Infusion pumps are a critical component in modern medical care, widely used in hospitals, clinics, and emergency response setups. These devices administer fluids, nutrients, or medications into a patient’s body in controlled amounts, making accuracy and reliability non-negotiable.
Given their role in delivering life-saving treatments, infusion pumps are now subject to stringent quality control measures under the regulatory framework of the Bureau of Indian Standards (BIS). BIS certification ensures that only devices conforming to safety, performance, and usability standards are sold or used in India.
This article offers a detailed breakdown of the BIS certification process for infusion pumps, applicable Indian standards, documentation requirements, benefits, and legal implications of non-compliance.

What is an Infusion Pump?

An infusion pump is a medical device used to deliver fluids, medication, or nutrients into a patient’s circulatory system. They are often used in:

• Intensive Care Units (ICUs)
• Operating rooms
• Oncology treatment
• Neonatal care
• Home care settings

There are various types of infusion pumps:

• Syringe pumps
• Volumetric pumps
• Ambulatory pumps
• Insulin pumps
• Elastomeric pumps

Due to the critical nature of their application, malfunction or inaccuracy can lead to serious health complications or even fatalities.

What is BIS Certification?

BIS certification, managed by the Bureau of Indian Standards under the Ministry of Consumer Affairs, ensures that products meet stringent quality, Safety, and reliability standards before reaching the Indian market. Products with ISI mark or BIS logo have undergone rigorous testing and comply with the relevant Indian Standards, offering trust to consumers and helping legal compliance for businesses.

Read More: Introduction To Bureau Of Indian Standards

Why is BIS Certification Mandatory for Infusion Pumps?

To ensure safety, accuracy, and reliability, the Government of India has made BIS certification compulsory for certain categories of medical devices under Quality Control Orders (QCOs).
For infusion pumps, this means:

• Manufacturers must meet Indian safety and performance standards
• Devices must be tested in BIS-recognised laboratories
• Only certified products bearing the ISI mark or BIS registration number can be sold

Legal Framework for BIS Certification

1. BIS Act, 2016

Provides the legal basis for certification, enforcement, penalties, and recall procedures.

 2. Medical Devices Rules, 2017 (MDR 2017)

While BIS handles quality standards, MDR governs the licensing and classification of medical devices, including infusion pumps.

3. Quality Control Orders (QCOs)

Infusion pumps are covered under a specific QCO issued by the Ministry of Health and Family Welfare, making compliance with BIS standards mandatory.

Applicable Indian Standard for Infusion Pumps

The key standard applicable is:

• IS/IEC 60601-2-24:2012
  Medical electrical equipment — Particular requirements for the safety and essential performance of infusion pumps and controllers

This standard addresses:

• Electrical and functional safety
• Infusion accuracy
• Alarm systems
• User interface
• Electromagnetic compatibility
• Battery operation safety

Who Must Obtain BIS Certification for Infusion Pumps ?

\Below we mentioned who must obtain BIS certificate for infusion pumps?

BIS Certification Schemes Applicable to Infusion Pumps

 1. ISI Mark Scheme (Scheme-I)

• Mandatory for all domestic manufacturers
• Requires factory inspection, product testing, and ISI mark stamping

 2. FMCS (Foreign Manufacturers Certification Scheme)

• Applicable to foreign manufacturers
• Requires appointment of an Authorized Indian Representative
• Includes overseas factory inspection by BIS officials or third-party auditors

Step-by-Step Process for BIS Certification of Infusion Pumps

Below we mationed some process for BIS Certificate for infusion pumps:

Step 1: Determine Certification Category

Check the BIS QCO to determine if the infusion pump is covered under:

• ISI Mark Scheme (for all classes)
• CRS (rarely applicable to infusion pumps)

Step 2: Documentation Preparation

Documents Required

• Manufacturing License or Company Incorporation Certificate
• Quality Management System (QMS) certificate – ISO 13485 preferred
• List of equipment and machinery
• Flow chart of manufacturing process
• Device Master File (DMF) & Plant Master File (PMF)
• Product technical specification sheet
• Label artwork
• List of standards being followed

Foreign manufacturers must also provide:

• Power of Attorney for AIR
• AIR’s authorization letter

Step 3: Product Testing in BIS-Recognized Lab

• Infusion pumps must undergo testing in a BIS-approved laboratory as per IS/IEC 60601-2-24
• Parameters tested include:
  
  • Infusion rate accuracy
  • Over-delivery and under-delivery limits
  • Alarm functions
  • Battery backup
  • EMI/EMC compliance
• The lab issues a detailed test report, which must be submitted with the application

Step 4: Factory Audit (for ISI or FMCS)

• BIS officials will inspect the factory for:
  • Raw material sourcing and QC
  • In-process checks
  • Final inspection procedures
  • Calibration records
  • packaging and labeling compliance

For foreign applicants, BIS may conduct a remote or physical inspection with the help of BIS empaneled auditors.

Step 5: Grant of BIS License

Once testing and audit are cleared, BIS will:

• Issue an ISI license under Form VI for domestic manufacturers
• Issue FMCS certificate for foreign manufacturers

The license remains valid for two years, and must be renewed upon expiry.

Step 6: Marking Requirements

Each certified infusion pump must display:

• ISI mark and license number (e.g., CM/L-1234567)
• Standard number (IS/IEC 60601-2-24)
• Manufacturer name and address
• Batch/serial number and manufacturing date

Markings must be durable, clear, and tamper-proof.

Timeline for BIS Certification

What is the Cost of BIS Certification for Infusion Pumps

Penalties for Non-Compliance

Renewal of BIS Certification

• License is valid for 2 years
• Renewal requires:
  • Submission of updated test reports
  • Payment of renewal fee
  • Declaration of continued compliance
    
• Periodic surveillance audits are conducted by BIS

Benefits of BIS Certification for Infusion Pumps

Below, we mentioned some benefits of BIS Certification for infusion pumps:

 For Manufacturers

• Legal compliance and eligibility for public procurement
• Competitive edge in institutional sales and tenders
• Enhanced consumer and healthcare provider trust

 For Importers

• Smooth customs clearance
• Access to e-commerce and hospital distribution networks

 For Consumers and Hospitals

• Assurance of safety and precision
• Reliable product backed by regulatory certification
• Reduced risk of failure or malfunction

BIS CARE App: Consumer Verification Tool

Consumers, hospitals, and procurement authorities can verify the certification using the BIS CARE mobile app. By entering the ISI license number, users can:

• Validate the authenticity of the product
• Access manufacturer details
• Lodge complaints or report misuse

Recent Developments & Trends

• BIS is moving toward digital audits and paperless licensing
• Integration of Unique Device Identification (UDI) with BIS registration is underway
• Post-market surveillance of BIS-certified devices is being strengthened
• Increased crackdown on non-compliant imports

Conclusion

Infusion pumps play a pivotal role in patient care, and their performance cannot be compromised. By making BIS certification mandatory, the Indian government ensures that only safe, reliable, and standard-compliant devices are made available in the healthcare ecosystem.

Manufacturers and importers must treat BIS certification not merely as a legal requirement, but as a quality assurance and brand-building opportunity. It opens doors to new markets, builds trust among healthcare providers, and most importantly, saves lives.