EN 12347:1998
(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 - Critères de performance pour les stérilisateurs à 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
- 17-Mar-1998
- Technical Committee
- CEN/TC 233 - Biotechnology
- Drafting Committee
- CEN/TC 233/WG 4 - Equipment
- Current Stage
- 9093 - Decision to confirm - Review Enquiry
- Start Date
- 11-Apr-2022
- Completion Date
- 14-Apr-2025
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
EN 12347:1998 is a standard published by the European Committee for Standardization (CEN). 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.
EN 12347:1998 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology; 07.100.99 - Other standards related to microbiology; 11.080 - Sterilization and disinfection. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12347:1998 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.
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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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기사 제목: EN 12347:1998 - 생물공학 - 증기 살균기와 오토클레이브의 성능 기준 기사 내용: 이 유럽 표준은 생물공학 프로세스에서 사용되는 미생물의 파괴와 방출을 방지하기 위해 사용되는 증기 살균기와 오토클레이브의 성능 기준을 명시한다. 이 유럽 표준은 증기 살균기나 오토클레이브의 의도된 사용이 위험하거나 잠재적으로 위험한 미생물을 포함하는 생물공학 프로세스에 사용되거나 작업자나 환경이 안전상의 이유로 이러한 미생물에 노출되는 경우에 적용된다.
The article discusses EN 12347:1998, a European Standard that lays out performance criteria for steam sterilizers and autoclaves used in biotechnological processes. The standard applies when these devices are used to destroy or prevent the release of hazardous microorganisms, or when there is a need to protect workers or the environment from such microorganisms for safety reasons.
記事のタイトル：EN 12347:1998 - バイオテクノロジー - 蒸気滅菌器およびオートクレーブの性能基準 記事内容：このヨーロッパ規格は、バイオテクノロジープロセスで使用される微生物の破壊と放出の防止に使用される蒸気滅菌器およびオートクレーブの性能基準を規定しています。このヨーロッパ規格は、蒸気滅菌器またはオートクレーブの使用目的が危険または潜在的に危険な微生物を含むバイオテクノロジープロセスに関連している場合や、労働者または環境が安全上の理由でこのような微生物に曝露される場合に適用されます。
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