BIS publishes IS 18561 to specify requirements for NSV instruments

No-scalpel vasectomy (NSV) has emerged as a minimally invasive alternative to conventional vasectomy procedures. It is a safer and effective technique, offering reduced complications such as bleeding, infection, and pain. Unlike traditional vasectomy, NSV does not involve cutting the scrotal skin but instead uses a puncture technique to access the vas deferens with specialised instruments. Recognising the need for standardized instruments in this field, the Bureau of Indian Standards (BIS) has published IS 18561, which specifies the requirements for NSV instruments.

Assurance of safety and reliability with IS 186561
When undergoing any medical procedure, patients want the reassurance that the tools used are of the highest quality, designed to ensure safety and precision. IS 18561 addresses this by setting standards for the manufacturing and performance of NSV instruments, ensuring:

• Patient safety: Instruments to be made of material which is lightweight surgical alloy, non-staining, corrosion-free, non-rusting and should be able to withstand the temperature of autoclaving.
• Precision: The standard includes the determination of dimensions which ensure dimensional accuracy and smooth finishes ensure minimal discomfort and maximum efficiency during the procedure.

Scope of IS 18561
The standard outlines the specifications for two key instruments used in NSV procedures:

1. Ringed fixation clamp
2. Sharpened curved dissecting forceps

These tools are designed to facilitate the procedure with precision and efficiency, ensuring patient safety and surgical effectiveness.

Material specifications
To maintain functionality and safety, IS 18561 specifies the following material requirements for the instruments:

• As mentioned above for assurance of patient safety, the requirements for material have been given as non-staining, corrosion-free, non-rusting and ability to withstand the temperature of autoclaving.
• Non-reflective surface: Buff coating to be done which ensures a matte finish, preventing light reflection during surgical procedures.
• Durability: The material should not be brittle and must retain its structural properties under repeated use.

Design and dimensional requirements
The standard gives the dimensional ranges for both ringed fixation clamps and sharpened curved dissecting forceps.

Determination of dimensions
IS 18561 specifies methodologies for determining the following critical dimensions, ensuring accuracy and uniformity in manufacturing:

1. Taper determination
2. Angle of tip
3. Radius of curvature

Why does IS 18561 matter?
Undergoing a medical procedure can be a stressful experience, and knowing that the tools being used meet stringent safety and quality standards, provides a sense of relief to the patient. IS 18561 ensures:

• Enhanced patient confidence: The standard guarantees that NSV instruments are designed to prioritize patient well-being, ensuring a safe and effective procedure.
• Reduced risk of complications: High-quality materials and precise manufacturing minimize the likelihood of infection, tissue damage, or other complications.
• Consistent care across facilities: By standardizing NSV instruments, patients can trust that their procedure will involve reliable equipment.

Development of IS 18561 is a pivotal step toward standardizing surgical instruments, ensuring patient safety, and promoting trust in surgical practices. As NSV continues to gain popularity as a reliable method, adhering to this standard will play a critical role in its widespread adoption.
MB Bureau