BIS Certification for Sterilizer, Shallow IS 3831

Shallow Sterilizers, also known as dressing drums, are used in hospitals, operating theatres and clinics for sterilizing and storing surgical instruments, gauze, and dressings under IS 3831:1979. Such equipment is subjected to multiple cycles of steam sterilization and handling. Therefore, they need to be made from material that is robust, durable and provides good lid-sealing properties to keep them clean and sterile.

The BIS certification program for Shallow Sterilizers involves the evaluation of the design, dimensions, materials, and functionality in sterilization of Shallow Sterilizers to meet the standards set out by IS 3831:1979. The article below describes the certification process, which includes the regulatory measures, testing process and certification process of Shallow Sterilizers in India.

BIS Certification Requirements Under IS 3831:1979

This is the Indian Standard for shallow sterilizers, commonly known as dressing drums, used in hospitals and healthcare facilities for sterilizing surgical dressings and instruments. It outlines requirements for design, materials, construction, and performance to ensure effective sterilization and safe medical use. As per the BIS (Bureau of Indian Standards), these reusable sterilization drums for hospitals are:

Assessed for material quality
Evaluated for construction and finish
Tested for functional performance
Checked for design conformity

Who needs to comply with IS 3831:1979 standard

BIS authorisation under IS 3831:1979 is required for businesses involved in manufacturing, importing, or supplying dressing drums for sterilization in India.

Applicable to:

Manufacturers (India) - Must get BIS approval if the products are covered under QCO.
Foreign Manufacturers - Need certification to export the shallow autoclave sterilizers to India.
Importers/Brand Owners - Must ensure that the products are BIS-certified before sale.
Sellers/Distributors - Should only sell certified surgical instrument sterilization containers.

Testing and Inspection Requirements

Understanding the need for efficient sterilization in hospitals, the Bureau of Indian Standards (BIS) sets out criteria for shallow sterilizers which are commonly referred to as dressing drums. The standards set out criteria that must be met to ensure that these products are produced using appropriate materials and construction. The following are the tests for the BIS quality and performance checks for Sterilizer:

Test Group	What is Tested	Purpose
Dimensional Accuracy Test	Drum diameter, height, body dimensions, perforation dimensions, and component measurements	Ensures conformity with IS 3831:1979 dimensional requirements and proper fit within sterilization equipment
Body Construction Test	Seamless cylindrical body formation and structural construction	Ensures uniform construction, strength, and hygienic design
Base Stability Test	Stability of the drum on three or more supports	Ensures the sterilizer rests securely without shake or imbalance during use
Lid Fitment Test	Snap-fit engagement between the lid and body	Ensures secure closure and proper sealing during sterilization and storage
Hinge Performance Test	Free swivel movement and alignment of the lid hinges	Ensures smooth opening, closing, and accurate lid positioning without side pressure
Hasp & Staple Functionality Test	Engagement and disengagement of the hasp mechanism	Ensures reliable locking and ease of operation
Belt Fitment Inspection	Uniform contact of the belt around the drum body	Ensures proper sealing performance without gaps, pockets, or excessive rubbing
Clip Tension Test	Performance of the clamping mechanism under operating conditions	Ensures the belt remains securely tensioned during sterilization and handling
Belt Sliding Resistance Test	Resistance of the clamped belt when subjected to a force of 70 N	Ensures the belt remains locked and does not slip during use
Belt Movement Test	Ease of belt movement when the clip is in the open position	Ensures smooth adjustment and user-friendly operation
Perforation Alignment Test	Alignment between body perforations and belt slots	Ensures proper airflow control and precise opening/closing of ventilation holes
Surface Finish Inspection	Smoothness, polishing quality, and overall finish of stainless steel parts	Ensures hygienic surfaces, ease of cleaning, and professional appearance

How BIS Grants Certification for Shallow Sterilizers

The BIS Authorisation process ensures that the Shallow Sterilizers used in Hospitals meet the required performance standards. This process is set by the Bureau of Indian Standards (BIS) and includes the following steps:

Online Registration: Manufacturers register on the BIS Manak portal by submitting company, factory, and product details. Foreign manufacturers must appoint an Authorized Indian Representative (AIR).
Testing at BIS-Approved Laboratory: Product samples are tested in BIS-approved laboratories for chemical composition, silica content, moisture content, fineness, compressive strength, and other physical performance parameters.
Application Submission: The application is submitted along with test reports, technical documents, and factory details. Foreign manufacturers must also submit AIR-related documents.
Factory Inspection: The Bureau of Indian Standards officials inspect the manufacturing units to verify the production process, safety measures, and quality control system.
Grant of BIS License: Upon successful verification of all requirements, BIS grants the certification license under Scheme-I.
Use of ISI Mark: Once approved, the manufacturer can use the ISI mark on the product with a CM/L number, confirming that the product meets BIS standards.

Documents requirements for BIS License application

Document Category	Documents Required
Basic Details	GST Certificate, Email ID & Contact Number, Factory & Office Address, Rent Agreement / Lease Deed (if applicable),Partnership Deed (if applicable for partnership firms)
Manufacturing Details	List of Machinery, Process Flow Chart, Factory Layout Plan
Raw Material Details	List of Raw Materials, Supplier Details, Raw Material Invoices, Raw Material Test Certificates
Testing & Quality Control	List of Testing Equipment, Calibration Certificates, QC/Lab In-charge Appointment Letter & Qualification
Production Details	Annual Installed Capacity, Last Year Production Value
Product & Packaging Details	Quantity per Package, Nature of Packing, Product Printing / Marking Details
Management Details	Top Management Details, BIS Communication Contact Person
Brand & Certification Documents	Trademark / Brand Certificate, Consent Letter from BIS Recognized Laboratory
Additional Documents	Weekly Off Details, Hygiene Document (if applicable), Relaxation Letter (if applicable), Any Other Relevant Document
Foreign Manufacturer Requirement	Appointment of Authorized Indian Representative (AIR) for BIS coordination and compliance in India

The Foreign manufacturers are required to appoint an Authorized Indian Representative (AIR) in India. The representative is the local point of contact for the Bureau of Indian Standards (BIS) and takes care of all rules and compliance work in India.

Marking Requirements & License Validity

Marking Requirements

Once the manufacturer obtains a BIS license, the ISI Mark for Shallow Sterilizers must be written clearly and permanently either on its packaging or on the product. Additional details are provided below:

Requirement	Details
ISI Mark	Indicates that the product is BIS certified and conforms to standards
Standard Number	IS 3831: 1979
CML Number	Certification Marks License (CML) number issued by BIS
Manufacturer Details	Name of manufacturer or registered trademark
Batch / Date	Batch number, heat number, or manufacturing date for traceability

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.

BIS License Validity and renewal process

particulars	Details
Initial Validity	Typically 1 to 2 years, depending on BIS approval conditions
Renewal	Must be renewed before expiry by submitting the application along with the prescribed fee and updated documents
Surveillane	BIS may inspect factories and test samples periodically
Annual Fees	Annual license fee must be paid regularly
Compliance	Continuous compliance with BIS requirements is necessary
License Format	BIS is shifting towards a 10-digit license number format
Non-Compliance Risk	May lead to suspension or cancellation of license

BIS registration and audit cost structure for IS 3831:1979

The cost of BIS Approval for the medical equipment includes charges for application, inspection, license, testing, and marking. These fees are paid to BIS as per Scheme I guidelines.

Charge Type	Indian Manufacturers	Foreign Manufacturers
Application Fee	INR 1,000	USD 15
Audit Charges	INR 7,000	USD 3,200 – 5,900
License Fee	INR 1,000	USD 15
Marking Fee	As applicable	As applicable
Testing Charges	As applicable	As applicable
EVTL India Consultancy Fee	As per actual	As per actual

Note:

Application fee for foreign manufacturers is payable via SWIFT (SAARC countries may pay in INR with applicable GST).
Audit charges for foreign manufacturers vary based on country/location.
The marking fee is determined based on the product category and production volume (MSME benefits may apply).
Testing charges are to be paid directly to BIS-recognised laboratories.
Consultancy fees can vary depending on product type and factory location.

Conclusion

Certification for Shallow Sterilizer (Dressing Drum) according to IS 3831:1979 ensures that medical storage equipment meets high standards of safety and quality requirements. Certification confirms the corrosion resistance, strength of the drum under repeated exposure to sterilizing conditions and closure performance. These are important attributes in order to ensure sterile integrity during the process of surgery.

BIS approval enhances product reliability and helps in ensuring consistent compliance with the procurement system in the Indian health care sector. It also helps manufacturers and importers to improve their market acceptability by having their products certified as conforming to regulations. EVTL India offers professional services in documentation, testing arrangements, and BIS licensing for the smooth processing of approval.