In line with the Government of India’s focus on strengthening quality standards and safeguarding public health, the Bureau of Indian Standards (BIS) has mandated that all Diagnostic Medical X-Ray Equipment must conform to IS 7620 (Part 1) – the Indian Standard for general and safety requirements of such equipment. This regulation is part of India’s broader policy to regulate medical devices under compulsory certification, ensuring that healthcare technologies meet rigorous safety, performance, and reliability benchmarks.
Understanding IS 7620 (Part 1)
IS 7620 (Part 1):1986—titled “Diagnostic Medical X-Ray Equipment – Mechanical and Electrical Safety Requirements”—defines the structural, mechanical, and electrical safety protocols that every X-ray device must fulfill. It addresses:
- Protection against electric shock and radiation
- Mechanical stability and durability
- Insulation resistance and high-voltage safety
- Earth resistance, leakage currents, and temperature rise
- Clear labelling and test procedures (type and routine tests)
This standard lays the foundation for reliable diagnostics, minimizing risk to both patients and operators. The BIS has made compliance with this standard mandatory for manufacturers and importers under the BIS Certification Scheme, reinforcing quality control in India’s rapidly growing medical device market.
The Role of BIS Certification
BIS certification under IS 7620-1 is legally binding and essential for:
- Market authorization within India
- Affixing the Standard Mark (ISI Mark)
- Participation in government tenders and healthcare procurement
- Gaining trust among hospitals, diagnostic centres, and healthcare professionals
Achieving this certification, however, involves extensive documentation, stringent testing, and precise technical compliance—all areas where expert guidance can make a critical difference.
Omega QMS Pvt. Ltd.: Your Trusted Partner in BIS Compliance
Navigating the BIS certification process can be complex and resource-intensive. Omega QMS Pvt. Ltd. specializes in regulatory affairs and quality compliance, offering end-to-end consultancy to streamline and secure your BIS certification under IS 7620-1.
- Omega’s End-to-End Support Includes:
- Regulatory Readiness & Gap Analysis
Omega conducts a meticulous review of your X-ray equipment and technical documentation against IS 7620-1 requirements. From design specifications to safety testing readiness, they ensure every aspect aligns with BIS expectations. - Documentation Preparation & Dossier Compilation
Preparation of compliance dossiers—including risk assessments, quality control plans, safety test data, and labeling information—is expertly managed by Omega’s team. - Testing Coordination with BIS-Recognized Labs
Omega facilitates mandatory testing (insulation, leakage current, temperature rise, etc.) through NABL- and BIS-approved laboratories. They ensure tests are executed correctly and all protocols are followed. - BIS Application Filing & Liaison
From filling Form VI to coordinating with BIS offices, Omega QMS acts as a single point of contact for all procedural formalities, reducing administrative burden and delays. - Post-Certification Support & Marking Compliance
Once certified, Omega helps you integrate the ISI mark properly on your products and packaging, and also advises on surveillance audits and renewals to ensure uninterrupted compliance.
Why Leading Medical Device Companies Choose Omega QMS
- Deep BIS Regulatory Expertise
- Fast-Tracked Certification Timelines
- Zero Non-Conformance Track Record
- Dedicated Compliance Team for Medical Devices
- Nationwide Clientele Including Leading OEMs & Importers
With BIS stepping up enforcement and quality scrutiny, non-compliance is no longer an option. Omega QMS Pvt. Ltd. empowers medical device manufacturers and importers to meet every BIS mandate with precision, speed, and confidence.
Final Word
BIS certification under IS 7620-1 is not just a regulatory checkbox—it is a commitment to safety, trust, and excellence in healthcare. As India’s regulatory landscape matures, companies that partner with experienced compliance specialists like Omega QMS Pvt. Ltd. are not only meeting standards—they’re setting them.
OMEGA QMS PVT. LTD.
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