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IS/ISO 11040 : Part 4 : 2015

IS/ISO 11040 : Part 4 : 2015 — Prefilled syringes Part 4 Glass barrels for injectables and sterilized subassembled syringes ready for filling

IS/ISO 11040 : Part 4 : 2015 is an Indian Standard titled Prefilled syringes Part 4 Glass barrels for injectables and sterilized subassembled syringes ready for filling, classified under Medical and Hospital Equipments and administered by the Ministry of Health and Family Welfare. Certification is voluntary.

IS Number
IS/ISO 11040 : Part 4 : 2015
Status
0
Certification
Voluntary
Ministry
Ministry of Health and Family Welfare
Committee
Hospital Equipment and Surgical Disposable Products
Type
Product Specification

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What is IS/ISO 11040 : Part 4 : 2015?

IS/ISO 11040 : Part 4 : 2015 is an Indian Standard published by the Bureau of Indian Standards (BIS) under the title Prefilled syringes Part 4 Glass barrels for injectables and sterilized subassembled syringes ready for filling. 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 11040 : Part 4 : 2015

  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.

Amendments to IS/ISO 11040 : Part 4 : 2015

AmendmentYear
First Amendment2024
View official document on bis.gov.in →

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