ISO 23907-2-2019 PDF

Full title and description

Sharps injury protection — Requirements and test methods — Part 2: Reusable sharps containers. This International Standard specifies safety, performance and test requirements for reusable containers intended to receive and retain potentially hazardous sharps medical waste (e.g., scalpel blades, trocars, hypodermic needles and syringes) and includes provisions for design, durability, cleaning/decontamination and microbiological validation to reduce risk of sharps injury during use and reprocessing.

Abstract

This document sets out requirements and test methods for reusable sharps containers supplied either complete by the manufacturer or as components for user assembly. It covers design features to protect users, lifespan simulation, resistance to penetration and damage, leakage/performance after drops and toppling, cleaning and decontamination processes, microbiological validation, and quality monitoring. It explicitly excludes single-use sharps containers (see ISO 23907-1 for single‑use requirements).

General information

• Status: Published (confirmed as current following review).
• Publication date: November 2019 (2019-11, Edition 1).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.99 (Other medical equipment).
• Edition / version: Edition 1 (2019).
• Number of pages: 17.

Key bibliographic details and life‑cycle status as published by ISO.

Scope

Applies to reusable sharps containers intended to hold potentially hazardous sharps produced in healthcare settings. The standard addresses complete containers and component sets intended for assembly by the user. It does not apply to single‑use sharps containers (covered by ISO 23907‑1:2019) nor to outer transport packaging for filled single‑use containers. Main areas covered include user‑safety design, containment integrity, durability under simulated service life, decontamination/cleaning validation and microbiological controls.

Key topics and requirements

• Design for user safety: features that reduce the need to touch sharps, secure permanent closures and safe temporary closures.
• Resistance to penetration: minimum penetration force requirements for materials and closures to resist sharp objects.
• Mechanical performance: tests for drop and topple resistance with criteria for no leakage, no breach of containment and continued functional integrity (closures, handles etc.).
• Lifespan simulation: durability testing to simulate repeated use, handling and reprocessing cycles for reusable designs.
• Cleaning and decontamination: procedures and validation for effective removal/inactivation of microbiological contaminants during reprocessing.
• Microbiological validation and quality monitoring: methods to demonstrate continued microbiological safety through the container’s service life.
• Performance test methods: defined test procedures and pass/fail criteria (examples include specified minimum penetration forces and visual/functional checks after impact tests).

Typical use and users

Primary users include manufacturers and designers of reusable sharps containers, healthcare facility procurement and infection control teams, reprocessing/sterilization departments, testing and certification laboratories, and regulatory bodies assessing device safety. The standard is used to specify design and acceptance criteria during development, to define test methods for product qualification, and to support compliance checks during procurement and regulatory review.

Related standards

Directly related: ISO 23907-1:2019 (Sharps injury protection — Requirements and test methods — Part 1: Single‑use sharps containers). Other related guidance and standards may include national regulations on medical waste handling, standards for sterilization validation and any regional device safety regulations administered by competent authorities.

Keywords

sharps injury protection; reusable sharps container; medical waste; containment; penetration resistance; drop test; toppling; cleaning validation; decontamination; microbiological validation; ISO 23907; ISO/TC 84.

FAQ

Q: What is this standard?

A: ISO 23907-2:2019 is an international standard that specifies requirements and test methods for reusable sharps containers used to collect and contain potentially hazardous medical sharps.

Q: What does it cover?

A: It covers design features for user safety, containment integrity, mechanical durability (including drop and topple resistance), resistance to penetration, cleaning and decontamination validation, microbiological safety and quality monitoring for reusable containers. It also defines test methods and acceptance criteria.

Q: Who typically uses it?

A: Manufacturers, product designers, testing/certification labs, healthcare procurement and infection control teams, reprocessing departments and regulatory reviewers use this standard to design, validate, test and procure reusable sharps containers.

Q: Is it current or superseded?

A: ISO 23907-2:2019 was published in November 2019 (Edition 1) and has been reviewed and confirmed as current by ISO (confirmation noted in ISO’s maintenance records). Users should check the ISO catalogue or national standards bodies for any subsequent revisions or amendments.

Q: Is it part of a series?

A: Yes — it is Part 2 of the ISO 23907 series on sharps injury protection; Part 1 (ISO 23907-1:2019) covers single‑use sharps containers. The series is maintained by ISO/TC 84.

Q: What are the key keywords?

A: Reusable sharps container; sharps injury protection; containment integrity; penetration resistance; drop/topple testing; cleaning validation; microbiological validation; ISO 23907-2:2019.