Need help?

EN ISO 10993-12:2021 Standard

wave
Save  

  Keywords:

#selection #sample #test #biological #device

  Directive

Medical devices Regulation ((EU) 2017/745)

  Last Official Journal reference

Tuesday 8th of April 2025

  Description:

Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)

  Purpose

ISO 10993-12 specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing.It is important that sample preparation methods be appropriate for both the biological evaluation methods and the materials being evaluated. Each biological test method requires the selection of materials, extraction solvents and conditions. ISO 10993-12 is based on existing national and international standards and regulations, wherever possible.ISO 10993-12 addresses:— test sample selection,— selection of representative portions from a medical device,— test sample preparation,— experimental controls,— selection of, and requirements for, reference materials,— preparation of extracts.The text of ISO 10993-12:2021 has been approved in Europe as EN ISO 10993-12:2021 without any changes.

  Publication

Wednesday 5th of January 2022

  Related Standards

EN ISO 13408-6:2021

Medical devices Regulation ((EU) 2017/745)

Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021)

EN ISO 10993-10:2023

Medical devices Regulation ((EU) 2017/745)

Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

EN ISO 11607-2:2020/A1:2023

Medical devices Regulation ((EU) 2017/745)

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes ...

EN ISO 17664-2:2023

Medical devices Regulation ((EU) 2017/745)

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical d...

EN ISO 11737-1:2018

Medical devices Regulation ((EU) 2017/745)

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

EN ISO 11737-2:2020

Medical devices Regulation ((EU) 2017/745)

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