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IS/ISO 8638 : 2010

IS/ISO 8638 : 2010 — Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (First Revision)

IS/ISO 8638 : 2010 is an Indian Standard titled Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (First Revision), classified under Medical and Hospital Equipments and administered by the Ministry of Health and Family Welfare. Certification is voluntary.

IS Number
IS/ISO 8638 : 2010
Status
1
Certification
Voluntary
Ministry
Ministry of Health and Family Welfare
Committee
Medical and Surgical Cardiology Equipment
Type
Product Specification

Need ISI Mark certification for IS/ISO 8638 : 2010? Fixed-fee, 6–12 week timeline.

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What is IS/ISO 8638 : 2010?

IS/ISO 8638 : 2010 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (First Revision). 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 8638 : 2010

  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.
View official document on bis.gov.in →

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