ISO 9626-2016 PDF
Name in English:
St ISO 9626-2016
Name in Russian:
Ст ISO 9626-2016
Original standard ISO 9626-2016 in PDF full version. Additional info + preview on request
Full title and description
ISO 9626:2016 — Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods. This International Standard specifies requirements and test methods for rigid stainless‑steel tubing intended for the manufacture of hypodermic and other medical needles and related medical devices.
Abstract
ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices for human use. It defines dimensional series, tolerances, mechanical properties and relevant test methods for tube sizes from 3.4 mm (10 gauge) down to 0.18 mm (34 gauge) and excludes flexible stainless steel tubing.
General information
- Status: Published (confirmed current after 2021 review).
- Publication date: August 2016 (Edition 2, 2016-08).
- Publisher: International Organization for Standardization (ISO).
- ICS / categories: 11.040.25 (medical and surgical instruments).
- Edition / version: Edition 2 (2016).
- Number of pages: 23.
Scope
Specifies requirements and test methods for rigid stainless‑steel tubing intended as the component tubing for manufacturing hypodermic needles and other medical devices. The standard gives metric size designations, dimensional tolerances, mechanical property requirements and test procedures; it does not cover flexible stainless tubing though its dimensional recommendations may be adopted by flexible‑tube manufacturers.
Key topics and requirements
- Dimensional series and nominal sizes (metric gauges covering ≈3.4 mm to 0.18 mm).
- Dimensional tolerances for outer diameter, inner diameter and wall thickness.
- Mechanical property requirements (tensile/elongation/other relevant characteristics) appropriate for rigid needle tubing.
- Surface condition and visual acceptance criteria relevant to needle manufacture.
- Specified test methods for verifying dimensions, mechanical performance and tubing toughness in production and incoming inspection.
- Exclusion of flexible tubing and guidance that flexible tubing manufacturers may adopt dimensional specifications if appropriate.
Typical use and users
Primary users are manufacturers of medical needles and needle components, medical‑device OEMs, incoming inspection and quality laboratories, test houses, procurement specialists specifying needle tubing, and regulatory and compliance teams assessing material conformity for sterile single‑use needle products.
Related standards
Standards commonly referenced alongside ISO 9626 include other medical device and needle/syringe standards such as ISO 7864 (hypodermic needles — sterile, single‑use), ISO 7886 series (hypodermic syringes), ISO 11070 (sterile single‑use intravascular introducers) and other device‑specific standards; catalogs of related references appear in standards distributors and cross‑reference listings.
Keywords
stainless steel, needle tubing, medical needles, hypodermic, dimensions, tolerances, mechanical properties, test methods, rigid tubing, ISO 9626.
FAQ
Q: What is this standard?
A: ISO 9626:2016 is an International Standard that specifies requirements and test methods for rigid stainless‑steel tubing used to manufacture hypodermic and other medical needles.
Q: What does it cover?
A: It covers dimensional series, tolerances, mechanical properties and test methods for rigid stainless‑steel needle tubing (nominal sizes from about 3.4 mm to 0.18 mm). It excludes flexible tubing but offers dimensional guidance manufacturers may adopt.
Q: Who typically uses it?
A: Needle and needle‑component manufacturers, medical device OEMs, QA/test laboratories, procurement professionals and regulatory compliance teams use ISO 9626 when specifying or verifying needle tubing.
Q: Is it current or superseded?
A: ISO 9626:2016 is published and was reviewed in 2021 (confirmed current at that review). ISO has an ISO/DIS 9626 draft under development indicating a future revision is planned. Users should check the ISO catalog or national body for any updates or replacement publications.
Q: Is it part of a series?
A: It is part of the broader family of standards covering needles, syringes and related medical device components (for example ISO 7864, ISO 7886, ISO 11070 and others) and is often used together with device‑specific standards and regulatory guidance.
Q: What are the key keywords?
A: Key keywords are stainless steel, needle tubing, hypodermic needle, dimensions, tolerances, mechanical properties, test methods, rigid tubing, ISO 9626.