CEN/TR 16953:2017
(Main)Medical gloves for single use - Guidance for selection
Medical gloves for single use - Guidance for selection
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.
Medizinische Einmalhandschuhe - Leitlinien für die Auswahl
Gants médicaux non réutilisables - Lignes directrices pour sélectionner des gants médicaux non réutilisables
Medicinske rokavice za enkratno uporabo - Smernice za izbiro
To tehnično poročilo podaja informacije za tiste, ki izbirajo ali uporabljajo sterilne in nesterilne rokavice za medicinsko uporabo na podlagi ocene tveganja. Obravnava rokavice, ki se nosijo predvsem za zaščito bolnika in uporabnika rokavic pred biološko navzkrižno kontaminacijo.
OPOMBA: Rokavice, ki se nosijo izključno za zaščito uporabnika rokavic pred npr. kemičnimi in biološkimi nevarnostmi, so zajete v direktivi EU o osebni zaščitni opremi (PPE) in povezanih standardih npr. EN 16523 1, EN 374-2, EN 374-4, EN ISO 374-1 in EN ISO 374-5.
Ta dokument opisuje utemeljitev za zahteve v skupini standardov EN 455 in preučuje možne kompromise pri izbiri rokavic v povezavi z različnimi dejavniki, ki vplivajo na rokavice, kot so fizične lastnosti, biološka združljivost, udobje in občutljivost. Preučene so tudi prednosti in pomanjkljivosti različnih alternativnih materialov za rokavice in morebitne biološke nevarnosti zaradi njihove uporabe.
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2018
Medicinske rokavice za enkratno uporabo - Smernice za izbiro medicinskih rokavic
za enkratno uporabo
Medical gloves for single use - Guidance for selection
Medizinische Einmalhandschuhe - Leitlinien für die Auswahl
Gants médicaux non réutilisables - Lignes directrices pour sélectionner des gants
médicaux non réutilisables
Ta slovenski standard je istoveten z: CEN/TR 16953:2017
ICS:
11.140 Oprema bolnišnic Hospital equipment
13.340.40 Varovanje dlani in rok Hand and arm protection
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN/TR 16953
TECHNICAL REPORT
RAPPORT TECHNIQUE
November 2017
TECHNISCHER BERICHT
ICS 11.140
English Version
Medical gloves for single use - Guidance for selection
Gants médicaux non réutilisables - Lignes directrices Medizinische Einmalhandschuhe - Leitlinien für die
pour sélectionner des gants médicaux non réutilisables Auswahl
This Technical Report was approved by CEN on 22 October 2017. It has been drawn up by the Technical Committee CEN/TC 205.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 16953:2017 E
worldwide for CEN national Members.
Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Considerations in glove selection. 8
4.1 General . 8
4.2 Cross contamination risk . 9
4.2.1 General . 9
4.2.2 Freedom from holes . 9
4.2.3 Physical properties . 10
4.2.4 Storage stability . 10
4.3 Biocompatibility . 11
4.3.1 General . 11
4.3.2 Allergenic potential . 11
4.3.3 Plasticisers. 13
4.4 Potential contaminants . 13
4.4.1 General . 13
4.4.2 Glove Powder . 13
4.4.3 Sterilisation residues (Endotoxins) . 14
4.4.4 Surface additives . 14
5 Raw materials . 14
5.1 Specific glove raw materials. 14
5.1.1 Natural rubber . 14
5.1.2 Synthetic rubber . 14
5.1.3 Thermoplastics . 14
5.2 Glove coating . 14
6 Glove disinfection. 15
7 Labelling . 15
Annex A (informative) Glove materials and their use . 16
Annex B (informative) Additional information . 18
B.1 Double gloving . 18
B.2 Food contact . 18
B.3 Handling chemicals and chemotherapy drugs . 18
B.4 Effects of creams or disinfectants on medical gloves . 18
B.5 Classes of medical gloves . 19
B.6 Sharp EU-Directive (2010/32/EEC). 19
B.7 Cytotoxicity of medical gloves . 19
B.8 Glove selection, use time and durability . 19
B.9 Use of sterile examination vs. sterile surgical gloves . 20
Annex C (informative) CE-Marking . 21
Bibliography . 22
European foreword
This document (CEN/TR 16953:2017) has been prepared by Technical Committee CEN/TC 205 “Non-
active medical devices”, the secretariat of which is held by DIN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
This Technical Report gives information for use in the EN 455 series of standards. EN 455, Medical
gloves for single use, which consists of the following parts:
— Part 1: Requirements and testing for freedom from holes
— Part 2: Requirements and testing for physical properties
— Part 3: Requirements and testing for biological evaluation
— Part 4: Requirements and testing for shelf life determination
Introduction
This Technical Report sets out guidance for users and choosers for selection, storage and use of gloves
for medical applications.
Glove selection is technically complex and should be undertaken by suitably qualified professionals.
Medical gloves have been shown to be a barrier to agents responsible for the transmission of infections.
In order to help ensure effectiveness, it is essential that the gloves fit properly, are free from holes, and
have adequate physical properties over their entire shelf life to resist barrier failure during use. In
addition it is important that adequate information is provided on any risks to the health of glove users
or patients that use of the gloves can cause, e.g. allergic reactions. These issues are addressed in the
EN 455 series.
EN Standards once mandated by the EU Commission are referred to as ‘harmonized’ and are binding on
CEN Member States. Products which comply with harmonized standards are assumed to comply with
relevant Essential Requirements. ‘Horizontal’ standards apply across a range of different types of
product (e.g. sterility or labelling). ‘Vertical’ standards apply to a specific type of product e.g. medical
gloves.
CE marking is a key indicator of a product’s compliance with EU legislation and enables the free
movement of products within the European market. By affixing the CE marking on a product, a
manufacturer is declaring conformity with all legal requirements to achieve CE marking and therefore
ensuring validity for that product to be sold throughout the EEA, the member states of the EU and
European Free Trade Association countries - Iceland, Norway, Liechtenstein and Turkey. Further
information regarding CE marking can be found in Annex C.
Single-use medical gloves fall into two main device classifications depending on degree of invasiveness
of their use.
Non sterile Examination gloves are class I medical devices and are CE marked by the manufacturer
without third party regulatory approval. They are usually, but not necessarily, ambidextrous and bulk-
packed. Sterile examination gloves are class I sterile medical devices designed for short non-invasive
aseptic procedures (generally less than 60 min) in patient care. They require regulatory approval for
their sterility. Because they are intended for short procedures only, examination gloves are generally
thinner, and less robust than surgical grade gloves. They are usually sold in a limited number of sizes.
The force at break requirements for such gloves are specified at levels which are lower than for surgical
gloves but are based on many years cumulative experience of minimum requirements needed to ensure
acceptable performance in use. Values differ for different materials and are reflected in the
requirements of EN 455-2. They are sold either powdered with donning powder or as ‘powder free’.
Powder free gloves may have surface treatments or added chemical agents to assist in easy donning.
Surgical gloves are class IIa medical devices and are designed for invasive procedures. CE marking
requires approval of a Notified Body. They are sold sterile in a range of full and half sizes and packed in
pairs of handed gloves. Packaging is normally in an easy peel pack that can deliver sterile inner
wrapped gloves onto the sterile surgical field. Sterility is achieved by e.g. gamma or electron beam
irradiation or by ethylene oxide treatment. Surgical gloves are sterilized to a sterility assurance level
−6
(SAL) of 10 (according to EN 556-1) which gives a one in a million probability of finding a non sterile
device. Force at break requirements are more rigorous than for examination gloves and reflect the
levels that can be achieved for the materials concerned balanced against other in-use factors such as
comfort, dexterity and sensitivity of touch.
1 Scope
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
properti
...
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