EN 12322:1999
(Main)In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media
This European Standard specifies requirements for the performance of culture media. It is concerned with the traceability, comparability, reproducibility and suitability of culture media used in microbiological laboratories. These characteristics are achieved by applying the quality criteria outlined in this standard. This European Standard is applicable to : a) commercial organizations distributing media to microbiology laboratories in ready-to-use form, as dehydrated media or as semi-finished media (see 2.5 in EN 1659 : 1996) ; b) non commercial organizations that distribute media to satellite locations ; c) laboratories that prepare culture media for their own use. Cell culture media are not covered by this standard.
In-vitro-Diagnostika - Kulturmedien für die Mikrobiologie - Leistungskriterien für Kulturmedien
Diese Europäische Norm legt Leistungsanforderungen an Kulturmedien fest. Sie bezieht sich auf die Rückverfolgbarkeit, Vergleichbarkeit, Reproduzierbarkeit und Eignung von Kulturmedien, die in mikrobiologischen Laboratorien eingesetzt werden. Diese Merkmale werden durch Einhaltung der in dieser Norm beschriebenen Qualitätskriterien erreicht.
Dispositifs médicaux de diagnostic in vitro - Milieux de culture de microbiologie - Critères de performance des milieux de culture
La présente norme européenne spécifie les exigences relatives à la performance des milieux de culture. Elle traite de la traçabilité, de la comparabilité, de la reproductibilité et de la pertinence des milieux de culture utilisés dans les laboratoires. Ces caractéristiques sont obtenues en appliquant les critères de qualité présentés dans la présente norme.
Diagnostični medicinski pripomočki in vitro – Gojišča za mikrobiologijo – Merila za kakovost gojišč
General Information
- Status
- Published
- Publication Date
- 20-Apr-1999
- Technical Committee
- CEN/TC 140 - In vitro diagnostic systems
- Drafting Committee
- CEN/TC 140/WG 7 - Culture media
- Current Stage
- 9060 - Closure of 2 Year Review Enquiry - Review Enquiry
- Start Date
- 02-Sep-2024
- Completion Date
- 02-Sep-2024
Relations
- Effective Date
- 22-Dec-2008
Overview
EN 12322:1999 is a CEN European Standard for in vitro diagnostic medical devices that sets performance criteria for culture media for microbiology. The standard defines quality criteria to ensure the traceability, comparability, reproducibility and suitability of culture media used in clinical and research microbiology laboratories. EN 12322 applies to commercial suppliers, non‑commercial distributors and laboratories that prepare media for their own use. Cell culture media are excluded from its scope.
Key Topics and Requirements
EN 12322 focuses on practical quality attributes rather than prescribing specific test methods. Key technical topics include:
- Performance criteria for culture media - requirements that media must meet to be suitable for microbiological use in diagnostics and laboratory testing.
- Traceability - documentation and records that link media materials and production batches to their sources and specifications.
- Comparability and reproducibility - criteria to ensure consistent results between lots, manufacturers and laboratory preparations.
- Suitability for intended use - evidence that a given medium supports the expected growth, recovery or inhibition characteristics required for its diagnostic purpose.
- Quality control and documentation - maintenance of records, specifications and performance data to demonstrate compliance with the standard.
- Applicability to different product formats: ready‑to‑use media, dehydrated media, and semi‑finished media (reference to EN 1659:1996 for semi‑finished media).
Note: Specific numerical thresholds or test procedures are not reproduced here; EN 12322 provides the quality framework and criteria that organizations use to demonstrate compliance.
Applications and Who Uses It
EN 12322 is intended for stakeholders involved in the manufacture, distribution and use of microbiological culture media:
- Commercial manufacturers and distributors producing ready‑to‑use, dehydrated or semi‑finished media for clinical and research laboratories.
- Non‑commercial organizations supplying media to satellite labs or decentralized testing sites.
- Clinical, public‑health and research laboratories that prepare culture media in‑house and need to demonstrate traceability and consistency.
- Quality assurance and regulatory teams ensuring in vitro diagnostic (IVD) products meet European expectations for laboratory reproducibility and documentation.
Practical uses include establishing media specifications, lot‑release criteria, internal quality control procedures, and evidence for audits or regulatory submissions.
Related Standards
- EN 1659:1996 - referenced for definitions and treatment of semi‑finished media.
- Other standards in the in vitro diagnostic medical devices domain may complement EN 12322 for broader IVD quality management and validation programs.
Keywords: EN 12322:1999, culture media, microbiology, performance criteria, in vitro diagnostic, traceability, reproducibility, comparability, CEN.
Frequently Asked Questions
EN 12322:1999 is a standard published by the European Committee for Standardization (CEN). Its full title is "In vitro diagnostic medical devices - Culture media for microbiology - Performance criteria for culture media". This standard covers: This European Standard specifies requirements for the performance of culture media. It is concerned with the traceability, comparability, reproducibility and suitability of culture media used in microbiological laboratories. These characteristics are achieved by applying the quality criteria outlined in this standard. This European Standard is applicable to : a) commercial organizations distributing media to microbiology laboratories in ready-to-use form, as dehydrated media or as semi-finished media (see 2.5 in EN 1659 : 1996) ; b) non commercial organizations that distribute media to satellite locations ; c) laboratories that prepare culture media for their own use. Cell culture media are not covered by this standard.
This European Standard specifies requirements for the performance of culture media. It is concerned with the traceability, comparability, reproducibility and suitability of culture media used in microbiological laboratories. These characteristics are achieved by applying the quality criteria outlined in this standard. This European Standard is applicable to : a) commercial organizations distributing media to microbiology laboratories in ready-to-use form, as dehydrated media or as semi-finished media (see 2.5 in EN 1659 : 1996) ; b) non commercial organizations that distribute media to satellite locations ; c) laboratories that prepare culture media for their own use. Cell culture media are not covered by this standard.
EN 12322:1999 is classified under the following ICS (International Classification for Standards) categories: 07.100.10 - Medical microbiology. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12322:1999 has the following relationships with other standards: It is inter standard links to EN 12322:1999/A1:2001. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12322:1999 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC, 98/79/EC; Standardization Mandates: M/252. 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)
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In vitro diagnostic medical devices - Culture media for microbiology - Performance
criteria for culture media
In-vitro-Diagnostika - Kulturmedien für die Mikrobiologie - Leistungskriterien für
Kulturmedien
Dispositifs médicaux de diagnostic in vitro - Milieux de culture de microbiol
...
The EN 12322:1999 standard is an essential framework that governs the performance criteria for culture media used in microbiology, underscoring its significance in the realm of in vitro diagnostic medical devices. This European Standard details the specific requirements necessary for ensuring that culture media meet high-quality benchmarks, which are crucial for accurate and reliable results in microbiological testing. One of the main strengths of this standard lies in its emphasis on traceability, comparability, reproducibility, and suitability of culture media. By establishing these parameters, EN 12322:1999 effectively promotes consistency and reliability among different types of culture media. This standard serves as a comprehensive guideline that aids commercial organizations that supply ready-to-use, dehydrated, or semi-finished culture media, as well as non-commercial entities that distribute these products to satellite laboratories. It also provides valuable insights for laboratories that prepare their own culture media, ensuring that they adhere to established quality criteria. Moreover, the applicability of this standard to a wide range of stakeholders in the microbiology field enhances its relevance, making it a critical reference point for various organizations involved in the preparation and distribution of culture media. However, it is important to note that the standard explicitly excludes cell culture media, which delineates its focus solely on microbiological applications. Despite this limitation, the EN 12322:1999 standard remains a pivotal resource for those involved in the production and utilization of culture media in microbiological laboratories, ensuring that they operate within the established performance criteria to facilitate effective and reliable diagnostic practices. Overall, the standard is a robust framework that significantly contributes to enhancing the quality and standardization of culture media used in clinical and research settings.
EN 12322:1999 표준은 미생물학 실험실에서 사용되는 배양 매체의 성능 기준을 명확하게 규정하고 있으며, 이로 인해 배양 매체의 추적성, 비교 가능성, 재현성 및 적합성에 대한 중요한 요구 사항이 포함되어 있습니다. 이 표준은 상업적으로 배양 매체를 배급하는 조직뿐만 아니라 비상업적인 조직 및 자체적으로 배양 매체를 준비하는 연구소에도 적용됩니다. 이러한 범위는 미생물학적 실험실에서 사용하는 배양 매체의 품질 균형을 보장하기 위한 것입니다. 주요 강점은 이 표준이 제시하는 품질 기준이 배양 매체의 성능을 향상시키고, 신뢰할 수 있는 실험 결과를 보장하며, 실험실 간의 결과 비교를 가능하게 한다는 점입니다. 또한, 이 표준은 배양 매체의 사용자들이 표준화된 접근법을 따르게 해 실험의 일관성을 높여줍니다. 이는 실험실 운영에 있어 중요한 요소로 작용하며, 정확한 진단을 위한 기본적인 바탕을 제공합니다. EN 12322:1999 표준의 적합성 역시 중요한 점으로, 미생물학 실험실의 품질 관리 시스템에 밀접하게 연관되어 있어 연구 및 질병 진단의 신뢰성을 높이는 데 기여합니다. 이 표준은 특히 연구소나 상업적 조직이 실험실에서의 공정성을 유지할 수 있도록 도와줍니다. 결론적으로, EN 12322:1999 표준은 미생물학적 배양 매체의 품질을 보장하는 데 필수적인 기준으로, 국제적 차원에서도 그 활용도가 높습니다. 이 표준을 준수함으로써 연구 및 진단의 정확성을 높일 수 있으며, 의료 기기 분야에서의 중요한 역할을 지속적으로 강화할 수 있습니다.
SIST EN 12322:2000に基づく標準は、微生物学における培養基の性能基準に関する非常に重要な文書です。この標準の範囲は、微生物学的研究で使用される培養基のトレーサビリティ、比較可能性、再現性、および適合性の要件を定義しています。具体的には、この標準は、商業組織が供給する即使用可能な形の培養基、脱水培養基、または半製品としての培養基に焦点を当てています。 この標準の強みは、微生物学の研究における培養基の質を保証するために必要な品質基準を明確に示している点です。これにより、研究者は、利用する培養基の性能を確実に比較できるようになります。その結果、研究結果の信頼性が向上し、特に医療および生物学研究の分野において、より高い精度の診断が可能になります。 また、SIST EN 12322は、商業および非商業の組織がそれぞれの目的に応じて培養基を配布する際に必要なガイドラインを提供しています。このように、非常に多岐にわたるユーザーがこの標準を適用できるため、その関連性が高いといえます。ただし、細胞培養用の培養基はこの標準には含まれていないため、ユーザーはその点を考慮する必要があります。 全体として、SIST EN 12322:2000は、微生物学的研究における培養基の品質を確保するための重要な基盤を提供しており、研究者や実験室にとって不可欠な文書です。
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