Back

ISO 11737-2:2009

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

General information

Withdrawn from 02.12.2019
ICS Groups
07.100.10 Medical microbiology 11.080.01 Sterilization and disinfection in general
Directives or regulations
None

Standard history

Status
Date
Type
Name
02.12.2019
Main
ISO 11737-2:2019
06.11.2009
Main
ISO 11737-2:2009
Main
ISO 11737-2:1998
ISO 11737-2:2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. These tests are intended to be performed when defining, validating or maintaining a sterilization process.

Required fields are indicated with *

*
*
*
PDF
82.61 € incl tax
Paper
82.61 € incl tax
Standard monitoring
English (PDF 605 KB)

Related products

Main

ISO 11737-2:2019

Sterilization of health care products -- Microbiological methods -- Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
Newest version Valid from 02.12.2019
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
Amendment

EVS-EN ISO 11135:2014/A1:2019

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Amendment 1: Revision of Annex E, Single batch release (ISO 11135:2014/Amd 1:2018)
Newest version Valid from 02.12.2019

Customers who bought this item also bought

Main + amendment

EVS-EN 1041:2008+A1:2013

Information supplied by the manufacturer of medical devices
Withdrawn from 17.05.2021
Main

EVS-EN ISO 11138-1:2006

Sterilization of health care products - Biological indicators - Part 1: General requirements
Withdrawn from 18.04.2017
Main

ISO/TS 11137-4:2020

Sterilization of health care products -- Radiation -- Part 4: Guidance on process control
Newest version Valid from 30.06.2020
Main

EVS-EN ISO 11737-1:2006

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Withdrawn from 15.02.2018

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