BIS Certification for Diagnostic Medical X-Ray Equipment

BIS Certification for Diagnostic Medical X-Ray Equipment. Diagnostic Medical X-ray equipment plays an important role in modern healthcare by providing essential internal imaging used for diagnosis and treatment. As such equipment involves the use of radiation, safety and quality assurance become important. In India, the Bureau of Indian Standards (BIS) mandates that all manufacturers and importers of diagnostic medical X-ray equipment comply with IS 7620 (Part-1) under the BIS ISI Mark Certification scheme. This article explains in detail the BIS Certification for Diagnostic Medical X-Ray Equipment, covering requirements, procedures, benefits, and more.
Introduction to BIS ISI Certification for Diagnostic Medical X-Ray Equipment
The BIS ISI Certification for Diagnostic Medical X-Ray Equipment is a mandatory certification required for manufacturing, importing, or selling X-ray diagnostic devices in India. It ensures that the equipment complies with Indian Standard IS 7620 (Part-1) and adheres to safety, performance, and quality benchmarks. The certification signifies the product has passed rigorous tests and evaluations, providing trust and safety to users and patients.
An ISI Mark on such equipment symbolizes that it conforms to the BIS's safety and quality requirements, which is vital for medical devices that deal with human health and safety.
Growth of the Medical Care Sector in India
India's medical sector is experiencing exponential growth due to technological innovations and increased healthcare awareness. Diagnostic devices, particularly X-ray machines, have evolved significantly and are now safer, more efficient, and user-friendly.
The rise in disposable income, access to premium healthcare services, and awareness about health and hygiene have driven demand for quality medical equipment. Additionally, healthcare insurance penetration and increasing out-of-pocket expenditure on private healthcare have further bolstered this growth. The Indian government’s goal to increase healthcare spending to 2.5% of GDP by 2025 is expected to further enhance the medical devices market, making ISI Mark Certification for Diagnostic Medical X-Ray Equipment an important compliance requirement.
Benefits of Obtaining BIS ISI Certification for Diagnostic Medical X-ray Equipment
The BIS Certification for Diagnostic Medical X-Ray Equipment offers several advantages:

Assurance of Quality: The ISI mark confirms that the X-ray equipment meets the standards of safety, durability, and performance.

Enhanced Customer Trust: ISI certification builds trust with end-users including hospitals, clinics, and diagnostic centers.

Reduction in Product Liability: A certified product is less prone to malfunction, reducing liabilities and improving patient safety.

Eligibility for Tenders and Government Supply: Government healthcare institutions usually mandate BIS certification for procurement.

Customer Grievance Redressal: If an ISI-marked product fails quality expectations, the manufacturer must replace it, ensuring accountability.

General Requirements for BIS ISI Certification for Diagnostic Medical X-ray Equipment
Mechanical and Physical Requirements
The X-ray equipment must be strong and capable of withstanding operational wear and tear without compromising safety. Metal enclosures must be of a minimum thickness of 0.6 mm to prevent damage. All moving parts must be protected to avoid user injury. Stability is mandatory, especially for equipment placed on tables or floors.
Electrical parts must be enclosed to prevent accidental contact with live wires. There must be protection against moisture, and all electrical insulation must be secure even in damp conditions.
Radiation Protection
The equipment must comply with IS 7061 standards to safeguard both operators and patients from harmful ionising radiation.
Temperature Rise
The materials used must withstand the heat generated during regular or prolonged use without any deterioration. Temperature limits for various components must not exceed prescribed safety values.
Earthing
Every exposed metal part must have proper earthing. All earthing points must be corrosion-resistant, and connections should have low resistance to prevent electric shocks.
Live Metal Parts
No enclosure part should act as a current-carrying conductor. Adequate insulation and locking mechanisms must be provided to avoid accidental contacts or misalignment.
Wiring and Terminals
All wiring must be enclosed or protected, especially for external interconnections. Only BIS-compliant or mutually agreed components must be used where IS standards do not exist.
Various Tests Required for BIS ISI Certification for Diagnostic Medical X-ray Equipment
The testing process for certification is divided into two categories:
Type Tests

Accuracy of X-ray control indications

Stabilisation under internal temperature changes

Recycling time and milliampere stabilisation

Interlock testing

Potter bucky grid pattern and clear-up tests

Installation and operation tests on tube stand and X-ray table

Body section device tests such as magnification and exposure angle

Routine Tests

Visual inspection and documentation checks

Functional tests on table, interlocks, and exposure timing

Current flow and stator functionality tests

These tests ensure that the product meets both performance and safety benchmarks set under IS 7620 (Part-1).
Documents Required for BIS ISI Certification for Diagnostic Medical X-ray Equipment
To apply for the ISI Mark Certification for Diagnostic Medical X-Ray Equipment, the following documents are required:

Factory address proof

Identity proof of applicant/manufacturer

Trademark registration certificate

Factory layout and manufacturing process flowchart

Utility bills and bank statement

Product drawings and packaging specifications

List and details of test equipment used

Certified test reports from BIS-authorised labs

Indian residency proof for domestic manufacturers/importers

Procedure for Obtaining BIS ISI Certification for Diagnostic Medical X-ray Equipment
Step 1: Select Product Code
Choose the applicable Indian Standard (IS 7620 Part-1) and corresponding product code.
Step 2: File the Application
Submit the filled application form through the BIS portal. Pay the applicable registration and inspection fees.
Step 3: Factory Inspection
BIS officials conduct a thorough inspection of the manufacturing unit. They assess production processes, safety measures, and collect product samples.
Step 4: Laboratory Testing
Collected product samples are sent to a BIS-authorised laboratory for evaluation against standard requirements.
Step 5: Review and Certification
Once all requirements are satisfactorily met, BIS grants the BIS ISI Certification for Diagnostic Medical X-Ray Equipment, authorising the use of the ISI mark.
Reasons for Rejection of BIS ISI Application
Several factors can lead to rejection:

Non-submission of product samples for testing

Incomplete or incorrect documents

Inadequate factory facilities

Lack of cooperation during factory inspection

Engagement in unethical or illegal activities by the applicant

Conclusion
The BIS Certification for Diagnostic Medical X-Ray Equipment is a vital regulatory requirement that assures safety, performance, and legal compliance. With rising demand for healthcare infrastructure and diagnostic tools, obtaining the ISI Mark Certification for Diagnostic Medical X-Ray Equipment is not only mandatory but also a competitive advantage. It empowers manufacturers and importers to legally supply quality X-ray diagnostic equipment while protecting the health and safety of patients and healthcare providers.
If you need any support or want to obtain BIS/ISI Mark Certification, then you can book a free consultation with BIS experts at Compliance Calendar LLP through email info@ccoffice.in or Call/Whatsapp at +91 9988424211.
FAQs
Q1. Which primary Indian standard applies to the general electrical safety requirements for diagnostic medical X-ray equipment under BIS certification? 
Ans. The primary Indian standard that specifies the general electrical safety requirements for diagnostic medical X-ray equipment is IS 7620 (Part 1):1993. This standard is closely aligned with international standards like IEC 60601-1.
Q2. Why is BIS certification mandatory for diagnostic medical X-ray equipment in India? 
Ans. BIS certification is mandatory for these devices in India due to Quality Control Orders (QCOs) issued by the Ministry of Health & Family Welfare and the Ministry of Electronics and Information Technology (MeitY). This ensures that the equipment is safe for patients and healthcare personnel, does not emit excessive radiation, and meets required durability and performance standards.
Q3. What are some of the key safety and technical requirements that diagnostic medical X-ray equipment must meet to obtain BIS certification? 
Ans. Key requirements include ensuring radiation safety through shielding and dose-limiting technologies, meeting electrical safety standards for insulation and grounding, adhering to mechanical safety standards for moving parts and housing, providing precise control interfaces for operators, and proper marking and labeling with manufacturer details, model number, manufacturing date, and the BIS Standard Mark.
Q4. Can you outline the general steps involved in obtaining BIS certification for diagnostic medical X-ray equipment? 
Ans. The process generally involves: (1) determining the applicable BIS standard(s), (2) submitting an application with technical documentation, (3) undergoing testing at a BIS-recognized laboratory, (4) a factory inspection by BIS officials, (5) granting of a license upon successful evaluation, and (6) post-certification surveillance to ensure ongoing compliance.
Q5. What are the potential consequences for manufacturers who sell diagnostic medical X-ray equipment in India without BIS certification? 
Ans. Manufacturers who distribute or sell uncertified X-ray equipment in India may face serious legal consequences under the BIS Act, 2016, including fines of up to INR 5 lakh, imprisonment for repeated violations, and potential seizure of products and cancellation of licenses.

Diagnostic Medical X-ray equipment plays an important role in modern healthcare by providing essential internal imaging used for diagnosis and treatment. As such equipment involves the use of radiation, safety and quality assurance become important. In India, the Bureau of Indian Standards (BIS) mandates that all manufacturers and importers of diagnostic medical X-ray equipment comply with IS 7620 (Part-1) under the BIS ISI Mark Certification scheme. This article explains in detail the BIS Certification for Diagnostic Medical X-Ray Equipment, covering requirements, procedures, benefits, and more.

Introduction to BIS ISI Certification for Diagnostic Medical X-Ray Equipment

The BIS ISI Certification for Diagnostic Medical X-Ray Equipment is a mandatory certification required for manufacturing, importing, or selling X-ray diagnostic devices in India. It ensures that the equipment complies with Indian Standard IS 7620 (Part-1) and adheres to safety, performance, and quality benchmarks. The certification signifies the product has passed rigorous tests and evaluations, providing trust and safety to users and patients.

An ISI Mark on such equipment symbolizes that it conforms to the BIS's safety and quality requirements, which is vital for medical devices that deal with human health and safety.

Growth of the Medical Care Sector in India

India's medical sector is experiencing exponential growth due to technological innovations and increased healthcare awareness. Diagnostic devices, particularly X-ray machines, have evolved significantly and are now safer, more efficient, and user-friendly.

The rise in disposable income, access to premium healthcare services, and awareness about health and hygiene have driven demand for quality medical equipment. Additionally, healthcare insurance penetration and increasing out-of-pocket expenditure on private healthcare have further bolstered this growth. The Indian government’s goal to increase healthcare spending to 2.5% of GDP by 2025 is expected to further enhance the medical devices market, making ISI Mark Certification for Diagnostic Medical X-Ray Equipment an important compliance requirement.

Benefits of Obtaining BIS ISI Certification for Diagnostic Medical X-ray Equipment

The BIS Certification for Diagnostic Medical X-Ray Equipment offers several advantages:

Assurance of Quality: The ISI mark confirms that the X-ray equipment meets the standards of safety, durability, and performance.
Enhanced Customer Trust: ISI certification builds trust with end-users including hospitals, clinics, and diagnostic centers.
Reduction in Product Liability: A certified product is less prone to malfunction, reducing liabilities and improving patient safety.
Eligibility for Tenders and Government Supply: Government healthcare institutions usually mandate BIS certification for procurement.
Customer Grievance Redressal: If an ISI-marked product fails quality expectations, the manufacturer must replace it, ensuring accountability.

General Requirements for BIS ISI Certification for Diagnostic Medical X-ray Equipment

Mechanical and Physical Requirements

The X-ray equipment must be strong and capable of withstanding operational wear and tear without compromising safety. Metal enclosures must be of a minimum thickness of 0.6 mm to prevent damage. All moving parts must be protected to avoid user injury. Stability is mandatory, especially for equipment placed on tables or floors.

Electrical parts must be enclosed to prevent accidental contact with live wires. There must be protection against moisture, and all electrical insulation must be secure even in damp conditions.

Radiation Protection

The equipment must comply with IS 7061 standards to safeguard both operators and patients from harmful ionising radiation.

Temperature Rise

The materials used must withstand the heat generated during regular or prolonged use without any deterioration. Temperature limits for various components must not exceed prescribed safety values.

Earthing

Every exposed metal part must have proper earthing. All earthing points must be corrosion-resistant, and connections should have low resistance to prevent electric shocks.

Live Metal Parts

No enclosure part should act as a current-carrying conductor. Adequate insulation and locking mechanisms must be provided to avoid accidental contacts or misalignment.

Wiring and Terminals

All wiring must be enclosed or protected, especially for external interconnections. Only BIS-compliant or mutually agreed components must be used where IS standards do not exist.

Various Tests Required for BIS ISI Certification for Diagnostic Medical X-ray Equipment

The testing process for certification is divided into two categories:

Type Tests

Accuracy of X-ray control indications
Stabilisation under internal temperature changes
Recycling time and milliampere stabilisation
Interlock testing
Potter bucky grid pattern and clear-up tests
Installation and operation tests on tube stand and X-ray table
Body section device tests such as magnification and exposure angle

Routine Tests

Visual inspection and documentation checks
Functional tests on table, interlocks, and exposure timing
Current flow and stator functionality tests

These tests ensure that the product meets both performance and safety benchmarks set under IS 7620 (Part-1).

Documents Required for BIS ISI Certification for Diagnostic Medical X-ray Equipment

To apply for the ISI Mark Certification for Diagnostic Medical X-Ray Equipment, the following documents are required:

Factory address proof
Identity proof of applicant/manufacturer
Trademark registration certificate
Factory layout and manufacturing process flowchart
Utility bills and bank statement
Product drawings and packaging specifications
List and details of test equipment used
Certified test reports from BIS-authorised labs
Indian residency proof for domestic manufacturers/importers

Procedure for Obtaining BIS ISI Certification for Diagnostic Medical X-ray Equipment

Step 1: Select Product Code

Choose the applicable Indian Standard (IS 7620 Part-1) and corresponding product code.

Step 2: File the Application

Submit the filled application form through the BIS portal. Pay the applicable registration and inspection fees.

Step 3: Factory Inspection

BIS officials conduct a thorough inspection of the manufacturing unit. They assess production processes, safety measures, and collect product samples.

Step 4: Laboratory Testing

Collected product samples are sent to a BIS-authorised laboratory for evaluation against standard requirements.

Step 5: Review and Certification

Once all requirements are satisfactorily met, BIS grants the BIS ISI Certification for Diagnostic Medical X-Ray Equipment, authorising the use of the ISI mark.

Reasons for Rejection of BIS ISI Application

Several factors can lead to rejection:

Non-submission of product samples for testing
Incomplete or incorrect documents
Inadequate factory facilities
Lack of cooperation during factory inspection
Engagement in unethical or illegal activities by the applicant

Conclusion

The BIS Certification for Diagnostic Medical X-Ray Equipment is a vital regulatory requirement that assures safety, performance, and legal compliance. With rising demand for healthcare infrastructure and diagnostic tools, obtaining the ISI Mark Certification for Diagnostic Medical X-Ray Equipment is not only mandatory but also a competitive advantage. It empowers manufacturers and importers to legally supply quality X-ray diagnostic equipment while protecting the health and safety of patients and healthcare providers.

If you need any support or want to obtain BIS/ISI Mark Certification, then you can book a free consultation with BIS experts at Compliance Calendar LLP through email info@ccoffice.in or Call/Whatsapp at +91 9988424211.

FAQs

Q1. Which primary Indian standard applies to the general electrical safety requirements for diagnostic medical X-ray equipment under BIS certification?

Ans. The primary Indian standard that specifies the general electrical safety requirements for diagnostic medical X-ray equipment is IS 7620 (Part 1):1993. This standard is closely aligned with international standards like IEC 60601-1.

Q2. Why is BIS certification mandatory for diagnostic medical X-ray equipment in India?

Ans. BIS certification is mandatory for these devices in India due to Quality Control Orders (QCOs) issued by the Ministry of Health & Family Welfare and the Ministry of Electronics and Information Technology (MeitY). This ensures that the equipment is safe for patients and healthcare personnel, does not emit excessive radiation, and meets required durability and performance standards.

Q3. What are some of the key safety and technical requirements that diagnostic medical X-ray equipment must meet to obtain BIS certification?

Ans. Key requirements include ensuring radiation safety through shielding and dose-limiting technologies, meeting electrical safety standards for insulation and grounding, adhering to mechanical safety standards for moving parts and housing, providing precise control interfaces for operators, and proper marking and labeling with manufacturer details, model number, manufacturing date, and the BIS Standard Mark.

Q4. Can you outline the general steps involved in obtaining BIS certification for diagnostic medical X-ray equipment?

Ans. The process generally involves: (1) determining the applicable BIS standard(s), (2) submitting an application with technical documentation, (3) undergoing testing at a BIS-recognized laboratory, (4) a factory inspection by BIS officials, (5) granting of a license upon successful evaluation, and (6) post-certification surveillance to ensure ongoing compliance.

Q5. What are the potential consequences for manufacturers who sell diagnostic medical X-ray equipment in India without BIS certification?

Ans. Manufacturers who distribute or sell uncertified X-ray equipment in India may face serious legal consequences under the BIS Act, 2016, including fines of up to INR 5 lakh, imprisonment for repeated violations, and potential seizure of products and cancellation of licenses.