Skip to content
Regulatory knowledge for medical devices
Articles on the development and approval of medical devices and other regulatory topics
Regulatory knowledge for medical devices
CONTACT USLogin
Search:
  • Academy
    • Seminars, Courses, and Workshops
  • Consulting
    • Market Access & Regulatory Affairs
      • In-house Production of IVD Medical Devices
      • US Market Access
      • International Approval
      • Clinical Strategy
      • IVD Performance Evaluation Strategy
      • MDR/IVDR Approval
    • Management Systems
      • Quality Management Systems (QMS)
      • QMSR Consulting
      • Information Security Management System (ISMS)
      • Integrated Management Systems (IMS)
    • Technical Documentation
      • Biological Safety
      • Electrical Safety & EMC
      • Clinical Evaluation
      • Shelf Life and Transport­ation Validation
      • IT Security
      • Clinical Evaluation
      • IVD Performance Evaluation
  • Product Testing
    • IVD Performance Studies
    • Clinical Trials and Studies
    • Biocompatibility Testing
    • Usability Evaluation
  • Outsourcing
    • Authorized Representative Services & Regulatory Roles
    • Legal Manufacturer EU
    • US Agent
  • Regtech & AI
  • Regulatory Intelligence
    • Post-Market Radar
    • Regulatory Radar
  • The Institute
    • Our Mission & Values
    • Our Company History
    • Who We Are
    • Locations
    • People
    • Customers & Partners
    • Locations
    • Jobs at Johner Institute
  • Academy
    • Seminars, Courses, and Workshops
  • Consulting
    • Market Access & Regulatory Affairs
      • In-house Production of IVD Medical Devices
      • US Market Access
      • International Approval
      • Clinical Strategy
      • IVD Performance Evaluation Strategy
      • MDR/IVDR Approval
    • Management Systems
      • Quality Management Systems (QMS)
      • QMSR Consulting
      • Information Security Management System (ISMS)
      • Integrated Management Systems (IMS)
    • Technical Documentation
      • Biological Safety
      • Electrical Safety & EMC
      • Clinical Evaluation
      • Shelf Life and Transport­ation Validation
      • IT Security
      • Clinical Evaluation
      • IVD Performance Evaluation
  • Product Testing
    • IVD Performance Studies
    • Clinical Trials and Studies
    • Biocompatibility Testing
    • Usability Evaluation
  • Outsourcing
    • Authorized Representative Services & Regulatory Roles
    • Legal Manufacturer EU
    • US Agent
  • Regtech & AI
  • Regulatory Intelligence
    • Post-Market Radar
    • Regulatory Radar
  • The Institute
    • Our Mission & Values
    • Our Company History
    • Who We Are
    • Locations
    • People
    • Customers & Partners
    • Locations
    • Jobs at Johner Institute
You are here:
  1. Home
  2. 2022
  3. March
  4. 31

March 31, 2022


Cytotoxicity testing according to EN ISO 10993-5: Avoiding pitfalls when choosing a laboratory

By Sarah GruberMarch 31, 2022Leave a comment

Cytotoxicity testing can be used to test a sample to determine how much it can damage, or even cause the death of, human cells. Standards and legislation require manufacturers to demonstrate that their devices are not cytotoxic. With a good test setup, it is possible to detect whether a sample is 100% cytotoxic, i.e., highly cytotoxic, or…

Details

Stay informed with our newsletter!

Medical Device Briefings

Your trustworthy source to safely navigate the medical device regulations.

SIGN UP
  • LinkedIn
  • Locations
  • GTC
  • Login
  • LinkedIn
JI Bottom Bar
Go to Top