DIN EN ISO 11737-1:2021-10
Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018 + Amd 1:2021); German version EN ISO 11737-1:2018 + A1:2021 / Note: To be replaced by DIN EN ISO 11737-1 (2026-04).
| Fecha edición: |
2021-10-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. This document does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442 3, ICH Q5A(R1) and ISO 13022. This document does not apply to the microbiological monitoring of the environment in which health care products are manufactured. |
| Keywords: | Analysis|Applications|Assessment|Bacteria|Bacterial count|Bacteriological quality|Biological hazards|CE marking|Characteristics|Colony count|Concentration|Conditions|Contamination|Corrections|Counting|Culture|Culture media|Definitions|Determination|EDP|Elections|Equipment|Estimation|Evaluations|Filtration|Germs|Guide books|Health protection|Hygiene|Incubation|Inspection|Instruments|Laboratories|Laboratory testing|Limits (mathematics)|Loading|Materials|Mathematical calculations|Media|Medical devices|Medical equipment|Medical instruments|Medical products|Medical sciences|Membranes|Methods|Methods of manufacture|Microbiological|Microbiological analysis|Microbiology|Micro-organisms|Microorganisms|Operation|Packages|Patterns|Personal health|Personnel|Population|Products|Quality assurance|Quality management|Raw materials|Reclamation|Release|Safety|Samples|Sampling methods|Selection|Solutions|Specification (approval)|Sterile|Sterility|Sterilization (hygiene)|Substances|Testing|Transfer|Transport|Treatment|Validation|Verification |
| ICS: | 11.080.01 - Esterilización y desinfeccion en general, 07.100.10 - Microbiología médica |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 11737-1:2018/A1:2021 Idéntica ISO 11737-1:2018/Amd 1:2021 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 11737-1:2018-11 Reemplaza a DIN EN ISO 11737-1/A1:2019-06 |
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