Understanding IS 13422:2024 – Standard for Single-Use Sterile Rubber Surgical Gloves
The Indian Standard IS 13422:2024 establishes the quality and performance requirements for single-use sterile rubber surgical gloves to ensure safety, sterility, and durability. This standard is aligned with ISO 10282:2023, reflecting international best practices while adhering to India’s regulatory framework.
Key Requirements of IS 13422:2024
- Material Specifications
- Gloves must be made from natural rubber latex, nitrile rubber, isoprene latex, polychloroprene rubber, or other specified polymers.
- They must be safe for medical use and conform to biological evaluation standards (ISO 10993 series).
- Performance & Quality Parameters
- Watertightness: Gloves must pass leakage tests to ensure they are impermeable.
- Tensile Strength & Elongation: The gloves must meet force-at-break and elongation-at-break requirements before and after aging.
- Thickness & Dimensions: The gloves should conform to defined size codes and minimum thickness specifications.
- Sterilization & Packaging
- The gloves must be sterile and packaged in a way that maintains sterility until use.
- Packaging should include clear labeling with manufacturing details, lot numbers, and compliance information.
- BIS Certification Marking
- As per the Bureau of Indian Standards (BIS) Act, 2016, manufacturers must obtain BIS certificationto sell gloves under IS 13422:2024.
- Certified products can bear the ISI mark, indicating compliance with national standards.
Role of Omega QMS Pvt. Ltd. in Facilitating BIS Certification for Manufacturers
Obtaining BIS certification is a complex and multi-step process requiring strict compliance with testing, documentation, and auditing procedures. Omega QMS Pvt. Ltd. plays a crucial role in guiding manufacturers through this process efficiently.
How Omega QMS Pvt. Ltd. Helps Manufacturers
- Pre-Certification Assessment
- Evaluates whether the manufacturer’s facilities, raw materials, and production processes align with IS 13422:2024.
- Identifies gaps in compliance and suggests necessary improvements.
- Technical Consultation & Documentation Support
- Assists in preparing the required documents, technical files, and test reports needed for BIS certification.
- Ensures adherence to material composition, sterilization, and packaging norms.
- Testing & Laboratory Coordination
- Facilitates sample testing at BIS-recognized laboratories to verify compliance with IS 13422:2024.
- Ensures that gloves pass all performance and safety tests, such as watertightness, tensile strength, and biocompatibility.
- Application & Audit Assistance
- Helps in filing BIS applications and liaising with BIS authorities.
- Provides support during BIS factory audits, ensuring seamless compliance.
- Post-Certification Compliance & Renewal
- Offers continuous compliance monitoring to help manufacturers maintain certification.
- Assists in renewals and periodic audits as required by BIS.
Conclusion
With IS 13422:2024, India ensures that single-use sterile rubber surgical gloves meet strict quality and safety standards for medical applications. BIS certification is mandatory for manufacturers, but the process can be challenging without expert guidance.
Omega QMS Pvt. Ltd. acts as a trusted compliance partner, simplifying the certification process, ensuring adherence to regulations, and enabling manufacturers to achieve BIS certification efficiently. By leveraging technical expertise, regulatory knowledge, and industry experience, Omega QMS helps manufacturers bring high-quality, certified surgical gloves to the market—enhancing patient safety and industry credibility.
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