SIST-TP CEN/TR 16953:2018
(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 374-1and 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
SIST-TP CEN/TR 16953:2018
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
SIST-TP CEN/TR 16953:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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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.
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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
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B.9 Use of sterile examination vs. sterile surgical gloves . 20
Annex C (informative) CE-Marking . 21
Bibliography . 22
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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
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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.
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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
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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
EN 455 (series), Medical gloves for single use
EN ISO 374-5, Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology
and performance requirements for micro-organisms risks (ISO 374-5)
EN ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin
sensitization (ISO 10993-10)
ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by
acceptance quality limit (AQL) for lot-by-lot inspection
3 Terms and definitions
For the purposes of this document, the terms and definitions given in the EN 455 series and the
following apply.
3.1
EU Directives
3.1.1
MDD
MD Directive
(Medical Device Directive)
legal act of the European Union covering the requirements that apply to medical devices including
gloves with a medical purpose in the patient environment
Note 1 to entry: Protection against chemicals such as disinfectants, chemotherapy drugs etc. or against
mechanical risks is not considered to be a medical purpose.
Note 2 to entry: Prior to amendment by Directive 2007/47/EC, MD Directive did not apply to personal
protective equipment covered by Directive 89/686/EEC. The principal intended purpose of the product was
decisive for deciding whether either the PPE Directive or the MD Directive was applicable.
Note 3 to entry: The interpretative document of the European commission's services of August 2009 clarifies
that products for which a manufacturer claims a double purpose (MD and PPE) are covered by the MD Directive.
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In case of simultaneous application of MDD and PPE Directives the product need to undergo the conformity
assessment procedures of both directives.
Note 4 to entry: The MDD will be superseded by the upcoming MDR (Medical Devices Regulation). For further
information see www.eur-lex.europa.eu .
3.1.2
PPED
PPE Directive
(Personal Protective Equipment Directive)
legal act of the European Union covering the requirements that apply to any device worn or held by an
individual for protection against one or more health and safety hazard
Note 1 to entry: PPE Directive covers only the safety of the glove user rather than the patient.
Note 2 to entry: Only a CE-mark approved by a notified body ensures compliance to PPE Directive category II
and III.
Note 3 to entry: The Directive 89/686/EEC will be superseded by the PPER (Personal Protective Equipment
Regulation 2016/425). For further information see http://eur-lex.europa.eu/homepage.html
3.2
single-use medical gloves
device intended to be used once only for a single patient
3.3
elastomer/elastic polymer
macromolecular material which returns rapidly to approximately its initial dimensions and shape after
substantial deformation by a weak stress and release of the stress
[SOURCE: ISO 1382:2012 modified, the heading “/elastic polymer” was added]
3.4
specific glove raw materials
3.4.1
natural rubber
NR
solid material with elastic properties obtained from the botanic source Hevea brasiliensis
Note 1 to entry: Cis-1,4-polyisoprene is the main constituent of NR.
[SOURCE: EN 923:2015, 2.3.15]
3.4.2
synthetic rubber
manufactured elastomeric material which in comparison to natural rubber, may have varying degrees
of elasticity and hardness
Note 1 to entry: For further information see 5.1.2.
3.4.3
thermoplastics
plastics that are capable of being repeatedly softened by heating and hardened by cooling through a
temperature range characteristic of the plastics and, in the softened state, of being repeatedly shaped by
flow into articles by moulding, extrusion or forming
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3.4.4
latex
colloidal aqueous dispersion of a polymeric material
[SOURCE: EN ISO 472:2013, 2.529]
Note 1 to entry: This may be naturally occurring as in e.g. natural rubber latex, the milky extract from the
rubber plant, or may be manufactured, as in dispersions of synthetic polymers in water, e.g. polychloroprene latex,
or as in latex paints which are pigments bound by polymeric resins dispersed in water. The term “latex glove” is
commonly understood to refer to natural rubber gloves but it can also apply to synthetic rubber gloves as these
are produced from a latex. There is therefore potential for misinterpretation.
4 Considerations in glove selection
4.1 General
Those wishing to select medical gloves for specific procedures will do so, on the basis of a risk
assessment of the potential hazards to patient and glove user.
The risk assessment will include:
— the risks associated with cross contamination (see 4.2);
— the length of the procedure/comfort/durability required;
— degree of manual dexterity envisaged e.g. procedures where thicker gloves or/and double gloving
is recommended to provide added protection will be at the expense of reduced sensitivity and
comfort. Micro surgery may require a thinner glove affording greater sensitivity at the expense of
durability;
— physical challenge of the procedure to the glove material e.g. handling sharp or potentially
damaging instruments/materials; and
— biocompatibility issues, i.e. the potential for allergic reaction by the glove user or patient and risk of
contamination of either by extractable/leachable glove components (see 4.3).
The following hazards are addressed by the EN 455 series:
— biological organism material (fungi, bacteria, viruses);
— non biocompatibility.
The following hazards are not addressed by the EN 455 series:
— chemical permeation or degradation e.g. by disinfectants or chemotherapy drugs;
— physical and mechanical damage e.g. by sharp instruments, needles.
Gloves that offer protection against the above hazards should comply with the PPE Directive and the
related standards e.g. EN 16523-1, EN 374-2, EN 374-4, EN ISO 374-1 and EN ISO 374-5. Medical gloves
required to perform this additional function should conform to the relevant PPE Directive and related
standards.
Guidance for selection of gloves with respect to the intended use and risk is given in Figure 1. Where
conformity with more than one directive is claimed this will be indicated by the affixing of the CE mark
with reference to the relevant directives.
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Additional information can be found in Annex B.
Figure 1 — Guidance for selection of gloves with respect to the intended use and risk
4.2 Cross contamination risk
4.2.1 General
The risk of cross contamination between medical glove user and patient varies with factors such as:
infection status of patient, degree of exposure to body fluids, status of patient immune system, degree of
invasiveness of procedure, barrier effectiveness of gloves, length of procedure, likelihood of physical
damage to gloves etc. These factors should be included in the risk assessment procedure to choose an
appropriate glove material and properties.
Any glove material is required to be tested to confirm that it is a barrier to microorganisms (bacteria,
viruses, fungi). This is confirmed by the bacteriophage test as described in EN ISO 374-5 or equivalent
(e.g. ASTM F1671-08). The effective barrier properties of any finished glove will be dependent on the
glove being intact and this is dependent on the quality of its manufacture (freedom from holes, physical
properties). These two factors are covered by EN 455-1 and EN 455-2.
4.2.2 Freedom from holes
Only an intact film will act as a barrier to microorganisms. Consequently, testing for freedom from holes
is an appropriate test to demonstrate barrier properties to microorganisms including viruses.
Requirements and testing for freedom from holes is considered in EN 455-1 which describes the testing
necessary to establish the required degree of freedom from holes as measured by a water tightness test.
The water tightness test is the reference test for detection of holes.
NOTE 1 A manufacturer's claim of 100 % air inflation testing is only of value if accompanied by visual
inspection to detect imperfections which could lead to rapid hole formation on extension, e.g. bubbles in finger
crotches. Tiny holes in areas which do not stretch greatly with air inflation will not be detected by this test. Any
claim based on electronic testing akin to that used in condom quality assurance is also not reliable due to
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difficulties in maintaining close contact between all parts of the glove and the electrically conducting former. This
means that holes in remote parts of the glove can go undetected.
Due to the nature of the manufacturers dipping process for elastomeric gloves it is not possible to
guarantee complete freedom from holes. The only course open to the manufacturer is therefore to take
a statistically representative sample of gloves and measure how many holes are present. Each
production lot is sampled according to ISO 2859-1 (Sampling Procedures for Inspection by Attributes)
with specified limits on sample size. The maximum level of holes allowed for compliance with ISO 2859-
1 is an Acceptance Quality Limit (AQL) of 1,5. This level was arrived at as being achievable in practice
without incurring undue consumer risk. Manufacturers wishing to consistently achieve this AQL with
minimized risk of failure will strive to maintain a process average for holes of consistently less than this.
Some manufacturers may be able to fine tune their manufacturing process to a level where they achieve
a lower AQL for holes and make a claim accordingly, e.g. AQL for holes of 1,0 or 0,65. Any such claim
needs to be fully supported by valid statistical data.
NOTE 2 AQL stands for “Acceptance Quality Limit” and is defined as the “quality level that is the worst
tolerable” in ISO 2859-1. It specifies the maximum number of defective units, beyond which a batch is rejected.
EN 455-1 only applies to product before use during shelf life. However it says nothing about the likelihood of holes
forming in the gloves during use. The duration of use of any particular glove will depend on the procedure and the
result of the risk assessment.
4.2.3 Physical properties
Requirements for physical properties of gloves are considered in EN 455-2.
EN 455-2 describes methods for measurement of a range of physical properties of medical gloves from
dimensions (length, width, thickness) to physical strength. It defines minimum median values for length
and force at break and median ranges for palm width, measured on 13 samples per lot.
Strength measurements are made on samples taken from the palm region of the glove so in order to
ensure that the required material strength is achieved at the glove finger tips a correction factor has to
be applied if thickness differs between the two regions by greater than 10 %. Values required differ
between natural and synthetic and elastomeric and thermoplastic materials but are generally based on
historical experience of what is achievable as representative of a well manufactured product and shown
to provide satisfactory in-use performance for each material.
The choice of glove for a particular procedure will be made on a variety of factors considered in the risk
assessment process.
Annex A summarizes the relative material properties of the commonly used glove materials.
4.2.4 Storage stability
Before products are placed on the market manufacturers are required to carry out accelerated stability
testing to estimate the product shelf life. And as part of the required post market surveillance
procedures, they are also required to initiate real time stability tests to confirm or extend the stated
shelf life.
The procedures to be followed in establishing and supporting the product shelf life are outlined in
EN 455-4. Accelerated testing involves storage at elevated temperatures for short periods and
extrapolating quantitative changes with time and temperature to shelf life at 25 °C. Measurements are
made of all properties which might reasonably be expected to change over the shelf life of the product.
These properties include but are not limited to, force at break, freedom from holes and, in the case of
sterile gloves, pack integrity. EN 455-4 requires that these tests are conducted on new products and on
any existing product where there has been any significant change in formulation or manufacturing
process.
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For product that is less than 12 months old it is a requirement of EN 455-2 that physical properties
remain in excess of the minimum requirements even after challenge testing for 7 days at 70 °C.
EN 455-4 requires that all medical gloves meet the requirements of EN 455 series throughout their
shelf-life.
To ensure that medical gloves will safely achieve their predicted shelf life manufacturers usually make
recommendations on long term storage of their products which usually include, dry conditions, above
e.g. 5 °C, below 30 °C or 25 °C and avoidance of direct sunlight, ozone or other sources of heat or
irradiation.
4.3 Biocompatibility
4.3.1 General
Biocompatibility issues are addressed in EN 455-3.
EN 455-3 was initiated in response to reports of adverse reactions to proteins in natural rubber latex
products which became prevalent in the late 1980s early 1990s. It also considers adverse reactions due
to other factors ranging from residual chemicals to lubricants to bacterial residues (endotoxins), after
sterilization.
4.3.2 Allergenic potential
4.3.2.1 General
The potential allergens present in medical gloves range from residual protein in natural rubber
products to residual chemicals used in the crosslinking process of sulphur cured elastomers, both
natural and synthetic.
Several factors contribute to the risk of reaction:
a) Type and level of allergens present in the glove;
b) the duration and frequency of skin contact with gloves;
c) the occlusive nature of the glove/skin interaction during glove use;
d) the manner of exposure to the allergens (skin, mucosa, tissue and inhalati
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