BIS Certificate For Artificial Limbs, Rehabilitation Appliances, And Equipment For The Disabled

Obtaining BIS Certificate for Artificial Limbs, Rehabilitation Appliances, And Equipment For The Disabled is very essential for quality and safety. These products aren’t just tools, they’re life-changing aids that help people regain mobility, independence, and confidence. But how can you be sure these devices are safe and reliable? That’s where BIS certification comes in.

The Bureau of Indian Standards ensures that products meet strict safety and quality standards before they reach the market. For manufacturers, getting BIS certification isn’t just about following the rules—it’s about showing their commitment to creating top-notch, trustworthy products.

In this article, we’ll break down what BIS certification means for these essential devices, why it’s important, and how businesses can go about getting certified. Whether you’re a manufacturer, distributor, or someone curious about how these products are regulated, this guide will make it all clear and simple.

What Is BIS Certificate For Artificial Limbs, Rehabilitation Appliances, and Equipment For the Disabled?

The BIS certificate, an official document issued by the BIS, is an important quality assurance mark in India, established under the Bureau of Indian Standard Act, 1986. As a national body, BIS plays a significant role in developing and promoting standards across various sectors including medical devices for disabled persons.

The grant of the BIS certificate involves rigorous testing and evaluation of products to ensure compliance with relevant standards. BIS engages in various activities involving product certification, quality control, testing, hallmarking, calibration schemes, and many more.

Who Can Apply For BIS Certificate For Artificial Limbs, Rehabilitation Appliances, And Equipment For The Disabled?

Below are some mentioned applicants who can apply for BIS certificate for artificial limbs, Rehabilitation Appliances, and equipment for the disabled:

• Manufacturers or Companies producing artificial limbs for disabled persons can apply for a BIS certificate.
• Rehabilitation centres offering rehabilitation services can apply for a BIS certificate to ensure they meet quality standards in their services.
• Importers who want to import and sell artificial limbs in India can apply for a BIS certificate.

Benefits Of Obtaining BIS Certificate For Artificial Limbs, Rehabilitation Appliances, And Equipment For The Disabled

Here we have mentioned the benefits of obtaining BIS certification for Artificial Limbs, Rehabilitation Appliances, And Equipment For The Disabled. Here’s why it matters:

• Ensuring Safety and Quality: These devices come into direct contact with users and often bear heavy physical and emotional responsibility. BIS certification ensures that they are tested and approved for safety, preventing potential malfunctions or risks to the user.
• Building User Trust: For those who depend on these products, trust is everything. A BIS-certified product gives users confidence that the equipment they’re using is safe, reliable, and designed with their needs in mind.
• Legal Compliance: In India, BIS certification is mandatory for many medical and assistive devices. Manufacturers who comply avoid legal penalties and gain access to a wider market.
• Supporting Innovation with Accountability: Certification allows manufacturers to innovate while staying accountable to regulatory standards, ensuring advancements in design and functionality don’t compromise safety.
• Empowering Accessibility: By ensuring quality, BIS certification helps make assistive devices more effective, durable, and widely accepted, improving the lives of people with disabilities.

Hence, if you are a manufacturer or distributor get BIS certification for Artificial Limbs, Rehabilitation Appliances, and Equipment for the Disabled.

Documents Required For Obtaining BIS Certificate For Artificial Limbs, Rehabilitation Appliances, and Equipment For The Disabled 

To apply for a BIS certificate for artificial limbs, Rehabilitation Appliances, and Equipment for the disabled, the applicant must prepare and submit the following documents:

• Application Form
• Company Documents
• Quality Management System (QMS) Documents
• Product Specification
• Test Reports
• Manufacturing Detail
• Labelling and Packaging
• Financial Documents

Procedure For Obtaining BIS Certificate For Artificial Limbs, Rehabilitation Appliances, and Equipment For The Disabled 

Following are the steps involved in granting of BIS certificate for artificial limbs, Rehabilitation Appliances, and Equipment for the disabled:

• Visit BIS Website: Visit the BIS website to understand specific requirements related to artificial limbs.
• Submission of Documents: Prepare and submit the required documents as listed above.
• Fees Proof: Pay the required fees based on the type and number of products.
• Factory Inspection: BIS will review the submitted application along with the documents and may conduct an on-site inspection of your manufacturing facility to assess compliance with standards.
• Testing and Evaluation: The product may need to undergo testing at the BIS-recognized laboratory.
• Grant of Certification: Once the evaluation is successfully performed, BIS will issue the certificate.

What Are The Indian Standards For Artificial Limbs, Rehabilitation Appliances, And Equipment For The Disabled?

Here is a list of the Indian standards required for BIS Certification for Ear, Nose, and Throat Surgical Instruments. You can review them here:

SI. No.	IS No.	TITLE
1	IS 10110: 1982	Specification for table spoon terminal device for artificial limbs
2	IS 10111: 1982	Specification for table fork terminal device for artificial limbs
3	IS 10537: 1983	Specification for ankle bolt for sach foot
4	IS 10538: 1983	Specification for kitchen knife terminal device for artificial limbs
5	IS 10539: 1983	Specification for a sickle terminal device for artificial limbs
6	IS 10926: 1984	Specification for a tweezer terminal device for artificial limbs
7	IS 10928: 1984	Specification for table, tilting, and manual
8	IS 10929: 1984	Specification for hook voluntary opening terminal device for artificial limbs
9	IS 10976: 1993/ISO 6440	Wheelchairs – Nomenclature, terms and definitions (First Revision)
	(1 Revision)
10	IS 11242: 1985	Specification for lumbo-sacral flexion-extension and lateral-flexion control brace
11	IS 11243: 1985	Specification for thoraco – Lumbo – Sacral flexion – Extension and lateral – Flexion control brace
12	IS 11279: 1985	Specification for braille slate
13	IS 11316: 1985	Specification for cosmetic hand, artificial limb
14	IS 11646: Part 1: 2003	Cane for visually handicapped – Specification: Part 1 rigid, long and white (First Revision)
	(1 Revision)
15	IS 11646: Part 2: 1986	Specification for cane for visually handicapped: Part 2 folding type
16	IS 11647: 1986	Specification for braille paper
17	IS 11708:1986	Specification for hand, mechanical
18	IS 12104: 1987	Specification for abacus for visually handicapped
19	IS 12152: 1987	Specification for pocket frame, braille writing
20	IS 12184: 1987	Specification for a stylus for braille writing
21	IS 12439: 1988	Specification for signature guide for visually impaired
22	IS 12664 Part 1: 2003	Artificial limbs – Sach foot for lower extremity prostheses: Part 1 design and dimensions (First Revision)
	(1 Revision)
23	IS 12683 Part 1: 1989	Measuring devices for visually impaired persons – Specification: Part 1 scale, general purposes
24	IS 12683: Part 2: 1989	Artificial limbs – Measuring devices for visually impaired persons: Part 2 type
25	IS 12683 Part 3: 2000	Measuring devices for visually impaired persons – Specification: Part 3 goniometer
26	IS 13017: 1991	Rehabilitation equipment – Walker rollator – Specification
27	IS 13822: 1993	Braille duplicating sheet specification
28	IS 13837: 1993	Braille duplicating machine specification
29	IS 13970: Part 1:1995/ISO 8549-1	Prosthetics and orthotics – Vocabulary: Part 1 general terms for external limb prostheses and external orthoses
30	IS 13970: Part 2: 1994/ISO 8549-2	Prosthetics and orthotics vocabulary: Part 2 terms relating to external limb prostheses and wearers of these prostheses
31	IS 13970 : Part 3: 1994/ISO 8549-3	Prosthetics and orthotics vocabulary: Part 3 terms relating to external orthoses
32	IS 14429: 1997/ISO 11040-3:2012	Braille shorthand machine – Specification
33	IS 14723: 1999	Artificial limbs – Knee shin Assembly – Specification
34	IS 14879: 2000	Anterior spinal hyperextension (ASH) brace – Specification
35	IS 15376 Part 1: 2003/ISO 8670-1	Ostomy collection bags: Part 1 Vocabulary
36	IS 15376 Part 2: 2003/ISO 8670-2	Ostomy collection bags: Part 2 Requirements and test methods
37	IS 17034: 2018	Specification for Jaipur foot
38	IS 17063: 2018	Specification for rehabilitation equipment? rough terrain active wheelchairs, folding, rider – I, adult and child size
39	IS 17154: 2019	Battery-operated motorized tricycle – Specification
40	IS 17155: 2019	Tricycle, single hand propelled (?Right?/?Left?) (?Junior Size?) ? specification
41	IS 17157: 2019	Multi-utility tricycle specification
42	IS 17194: 2019	Surgical ankle boot with broad toe (Child And Adult Size) – Specification
43	IS 4534 : 1980	Specification for adapter for terminal devices, artificial limbs (First Revision)
	(1 Revision)
44	IS 4535: 1968	Specification for saw – Grip terminal device for artificial limbs
45	IS 4554: 1968	Specification for hammers terminal devices, ball pein and claw, for artificial limbs
46	IS 4555: 1980	Specification for biprong terminal device, draughtsman, for artificial – Limbs (First Revision)
	(1 Revision)
47	IS 4556 : 1968	Specification for typing finger terminal device for artificial limbs
48	IS 4567: 1968	Specification for pliers terminal device, quick – Grip, for artificial limbs
49	IS 4577: 1980	Specification for spade – Grip terminal device for artificial limbs (First Revision)
	(1 Revision)
50	IS 4609: 1980	Specification for a pencil – A holding device for artificial limbs (First Revision)
	(1 Revision)
51	IS 4675: 1968	Specification for light split-hook device for artificial limbs
52	IS 4677: 1968	Specification for steering appliance for artificial limbs
53	IS 5015: 1969	Specification for knife – Terminal device for artificial limbs
54	IS 5143: 1988	Specification for adjustable axillary crutches (Second Revision)
	(2 Revision)
55	IS 5144: 1980	Specification for metal forearm crutches (Canadian Pattern) (First Revision)
	(1 Revision)
56	IS 5145: 1969	Specification for walking sticks
57	IS 5150: 1969	Specification for rubber tips for crutches and walking sticks
58	IS 5586: 1970	Specification for metal component for sectional forearm
59	IS 5594: 1983	Specification for wrist unit, rotary, for hand prosthesis (First Revision)
	(1 Revision)
60	IS 5603: 1983	Specification for mechanical elbow joint (First Revision)
	(1 Revision)
61	IS 5607: 1970	Specification for semi – Automatic elbow joint
62	IS 5665: 1982	Specification for shoulder wheel (First Revision)
	(1 Revision)
63	IS 5745: 1986	Specification for heel socket and plate for orthosis (First Revision)
	(1 Revision)
64	IS 5796: 1970	Specification for disc type weight set for physio – Therapy exercisers other than pulley arrangements
65	IS 5809: 1986	Specification for ankle joint for orthosis (First Revision)
	(1 Revision)
66	IS 5810: 1986	Specification for knee joint with lock for orthosis (First Revision)
	(1 Revision)
67	IS 5827: 1982	Specification for paraffin wax bath (First Revision)
	(1 Revision)
68	IS 5956: 1986	Specification for hip joint with lock for orthosis (First Revision)
	(1 Revision)
69	IS 5963: 1971	Specification for knee joint without lock for steel orthopaedic calipers
70	IS 5964: 1971	Specification for round spur for orthopaedic calipers
71	IS 6069: 1971	Specification for sliding seat exerciser
72	IS 6099: 1991	Rehabilitation equipment – Invalid walkers with crutches – Specification (Second Revision)
	(2 Revision)
73	IS 6205: 1982	Specification for stationary cycle exerciser for adults (First Revision)
	(1 Revision)
74	IS 6221: 1971	Specification for a pelvic band for steel orthopaedic calipers and braces
75	IS 6222: 1971	Specification for thigh band for orthopaedic calipers and braces
76	IS 6223: 1971	Specification for calf band for orthopaedic calipers and braces
77	IS 6224: 1980	Specification for tuber band for orthopaedic calipers and braces
	(1 Revision)
78	IS 6275: 1971	Specification for lower extremity full length brace with joints with locks
79	IS 6302: 1971	Specification for whirlpool bath
80	IS 6414: 1972	Specification for parallel walking bars, adult and child sizes, for the handicapped
81	IS 6571: 1991	Rehabilitation equipment – Wheelchairs, non – Folding, adult size, institutional model – Specification (First Revision)
	(1 Revision)
82	IS 6624333: 1972	Specification for basic hand splint, palmar arch support
83	IS 66253333: 1972	Specification for basic hand splint component
84	IS 6626: 1972	Specification for basic hand splint, forearm piece
85	IS 6781: 1972	Specification for staple ankle joint
86	IS 6802: 1986	Specification for prosthetic hip joint (First Revision)
	(1 Revision)
87	IS 6809: 1990	Rehabilitation equipment – Fixed height walking frame – Specification (First Revision)
	(1 Revision)
88	IS 6810: 1990	Rehabilitation equipment – Metal tripod and tetrapod sticks- Specification (First Revision)
	(1 Revision)
89	IS 6812: 2003	The knee joint, uniaxial for below knee prostheses – Specification (Second Revision)
	(2 Revision)
90	IS 6979: 1973	Specification for cerebral palsy chai, tubular, institutional model
91	IS 6992: 1982	Specification for cerebral palsy chair, domestic model (First Revision)
	(1 Revision)
92	IS 6993: 1973	Specification for pan knee joint
93	IS 6995: 1973	Specification for cruciform below-knee joint
94	IS 7373: 2003	Hip disarticulation joint unit for lower limb prosthetic fitments – Specification (Second Revision)
	(2 Revision)
95	IS 7419: 1983	Requirements for stairs for physical rehabilitation (First Revision)
	(1 Revision)
96	IS 7454 : 1991	Rehabilitation equipment – Wheelchairs, folding, adult size- Specification (First Revision)
	(1 Revision)
97	IS 7924: 1976	Specification for thigh blocks, wooden
98	IS 8086: 1991	Rehabilitation equipment – Wheelchairs, folding, junior size- Specification (First Revision)
	(1 Revision)
99	IS 8088: 2019	Tricycle, hand-propelled specification (First Revision)
	(1 Revision)
100	IS 8492 : 1985	Specification for ankle blocks, wooden (First Revision)
	(1 Revision)
101	IS 8511: 1985	Specification for valves for suction socket for artificial limbs (First Revision)
	(1 Revision)
102	IS 8798 : 1978	Specification for wheel, multipurpose
103	IS 9471: Part 1: 1980	Specification for modular lower limb orthotic components: Part 1 stirrups
104	IS 9471 : Part 2 : 1980	Specification for modular lower limb orthotic components: Part 2 stirrups, split
105	IS 9471 : Part 3 : 1980	Specification for modular lower limb orthotic components: Part 3 stirrup plates
106	IS 9471: Part 4: 1980	Specification for modular lower limb orthotic components: Part 4 joint unit, ankle
107	IS 9471: Part 5: 1980	Specification for modular lower limb orthotic components: Part 5 joint unit, knee
108	IS 9471: Part 5: Sec 2 : 2019	Specification for modular lower limb orthotic components: Part 5 joint unit section 2 standard knee
109	IS 9471 : Part 6 : 2000	Modular lower limb orthotic components part 6 orthotic hip joint (Joint Unit, Hip Drop Lock) – Specification
110	IS 9471 : Part 7 : 2000	Modular lower limb orthotic components – Specification: Part 7 orthotic joint bars, ankle and knee (Upper And Lower)
111	IS 9797 : 1981	Specification for cycle, fret – Saw
112	IS/ISO 16021: 2000/ISO 16021 :2000	Urine-Absorbing Aids — Basic Principles for Evaluation of Single-Use Adult-Incontinence- Absorbing Aids from the Perspective of Users and Caregivers
113	IS/ISO 22523: 2006/ISO 22523:2006	External limb prostheses and external orthoses – Requirements and test methods
114	IS/ISO 22675: 2016/ISO 22675:2016	Prosthetics – Testing of ankle – Foot devices and foot units – Requirements and test methods
115	IS/ISO 7176: Part 26: 2007/ISO 7176-26: 2007	Wheelchairs: Part 26 Vocabulary
116	IS/ISO 8669: Part 2:1996/ISO 8669-2:1996	Urine Collection Bags Part 2 Requirements and Test Methods

What Is The Validity Of BIS Certificate For Artificial Limbs, Rehabilitation Appliances, And Equipment For The Disabled?

A BIS certificate for Artificial Limbs, Rehabilitation Appliances, and Equipment for the Disabled is typically valid for one year, after which renewal is necessary. Renewal involves a reassessment of compliance with the standards and may require updated documentation and fees.

Timeline For Obtaining BIS Certificate For Artificial Limbs, Rehabilitation Appliances, And Equipment For The Disabled

The timeline for granting of BIS certificate for Artificial Limbs, Rehabilitation Appliances, and Equipment for the Disabled may take around 30-40 days based on the effectiveness of the application.

How ELT Corporate Can Assist You With BIS Certificate For Artificial Limbs, Rehabilitation Appliances, And Equipment For The Disabled?

At ELT corporate, we ensure the timely submission of applications and grant of BIS certificates. We specialize in obtaining BIS certificates for our clients navigating the regulatory framework backed by years of experience in the medical device sector.

Obtaining a BIS certificate through ELT corporate guarantees that your product meets stringent safety and quality standards. We make the certification process seamless, saving you time and effort. Let’s connect for further information.