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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 guides 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 *

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Standard monitoring

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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