ISO 23907-1-2019 PDF

Full title and description

Sharps injury protection — Requirements and test methods — Part 1: Single-use sharps containers. This International Standard specifies design, performance and test requirements for single‑use sharps containers intended to collect potentially hazardous medical sharps (for example scalpels, trocars, hypodermic needles and syringes). It covers containers supplied complete by the manufacturer and containers supplied as components to be assembled by the user.

Abstract

This document sets out mandatory requirements and associated test methods for single‑use sharps containers to reduce sharps‑injury risk during disposal, handling and storage. It defines construction and stability criteria, strength of handles, aperture and closure design, resistance to penetration and to damage or leakage after dropping or toppling, fill‑line indicators, labelling and instructions for use. It excludes reusable sharps containers and outer transport containers used for shipping filled single‑use units.

General information

• Status: Published (confirmed).
• Publication date: January 2019 (published 15 January 2019 in several national adoptions; ISO record lists 2019‑01).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.99 (Medical equipment, sharps disposal).
• Edition / version: Edition 1 (2019).
• Number of pages: 12 (ISO published document).

Scope

ISO 23907‑1:2019 applies to single‑use sharps containers designed to hold potentially hazardous sharps medical waste, with or without integrated sharps‑protection features. It applies to units delivered fully assembled by the manufacturer and to component kits intended for user assembly. The standard does not apply to reusable sharps containers or to outer transport containers used for shipping filled single‑use containers. The standard specifies both requirements and the test methods to verify conformance.

Key topics and requirements

• Construction and general requirements: container geometry, materials and manufacturing robustness to ensure containment during intended use and foreseeable misuse.
• Container stability: tests and acceptance criteria to prevent toppling during normal placement or handling.
• Strength of handles: requirements and tests for handles (where fitted) to remain secure under specified loads.
• Aperture and closure design: requirements for safe insertion, one‑handed operation where appropriate, temporary and permanent closures, and prevention of access to disposed sharps.
• Resistance to penetration: puncture‑resistance requirements and test procedures to limit risk of sharps protrusion.
• Resistance to damage and leakage after dropping and toppling: specified drop/topple tests and inspection criteria to verify no leakage or breach.
• Fill‑line indicator: requirement for a visible maximum fill level to reduce overfilling hazards.
• Labelling and instructions for use: mandatory marking, warnings and user instructions to ensure safe handling, disposal and closure.
• Test methods: standardized apparatus, procedures and pass/fail criteria for the above performance tests (clauses covering stability, handle strength, penetration, drop and toppling tests).

Typical use and users

Primary users include manufacturers and product designers of single‑use sharps containers, quality and compliance teams, testing laboratories performing conformance testing, hospital procurement and infection‑prevention staff assessing device selection, and regulatory authorities reviewing product safety. The standard is used for product development, type testing, certification and procurement specifications.

Related standards

Related documents and series include ISO 23907‑2:2019 (requirements and test methods for reusable sharps containers) and other sharps‑injury protection standards such as ISO 23908 (standards addressing sharps‑injury protection mechanisms and related test methods). National and regional adoptions exist (for example EN/BS/DIN adoptions of ISO 23907‑1). The earlier ISO 23907:2012 was withdrawn and superseded by this 2019 Part 1/Part 2 structure.

Keywords

Sharps containers, sharps injury protection, single‑use, medical waste, puncture resistance, drop test, toppling, fill line, labelling, ISO 23907‑1:2019.

FAQ

Q: What is this standard?

A: ISO 23907‑1:2019 is an International Standard that specifies requirements and test methods for single‑use sharps containers used to collect potentially hazardous medical sharps; it defines performance, construction and labelling requirements and the tests to verify them.

Q: What does it cover?

A: It covers container construction and stability, handle strength, aperture and closure design, resistance to penetration, resistance to damage or leakage after dropping or toppling, fill‑line indicators, labelling and instructions for use, plus the associated test methods. It excludes reusable sharps containers and outer transport containers for filled single‑use units.

Q: Who typically uses it?

A: Manufacturers, product designers, test laboratories, hospital procurement and infection‑prevention professionals, and regulatory/compliance bodies use the standard for product design, testing, certification and procurement decisions.

Q: Is it current or superseded?

A: ISO 23907‑1:2019 is the current published Part 1 for single‑use sharps containers, published in 2019; it superseded the earlier ISO 23907:2012 (which was withdrawn). ISO records show the 2019 edition as published and recently confirmed. Users should verify the latest confirmation or revision status through their national standards body or ISO if absolute currentness is required.

Q: Is it part of a series?

A: Yes — ISO 23907 is organised as a multi‑part series: Part 1 (single‑use containers, 2019) and Part 2 (reusable sharps containers, 2019). There are related ISO documents addressing sharps‑injury protection and test methods (for example ISO 23908 and other related standards).

Q: What are the key keywords?

A: Sharps container, single‑use, sharps injury protection, puncture resistance, drop test, toppling, fill line, labelling, ISO 23907‑1:2019.