BIS Certificate For Obstetric And Gynaecological Instruments And Appliances

Looking to ensure your Obstetric and gynaecological instruments stand out in this competitive & crowded market? Obtaining a BIS Certificate for these medical devices is the key to gaining customer trust and ensuring safety and quality in healthcare.

In an industry where the stakes are high, having a BIS certificate for obstetric and gynaecological instruments will assure healthcare providers that your products meet the standards necessary for patient care. Therefore, this guide will walk you through the complete process of obtaining BIS certification for obstetric and gynaecological instruments and appliances. From understanding the requirements to navigating the application procedure, we’ll cover everything you need to know in this article.

What Is The BIS Certificate?

The BIS certificate known as the ISI mark, is a quality certification mark. It is the national standards body in India responsible for developing standards for various products and services. The BIS Certificate for obstetric and gynaecological instruments ensures that the instruments meet safety and quality benchmarks. This certification is essential not only for compliance but also for building trust with your clients and patients.

Why Is BIS Certificate Important For Healthcare Providers?

BIS certification is really important for healthcare providers for several key reasons, mentioned below:

• Ensuring Quality and Performance: The Bureau of Indian Standards sets specific guidelines for medical devices and equipment. When a product is BIS certified, it means it meets these high-quality standards, giving healthcare providers confidence in its reliability.
• Protecting Consumers: BIS certification acts like a safety net for consumers. It ensures that the products comply with Indian standards, which helps keep people safe from potentially harmful or subpar medical devices.
• Building Trust: When a company has BIS certification, it shows they are serious about maintaining quality. This commitment to Indian standards helps build trust with customers, making them feel more secure about the products they’re using.
• Reduces Health Risks: By adhering to BIS standards, the chances of health risks related to defective medical devices are significantly lowered. This is crucial in a field where patient safety is the top priority.
• Permits Use Of ISI Mark: With BIS certification, companies can proudly display the ISI (Indian Standards Institution) mark on their products. This mark signifies that the product meets specific quality standards, making it easier for healthcare providers and consumers to identify trustworthy products.

Process To Obtain BIS Certificate For Obstetric And Gynaecological Instruments And Appliances

Here’s a step by step guidelines to get BIS certification for Obstetric And Gynaecological Instruments And Appliances:

• Select Applicable Standards: To begin the certification process, you need to identify the relevant standard for the instruments and appliances. This may involve consulting the BIS catalogue or working with a consultant who specializes in medical device certification.
• Prepare Required Documentation: Gather the necessary documents, such as product technical specifications, design and manufacturing details, test reports, etc.
• Submit Application To BIS: Complete the application form and submit it with all required documentation. Apart from this, BIS will conduct a review of your application and submitted documents. They may request additional information or clarification during this phase.
• Factory Inspection: once the application is submitted, a BIS official will conduct a factory inspection to evaluate your quality management system, manufacturing processes, and overall compliance with the standards. Be prepared to demonstrate your processes and provide access to relevant records.
• Certification Evaluation: following the inspection, BIS will assess all findings. If your products and processes meet the necessary standards, they will approve your application for certification.
• Receive BIS Certificate: Once approved, you will receive the BIS certificate for obstetric and gynaecological instruments. Allowing you to label your products as compliant with Indian standards.

Hence, by following these steps carefully you can obtain obstetric and gynaecological instruments and appliances BIS certificate.

What Are The Indian Standards For Obstetric And Gynaecological Instruments?

Here we have listed down the Indian Standards for BIS certificate for Obstetric And Gynaecological Instruments And Appliances, you can check them here:

SI. No.	IS No.	Title
1	IS 10156: 1982	Specification for the cannula, intra – Uterine, hysterosalpingography
2	IS 10545: 1992	Gynaecological and obstetric instruments – Clamp, curved on flat, Heaney’s pattern – Shape and dimensions
3	IS 12256: 1988	Specification for curette, uterine, biopsy, angled
4	IS 12270: 1988	Cannula, Spackmann’s Pattern
5	IS 12271: 1988	Specification for laproscopic trocar and cannula
6	IS 13009: 2021/ISO 19351:2019	Fallopian rings – Requirements and test methods
7	IS 17692: 2021/ISO 16038:2017	Male condoms Guidance on the use of IS ISO 4074 and IS ISO 23409 in the quality management of condoms
8	IS 5829: 1982	Specification for sound, uterine (First Revision)
9	IS 5849: 1970	Retractor, Anterior Vaginal Wall (Sim’s pattern)
10	IS 5906: 1970	Speculum, Vaginal (Cusco’s pattern)
11	IS 6111: 1971	Specification for curette, uterine (Suction Type)
12	IS 6112: 1971	Speculum, Vaginal, Double Ended (Sim’s Pattern)
13	IS 6114: 1991	Gynaecological instruments forceps, uterine vulsellum – Shape and dimensions (First Revision)
14	IS 6115: 1991	Gynaecological instruments – Forceps, uterine tenaculum – Shape and dimensions (First Revision)
15	IS 6373: 1971	Specification for sucker, mucus
16	IS 6499: 1971	Curette, Uterine, Double-ended, Sharp, Sim’s Pattern
17	IS 6505: 1971	Curette, Uterine, Double-ended, Sharp and Blunt, Sim’s Pattern
18	IS 6510: 1971	Specification for curette, endometrial biopsy, suction type
19	IS 6565: 1972	Stethoscope (foetoscope ) for – Foetal Heart Sounds, Pinard’s Pattern
20	IS 6578: 1992	Obstetrics Instruments – Forceps, ovum – Shape and dimensions (First Revision)
21	IS 6584: 1972	Dilators, Uterine, Single Ended, Hegar’s Pattern
22	IS 6589: 1992	Gynaecological Instruments – Forceps, uterine, dressing, Bozemann’s pattern – Shape and dimensions
23	IS 6957: 1973	Specification for curette, blunt, uterine
24	IS 6958: 1973	Specification for knife, decapitation
25	IS 6959: 1973	Specification for scissors, embryotomy, curved on flat
26	IS 6960: 1973	Specification for catheters, metal, female
27	IS 6999: 1973	Specification for canhlUla, artificial insemination
28	IS 7080: Part 1: 1992	MTP suction apparatus – Specification: Part 1 manually operated (Second Revision)
29	IS 7080: Part 2: 1992	MTP suction apparatus – Specification: Part 2 electrical – Cum – Manually operated (First Revision)
30	IS 7080: Part 3: 1992	MTP suction apparatus specification: Part 3 electrically operated
31	IS 7100: 1973	Hook, Decapitation, Jardine’s Pattern
32	IS 7103: 1973	Specification for scissors, episiotomy
33	IS 7115: 1973	Specification for apparatus, tubal patency
34	IS 7116: 1973	Specification for forceps, midwifery, short
35	IS 7117: 1973	Specification for scissors, umbilical cord
36	IS 7432: 1974	Clamp, Myomectomy, Bonney’s Pattern
37	IS 7433: 1992	Obstetrics Instruments – Forceps, round ligament, Bonney’s pattern – Shape and dimensions
38	IS 7475: 1992	Obstetric instruments – Clamp, vaginal, angled – Shape and dimensions (First Revision)
39	IS 7480: 1974	Perforator, Simpson’s Pattern
40	IS 7484: 1974	Retractor, Vaginal, Purandare’s Pattern
41	IS 7725: 1975	Hook, IUCD, shirodkar’s Pattern
42	IS 7735: 1992	Forceps, sponge holding – Shape and dimensions (First Revision)
43	IS 7736: 1975	Specification for screw, myoma
44	IS 7737: 1975	Specification for forceps, punch, cervical biopsy
45	IS 7964: 1992	Obstetric instruments – Forceps, caesarean section, haemostasis, green – Armytage pattern – Shape and dimensions (First Revision)
46	IS 7981: Part 1: 1976	Instruments, Tuboplasty – Part I: Occluder, Cervical, shirodkar’s Pattern
47	IS 7981: Part 2: 1976	Specification For Instruments. Tuboplasty – Part II: Cannula, shirodkar’s Pattern
48	IS 7981: Part 3: 1976	Instruments, Tuboplasty – Part III: Guide, shirodkar’s Pattern
49	IS 7981: Part 4: 1976	Instruments, Tuboplasty – Part IV: Probe, Single-Ended, Shirodkar’s Pattern
50	IS 7981: Part 5: 1976	Instruments, Tuboplasty – Part V: Probe, Double-Ended, Shirodkar’s Pattern
51	IS 8313: 1977	Specification for cannula, flexible, Karman type
52	IS 8314: 1977	Forceps, Midwifery, Modified Kedarnath Das’ Pattern, without Axis Traction
53	IS 8342: 1977	Forceps, Midwifery, Modified Kedarnath Das’s Pattern, with Axis Traction
54	IS 8458: 1977	Manipulators, Uterine, Dr Purandare’s Pattern
55	IS 8459: 1977	Specification for menstrual regulation syringe
56	IS 9756: 1981	Specification for cups, vacuum extraction
57	IS/ISO 11249: 2018/ISO 11249:2018	Copper-Bearing Intrauterine Contraceptive Devices — Guidance on the Design, Execution, Analysis and Interpretation of Clinical Studies
58	IS/ISO 16037: 2002	Rubber condoms for clinical trials – Measurement of physical properties
59	IS/ISO 16038: 2005	Rubber condoms – Guidance on the use of IS/ISO 4074 in the quality management of natural rubber latex condoms
60	IS/ISO 23409: 2015/ISO 23409:2011	Male condoms – Requirements and test methods for condoms made from synthetic materials
61	IS/ISO 25841: 2014/ISO 25841:2014	Female condoms – Requirements and test methods
62	IS/ISO 29941: 2010/ISO 29941: 2010	Condoms – Determination of nitrosamines migrating from natural rubber latex condoms
63	IS/ISO 29942: 2011/ISO 29942:2011	Prophylactic dams – Requirements and test methods
64	IS/ISO 29943: Part 1: 2017/ISO 29943-1:2017	Condoms Guidance on clinical studies Part 1: Male condoms clinical function studies based on self-reports
65	IS/ISO 29943: Part 2: 2017/ISO 29943-2:2017	Condoms Guidance on Clinical Studies Part 2: Female condoms Clinical function studies based on Self-reports
66	IS/ISO 4074: 2015/ISO 4074:2015	Natural rubber latex male condoms – Requirements and test methods (First Revision)
67	IS/ISO 7439: 2015	Copper – Bearing contraceptive intrauterine devices – Requirements and tests (First Revision)
68	IS/ISO 8009: 2014/ISO 8009:2014	Mechanical contraceptives – Reusable natural and silicone rubber contraceptive diaphragms – Requirements and tests (First Revision)

Who Needs BIS Certificate For Obstetric And Gynaecological Instruments And Appliances?

If you are involved in making or selling obstetric and gynaecological instruments and appliances in India, you’ll need a BIS certificate. Such as manufacturers who make these items, as they must ensure their products meet safety and quality standards. 

If you want to bring BIS medical devices into the country, you’ll also need a BIS certificate as it is important for distributors and retailers. Even hospitals and clinics often prefer to buy only BIS-certified products to ensure they’re safe & reliable for patients.

Overall, having a BIS certification for obstetric and gynaecological instruments and appliances is helpful for everyone to trust that the medical tools being used are of good quality.

Documents Required To Get BIS Certification For Obstetric And Gynaecological Instruments And Appliances

To obtain BIS certificate for obstetric and gynaecological instruments and appliances, you’ll need to provide the following documents:

• Application Form
• Company Profile
• Product Details
• Quality Control Procedures
• Test Reports
• Manufacturing Process
• Compliance Certificates
• Fee Payment Receipt
• Authorization Letter

Having these documents ready will help in obtaining the BIS application process and improve your chances of obtaining the certification successfully.

Also Read: BIS Registration Documents Required