DS/EN 17141:2020

Cleanrooms and associated controlled environments – Biocontamination control


Status:
Current
Type:
Standard
Language:
English
Subject:
Price from:
€ 96.69

Scope

This document establishes the requirements, recommendations and methodology for microbiological contamination control in clean controlled environments. It also sets out the requirements for establishing and demonstrating microbiological control in clean controlled environments.

This document is limited to viable microbiological contamination and excludes any considerations of endotoxin, prion and viral contamination.

There is specific guidance given on common applications, including Pharmaceutical and BioPharmaceutical, Medical Devices, Hospitals and Food.


Number of pages: 51

Published: 2020-08-19

Date of approval: 2020-08-17

International relationships : EN 17141:2020 IDT

ICS: 13.040.35 - Cleanrooms and associated controlled environments

Item number: M316126


Committees

Committee

  • CEN/TC 243
  • CEN/TC 243/WG 5

Danish committee

DS/S-438