PD CEN/TR 16953:2017 - Medical gloves for single use. Guidance for selection

PD CEN/TR 16953:2017

Medical gloves for single use. Guidance for selection

Status : Current   Published : December 2017



This Technical Report provides information for those choosing or using sterile and non-sterile gloves for medical applications based on a risk assessment. It deals with gloves worn primarily for the protection of the patient and glove user from biological cross contamination. NOTE Gloves worn specifically for the protection of the glove user from e.g. chemical and biological hazards are covered by the EU-Directive on Personal Protective Equipment (PPE) and the related standards e.g. EN 16523-1, EN 374-2, EN 374-4, EN ISO 374-1 and EN ISO 374-5. This document describes the rationale behind the requirements of the EN 455 series and explores the possible trade-offs in glove selection between the various factors which affect glove, physical properties, biocompatibility, comfort and sensitivity. The strengths and weaknesses of various alternative glove materials and the potential biological hazards presented by their use are also explored.

Standard NumberPD CEN/TR 16953:2017
TitleMedical gloves for single use. Guidance for selection
Publication Date13 December 2017
Normative References(Required to achieve compliance to this standard)EN ISO 10993-10, EN ISO 374-5, EN 455 (series), ISO 2859-1, ISO 10993-10
Informative References(Provided for Information)EN 374-4, ASTM F1671-08, EN 374-2, EN 420, EN 388, EN 556-1, EN ISO 10993-5, EN ISO 374-1, EN 16523-1, BS EN 923:2015, EN ISO 472 (ISO 472:2013) AS, ISO 472:2013 ED4, ISO 10993-5:2009, ISO 1382:2012 ED6, ISO 374-1:2016
International RelationshipsCEN/TR 16953:2017
DescriptorsGuidance systems, Hospital equipment, Surgical gloves, Gloves (protective), Medical equipment
Title in FrenchGants médicaux non réutilisables. Lignes directrices pour sélectionner des gants médicaux non réutilisables
Title in GermanMedizinische Einmalhandschuhe. Leitlinien für die Auswahl
ISBN978 0 580 98604 8
File Size551 KB

 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents

Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version

Worldwide Standards
We can source any standard from anywhere in the world


Access, view and download standards with multiple user access, across multiple sites with BSOL