JIS T 3228-2018 PDF

Full title and description

JIS T 3228:2018 — "Biopsy needles for single use." This Japanese Industrial Standard specifies requirements for single‑use biopsy needles intended to obtain biological tissue specimens; it is written in Japanese with an English translation available.

Abstract

This standard covers the definition, configuration (names of each part), basic design and performance requirements, packaging and labelling for single‑use biopsy needles. It also applies to needles that are capable of injecting drug solutions except in situations where intended injection use would be hazardous. Annex A provides informative guidance on the concept of needle rigidity.

General information

• Status: Current / valid.
• Publication date: 1 February 2018 (JIS T 3228:2018).
• Publisher: Japanese Standards Association (JSA).
• ICS / categories: 11.040.25 — Syringes, needles and catheters.
• Edition / version: JIS T 3228:2018 (this edition; revisions were issued previously in 2011 and 2005).
• Number of pages: Japanese edition: 12 pages; English translation: 11 pages (approx.).

Key bibliographic details above are taken from the JSA publication and standard distributors listing for JIS T 3228:2018.

Scope

The scope of JIS T 3228:2018 is to specify requirements for single‑use biopsy needles used to obtain tissue specimens for diagnostic examination. The standard addresses product configuration and nomenclature, required performance and safety characteristics, packaging and labelling. It is broadly applicable to biopsy needles that may also be capable of injecting liquids except where such injection use would create a hazard under intended use.

Key topics and requirements

• Definitions and terms for biopsy‑needle components and measurements.
• Configuration and names of each part (hub, sheath, needle tube, cutting elements, etc.).
• Design and material considerations to ensure appropriate rigidity, strength and safety (guidance on needle rigidity in Annex A).
• Performance requirements (mechanical integrity, dimensional tolerances and functional characteristics appropriate to biopsy function).
• Sterility, packaging and transport requirements to maintain sterility until point of use.
• Labelling and instructions for use (intended use, warnings, lot/batch identification, sterilization method, etc.).
• Reference to normative documents and test methods used to demonstrate conformance.

The standard’s table of contents explicitly lists scope, normative references, terms and definitions, configuration, requirements, packaging and labelling, plus an informative annex on rigidity.

Typical use and users

Primary users include manufacturers and designers of single‑use biopsy needles, quality and regulatory teams preparing technical files and declarations of conformity, testing laboratories performing product verification, procurement and clinical engineering departments, and clinicians/end users who require device information for safe use. Regulators and notified bodies may also reference the standard during conformity assessment for medical devices marketed in Japan.

Related standards

Standards commonly referenced together with JIS T 3228 include international and sector standards for needles, biocompatibility, sterilization and packaging — for example ISO 7864 (sterile hypodermic needles for single use), ISO 11070 (sterile single‑use intravascular introducers, dilators and guidewires), the ISO 10993 series on biological evaluation/biocompatibility and ISO 11607 on packaging for terminally sterilized medical devices. These documents address complementary requirements (needle geometry and testing, biological safety, sterilization and sterile packaging) that manufacturers typically consider in device development and conformity assessment.

Keywords

JIS T 3228, biopsy needle, single‑use, disposable biopsy needle, sterile medical device, needle rigidity, packaging, labelling, JSA, 2018.

FAQ

Q: What is this standard?

A: JIS T 3228:2018 is the Japanese Industrial Standard that sets requirements for single‑use biopsy needles used to obtain tissue specimens.

Q: What does it cover?

A: It covers terminology, product configuration, basic design and performance requirements, sterility/packaging and labelling requirements, plus an informative annex on needle rigidity; it can also apply to needles capable of injecting solutions except where injection use would be hazardous.

Q: Who typically uses it?

A: Manufacturers, product engineers, quality/regulatory teams, test laboratories, procurement/clinical engineering and regulators involved with medical device conformity and safe clinical use.

Q: Is it current or superseded?

A: JIS T 3228:2018 is the current edition (published 1 February 2018). It replaced earlier editions published in 2011 and 2005. Consult the JSA publication listing to confirm current status before relying on the standard for certification or regulatory submission.

Q: Is it part of a series?

A: It is part of the JIS medical equipment group (JIS T series) covering needles, syringes, catheters and related devices; manufacturers commonly use it alongside other product and process standards (for example JIS/ISO standards addressing hypodermic needles, biocompatibility, sterilization and packaging).

Q: What are the key keywords?

A: Biopsy needle, single‑use, disposable needle, sterile, needle rigidity, packaging, labelling, JIS T 3228, Japanese Standards Association.