BIS formulates IS 18562 to standardize PPIUCD insertion forceps

The Indian Standard IS 18562, has been formulated by a section of Medical Equipment and Hospital Planning Division Council of BIS. It lays specifications for PPIUCD (Postpartum Intrauterine Contraceptive Device) insertion forceps. These forceps, typically fabricated from stainless steel, are designed for reuse during surgical procedures.

Given the wide clinical need for instruments used in general and surgical procedures, this standard ensures uniformity in design, material, and performance requirements.

Key features of IS 18562
Material requirements

1. The standard specifies material that is light-weight surgical alloy, non-staining, corrosion free and non-rusting.
2. The material shall withstand autoclaving temperatures, be non-brittle, and feature a matte surface finish to avoid light reflection.
3. The chemical and mechanical properties of the material have also been added.

Shape and dimensions
The standard specifies the dimensions of the forceps as well as the structure ensuring usability in surgical applications.

Surface finish and workmanship
The standard addresses all aspects of finishing requirements including appearance, symmetry, serrations, joints and surface finish.

Heat treatment and corrosion resistance

1. The tips of the forceps shall have a specific hardness through heat treatment.
2. The instrument shall pass the boiling and autoclaving test ensuring resistance to corrosion and durability.

Packaging requirements
The following requirements have been specified for packaging of the product:

1. Each product is to be wrapped in wax paper and packed in a polyethylene bag or cardboard box.
2. Non-biodegradable packaging materials to be recyclable, marked with the universal recycling symbol and applicable recycling code.

Importance of IS 18562
This standard combines traditional craftsmanship with modern manufacturing techniques to meet the demands of surgical procedures. Defining the specifications, materials, and performance requirements, it ensures that PPIUCD insertion forceps supplied by different manufacturers adhere to consistent benchmarks.

Standardization for this, not only enhances patient safety and surgical precision but also fosters trust in the medical devices industry. With its emphasis on quality, durability, and sustainability, IS 18562 underscores the importance of harmonized practices in medical equipment manufacturing.
MB Bureau