BIS Standards Archives

Public Notice on Medical Devices Standards from Department of Pharmaceuticals

Public notice on Medical Devices from Department of Pharmaceuticals on what Standards industry and stakeholders have to follow, refer while dealing with Medical Devices.

Medical Device Sector is brought under 100% Regulation which means that it’s well defined framework , structure and has well established regulatory protocols .

Healthcare Services should understand more about the Supply Chain Quality – understand the Regulations, Standards , Certifications , Testing , Inspection norms that are prescribed for the market players.

Unless the supply chain quality is understood correctly, Service providers delivery can’t have the necessary assurance to users .

Procurement teams, QA teams in healthcare services should know about National, International Conformity Assessment practices, norms for Healthcare Products.

Since Users, Patients, stakeholders etc are always seeing Global Quality Campaigns while introducing, prescribing Products, it’s important to respond to queries on the same when asked.

Download Here Public Notice BIS Standards

Source: Public Notice No.31026/83-2021-MD dt. 01.02.2022 issued by Department of Pharmaceutical

BIS LICENSES FOR MASKS AND PPES & REVISED GUIDELINES

BIS LICENSES FOR MASKS AND PPES & REVISED GUIDELINES – UPDATES FROM BIS

Industry and stakeholders are invited to refer the same . With the continuous spread of many variants of Sars Cov 2 , the global focus is again shifted to using Masks, protecting healthcare workers with coveralls etc. Global Call of Action is again shifted back to providing high quality masks which offer more protection to all users. BIS has released Standards for Coveralls and revised licensing guidelines too for the Indian Industry to follow.

BIS LICENSES FOR MASKS AND PPES

S.No	Indian Standard	Product	BIS Licenses
1	IS 9473:2002	Filter Half Masks	Click here
2	IS 16289:2014	Surgical Face Masks	Click here
3	IS 5983:1980	Eye Protectors	Click here
4	IS 17423:2020	Cover All	Click here

REVISED GUIDELINES FOR ISSUE OF LICENSES

S.No	Indian Standard	Product	Product Specific Relaxation guidelines	Product Manual
1	IS 9473:2002	Filter Half Masks	Click here	Click here
2	IS 16289:2014	Surgical Face Masks	Click here	Click here
3	IS 5983:1980	Eye Protectors	Click here	Click here
4	IS 17423:2020	Cover All	Click here	Click here

Source : https://www.bis.gov.in/index.php/bis-licenses-for-marks-ppes/

BIS has released IS 17423 : 2021 – Medical Textiles — Bio-Protective Coveralls — Specification (First Revision) recently. This is the latest Product Standard for Coveralls to be followed by Industry.

BIS has compiled list of all published Technical Standards for Medical Textiles , totally 70 Standards (TXD 36) for industry reference as mentioned below :

TXD 36 – Technical Textiles for Medtech Applications

Refer the List – https://www.services.bis.gov.in:8071/php/BIS/PublishStandards/published/standards?commttid=MTM0