ISO 23958-2:2022 PDF

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

Название (английский):

ISO 23958-2:2022

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 25 мая 2022 г.
Издание:: ISO IS 23958 edition 1 version 1
ICS:: 11.040.25

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Описание (английский):

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.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 23958-2:2022 - Traditional Chinese medicine - Dermal needles for single use - Part 2: Roller-type specifies safety and essential performance requirements for roller-type dermal needles intended to penetrate the skin. It covers structure and dimensions, materials and biocompatibility, performance (appearance, puncture, hardness, corrosion resistance), sterility, packaging/identification, and transit and storage. This part applies only to single‑use roller-type devices and excludes tapping-type and reusable rollers.

Key topics and technical requirements

Scope & device definition: Roller-type dermal needle = handle + rotating roller with evenly spaced micron‑needles designed to stimulate skin/meridians.

Size designation: Metric size expressed as diameter × length (example: ⌀0.16 mm × 1.0 mm). Tolerances for nominal lengths and diameters are specified by ranges.

Needle density & roller size: Indicative needle density is specified (typically 6–20 needles per cm², defined in the standard); roller diameter range 10–50 mm.

Materials & biocompatibility:

Needle body commonly from austenitic stainless steels (e.g., X5CrNi18‑9 or X7CrNi18‑9 as referenced).
Handle/roller typically polycarbonate (PC) or equivalent engineering plastics.
Biocompatibility assessment per ISO 10993‑1; specific tests (cytotoxicity, sensitization, intracutaneous reactivity) and EO residuals per ISO 10993‑7 when applicable.

Performance & quality:

Visual and microscopic inspection requirements (clean, bright, no burrs; needle tips smooth under 10× magnification).
Puncture performance referenced to ISO 17218.
Hardness requirement: Vickers hardness specified (refer to ISO 6507‑1 for testing); minimum ~350 HV as indicated.
Corrosion resistance, smooth roller rotation, and surface cleanliness criteria.

Packaging & labelling:

Primary packaging must provide a microbial barrier; secondary packaging and identification requirements are defined for traceability and distribution.

Transit and storage: Requirements to protect sterility, packaging integrity and device performance during distribution and storage.

Applications and users

Manufacturers and product designers: guidance for designing, selecting materials, and setting production tolerances for single‑use roller dermal needles.

Quality assurance & regulatory teams: benchmarks for testing, sterility, biocompatibility and labelling to demonstrate compliance.

Purchasing and procurement: specification language for procurement of compliant roller-type dermal needles.

Clinicians and TCM practitioners: assurance of single‑use device safety, sterility and consistency in clinical use.

Related standards

ISO 10993‑1, ISO 10993‑7 (biological evaluation)

ISO 17218 (sterile acupuncture needles - referenced for puncture testing)

ISO 6507‑1 (Vickers hardness test)

ISO 15223‑1 (medical device symbols)

ISO 15510 (reference for commonly used stainless steels)

Keywords: ISO 23958‑2, roller‑type dermal needles, traditional Chinese medicine, single‑use dermal needle, sterility, biocompatibility, needle density, Vickers hardness, ISO 17218.

ISO 23958-2:2022 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

ISO 10993-7:2008/Amd 1:2019

Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Appl…

ISO 17218:2014

Sterile acupuncture needles for single use

SIST EN ISO 6507-1:2023

Metallic materials - Vickers hardness test - Part 1: Test method (ISO 6507-1:2023)

SIST EN ISO 15223-1:2021/A1:2026

Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General re…

ISO 15510:2010

Stainless steels — Chemical composition