotechnological processes. This European Standard applies if the intended use of steam sterilizers or autoclaves includes hazardous or potentially hazardous microorganisms used in biotechological processes or if exposure of the worker or the environment to such microorganisms is restricted for reasons of safety.
SIST EN 12347:1999 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology; 11.080.10 - Sterilizing equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 12347:1999 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 12347:1999 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.Biotehnologija – Merila za delovanje parnih sterilizatorjev in avtoklavovBiotechnik - Leistungskriterien für Dampf-Sterilisatoren und AutoklavenBiotechnologie - Criteres de performance pour les stérilisateurs a la vapeur d'eau et les autoclavesBiotechnology - Performance criteria for steam sterilizers and autoclaves11.080.10Sterilizacijska opremaSterilizing equipment07.080Bi
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