Medical examination gloves that are disposable and made of rubber latex or rubber solution are used extensively in healthcare setups in order to prevent any possibility of contamination or infections in the medical procedures carried out in hospitals, clinics, laboratories, and diagnostic centers. Medical examination gloves are extremely important in ensuring a safe distance between the health care professional and the patient during the procedure carried out.
In order to regulate quality and ensure the safety of patients, the Bureau of Indian Standards (BIS) has formulated IS 15354 (Part 1):2023 standard for requirements of medical examination gloves made of rubber latex or rubber solution. This standard deals with the physical properties, performance requirements, sampling and test conditions, in order to ensure the quality of products.
It is mandatory to comply with the BIS Certification for Single-use Medical Examination Gloves (IS 15354 (Part 1):2023) under the relevant BIS Quality Control Order (QCO). In order to supply these medical examination gloves in India, it is necessary to have a valid BIS license and ISI Mark on the product.
Overview of IS 15354 (Part 1):2023 Standard
IS 15354 (Part 1):2023 outlines the specifications for single-use medical examination gloves made of rubber latex or rubber solution. This standard makes sure that the gloves conform to high-quality standards which are necessary in health care facilities and laboratories. Key aspects covered under this standard include -
- Physical dimensions and sizing requirements
- Tensile strength and elongation properties
- Barrier protection efficiency
- Freedom from holes and defects
- Powdered and powder-free glove specifications
- Biocompatibility and safety requirements
- Sampling and testing procedures
- Packaging and labeling guidelines
Importance of ISI Mark Certification
Here are some factors mentioned that showcase how important ISI Mark Certification for Single-use Rubber Examination Gloves are:
- Medical Safety Assurance : Guarantees protection against infections and contamination of the medical procedure.
- Regulatory Compliance : Authorizes manufacturing, sale, and distribution of drugs under standards which are notified.
- Market Acceptance : Favored by hospitals, diagnostic centers as well as government healthcare institutions.
- Tender Eligibility : Allows it to take part in health and hospital procurement tenders.
- Brand Credibility : Earns medical practitioners and regulators trust.
Technical Specification As Required By IS 15354 (Part 1)
IS 15354 (Part 1) standard is a crucial standard because it provides safety, reliability, and performance assurances of single-use examination gloves made of rubber and used in a medical facility. The standard outlines the requirements in terms of dimensions, thickness, tensile strength, and elongation so as to offer durability during use.
It orders the absence of holes and defects with regards to Acceptable Quality Level testing. Powder content, protein residue, and surface finish limits are established in order to minimize allergic reactions. Packaging, labeling, sterility declaration, and ISI marking are provisions that guarantee traceability and regulatory compliance.
Essential Documentation Checklist for BIS Registration
The following documents are necessary for Domestic Manufacturers:
- List of raw material
- Layout plan of the factory premises
- List of testing equipment as per the Indian standard
- Quality Control (QC) Personnel Details (Education degree and Aadhaar card)
- GST
- Authorized Person Aadhar & Pan Card
- MSME
- Electricity Bill
- Email Address & Permanent Contact Number
- Office Address
- Factory Address
- Copy of Partnership Deed / MOA (for Private Limited Co.)
- Premises document / Rent Agreement
- List of Manufacturing Machinery
The following documents are necessary for Foreign Manufacturers:
- Checklist for Application
- Copy of Swift Remittance
- Duly Filled Application Form
- Copy of Business License
- List of Machinery
- List of Raw Material
- Test certificate of Raw Material
- List of Testing Equipment
- Calibration certificate of Test Equipment
- Process Flowchart
- Layout Plan
- Location Plan (Route Map)
- Details of Technical Personnel
- Qualification of QC
- Copy of Certification of Product and/ System
- Factory Test Report
- Agreement with AIR
- Aadhar Card of AIR
- AIR Nomination Form
- Educational Degree of AIR
- Undertakings
- Scope of License
Key Required Steps for Manufacturers to Obtain BIS Certification
There are two key procedures to get your BIS license: Simplified and Normal.
Simplified Procedure
The steps involved in the simplified procedure are:
- Document Collection : All the necessary KYC and technical documents are collected in order to start the BIS application without problems.
- BIS Portal Registration : The license application is processed by the manufacturer being registered on the official portal of BIS.
- Pre-Testing of Samples : Before submission, product samples are tested in a BIS authorized laboratory.
- In-House Lab Requirement : Depending on the product, an internal laboratory facility might be necessary according to the BIS requirements.
- BIS Review & Clarifications : BIS examines the submissions of documents and test reports and may request clarification.
- BIS Audit at Factory : The audit of the product samples carried out by the BIS inspectors is done at the factory.
- Timely Audit Completion : The audit, inspection and sample collection are conducted within 17 days of the application submission along with the EVTL India engineer.
- EVTL India Engineer- Factory Inspection : The BIS auditor and an engineer at EVTL India undertake a proper inspection at the factory.
- Independent Collection of Samples : The BIS auditor draws samples to be tested by the post-audit.
- Sample Testing at BIS Lab : BIS sealed samples are sent to BIS laboratories, and the BIS department pays the price of testing.
- Grant of BIS License : Upon satisfactory document inspection, testing and audit, ISI license is issued.
Normal Procedure
The steps involved in the normal procedure are:
- Submit Documents : Firstly, it is required to submit all the KYC and technical documentation to start the BIS application.
- Plan In-House Laboratory and Technical Proposal : Prepare an internal lab in case necessary and prepare all technical documentation.
- Ready Factory Test Report (FTR) : Carry out in-house tests and document the FTR to demonstrate that the product is to the standards.
- Submit Application & Fees : Includes your BIS application and the amount of fees necessary by the government.
- BIS Audit : An audit of documents and processes at a BIS takes place within 3 weeks.
- EVTL India Engineer Factory Inspection : BIS auditor inspects the factory with an EVTL India engineer to make sure that everything is in order.
- Sample Collection & Sealing : The BIS auditor picks samples randomly, puts them into a sealed sample and forward the sample to a BIS authorized lab to be tested.
- License Approval : After the lab tests of the sample are passed-on, BIS issues the ISI license, and your product is certified and market-ready.
Expected timeframe for BIS Licensing Approval
According to IS 15354 (Part 1), a BIS license for Single-use Rubber Examination Gloves is expected to take:
For Simplified Procedure (Indian manufacturers)
Average 40-45 days
For Normal procedure
- For Indian Manufacturers : 50-60 days
- For International Manufacturers : Approximately 180 days
Why EVTL India works best for BIS Approval?
EVTL India is an influential BIS consultant for Single-use Rubber Examination Gloves that has a great experience in medical devices and certification of healthcare products. Their team deals with full documentation, filing of the BIS portal and the coordination with the BIS recognized laboratories.
EVTL India involves itself in technical advice of quality control systems and preparation of factory audits. They have a solid regulatory background that assists the manufacturers to obtain faster approval and full compliance.
Conclusion
BIS Certification for Single-use Rubber Examination Gloves of IS 15354 (Part 1) is compulsory to manufacturers and importers of medical gloves provided in India. Certification guarantees medical safety, regulatory and uniformity in product performance.
Through the help of the professional team EVTL India, the businesses will be able to streamline the BIS certification process, cut down the approval processes, and be assured to provide the ISI-marked examination gloves to the hospitals, laboratories, and medical institutions.
