SIST EN 455-3:2015/oprA1:2016

SIST EN 455-3:2015/oprA1:2016 - Medical Gloves Biological Evaluation Standard

Overview

SIST EN 455-3:2015/oprA1:2016 is a critical European standard published by CEN that defines requirements and testing methods for the biological evaluation of single-use medical gloves. Designed as Part 3 of the EN 455 series, this standard ensures that medical gloves used in healthcare settings meet stringent biological safety criteria to protect patients and users from potential health risks. It also clarifies labelling obligations and mandates transparency regarding testing procedures relevant to biological safety.

Key Topics

• Biological Safety Requirements
  Medical gloves must undergo rigorous biological evaluation to verify they do not pose a health risk due to allergic reactions, toxicity, or contamination. This standard specifies the evaluation framework to confirm gloves are safe for single use on one patient only as per EU Medical Device Directive (MDD 93/42/EEC).

• Labelling Requirements
  The standard mandates clear labelling instructions emphasizing that these gloves are for single use on a single patient. Labels must avoid any language suggesting cleaning, disinfection, reprocessing, or reuse, ensuring compliance with regulatory definitions of single-use medical devices (SUMD).

• Testing Methods
  It specifies biological testing methods for medical gloves, including but not limited to assessment of potential cytotoxicity, sensitization, irritation, and microbial contamination. This evaluation supports healthcare providers in selecting gloves that meet safety and performance expectations.

• Scope and Compliance
  Applicable to all single-use medical gloves across European countries under the jurisdiction of CEN members, including Austria, Germany, France, UK, and others. National standards bodies are required to implement this standard following CEN/CENELEC Internal Regulations once officially adopted.

Applications

Healthcare facilities, hospitals, clinics, and medical device manufacturers use SIST EN 455-3:2015/oprA1:2016 as a vital guideline to:

• Ensure patient safety during medical procedures by using gloves that meet comprehensive biological safety standards.
• Support compliance with EU directives for medical devices by proper product labelling and documentation of biological evaluations.
• Facilitate procurement decisions by providing clear safety and testing information on medical glove products.
• Guide glove manufacturers in the design, testing, and labelling processes necessary to market medical gloves within the EU and other regulated markets.

Related Standards

EN 455 is a multi-part series dealing with medical gloves for single use:

• EN 455-1: Requirements and testing for freedom from holes (physical integrity)
• EN 455-2: Requirements and testing for physical properties such as strength and elongation
• EN 455-4: Requirements and testing for shelf life determination of medical gloves

Together, these standards form the comprehensive framework for safety, quality, and performance of single-use medical gloves.

Summary: SIST EN 455-3:2015/oprA1:2016 establishes essential biological evaluation criteria and labelling requirements for single-use medical gloves. This standard enhances patient safety, supports regulatory compliance, and guides manufacturers and healthcare providers in the selection and use of biologically safe gloves. Implementing this standard is vital for maintaining high-quality medical gloves in clinical environments and safeguarding public health.