SIST EN 12347:1999

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.