IS/ISO 15198 : 2004 — Clinical Laboratory Medicine - In vitro Diagnostic Medical Devices - Validation of User Quality Control Procedures by the Manufacturer

What is IS/ISO 15198 : 2004?

IS/ISO 15198 : 2004 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Clinical Laboratory Medicine - In vitro Diagnostic Medical Devices - Validation of User Quality Control Procedures by the Manufacturer. It falls under the <strong>Medical and Hospital Equipments</strong> group and is administered by the Ministry of Health and Family Welfare. Certification under this standard is voluntary.

How to get certified for IS/ISO 15198 : 2004

1. 1
   Apply online — Submit the BIS portal application with product details, factory information, and test reports.
2. 2
   Lab testing — Submit product samples to a BIS-recognised testing laboratory for evaluation against the standard.
3. 3
   Factory inspection — A BIS officer visits your manufacturing facility to verify quality control systems.
4. 4
   Licence grant — On approval, BIS issues the licence. You may then affix the ISI Mark on compliant products.

Related Indian Standards

• IS 18298Clinical Laboratory Testing and in Vitro Medical Devices Requirements for in Vitro Monitoring Systems for Self-Testing of Oral Anticoagulant Therapy First Revision
• IS 15393Accuracy (Trueness And Precision) of measurement methods and results: Part 1 general principles and definitions
• IS 7920Statistical - Vocabulary and symbols: Part 1 general statistical terms and terms used in probability (Third Revision)
• IS/ISO 13485 : 2016Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes ( First Revision )
• IS/ISO 14971 : 2019Medical devices - Application of risk management to medical devices First Revision