BIS Certification for Diagnostic Medical X-Ray Equipment as per IS 7620 (Part 1)

In line with the Government of India’s mission to enhance quality standards and ensure public health safety, the Bureau of Indian Standards (BIS) has made it mandatory for all Diagnostic Medical X-Ray Equipment to comply with IS 7620 (Part 1):1986. This Indian Standard outlines the mechanical and electrical safety requirements of X-ray machines used in medical diagnostics.

As part of India's push toward regulating medical devices through compulsory BIS certification, this move ensures that healthcare technologies meet stringent safety, performance, and quality benchmarks, protecting both patients and operators.

What is IS 7620 (Part 1):1986? – Indian Standard for Diagnostic X-Ray Equipment

IS 7620 (Part 1):1986, titled "Diagnostic Medical X-Ray Equipment – Mechanical and Electrical Safety Requirements," is the official Indian Standard defining safety guidelines for X-ray machines used in healthcare.

Key Safety Requirements Covered Under IS 7620-1

• Protection against electric shock and radiation

• Mechanical strength and operational stability

• Insulation resistance and high-voltage safety checks

• Leakage current, earth resistance, and temperature rise limits

• Labeling, test procedures, and routine testing guidelines

This standard forms the foundation for safe and reliable diagnostic imaging systems, helping reduce risks for healthcare workers and patients alike. Under the BIS Certification Scheme, compliance with IS 7620-1 is mandatory for both manufacturers and importers of diagnostic X-ray equipment in India.

Why BIS Certification is Mandatory for X-Ray Equipment in India

Obtaining BIS certification under IS 7620 (Part 1) is legally required and vital for:

• Selling or importing medical X-ray devices in India

• Using the ISI Mark (Standard Mark) on products

• Participating in public tenders and hospital procurement

• Building trust with diagnostic centers, hospitals, and healthcare providers

However, achieving certification involves comprehensive testing, technical compliance, and documentation—areas where expert support is highly beneficial.

Why Top Medical Device Companies Trust Absolute Veritas

• Proven Track Record in BIS Compliance for Medical Devices

• Faster Certification Turnaround

• 100% Compliance with No Non-Conformities

• Dedicated Medical Device Regulatory Team

• Trusted by OEMs and Importers Across India

With increased enforcement by BIS, non-compliance is no longer an option. Absolute Veritas ensures your products meet every technical and legal requirement with accuracy and speed.

Expert BIS Certification Consultants for X-Ray Equipment

Absolute Veritas Pvt. Ltd. is a leading BIS certification consultancy in India, offering specialized services for medical device manufacturers seeking compliance with IS 7620-1. With deep domain knowledge and proven expertise, Absolute Veritas simplifies and accelerates the BIS certification process.

• Regulatory Compliance Assessment & Gap Analysis: A detailed review of your product design, documentation, and safety mechanisms to ensure alignment with IS 7620 (Part 1) requirements.

• Technical Documentation & Dossier Preparation: Absolute Veritas prepares complete compliance documentation, including risk assessments, quality assurance plans, labeling details, and safety test reports.

• Testing Support in BIS/NABL-Recognized Labs: Absolute Veritas coordinates testing for insulation resistance, leakage current, temperature rise, and other key parameters in BIS-approved laboratories.

• BIS Application Filing & Process Management: From completing Form VI to scheduling inspections, Absolute Veritas acts as your single point of contact with BIS, handling every step of the application process.

• Post-Certification Support & ISI Marking Guidance: Once certified, Absolute Veritas assists in proper usage of the ISI Mark on packaging and products, and also supports surveillance audits and certification renewals.

Conclusion

BIS certification under IS 7620 (Part 1) is more than just a regulatory requirement—it’s a commitment to quality, safety, and trust in healthcare. As India's regulatory landscape for medical devices evolves, manufacturers and importers must adapt quickly to stay compliant and competitive.

With Absolute Veritas Pvt. Ltd. by your side, the journey to BIS certification becomes seamless, allowing you to focus on innovation while leaving the regulatory complexities to the experts.

For more information contact us at cs@absoluteveritas.com