Back

EVS-EN ISO 11737-1:2006

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products

General information

Withdrawn from 15.02.2018
Base Documents
ISO 11737-1:2006; EN ISO 11737-1:2006
ICS Groups
07.100 Microbiology 07.100.10 Medical microbiology 11.080 Sterilization and disinfection 11.080.01 Sterilization and disinfection in general
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.02.2018
Main
EVS-EN ISO 11737-1:2018
07.05.2009
Corrigendum
EVS-EN ISO 11737-1:2006/AC:2009
06.06.2006
Main
EVS-EN ISO 11737-1:2006
Main
EVS-EN 1174-1:1999
Main
EVS-EN 1174-2:1999
Main
EVS-EN 1174-3:1999
This part of ISO 11737 specifies requirements and provides guidance for the enumeration and microbial characterization of the population of viable microorganisms on or in a medical device, component, raw material or package.

Required fields are indicated with *

*
*
*
PDF
26.84 € incl tax
Paper
26.84 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring
English (PDF 321 KB)

Related products

Main

EVS-EN ISO 11737-1:2018

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
Valid from 15.02.2018
Corrigendum

EVS-EN ISO 11737-1:2006/AC:2009

Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
Withdrawn from 15.02.2018
Main

EVS-EN ISO 11737-2:2020

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019)
Newest version Valid from 02.06.2020
Main

EVS-EN ISO 11135:2014

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)
Newest version Valid from 04.08.2014

Customers who bought this item also bought

Main

EVS-EN ISO 11737-2:2010

Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Withdrawn from 02.06.2020
Main

EVS-EN ISO 10993-7:2008

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Valid from 09.01.2009
Main

EVS-EN ISO 10993-1:2011

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Withdrawn from 31.12.2020
Main

EVS-EN 62366:2008

Medical devices – Application of usability engineering to medical devices
Withdrawn from 05.01.2016

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English