ISO 23958-2:2022 PDF

Scope: This document specifies the particular requirements for the basic safety and essential performance of roller-type dermal needles for single use. It applies to roller-type dermal needles that have the capacity to penetrate the skin. It specifies structure and dimension, materials, and performance requirements for appearance and cleanliness, corrosion resistance, sterility, packaging and identification, transit and storage of roller- type dermal needles. It does not apply to tapping-type dermal needles or reusable roller-type dermal needles.

ISO 23958-2:2022 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
ISO 17218:2014 Sterile acupuncture needles for single use
ISO 6507-1 Metallic materials — Vickers hardness test — Part 1: Test method*， 2023-08-01 Update

2022 ISO 23958-2:2022 Traditional Chinese medicine — Dermal needles for single use — Part 2: Roller-type