BIS Certificate For Ophthalmic Instruments And Appliances

bis certification for Ophthalmic Instruments And Appliances

Whether you’re a manufacturer, supplier, or healthcare professional, obtaining BIS Certificate for Ophthalmic Instruments And Appliances is very important. Products like surgical microscopes, diagnostic equipment, and other tools are critical for patient safety and treatment effectiveness. Therefore, ensuring these devices meet the required BIS standards is vital before entering the Indian market. The BIS certificate guarantees that your ophthalmic instruments comply with national quality standards, enhancing credibility and marketability. This article will explore the BIS Certificate for ophthalmic instruments, the certification process, its benefits, and many more.

Table of Contents

What Is BIS Certification For Ophthalmic Instruments And Appliances?

The BIS Certificate for ophthalmic instruments and appliances is an official approval ensuring these medical devices meet safety and quality standards set by the Bureau of Indian Standards. It acts as a stamp of approval, confirming that products like surgical microscopes and diagnostic tools are safe and effective.

Instruments undergo rigorous testing and evaluation to get BIS certification. For manufacturers and suppliers, having the BIS mark builds trust with healthcare providers and opens up wider market opportunities. It’s an essential step for anyone in the ophthalmic field looking to ensure product reliability and compliance with national standards.

Importance Of Obtaining BIS Certificate For Ophthalmic Instruments And Appliances Products?

Obtaining a BIS Certification for ophthalmic instruments and appliances is crucial for several reasons:

Safety Guarantee: The certification ensures that products meet stringent safety and quality standards, protecting patients and healthcare providers.
Regulatory Compliance: Many healthcare facilities and regulatory bodies require BIS certification to comply with national regulations, helping you avoid legal issues.
Market Access: obtaining a BIS Certificate for your product can open doors to new markets and customers, as many distributors and healthcare institutions prioritise certified products.
Consumer Trust: Patients and healthcare professionals are more likely to trust and choose products that have been certified. Hence, getting a BIS marked on your product will be very beneficial.
Risk Management: The certification process involves thorough testing and evaluation, helping identify potential issues early on, which can minimise risks in product use.
Competitive Advantage: In a crowded market, having a BIS Certificate can set you apart from competitors who may not have this certification, making your products more appealing.

Therefore, obtaining a BIS license for Ophthalmic Instruments And Appliances is not just a regulatory requirement; it’s a crucial step in ensuring quality, safety, and success in the market.

How Can You Obtain BIS Certification For Ophthalmic Instruments And Appliances?

Here, we have explained the step-by-step process for obtaining a BIS Certificate for ophthalmic instruments and appliances:

Identify The Standards: Start by familiarising yourself with your product type’s specific standards and requirements. The BIS has guidelines depending on the instruments or appliances you want to certify.
Prepare Your Documentation: Gather all necessary documents, including product specifications, manufacturing details, and any existing test reports. This paperwork is crucial for the application process.
Testing: Your products must undergo testing at a BIS-recognized laboratory. This step ensures that your instruments meet the required safety and quality standards. Make sure to choose a lab that specialises in ophthalmic devices.
Submit Your Application: Once you have your documents and test results, complete the BIS application form and submit it with all the necessary paperwork. This is where you officially apply for the certification.
Factory Inspection: A BIS inspector will visit your manufacturing place to ensure everything complies with the standards. So, be prepared to demonstrate your processes and quality controls during this inspection.
Receive Your Certificate: If your application is approved and everything checks out, you’ll receive your BIS Certificate for the ophthalmic instrument.

Documentation Required To Get BIS Certificate For Ophthalmic Instruments And Appliances

Here’s the list of documents needed to obtain BIS certification for ophthalmic instruments and appliances:

Application Form
Product Specifications
Test Reports
Quality Management System (QMS) Documents
Manufacturing Process Details
Labeling and Packaging Information
Company Profile
Compliance Certificates (if applicable)
Fees Payment Proof

List Of Indian Standards Of BIS For Ophthalmic Instruments And Appliances

Here we have listed down products covered under the BIS certificate For Ophthalmic Instruments And Appliances:

SI. No.	IS No.	TITLE
1	IS 10058: 1985	Breaker and Holder, Razor Blade, Barraquer’s Pattern
2	IS 10058: 1985	Punch, Lacrymal Bone, Beyer’s Pattern
3	IS 10058 : 1985	Forceps, Fixation, Graefe’s Pattern (Modified)
	(1 Revision)
4	IS 10389: 1983	Fixation Hook, Eye, Guthrie’s Pattern
5	IS 10390: 1983	Specification for muscle hook
6	IS 10408: 1983	Spatula, Eye, Green’s Pattern
7	IS 10696: 1983	Specification for round segment fused bifocal blanks
8	IS 10847: 1984	Specification for Speculum with Screw Adjustment, Eye, Right and Left, Arruga’s Pattern
9	IS 10848: 1984	Irrigator Anterior Chamber, Eye, Bishop Harmann’s Pattern
10	IS 11244: 1985	Specification for trephine, bone lacrimal with handle
11	IS 12947: 1990	Eye surgery instruments tonometers – Specification
12	IS 13783: 1993/IS0 8429: 1986	Optics and optical instruments – Ophthalmology – Graduated dial scale
13	IS 14895: 2000	Ophthalmic instruments – Spuds, foreign body – Waltons sizes 1 and 1.5 mm wide, stainless steel – Specification
14	IS 4382: 1967	Specification for non – Tinted ophthalmic glass
15	IS 4569: Part 1: 1985	Specification for scissors, eye: Part 1 corneal (Second Revision)
	(2 Revision)
16	IS 4569: Part 2: 1985	Specification for scissors, eye: Part 2 conjunctival, blunt and sharp – Point scissors (Second Revision)
	(2 Revision)
17	IS 4569: Part 3: 1985	Specification for scissors, eye: part 3 scissors, tenotomy (Second Revision)
	(2 Revision)
18	IS 4569: Part 4: 1985	Specification for scissors, eye: Part 4 scissors, enucleation (Second Revision)
	(2 Revision)
19	IS 4569: Part 5: 1985	Scissors, Eye – Part 5: Scissors, Spring Action, Vanna’s Pattern (Modified)
	(2 Revision)
20	IS 4569: Part 6: 1985	Specification for scissors, eye: Part 8 scissors, Iris (Second Revision)
	(2 Revision)
21	IS 4790: 1989	Eye Surgery Instruments – Knife, Corneal Splitting, Lang’s and Tooke’s Pattern (Modified)
	(2 Revision)
22	IS 4978: 1985	Specification for forceps, eye, fixation (Toothed) (First Revision)
	(1 Revision)
23	IS 5157: 1981	Specification for forceps, eye, and Iris (First Revision)
	(1 Revision)
24	IS 5232: 1990	Eye Surgery Instruments – Forceps, Eye, Cilia, Beer’s
	(2 Revision)	Pattern (modified)
25	IS 5367: 1969	Forceps, Eye, Strabismus for Advancement (Prince’s and Worth’s Patterns)
26	IS 5668: 1989	Eye surgery instruments – Forceps, eye, dissecting, serrated, fine specification (First Revision)
	(1 Revision)
27	IS 5678: 1970	Forceps, Eye, Conjunctival, Suture (Moorfield’s Pattern)
28	IS 5721: 1970	Forceps, Eye, Peripheral Iridectomy (Sinclair’s pattern)
29	IS 5722: 1970	Hook, Eye, Iris (Tyrrell’s Pattern)
30	IS 6420: 1989	Eye Surgery Instruments – Retractor, Eye Lachrymal Sac, Muller’s Pattern (Modified)
	(1 Revision)
31	IS 6472: 1971	General requirements for tinted ophthalmic glass
32	IS 6473: 1972	Specification for trial spectacle lens sets
33	IS 7006: 1973	Specification for visual acuity test charts
34	IS 7734: 1975	Forceps, Eye, Peripheral Iridectomy, Traquair’s Pattern
35	IS 7758: 1975	Curette, Eye, Evacuation, Moorfield’s Pattern
36	IS 7762: 1975	Specification for hook, eyelid
37	IS 7767: 1975	Spatula, Eye, Cyclodialysis, Sinclair’s Pattern
38	IS 7786: 1975	Retractor, Eyelid, Desmarre’s Pattern
39	IS 8106: 1976	Needle Holder, Eye, Kalt’s Pattern
40	IS 8109: 1976	Needle Holder, Eye, Castroviejo’s Pattern
41	IS 8181: 1976	Specification for repositor, Iris
42	IS 8257: 1976	Specification for ophthalmoscope
43	IS 8260: Part 1: 1976	Glossary of terms relating to ophthalmic lenses and spectacle frames: Part 1 Ophthalmic lenses
44	IS 8771: 1985	Needle Holder, Eye, Scissors and Forceps Combined, Castroviejo’s Pattern (Modified)
	(1 Revision)
45	IS 8772: 1985	Needle Holder, Eye, Barraquer’s Pattern (Modified)
	(1 Revision)
46	IS 8773: 1985	Dissector, Lacrimal Sac, Lang’s Pattern (Modified)
	(1 Revision)
47	IS 8810: 1985	IS 10009: 1981
	(1 Revision)
48	IS 9061: 1989	Eye Surgery Instruments – Dilators, Punctum, Wilder’s Pattern (Modified)
	(1 Revision)
49	IS 9062: 1987	Probes, Lacrimal, Bowman’s Pattern (Modified)
	(1 Revision)
50	IS 9134: 1987	Trephine, Corneal, Castroviejo’s Pattern (Modified)
	(1 Revision)
51	IS 9329: 1987	Speculum, Eye, Clark’s Pattern (Modified)
	(1 Revision)
52	IS 9378: 1987	Speculum, Eye, Castroviejo’s Pattern (Modified)
	(1 Revision)
53	IS 9626: 1990	Eye Surgery Instruments – Calipers Castroviejo’s Pattern (Modified)
	(1 Revision)
54	IS 9688: 1992	Eye surgery instruments – Hooks, strabismus – Specification ( first revision)
	(1 Revision)
55	IS 9983: 1981	Specification for wire Vectis and lens expression, eye
56	IS 9984: 1981	Specification for cannula, air injection, eye
57	Rougine for Lacrimal SAC, rolleth’s Pattern (Modified)	Ophthalmic instruments – Eye refractometers
58	IS/ISO 10940: 2009/ISO 10940:2009	Ophthalmic Optics — Chart Displays for Visual Acuity Measurement — Printed, Projected and Electronic ( First Revision )
	(1 Revision)
59	IS/ISO 10939: 2017/ISO 10939:2017	Ophthalmic instruments Slit-lamp microscopes First Revision
	(1 Revision)
60	IS/ISO 10342: 2010/ISO 10342:2010	Ophthalmic instruments – Fundus cameras
61	IS/ISO 10938: 2016/ISO 10938:2016 Oph	Ophthalmic instruments – Direct ophthalmoscopes
62	IS/ISO 10943: 2011/IS/ISO 10943:2011	Ophthalmic instruments – Indirect ophthalmoscopes
63	IS/ISO 11979: Part 1: 2018/ISO 11979-1:2018	Ophthalmic implants Intraocular lenses Part 1:Vocabulary First Revision
	(1 Revision)
64	IS/ISO 10942: 2006/ISO 10942:2006	Ophthalmic implants Intraocular lenses Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes First Revision
	(1 Revision)
65	IS/ISO 11979: Part 10:2018/ISO 11979-10:2018	Ophthalmic implants – Intraocular lenses: Part 2 Optical properties and test methods
66	IS/ISO 11979: Part 2:1999/IS/ISO 11979-2:2014	Ophthalmic implants – Intraocular lenses: Part 3 mechanical properties and test methods
67	IS/ISO 11979: Part 3:2006/IS/ISO 11979-3:2014	Ophthalmic implants – Intraocular lenses: Part 4 labelling and information
68	IS/ISO 11979: Part 5: 2006/ISO 11979: Part 5: 2006	Ophthalmic implants – Intraocular lenses: Part 5 biocompatibility
69	IS/ISO 11979: PART 4:2008/ISO 11979: PART 4: 2008	Ophthalmic implants – Intraocular lenses: Part 6 shelf – Life and transport stability testing
	(1 Revision)
70	IS/ISO 11979: PART 6:2014/IS/ISO 11979-6:2014	Ophthalmic implants Intraocular lenses Part 7: Clinical investigations of intraocular lenses for the correction of aphakia First Revision
	(1 Revision)
71	IS/ISO 11979: PART 7:2018/ISO 11979-7:2018	Ophthalmic implants Intraocular lenses Part 8 Fundamental requirements First Revision
	(1 Revision)
72	IS/ISO 11979: Part 9: 2006/ISO 11979: Part 9: 2006	Ophthalmic Implants – Intraocular Lenses: Part 5 Biocompatibility
73	IS/ISO 11986: 2017/ISO 11986:2018	Ophthalmic optics Contact lenses and contact lens care products Determination of preservative uptake and release
74	IS/ISO 11979: PART 8:2018/ISO 11979-8:2017	Ophthalmic instruments – Retinoscopes
75	IS/ISO 12865: 2006/ISO 12865:2006	Ophthalmic instruments – Perimeters
76	IS/ISO 16671: 2015/IS/ISO 16671:2015	Ophthalmic implants – Irrigating solutions for ophthalmic surgery
77	IS/ISO 12866: 1999/ISO 12866:1999	Ophthalmic implants – Ocular endotamponades
78	IS/ISO 18369: Part 2: 2017/ISO 18369-2:2017	Ophthalmic optics – Contact lenses Part 2: Tolerances First Revision
	(1 Revision)
79	IS/ISO 18369: Part 3: 2017/ISO 18369-3:2017	Ophthalmic optics Contact lenses Part 3: Measurement methods First Revision
	(1 Revision)
80	IS/ISO 18369:Part 4: 2017/ISO18369-4:2017	Ophthalmic optics Contact lenses Part 4: Physicochemical properties of contact lens materials First Revision
	(1 Revision)
81	IS/ISO 18369 :Part1 : 2017/ISO 18369-1:2017	Ophthalmic optics Contact lenses Part 1 Vocabulary classification system and recommendations for labelling specifications First Revision
	(1 Revision)
82	IS/ISO 16672: 2015/ISO 16672:2015	Ophthalmic optics – Spectacle frames – Lists of equivalent terms and vocabulary
83	IS/ISO 8596: 2017/ISO 8596:2017	Ophthalmic optics Visual acuity testing Standard and clinical optotypes and their presentation First Revision
	(1 Revision)
84	IS/ISO 8598: 1996/ISO 8598	Optics and optical instruments – Focimeters
85	IS/ISO 8598: Part 1 :2014/IS/ISO 8598-1:2014	Optics and optical instruments – Focimeters: Part 1 general purpose instruments
86	IS/ISO 8612: 2009/ISO 8612:2009	Ophthalmic instruments – Tonometers
87	IS/ISO 7998: 2005/ISO 7998:2005	Ophthalmic optics – Spectacle frames – Measuring system and terminology
88	IS/ISO 8980: Part 1: 2017/ISO 8980-1:2017	Ophthalmic optics Uncut finished spectacle lenses Part 1 Specifications for single-vision and Multifocal Lenses (First Revision)
	(1 Revision)
89	IS/ISO 8624: 2011/ISO 8624:2011	Ophthalmic optics – Uncut finished spectacle lenses: Part 3 transmittance specifications and test methods
90	IS/ISO 8980: Part 3:2013/IS/ISO 8980-3:2013	Ophthalmic optics – Uncut finished spectacle lenses: Part 4 specifications and test methods for anti – Reflective coatings
91	IS/ISO 8980: Part 4:2006/IS/ISO 8980-4:2006	Ophthalmic optics – Uncut finished spectacle lenses: Part 5 minimum requirements for spectacle lens surfaces claimed to be abrasion-resistant
92	IS/ISO 9801: 2009/ISO 9801:2009	IS/ISO 8980: Part 5:2005/IS/ISO 8980-5:2005

Can I Export Ophthalmic Instruments Without BIS Certificate?

No, you can only export Ophthalmic Instruments And Appliances to India with a BIS certificate since the BIS mark ensures compliance with safety and quality standards.

What Is The HS Code For Ophthalmic Instruments And Appliances?

901850 is the HS Code for Ophthalmic Instruments And Appliances. It’s a standardised global code for classifying goods in trade, helping customs accurately identify products, set tariffs, etc.