BIS Certification for
Oral Hygiene Appliances

BIS certification for these products is mandatory under the Safety of Household, Commercial and Similar Electrical Appliances (Quality Control) Order, 2026, and the licence is issued by the Bureau of Indian Standards (BIS). Getting BIS Certification is an important step for manufacturers and importers to comply with regulations, gain market access, and build consumer confidence in India. 

Certification of oral hygiene appliances, such as electric toothbrushes and flossers, falls under Oral Hygiene Appliances, which have become an integral part of the modern-day personal care routine, as they are basic necessities for health and a hygienic lifestyle. As these appliances come into direct contact with users and operate using electricity, they must comply with safety requirements to ensure reliable performance and minimise the risks of electric shock, overheating, and mechanical hazards associated with their use. The BIS Certification of Oral Hygiene Appliances as per IS 302 (Part 1):2024/IEC 60335-1 is a general requirement certifying that the product complies with all essential electrical safety standards.

What are Oral Hygiene Appliances under IS 302 Part 1: 2024/IEC 60335-1?

Oral hygiene appliances are tools and devices used alongside traditional brushing to remove plaque, food particles, and bacteria from the teeth and gums. Under IS 302 (Part 1): 2024 / IEC 60335-1, Oral Hygiene Appliances are classified as electrically operated or battery-powered personal care devices designed to maintain dental health. This standard serves as the general safety framework, technically equivalent to the global IEC 60335-1:2020 standard that governs the manufacture, import, and sale of these products in India. 

Key Highlights for IS 302 (Part 1) for Oral Hygiene Appliances 

Testing Parameters for Oral Hygiene Appliances IS 302 Part 1: 2024/IEC 60335-1

Electric toothbrushes and flossers must carry the ISI Mark under IS 302 Part 1/IEC 60335-1. Most of these are low-voltage, battery-operated (Class III) devices charged through a mains adaptor. They must pass the following tests: 

• Moisture Protection and Water Intrusion: This test is conducted to confirm the protection provided by seals and IP ratings for the circuitry against water during use in bathrooms.

• Leakage Current and Electrical Strength Test: Performed at both room and operating temperatures to ensure appliances do not pose an electrical shock hazard to users.

• Resistance to Heat and Fire: This test evaluates materials' resistance to fire using methods such as the glow-wire test.

• Overheating (Temperature Rise) Test: This test is conducted to confirm that the surfaces of batteries and heating components do not reach unsafe temperatures during charging and usage.

• Battery and Charging Safety: This test confirms safe charging behaviour and protection against overcharging or short-circuiting in battery-powered appliances.

List of Documents Required for ISI Mark Certification of Oral Hygiene Appliances

Before applying for ISI Mark Certification, collect all necessary documents. See the documents necessary for BIS Certification of Oral Hygiene Appliances.

BIS Certification Process for Oral Hygiene Appliances in India

Both Indian and foreign manufacturers must follow the certification process to obtain the ISI Mark on their products: 

• ISI Mark certification steps for oral hygiene appliance makers in India 

• FMCS certification steps for overseas oral hygiene appliance makers
  
  

BIS Certification Cost for Oral Hygiene Appliances (2026)

Below, you can go through the table for the BIS Certification cost of Oral Hygiene Appliances: 

Why Choose ERCS as Your BIS Certification Consultant for Oral Hygiene Appliances? 

ERCS Pvt. Ltd., the Top BIS Consultant, provides the most comprehensive BIS certification service for oral hygiene appliances in accordance with IS 302 Part 1 and can offer the most efficient, expert advice on documentation, testing, and regulatory requirements for both domestic and foreign manufacturers.

• ERCS Pvt. Ltd. assist with the complete ISI Mark Certification process, which covers certification under IS 302 Part 1:2024/IEC 60335-1. We support you at every stage (such as preparation of documentation, coordination of all activities with BIS Officials, and coordination of all sample testing), which will minimise the likelihood of your certification application being refused.

• ERCS has extensive experience with Indian safety standards; therefore, ERCS can guarantee that your products will meet requirements for electrical and thermal hazard protection.

• ERCS is a company that develops its consultancy activities on time and efficiently, and can help you obtain the BIS license to trade legally in India.