Need help?

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

wave
Save  

  Keywords:

#standard #products #main #text #amendment

  Directive

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

  Last Official Journal reference

Monday 9th of November 2026

  Description:

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

  Purpose

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

  Publication

Friday 7th of January 2022

  Amendment

This standard is an amendment for "EN ISO 11737-1:2018"

  Related Standards

EN ISO 11135:2014

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a ste...

EN ISO 11135:2014/A1:2019

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a ste...

EN ISO 11137-1:2015

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

EN ISO 11137-1:2015/A2:2019

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a ster...

EN ISO 11737-1:2018

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on produ...

EN ISO 11737-2:2020

In vitro diagnostic medical devices Regulation ((EU) 2017/746)

Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validati...

  Stay up to date

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0