Introduction
Surgical gloves are indispensable items of equipment for carrying out medical procedures; they are aimed at ensuring protection and safety for health professionals and patients alike. The use of disposable surgical rubber gloves in health care has become a critical means to prevent the transmission of infection. However, these gloves need to be manufactured as per strict standards laid out by national regulators to give maximum protection.
In India, one such standard is IS 13422:1992 relating to disposable surgical rubber gloves. In this blog, we will explore information regarding IS 13422:1992, the BIS ISI mark process, the Scheme of Inspection and Testing, and the List of Test Equipment all crucial in ensuring these gloves quality and reliability.
Apart from meeting the requirements of IS 13422:1992, glove manufacturers could seek Diligence Certification. It is the highest level of assurance that indicates a company’s commitment to best practices and high levels of accountability through all stages of production. A manufacturer Diligence Certification is a tool that characterizes manufacturing as responsible for them by quality, health and safety environment matters.
What is IS 13422:1992?
Indian Standard IS 13422:1992 specifies the requirements for disposable surgical rubber gloves for medical and health services. This document sets forth the quality and safety standards to which manufacturers of gloves must conform before their products can be rendered safe for medical use.
The standard covers the following aspects related to surgical gloves:
- Material: The surgical gloves must be made of rubber that conforms to specific quality criteria in terms of elasticity and durability.
- Physical properties: Should be able to take mechanical stress without alteration to the barrier properties.
- Sterilization: Since the gloves are to be used sterilely, IS 13422:1992 provides the sterilization method for gloves.
- Performance requirements: These should withstand the punishment of piercing, tearing, and various other damages met in medical procedures.
It is sufficient that a surgical glove should confirm the IS 13422:1992 for ensuring it provides the necessary protection and performance needed for a medical environment.
BIS ISI Mark Process for Disposable Surgical Rubber Gloves
Bureau of Indian Standards (BIS) administers and organizes certification and licensing for products under the ISI mark to comply with Indian standards, IS 13422:1992. For disposable surgical rubber gloves to be awarded the ISI mark, there are rigorous procedures that manufacturers undergo to ensure both product and manufacturing practices are at par.
Steps to Getting a BIS ISI Mark for Surgical Rubber Gloves
- Submit an application: The manufacturer submits an application to the Bureau of Indian Standards requesting certification for its products-disposable surgical rubber gloves. This application holds information about the company, manufacturing facilities, and the list of products for which certification is being sought.
- Preliminary Evaluation: BIS conducts initial evaluation of the production facilities to see if they are capable of producing products conforming to IS 13422:1992. The evaluation includes the quality of raw materials, affected equipment, and manpower capabilities.
- Sample Testing: Upon passing the inspection of producing plants, BIS collects the selected gloves samples for testing. This involves several tests measuring physical properties, sterilization grades, and durability according to the required standards.
- Inspection Compliance Verification: BIS ensures that the manufacturing processes quality control and final product fulfillment are stipulated in IS 13422:1992. This is done through factory periodic inspections followed by product audits for compliance.
- Granting of ISI Mark: After carrying out all laboratory tests and evaluation, the manufacturer receives the BIS ISI mark indicating that second disposable surgical rubber gloves meet such safety and performance standards
Key Highlights of IS 13422:1992 for Surgical Rubber Gloves
The following table provides an overview of the key requirements outlined in IS 13422:1992 for disposable surgical rubber gloves:
| KEY HIGHLIGHTS | DETAILS |
| 1.Material | That they are made of rubber materials, generally latex, and meet the required standards for the quality of medical purposes. |
| 2.Design and Construction | Gloves should be free from any defects such as holes, tears, or pinholes. |
| 3.Thickness | The gloves must be the same in thickness at all points to provide an adequate barrier to infection. |
| 4.Sterilization | They must be sterilized, usually by ethylene oxide, before use. |
| 5.Dimensions | Gloves should be dimensioned to fit comfortably over hands of different sizes at required length and width. |
| 6.Puncture Resistance | Gloves are to be subjected to puncture resistance tests to ensure that sharp objects cannot penetrate them at all times during medical processes. |
| 7.Elasticity | Surgical gloves shall have their elasticity and ability to be flexible for movement and dexterity. |
| 8.Biocompatibility | Not to induce any allergic reactions or irritation in the skin. |
Scheme of Inspection and Testing for Surgical Rubber Gloves
The Scheme of Inspection and Testing (SIT) constitutes a set of guidelines regarding procedures and tests for the manufacture of disposable surgical rubber gloves under IS 13422:1992. It says that every batch produced of disposable surgical rubber gloves should conform to the above standards.
Key Components of the Scheme of Inspection and Testing
- Testing Frequency: Sampling and testing for the value are conducted regularly with predetermined intervals during the process to ensure quality consistency.
- Determination of Physical Properties: These include tests of tensile strength, elongation, and puncture resistance.
- Chemical and Biocompatibility Testing: Gloves allow testing for symptoms caused by chemicals potentially harmful to the users. The gloves must be biocompatible, that is, they should not produce a detrimental effect on skin or cause any allergic reaction.
- Sterilization Validation: Sterilization is checked to ensure gloves are absent of microbial contamination.
- Batch and Lot Testing: Prior to approval of a lot for sale, samples from each production batch are tested for compliance.
The Scheme of Inspection and Testing ensures that each piece of surgical glove with the ISI mark satisfies the requirements set out in the IS13422:1992 standard, hence preserving quality standards for medical usage.
List of Test Equipment for Surgical Rubber Gloves
In order to comply with IS 13422:1992, manufacturers must incorporate the necessary test equipment during manufacturing and inspection. Therein lies the considerable number of test equipment items, such as:
- Tensile Testing Machine: Used to test the rubber for strength or elasticity.
- Puncture Test Machine: To assess the resistance of the glove against piercing by sharp objects.
- Air Pressure Testing Apparatus: To check the glove surface for any small pinholes or other defects by detection of air leakage through.
- Sterility Test Apparatus: For checking the sterility of gloves, often using methods with microbial cultures.
- Chemical Testing Equipment: Equipment to assess the chemical composition of the rubber material to prove its safety and non-toxicity.
- Allergen Detection Kits: To ascertain that latex or other used materials in the gloves do not trigger allergic effects.
Conclusion
This is the perfect guideline IS 13422:1992- for surgical disposable rubber gloves for all manufacturers within India: a must-have, essential precaution for these medical products as they should be effective, safe, and reliable. In addition to the BIS ISI mark, the Scheme of Inspection and Testing, and the proper test equipment, the certification process ensures that surgical gloves achieve the requisite safety standards in all medical aspects. It assures all involved, both healthcare professionals and patients, through confidence in the quality of the medical products. The IS 13422:1992, in effect, guarantees that surgical gloves cover the necessary protection and performance, which makes healthcare practices safer in the country.
The IS 13422:1992 standard regulates the necessary criteria for disposable surgical rubber gloves to protect health care professionals and patients alike. The consistent quality of these gloves is ensured by the Scheme of Inspection and Testing and the BIS ISI mark. The provision of Diligence Certification adds another confidence assurance in manufacturers’ ethical and sustainable practices. Thus, through these processes, healthcare can be assured of safety, reliability, and effectiveness in preventing the transmission of infections through gloves being used.
