SIST EN 12689:1999
(Main)Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products
Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products
This European Standard gives guidance on assessment of technical specifications of microorganism based products (MBPs) for product quality evaluation. It is also applicable for purposes of product registration. NOTE 1: In this European Standard, the technical specifications are considered to be purity, biological activity and stability of microorganism based product. This European Standard describes criteria and factors considered for the validity of the assessment of the technical specifications.
Biotechnik - Leitfaden zur Bewertung der Reinheit, biologischen Aktivität und Stabilität von Produkten, die auf Mikroorganismen basieren
Diese Europäische Norm gibt im Hinblick auf die Beurteilung der Produktqualität eine Anleitung zur Bewertung technischer Spezifikationen von Produkten, die auf Mikroorganismen basieren (MBPs). Sie ist auch für Zwecke der Registrierung von Produkten anwendbar. ANMERKUNG 1: In dieser Europäischen Norm werden die Reinheit, biologische Aktivität und Stabilität von Produkten, die auf Mikroorganismen basieren, als technische Spezifikationen betrachtet.
Biotechnologie - Guide pour l'évaluation de la pureté, l'activité biologique et la stabilité des produits a base de microorganismes
La présente norme européenne donne des indications relatives à l'évaluation des spécifications techniques des produits à base de microorganismes pour l'évaluation de la qualité des produits. Elle s'applique également à l'enregistrement des produits. NOTE 1: Dnas la présente norme, la pureté, l'activité biologique et la stabilité sont considérées comme les spécifications techniques d'un produit à base de microorganismes. La présente norme européenne décrit les critères et les facteurs qui sont pris en considération pour la validité de l'évaluation des spécifications techniques.
Biotehnologija - Navodilo za ocenjevanje čistosti, biološke aktivnosti in obstojnosti mikrobioloških proizvodov
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
- Directive
- Not Harmonized90/219/EEC - Contained use of genetically modified micro-organisms
Overview
SIST EN 12689:1999 is a European standard developed by the Slovenski inštitut za standardizacijo (SIST) that provides comprehensive guidance on the assessment of purity, biological activity, and stability of microorganism based products (MBPs). This standard is essential for ensuring the quality evaluation of MBPs and serves as a practical reference for product registration procedures. Stakeholders in biotechnology, microbiology, and related fields rely on this standard to assure the integrity and validity of product specifications.
Key Topics
- Purity Assessment: The standard outlines methods and criteria for evaluating the purity of microorganism based products. This includes considerations for identifying contaminants and ensuring consistency in product composition.
- Biological Activity: SIST EN 12689:1999 offers guidance on assessing the intended biological effects of MBPs, helping manufacturers demonstrate the efficacy and function of their products.
- Stability Evaluation: Recommendations cover how to determine the shelf life and durability of microorganism based products under defined storage and usage conditions.
- Technical Specifications: The document emphasizes critical technical parameters required for product quality and registration, linking assessment practices to regulatory acceptance.
- Validity of Assessments: The standard details factors that contribute to reliable and repeatable results in each area of assessment.
Applications
SIST EN 12689:1999 is widely used across several sectors, including:
- Biotechnology Product Development: Assists manufacturers in the quality evaluation process for microorganism based products, including biofertilizers, biopesticides, and probiotic formulations.
- Regulatory Compliance: Provides a standardized framework for compiling technical documentation required for product registration with regulatory bodies in the European Union.
- Quality Control Laboratories: Serves as a foundation for developing laboratory protocols related to testing the purity, biological activity, and stability of MBPs.
- Research and Development: Guides researchers in designing studies and experiments that align with recognized standards for product safety and performance.
- Supplier Qualification: Helps purchasers and end-users assess the specifications of MBP suppliers, ensuring consistent product quality.
Related Standards
When working with microorganism based products and their assessment, the following related standards may also be relevant:
- EN 12687: Biotechnology standards related to other quality or testing aspects.
- ISO 17025: General requirements for the competence of testing and calibration laboratories, which can be applied to laboratories conducting MBP assessments.
- ISO 13485: Quality management systems for medical devices, applicable when MBPs are used in healthcare settings.
- ISO 9001: Quality management systems requirements, valuable for organizations manufacturing or handling biological products.
By adhering to SIST EN 12689:1999, organizations enhance the credibility and reliability of their microorganism based products, facilitating market acceptance and regulatory approval while promoting high standards in biotechnology and life sciences.
Frequently Asked Questions
SIST EN 12689:1999 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Biotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products". This standard covers: This European Standard gives guidance on assessment of technical specifications of microorganism based products (MBPs) for product quality evaluation. It is also applicable for purposes of product registration. NOTE 1: In this European Standard, the technical specifications are considered to be purity, biological activity and stability of microorganism based product. This European Standard describes criteria and factors considered for the validity of the assessment of the technical specifications.
This European Standard gives guidance on assessment of technical specifications of microorganism based products (MBPs) for product quality evaluation. It is also applicable for purposes of product registration. NOTE 1: In this European Standard, the technical specifications are considered to be purity, biological activity and stability of microorganism based product. This European Standard describes criteria and factors considered for the validity of the assessment of the technical specifications.
SIST EN 12689:1999 is classified under the following ICS (International Classification for Standards) categories: 07.080 - Biology. Botany. Zoology; 07.100.01 - Microbiology in general. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 12689:1999 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 12689:1999 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.Biotechnik - Leitfaden zur Bewertung der Reinheit, biologischen Aktivität und Stabilität von Produkten, die auf Mikroorganismen basierenBiotechnologie - Guide pour l'évaluation de la pureté, l'activité biologique et la stabilité des produits a base de microorganismesBiotechnology - Guidance on assessment of the purity, biological activity and stability of microorganism based products07.100.01Mikrobio
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