BIS Certification for Modular Lower Limb Orthotic Components - Stirrups, Split (IS 9471 (Part 2): 2026) mentions safety and performance criteria. It also outlines the ISI marking requirements for split stirrups for modular orthotic systems for the lower limb.
BIS for IS 9471 (Part 2) serves as a guide for companies to manufacture reliable, compatible and safe Orthotic components. In addition, it ensures clinicians choose components that will be compatible with the existing devices and meet the Indian standards. Thus it guarantees the orthotic component is safe for use.
The process of BIS Registration for Stirrups ensures that the product has been manufactured according to the Indian quality standards. The BIS ISI Mark Certification for Split Stirrups is useful for manufacturers as it increases their customers' confidence and expands their presence in the Indian market. For healthcare professionals and end-users, BIS-certified split stirrups provide reliability and high performance during everyday activities.
What is IS 9471 (Part 2):2026?
IS 9471 (Part 2):2026 is an Indian Standard that outlines technical specifications of Modular Lower Limb Orthotic Components - Split Stirrups. The standard includes technical specifications related to design, materials, dimensions, mechanical properties, anti-corrosion treatment and performance testing of split stirrups. The BIS for IS 9471 (Part 2) ensures that split stirrups are strong and fit properly with the orthotic devices.
Key Requirements for Split Stirrups
Some of the important requirements that have been mentioned in BIS IS 9471 (Part 2):2026 are as follows -
- Strong steel or approved alloy construction
- Accurate dimensions for proper fitting
- Smooth edges without sharp projections
- High resistance to corrosion and wear
- Sufficient load-bearing strength
- Secure connection with orthotic assemblies
Eligibility for BIS Certification under IS 9471 (Part 2):2026
The BIS Certification under IS 9471 (Part 2):2026 applies to companies engaged in the manufacturing or supplying of Split Stirrups for the Indian market.
Applicable To -
- Indian Manufacturer - Required to obtain BIS approval if the product is covered under the applicable BIS QCO for Split Stirrups.
- Foreign Manufacturer - They need to get a BIS License for Split Stirrups to sell the Orthotic Components in the Indian market.
- Importers - Should ensure that the imported Split Stirrups are BIS-certified before supplying them in India.
Benefits of BIS ISI Mark for Split Stirrups
BIS License for split stirrups as per BIS IS 9471 (Part 2):2026 offers many advantages for manufacturers, importers and sellers. Some of the benefits include -
- Better product credibility in the market.
- Easier acceptance by hospitals, clinics, and dealers.
- Improved confidence in safety and quality.
- Support for regulatory compliance where certification is required.
BIS Testing Requirements for Split Stirrups as per IS 9471 (Part 2)
The BIS testing requirement for split stirrups under IS 9471 (Part 2):2026 checks whether the split stirrups comply with all quality and strength standards. The BIS testing parameters and quality checks for the Orthotic Components Stirrups Split are mentioned below -
- Dimensional Tests: Check the shape, size, and overall dimensions of split stirrups to ensure accurate measurements and proper fit.
- Workmanship & Finish Tests: Inspect surface finish, edges, plating quality, and workmanship to ensure smooth construction and user safety.
- Visual Inspection: Verify product marking, appearance, and manufacturing defects to ensure BIS compliance and defect-free products.
- Quality Control Checks: Review production records, equipment calibration, and inspection procedures to ensure consistent product quality and compliance with BIS requirements.
Process to Obtain BIS License for Split Stirrups (IS 9471 (Part 2): 2026)
The BIS Registration for Split Stirrups includes several steps that ensure the manufacturer completes each step to obtain the BIS Approval for Split Stirrups. The steps mentioned below can be followed by manufacturers to get the BIS ISI Mark for Split Stirrups -
- Online Registration - Registration of the company and product at the BIS portal.
- Product Testing - Product samples should be sent to BIS-accredited laboratories.
- Application Filing - Technical documents and manufacturing information should be filed.
- Factory Inspection - BIS will conduct a factory inspection and quality control process.
- Grant of BIS License - If all the above requirements are satisfactorily met, BIS grants the certification license under Scheme-I.
- Use of ISI Mark - After approval, the manufacturer can affix the ISI mark on the Split Stirrups
Documents Required for BIS License under IS 9471 (Part 2):2026
To obtain the BIS ISI Mark for Split Stirrups, manufacturers must submit the following documents to the BIS -
- GST Registration Certificate
- Company Registration Documents
- Factory Address Proof (Ownership/Rent Agreement/Lease Deed)
- Manufacturing Process Flow Chart
- Factory Layout Plan
- Product Technical Specifications (TDS)
- List of Manufacturing Machinery
- List of Raw Materials and Supplier Details
- Raw Material Test Certificates
- List of Testing Equipment
- Calibration Certificates of Testing Equipment
- Quality Control (QC) In-charge Details and Qualification
- Product Marking and Labeling Details
- Annual Production Capacity Details
- Trademark / Brand Authorization Documents (if applicable)
- Consent Letter from a BIS-Recognized Laboratory
- Authorization Letter for the Authorized Signatory
- Required BIS Undertakings and Declarations
For Foreign Manufacturers -
- Authorized Indian Representative (AIR) Agreement
- AIR Nomination Form
- Scope of License and Required Undertakings
ISI Marking Requirements under BIS for IS 9471 (Part 2): 2026)
Once a company gets a BIS License as per IS 9471 (Part 2):2026, the ISI mark must be displayed on each Split Stirrup or on its package. Additional details are mentioned below -
| Requirement | Details |
|---|
| ISI Mark | Indicates BIS-certified product |
| Standard Number | IS 9471 (Part 2):2026 |
| CML Number | Certification Marks Licence Number issued by BIS |
| Manufacturer Details | Name or Registered Trademark |
| Batch / Date | Batch Number or Manufacturing Date |
Validity of BIS Licence for IS 9471 (Part 2):2026
| Particulars | Details |
|---|
| Validity | Usually 1 to 5 years depending on BIS approval |
| Renewal | Apply before licence expiry with updated documents |
| Surveillance | BIS conducts regular inspections and sample testing |
| Compliance | Continuous compliance with BIS standards is mandatory |
| Risk | Non-compliance may lead to suspension or cancellation of licence |
BIS ISI Mark Certification Fee Structure for Split Stirrups
The overall cost of BIS Approval for Orthotic Component Split Stirrups includes application fee, audit fee, license fee, product test fee, marking fee and consultancy fee when applicable. Further details are mentioned below -
| Charge Type | Indian Manufacturers | Foreign Manufacturers |
|---|
| Application Fee | INR 1,000 | USD 15 |
| Audit Charges | INR 7,000 | USD 3,200 - 5,900 |
| License Fee | INR 1,000 | USD 15 |
| Marking Fee | As applicable | As applicable |
| Testing Charges | As applicable | As applicable |
| EVTL India Consultancy Fee | As per actual | As per actual |
Note -
- Application fee for foreign manufacturers is payable via SWIFT (SAARC countries may pay in INR with applicable GST).
- Audit charges for foreign manufacturers vary based on country/location.
- The marking fee is determined based on the product category and production volume (MSME benefits may apply).
- Testing charges are paid directly to BIS-recognised laboratories.
- Consultancy fees vary depending on product type and factory location.
Why Choose EVTL India as Your BIS Consultant for Split Stirrups?
A BIS Consultant for Split Stirrups guide the manufacturer on BIS standards and documentation to meet BIS compliance requirements. Assistance from a professional BIS Agent for Split Stirrups makes the certification process easy.
Manufacturers in search of a professional BIS Agent for Stirrups can contact EVTL India. The team of professionals assists applicants in preparing documents, conducting tests, undergoing inspections, and complying with BIS regulations. Being one of the top BIS consultants in India, we offer support in -
- Factory Inspection Support: BIS ISI Mark Consultant for Split Stirrups, like EVTL India, helps manufacturers prepare for BIS factory inspections under IS 9471.
- Compliance Assistance: BIS Consultant for IS 9471 (Part 2):2026 ensures compliance with BIS requirements while reducing documentation errors and certification delays.
- Application & Follow-up: As a BIS Agent for Split Stirrups, our team manages application submission on behalf of the manufacturers.
- Documentation Support: BIS ISI Mark Consultant for Split Stirrups assists in preparing and verifying BIS application documents and technical records.
- Testing Coordination: With 12+ years of experience, EVTL India coordinates product testing with BIS-approved laboratories and reviews test reports.
Conclusion
BIS certification for Split Stirrups as per IS 9471 (Part 2): 2026 is important to maintain the quality of the orthotic component. BIS License for Split Stirrups ensures that the product meets the design, strength, durability and performance standards.
Obtaining the BIS Approval for the Split Stirrups also helps the manufacturers maintain product quality during manufacturing.
With assistance from a BIS Consultant for Split Stirrups, manufacturers can avoid documentation errors. EVTL India, a Top BIS consultant in India, assists manufacturers in obtaining their BIS ISI mark for Stirrups easily.
