Modular lower limb orthotic devices have found extensive use in rehabilitation medicine, orthopaedic surgery, and ambulation aids among lower limb disabled persons. Various parts of an orthosis assembly such as stirrup plates, are important components for achieving correct positioning and proper load transfer and stability of the assembled orthosis. Hence, BIS Certification for Modular Lower Limb Orthotic Components Stirrup Plates according to IS 9471 (Part 3):2024 is necessary for manufacturers.
The Indian Standard IS 9471 (Part 3):2024 describes specifications with respect to mechanical strength, load-carrying capacity, dimensional accuracy, material properties, surface characteristics, corrosion resistance, and fatigue resistance properties. Specifications mentioned will help achieve efficient performance of stirrup plates under repetitive loading conditions.
This is the Indian Standard for Modular Lower Limb Orthotic Components Stirrup Plates used in orthotic and prosthetic systems for rehabilitation and mobility support. It defines the design requirements, mechanical strength, material specifications, and performance criteria to ensure safe and reliable use in medical applications. As per the BIS (Bureau of Indian Standards), these stirrup plates are:
Certification of Modular Lower Limb Orthotic Components Stirrup Plates: IS 9471 (Part 3):2024 is necessary in ensuring compliance with standards regarding the material quality, dimensional accuracy, manufacturing process workmanship and zinc plating. Since stirrup plates constitute an important load-carrying member of orthoses like AFOs (Ankle-Foot Orthoses) and KAFOS (Knee-Ankle-Foot Orthoses), their certification ensures that they offer a reliable structure support, proper alignment and also protect from corrosion to enable safe use during rehabilitation.
BIS authorisation under IS 9471 (Part 3):2024 is required for businesses involved in manufacturing, importing, or supplying Lower Limb Orthosis Stirrup Plates in India.
Applicable to:
To maintain uniform standards for Modular Lower Limb Orthotic Components - Stirrup Plates, the Bureau of Indian Standards (BIS) provides certain minimum standards as per IS 9471 (Part 3):2024. This certification is necessary to guarantee that stirrup plates made by manufacturers will have sufficient mechanical strength, proper dimensions, material consistency, and performance reliability. The following are the Stirrup Plate testing requirements according to BIS standards:
The BIS Authorisation process ensures that Modular Lower Limb Orthotic Components Stirrup Plates (IS 9471 (Part 3):2024) meet the required standards for safe, reliable, and consistent performance in orthotic applications. This process is governed by the Bureau of Indian Standards (BIS) and includes the following steps:
The Foreign manufacturers must designate an Authorized Indian Representative (AIR) in India. The representative is the local point of contact for the Bureau of Indian Standards (BIS) and manages all compliance and regulatory requirements in India.
Once the manufacturer is licensed under the BIS, the ISI Mark Certification for Orthotic Components Stirrup Plates must be clearly marked on the orthotic component itself and/or the packaging. Other important information, such as the manufacturer's identification and BIS license number (CM/L), also needs to be marked along with it. Other relevant details are given below:
Note: Marking is typically applied using durable stamping, tagging, or permanent printing to ensure clear identification during handling, storage, and transportation, as per BIS marking requirements.
The BIS Approval fee for Lower Limb Orthotic Stirrup Plates comprises application, inspection, license, testing, and marking fees. The above fees should be paid to BIS in accordance with Scheme I, and these fees may change as per the scope of the product and other relevant criteria.
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The effectiveness of modular lower limb orthotic devices can be largely influenced by the quality, precision in dimensions, and resistance to corrosion of stirrup plates. IS 9471 (Part 3):2024 helps the manufacturers in making sure that their stirrup plates comply with the standards of materials, dimensions, manufacturing process, craftsmanship, and zinc plating. BIS Certification of Modular Lower Limb Orthotic Devices Stirrup Plates assists in building trust among the medical personnel, orthotists, rehab facilities, and end-users.
Obtaining certification from BIS under IS 9471 (Part 3):2024 is a method that will ensure the market acceptance of Stirrup Plates as well as indicate a manufacturer's dedication to quality and compliance. For manufacturers requiring help with technical document preparation, product testing coordination, BIS certification and other related matters, EVTL India provides professional certification services.