ISO 23908:2011 PDF

Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

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Title (English):

ISO 23908:2011

Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

Document status:: Withdrawn
Format:: Electronic (PDF)
Number of pages:: 11
Publication date:: May 27, 2011
Edition:: ISO IS 23908 edition 1 version 1
ICS:: 11.040.25

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Description (English):

ISO 23908:2011 gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection. It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself.

Technical details

Technical committee: ISO/TC 84 - Devices for administration of medicinal products and catheters
SKU: ISO 23908:2011

Abstract

Overview

ISO 23908:2011 specifies requirements and test methods for sharps injury protection features on medical devices that contain sharp hypodermic needles for single use - including single‑use hypodermic needles, catheter introducers and blood‑sampling needles/lancets. It is a horizontal standard that focuses on performance verification of active or passive safety features (integral or combined prior to use) - not on storage/handling before use or on the medical device’s clinical function.

Key topics and technical requirements

Scope and intent: performance evaluation of sharps protection systems intended to reduce accidental post‑use sharps injuries and potential disease transmission.
Active vs. passive features: definitions and expectations - active features require a user step to deploy; passive features deploy automatically after intended use.
Safe mode requirements: once activated the device must remain in a safe mode that prevents access to the sharp until disposal and must be apparent to the user (visual, tactile and/or audible indication).
Activation characteristics:
- Activation forces must be appropriate for intended users (patients, healthcare workers, caregivers) and selected via a risk‑based approach (consistent with ISO 14971).
- One‑handed operation is recommended for active devices; user hands must remain behind the contaminated sharp during activation.
Security of safe mode: devices must resist unintended exposure and minimize accidental access; manufacturers determine overriding forces by risk analysis.
Test methods:
- Procedures for testing activation (tensile/compressive/torque), challenging the device in safe mode, testing access to the sharp in safe mode, and simulated clinical use studies.
- Standard test conditions: temperature (23 ± 5) °C and relative humidity (50 ± 25) %, with devices preconditioned for at least 4 hours.
- Statistical sampling and analysis references: ISO 2859 / ISO 3951 (sampling) and ISO 16269‑6 (statistical tolerance intervals).
Manufacturer information: marking/labeling and instructions for use are required; guidance on simulated user studies is provided (Annex A) and specific access test methods (Annex B).

Practical applications - who uses ISO 23908:2011

Medical device manufacturers designing and verifying sharps protection features for regulatory submissions and product development.
Quality and regulatory engineers creating test protocols and risk assessments.
Test laboratories performing activation, security and simulated‑use testing.
Procurement and hospital safety teams evaluating safety performance of single‑use needle products.
Usability specialists conducting simulated clinical use studies in line with IEC 62366 guidance.

Related standards

ISO 14971 - risk management for medical devices
ISO 2859 / ISO 3951 - sampling procedures
ISO 16269‑6 - statistical tolerance intervals
IEC 62366 - usability engineering (recommended for usability considerations)

ISO 23908:2011 helps ensure sharps protection features are effective, user‑appropriate and demonstrably safe under realistic use conditions - supporting safer healthcare practice and regulatory compliance.

Related standards

Standards mentioned in the description

Abstract

Overview

Key topics and technical requirements

Scope and intent: performance evaluation of sharps protection systems intended to reduce accidental post‑use sharps injuries and potential disease transmission.
Active vs. passive features: definitions and expectations - active features require a user step to deploy; passive features deploy automatically after intended use.
Safe mode requirements: once activated the device must remain in a safe mode that prevents access to the sharp until disposal and must be apparent to the user (visual, tactile and/or audible indication).
Activation characteristics:
- Activation forces must be appropriate for intended users (patients, healthcare workers, caregivers) and selected via a risk‑based approach (consistent with ISO 14971).
- One‑handed operation is recommended for active devices; user hands must remain behind the contaminated sharp during activation.
Security of safe mode: devices must resist unintended exposure and minimize accidental access; manufacturers determine overriding forces by risk analysis.
Test methods:
- Procedures for testing activation (tensile/compressive/torque), challenging the device in safe mode, testing access to the sharp in safe mode, and simulated clinical use studies.
- Standard test conditions: temperature (23 ± 5) °C and relative humidity (50 ± 25) %, with devices preconditioned for at least 4 hours.
- Statistical sampling and analysis references: ISO 2859 / ISO 3951 (sampling) and ISO 16269‑6 (statistical tolerance intervals).
Manufacturer information: marking/labeling and instructions for use are required; guidance on simulated user studies is provided (Annex A) and specific access test methods (Annex B).

Practical applications - who uses ISO 23908:2011

Medical device manufacturers designing and verifying sharps protection features for regulatory submissions and product development.
Quality and regulatory engineers creating test protocols and risk assessments.
Test laboratories performing activation, security and simulated‑use testing.
Procurement and hospital safety teams evaluating safety performance of single‑use needle products.
Usability specialists conducting simulated clinical use studies in line with IEC 62366 guidance.

Related standards

ISO 14971 - risk management for medical devices
ISO 2859 / ISO 3951 - sampling procedures
ISO 16269‑6 - statistical tolerance intervals
IEC 62366 - usability engineering (recommended for usability considerations)

ISO 23908:2011 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Practical applications - who uses ISO 23908:2011

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Practical applications - who uses ISO 23908:2011

Related standards

Related standards

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