Independent BIS consultants. Not affiliated with the Bureau of Indian Standards.
Complyr

IS/IEC 80601 : Part 2 : Sec 58 : 2016

IS/IEC 80601 : Part 2 : Sec 58 : 2016 — Medical electrical equipment Part 2 Particular requirements for the basic safety and essential performance Section 58 Lens removal devices and vitrectomy devices for ophthalmic surgery

IS/IEC 80601 : Part 2 : Sec 58 : 2016 is an Indian Standard titled Medical electrical equipment Part 2 Particular requirements for the basic safety and essential performance Section 58 Lens removal devices and vitrectomy devices for ophthalmic surgery, classified under Medical and Hospital Equipments and administered by the Ministry of Health and Family Welfare. Certification is voluntary.

IS Number
IS/IEC 80601 : Part 2 : Sec 58 : 2016
Status
0
Certification
Voluntary
Ministry
Ministry of Health and Family Welfare
Committee
Electromedical, Diagnostic Imaging and Radiotherapy Equipment
Type
Product Specification

Need ISI Mark certification for IS/IEC 80601 : Part 2 : Sec 58 : 2016? Fixed-fee, 6–12 week timeline.

Get a quote

What is IS/IEC 80601 : Part 2 : Sec 58 : 2016?

IS/IEC 80601 : Part 2 : Sec 58 : 2016 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Medical electrical equipment Part 2 Particular requirements for the basic safety and essential performance Section 58 Lens removal devices and vitrectomy devices for ophthalmic surgery. 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/IEC 80601 : Part 2 : Sec 58 : 2016

  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 →

Complyris an independent compliance consultancy. We are not affiliated with, endorsed by, or representing the Bureau of Indian Standards or any government body. All Indian Standards are © Bureau of Indian Standards. Visit bis.gov.in for official standard documents.

Get your IS/IEC 80601 : Part 2 : Sec 58 : 2016 licence with Complyr

Fixed fee. End-to-end handling. We manage the entire BIS certification process.

Talk to a consultantView on bis.gov.in →
Talk to a consultant