Back

EVS-EN ISO 11737-1:2018/A1:2021

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)

General information

Valid from 01.07.2021
Base Documents
ISO 11737-1:2018/Amd 1:2021; EN ISO 11737-1:2018/A1:2021
ICS Groups
07.100.10 Medical microbiology 11.080.01 Sterilization and disinfection in general
Directives or regulations
2017/745 Medical devices (MDR) 2017/746 In vitro diagnostic medical devices (IVDMDR)

Standard history

Status
Date
Type
Name
01.07.2021
Amendment
EVS-EN ISO 11737-1:2018/A1:2021
01.07.2021
Main + amendment
EVS-EN ISO 11737-1:2018+A1:2021
15.02.2018
Main
EVS-EN ISO 11737-1:2018
ISO 11737-1 is a sterilization standard that specifies requirements and provides guidance on the enumeration and microbial characterization of microorganisms on healthcare products. EN ISO 11737-1:2018/A1:2021 modifies the European standard EN ISO 11737-1:2018. The main text and the consolidated version which consists of the main text and the amendment can be found in the standard’s history.

In this amendment you can find:

— Relationship between EN ISO 11737-1 and the General Safety and Performance Requirements of Regulation (EU) 2017/745

— Relationship between EN ISO 11737-1 and the General Safety and Performance Requirements of Regulation (EU) 2017/746

Required fields are indicated with *

*
*
*
PDF
12.20 € incl tax
Paper
12.20 € incl tax
Browse standard from 2.44 € incl tax
Standard monitoring

Related products

Main + amendment

EVS-EN ISO 11737-1:2018+A1:2021

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018+ISO 11737-1:2018/Amd 1:2021)
Newest version Valid from 01.07.2021
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
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 15223-1:2021

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
Newest version Valid from 01.10.2021
Amendment

EVS-EN ISO 13485:2016/A11:2021

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Valid from 16.09.2021
Main

EVS-EN ISO 10993-12:2021

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
Newest version Valid from 01.07.2021
Main

EVS-EN ISO 10993-9:2021

Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019)
Newest version Valid from 15.10.2021

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