EN 455-3:2006
(Main)Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It gives requirements for labelling and the disclosure of information relevant to the test methods used.
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und Prüfung für die biologische Bewertung
Dieser Teil der EN 455 legt Anforderungen für die Bewertung der biologischen Sicherheit von medizinischen Einmalhandschuhen fest. Er enthält Anforderungen für die Kennzeichnung und die Angabe von Informationen über die angewendeten Prüfmethoden.
Gants médicaux non réutilisables - Partie 3: Exigences et essais pour évaluation biologique
La présente partie de l�EN 455 spécifie les exigences permettant d�évaluer la sécurité biologique des gants
médicaux à usage unique. Elle mentionne les exigences d�étiquetage des gants et de diffusion des informations
concernant les méthodes d�essai utilisées.
Medicinske rokavice za enkratno uporabo - 3. del: Zahteve in preskusi za biološko ovrednotenje
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2007
1DGRPHãþD
SIST EN 455-3:2000
Medicinske rokavice za enkratno uporabo - 3. del: Zahteve in preskusi za biološko
ovrednotenje
Medical gloves for single use - Part 3: Requirements and testing for biological evaluation
Medizinische Handschuhe zum einmaligen Gebrauch - Teil 3: Anforderungen und
Prüfung für die biologische Bewertung
Gants médicaux non réutilisables - Partie 3: Exigences et essais pour évaluation
biologique
Ta slovenski standard je istoveten z: EN 455-3:2006
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 455-3
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2006
ICS 11.140 Supersedes EN 455-3:1999
English Version
Medical gloves for single use - Part 3: Requirements and testing
for biological evaluation
Gants médicaux non réutilisables - Partie 3: Exigences et Medizinische Handschuhe zum einmaligen Gebrauch - Teil
essais pour évaluation biologique 3: Anforderungen und Prüfung für die biologische
Bewertung
This European Standard was approved by CEN on 13 October 2006.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 455-3:2006: E
worldwide for CEN national Members.
Contents Page
Foreword.3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .6
4 Requirements.6
5 Test methods.8
6 Test report .9
Annex A (normative) Method for the determination of aqueous extractable proteins in natural
rubber gloves using the modified Lowry assay .10
Annex B (informative) Immunological methods for the measurement of natural rubber latex
allergens .20
Annex C (informative) Amino acid analysis (AAA) by high pressure liquid chromatography
(HPLC).27
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC Medical Devices.36
Foreword
This document (EN 455-3:2006) has been prepared by Technical Committee CEN/TC 205 “Non-active
medical devices”, the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by June 2007, and conflicting national standards shall be withdrawn at the
latest by June 2007.
This document supersedes EN 455-3:1999.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive 93/42/EEC.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
EN 455 consists of the following parts under the general title "Medical gloves for single use":
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
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Cyprus, Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden,
Switzerland and United Kingdom.
Introduction
Adverse reactions to proteins in latex products have been reported over several years in variable rates of
prevalence. Additionally, adverse reactions due to chemicals, lubricants, sterilization residues, pyrogens or
other residues are described in the scientific literature. Adverse reactions are most often reported due to
gloves made from natural rubber latex, but some of the reactions can also be seen due to gloves made from
synthetic polymers.
EN ISO 10993 specifies requirements and test methods for biological evaluation of medical devices. However
it does not specifically address adverse reactions that can result from the use of medical gloves (e.g,
immediate type allergies). These adverse reactions occur to specific allergens that can be present in gloves.
Several factors contribute to the risk of reaction:
a) the duration and frequency of skin contact with gloves;
b) the exposure to the allergens through direct contact to mucosa and skin (especially when not intact) and
by inhalation of particles;
c) the occlusive nature of the glove/skin interaction during glove use.
This part of EN 455 gives requirements and test methods for evaluation of the biological safety of medical
gloves as part of a risk management process, in accordance with EN ISO 14971 and EN ISO 10993.
1 Scope
This part of EN 455 specifies requirements for the evaluation of biological safety for medical gloves for single use. It
gives requirements for labelling and the disclosure of information relevant to the test methods used.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references,
only the edition cited applies. For undated references, the latest edition of the referenced document (including any
amendments) applies.
EN 980, Graphical symbols for use in the labelling of medical devices
EN 1041, Information supplied by the manufacturer with medical devices
EN ISO 10993 (all parts), Biological evaluation of medical devices
EN ISO 14971, Medical devices ― Application of risk management to medical devices (ISO 14971:2000)
EN ISO 21171:2006, Medical gloves ― Determination of removable surface powder (ISO 21171:2006)
European Pharmacopoeia, Monograph 2.6.14 Bacterial Endotoxins: publisher EDQM Council of Europe; 226
avenue de Colmar B.P. 907; F-67029 Strasbourg; France http://www.pheur.org
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
chemicals
substances added or formed during any step of the manufacturing process or in storage which may be
available in the final product
NOTE These can include lubricants, chemical coatings and sterilizing agents. Several chemical ingredients are
commonly used during processing of gloves, some of them are known to cause type IV allergic reactions. The type and
amount of residual chemicals added and finally present are variable.
3.2
endotoxins
lipo-polysaccharides originating from the outer cell-membrane of Gram-negative bacteria
NOTE Endotoxins are one type of pyrogen. Sources of endotoxins can include bacterial contamination of the raw
materials, especially the process water used during manufacturing and manual handling of the gloves.
3.3
powder
all water insoluble material on the surface of a glove that is removed by washing under the conditions of the
test
[EN ISO 21171:2006, definition 3.1]
NOTE This includes both deliberately added powder and other processing aids or materials accidentally present
which may be readily detached from the surface of the glove. For the purpose of this European Standard any glove
containing 2 mg or less powder is a powder-free glove and more than 2 mg is a powdered glove (for requirement see 4.4.).
3.4
process limit
highest value likely to be encountered for a validated manufacturing process
3.5
proteins, allergenic
proteins capable of causing a type I allergic reaction
3.6
proteins, leachable
aqueous proteins and peptides extractable from the final product
3.7
pyrogens
substances creating fever in rabbits which can be related to fever and other adverse reactions in humans
4 Requirements
4.1 General
Medical gloves for single use shall be evaluated as described in the EN ISO 10993 series. Part 1 of this series
describes the general principles governing the biological evaluation of medical devices and shall be used to
select the appropriate tests as described in other parts of the series.
A risk management process in accordance with EN ISO 14971 shall be established.
4.2 Chemicals
Gloves shall not be dressed with talcum powder (magnesium silicate).
Chemicals known to be allergenic shall be avoided if technical alternatives exist. Wherever possible allowable
limits for leachable residual chemicals shall be established using EN ISO 10993-17 and these limits shall be
complied with. Wherever this is not possible, the residual chemicals level shall be "As Low As Reasonably
Practicable" (ALARP – see EN ISO 14971).
The manufacturer shall disclose, upon request, a list of chemical ingredients either added during
manufacturing or already known to be present in the product such as accelerators, antioxidants and biocides,
that are known to cause adverse health effects based on current data.
4.3 Endotoxins
The manufacturer shall monitor the endotoxin contamination of sterile gloves using the test method specified
in 5.1 if the gloves are labelled with 'low endotoxin content'. For such labelled gloves the endotoxin content
shall not exceed the limit of 20 endotoxin units per pair of gloves.
4.4 Powder
For powder free gloves the total quantity of powder residues determined according to the test method under
5.2 shall not exceed 2 mg per glove. Any glove containing more than 2 mg powder is a powdered glove.
4.5 Proteins, leachable
The manufacturer shall monitor the process limit of leachable protein in the finished gloves containing natural
rubber latex by the method specified in 5.3 and described in Annex A. The documentation of these results
shall be retained. The results of the test and applied test method shall be made available on request.
The leachable protein level shall be "As Low As Reasonably Practicable" (ALARP).
NOTE Proteins, allergenic: This European Standard specifies a method measuring a broad approximation for the
allergen content, e.g. leachable proteins. There is no direct correlation between leachable proteins and allergen content.
Quantitative methods to measure allergenic proteins are under development, as described in Annex B.
4.6 Labelling
In addition to the labelling specified in EN 1041 and the relevant symbols given in EN 980, the following
requirements apply:
a) medical gloves containing natural rubber latex shall be labelled at least on the packaging, of the smallest
packaging unit with the following symbol (EN 980 general requirements for symbols apply);
Figure 1 — Symbol for products containing natural rubber latex
b) the labelling shall include the following or equivalent warning statement together with the symbol:
‘(Product) contains natural rubber latex which may cause allergic reactions, including anaphylactic
responses;
c) the labelling shall include a prominent indication of whether the glove is powdered or powder-free;
d) sterile powdered gloves shall be labelled with the following or equivalent:
'CAUTION: Surface powder shall be removed aseptically prior to undertaking operative procedures in
order to minimize the risk of adverse tissue reactions;
NOTE 2 This caution statement can be given on the inner wrapping.
e) for any medical glove containing natural rubber latex the product labelling shall not include:
any term suggesting relative safety, such as low allergenicity, hypoallergenicity or low protein;
any unjustified indication of the presence of allergens;
f) if the manufacturer labels the gloves with the protein content, the process limit, measured as specified in
5.3 shall be given.
NOTE 3 This does not allow a protein labelling claim below 50 µg/g. Lower claims are n
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