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Normas DIN – AENOR
DIN EN 17141:2017-08

DIN EN 17141:2017-08

Cleanrooms and associated controlled environments - Biocontamination control; German and English version prEN 17141:2017 / Note: Date of issue 2017-07-07

Salles propres et environnements maîtrisés apparentés - Maîtrise de la biocontamination; Version allemande et anglaise prEN 17141:2017 / Attention: Date de parution 2017-07-07

Reinräume und zugehörige Reinraumbereiche - Biokontaminationskontrolle; Deutsche und Englische Fassung prEN 17141:2017 / Achtung: Erscheinungsdatum 2017-07-07

Fecha Anulación:
2018-09 /Withdrawn
Equivalencias internacionales:

prEN 17141 (2017-06)

Relación con otras normas DIN:

Reemplazada por: DIN EN 17141:2018-09

Resumen:
This European Standard establishes the principles and basic methodology of a formal system of biocontamination control in Cleanrooms and associated controlled environments. These principles are based on establishing control and then on demonstrating control. This standard specifies the methods required for assessing risk monitoring risk zones in a consistent way and for applying control measures appropriate to the degree of risk involved. It will also give guidance on the assessment and verification of microbiological sampling devices, with the aim of helping users standardize their monitoring so that results from one facility to another can be compared. Within this standard, only microbiological hazards are addressed. There is specific guidance given on common applications, including Food, Hospitals and Life Sciences (Pharma/Biopharma and Medical Devices).
Keywords:
Air pollution, Biocontamination, Checks, Clean rooms, Clean-room technology, Concentration of particles, Contamination, Definitions, Hazards, Medical sciences, Microbiological, Number of particles, Sampling methods, Specification (approval), Surveillance (approval), Verification
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