New GOST for surgical needles will come into force in Russia on March 1
Quick Look
- From March 1, a new GOST for surgical needles will come into force in Russia, replacing the document from 1983.
- New classifications for bends and shapes have been introduced, requirements for material (stainless steel only) and workmanship have been established, including the maximum sharpness of the piercing part - no more than 0.02 mm.
- The assigned resource of needles must be at least 650 punctures, the full average - at least 850 punctures, with an endurance of 20 cycles of sanitary treatment.
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Why It Matters
The previous GOST for surgical needles had been in force since 1983 and required updating due to the development of medical technologies and increasing requirements for the safety and quality of medical products.
The new GOST for surgical needles for suturing tissue during operations will come into force in Russia on March 1, it will replace the document from 1983, it follows from Rosstandart documents, which RIA Novosti reviewed.
GOST has undergone significant changes. Thus, depending on the bend, the needles are divided into straight, ski-shaped, arched, hook-shaped, and complexly curved. In this case, other bends of the needles are allowed in accordance with the manufacturer’s technical documentation. Depending on the shape, the needles are: piercing, piercing-cutting, cutting, spatula and blunt-pointed.
GOST notes that needles should be made only of stainless steel. In addition, there should be no burrs or sharp edges on the inner surfaces of the tool ears that could damage or tear the suture material when inserting the thread or during operation. The sharpness of the piercing part of the needles should not exceed 0.02 millimeters.
The designated and full average needle life must be at least 650 and 850 punctures, respectively, with 20 sanitization cycles.
Open Questions
- Which manufacturers of surgical needles in Russia are already certified according to the new GOST?
- Will there be a transition period for using old needles after March 1st?
- How will compliance with the new requirements be monitored in production and in medical institutions?
