SIST EN 455-1:2020/oprA1:2021

Overview

EN 455-1:2020/prA1 is a draft amendment to the European standard EN 455-1:2020 published by CEN. It covers requirements and the test method for determining freedom from holes in medical gloves for single use. The amendment (prA1) clarifies key terms and updates sampling and inspection provisions used to demonstrate glove integrity, and was prepared by CEN/TC 205 (Non-active medical devices).

Key topics and requirements

• Scope: Applies to single-use medical gloves and the standardized leak-test methods used to detect holes that could compromise barrier performance.
• New term - lot: Adds a definition of lot (Clause 3.3) as a collection of gloves of the same design, colour, shape, size and formulation manufactured under the same conditions and packed in the same type of container (sourced from EN 455-4:2009).
• Sampling and AQL: Modifies Clause 6 to permit sampling in accordance with standardized AQL (Acceptance Quality Level) tables for single or multiple sampling plans. The amendment requires use of general inspection level I, but mandates a minimum sample size and acceptance/rejection numbers equivalent to sample size code letter L.
• Testing focus: Emphasizes statistical sampling and leak/detection testing to verify freedom from holes rather than prescribing material or design characteristics.

Practical applications and who uses this standard

• Glove manufacturers: Implement sampling and testing protocols during production and final inspection to demonstrate compliance with freedom-from-holes requirements.
• Quality assurance and regulatory teams: Use the standard to define lot acceptance criteria, AQL targets, and conformity documentation required for CE marking and national regulatory compliance.
• Testing laboratories: Apply the defined sampling plans and leak-test methods when performing conformity assessments or contract testing for clients.
• Procurement and healthcare providers: Reference the standard when specifying single-use medical gloves for clinical use to ensure barrier integrity and acceptable quality levels.
• Notified bodies and market surveillance: Use the requirements to evaluate manufacturer quality systems and product conformity.

Related standards

• EN 455 series (EN 455-1, EN 455-2, EN 455-3, EN 455-4) - EN 455-4 is specifically cited as the source for the lot definition.
• Other CEN/CENELEC guidance on medical gloves and device classification may be relevant for full conformity and labeling requirements.

Keywords: EN 455-1:2020/prA1, medical gloves, single-use gloves, freedom from holes, AQL, sampling plan, lot definition, CEN, leak testing, quality control.