Protective gloves against ionizing radiation and radioactive contamination

This European Standard specifies requirements and test methods for gloves to protect against ionizing radiation and radioactive contamination. The standard is applicable to gloves offering protection to the hand and various parts of the arm and shoulder. It applies also to gloves to be mounted in permanent containment enclosures. This European Standard also applies to intermediary sleeves used between a glove and a permanent containment enclosure (report to 4.7.2.3). The requirements of this European Standard do not apply to protective gloves against X-ray radiation.

Schutzhandschuhe gegen ionisierende Strahlung und radioaktive Kontamination

Diese Europäische Norm legt Anforderungen an und Prüfverfahren für Schutzhandschuhe gegen ionisierende Strahlung und radioaktive Kontamination fest. Die Norm gilt für Handschuhe, die die Hand und verschiedene Teile des Arms und der Schulter schützen. Sie gilt außerdem für Handschuhe, die in permanenten Umschließungen anzubringen sind. Diese Norm gilt auch für Übergangsärmel, die zwischen einem Handschuh und einer permanenten Umschließung eingesetzt werden (siehe 4.7.2.3). Die Anforderungen dieser Europäischen Norm gelten nicht für Schutzhandschuhe gegen Röntgenstrahlen.

Gants de protection contre les rayonnements ionisants et la contamination radioactive

La présente norme spécifie les exigences et les méthodes d'essai relatives aux gants de protection contre les rayonnements ionisants et la contamination radioactive. La norme est applicable aux gants offrant une protection pour la main et diverses parties du bras et de l'épaule. Elle s'applique également aux gants destinés a etre fixés sur des enceintes de confinement permanent.
NOTE   La présente norme s'applique aussi aux manches intermédiaires utilisées entre un gant et une enceinte de confinement permanent (voit 4.5 de la présente norme).

Varovalne rokavice za zaščito pred ionizirnim sevanjem in radioaktivno kontaminacijo

Ta evropski standard določa zahteve in preskusne metode za rokavice, ki ščitijo pred ionizirnim sevanjem in radioaktivno kontaminacijo. Standard velja za rokavice, ki zagotavljajo zaščito za dlani in različne dele roke in ramena. Velja tudi za rokavice, nameščene v stalnih zadrževalnih ograjenih prostorih. Ta evropski standard velja tudi za vmesne rokave, ki se uporabljajo med rokavico in stalnim zadrževalnim ograjenim prostorom (sklic na 4.7.2.3). Zahteve tega evropskega standarda ne veljajo za varovalne rokavice za zaščito pred rentgenskim sevanjem.

General Information

Status
Published
Public Enquiry End Date
14-Jan-2008
Publication Date
14-Sep-2010
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
19-Aug-2010
Due Date
24-Oct-2010
Completion Date
15-Sep-2010

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2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.WLYQRNRQWDPLQDFLMRSchutzhandschuhe gegen ionisierende Strahlung und radioaktive KontaminationGants de protection contre les rayonnements ionisants et la contamination radioactiveProtective gloves against ionizing radiation and radioactive contamination13.340.40Varovanje dlani in rokHand and arm protection13.280Varstvo pred sevanjemRadiation protectionICS:Ta slovenski standard je istoveten z:EN 421:2010SIST EN 421:2010en,fr,de01-oktober-2010SIST EN 421:2010SLOVENSKI
STANDARDSIST EN 421:19961DGRPHãþD



SIST EN 421:2010



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 421
May 2010 ICS 13.280; 13.340.40 Supersedes EN 421:1994English Version
Protective gloves against ionizing radiation and radioactive contamination
Gants de protection contre les rayonnements ionisants et la contamination radioactive
Schutzhandschuhe gegen ionisierende Strahlung und radioaktive Kontamination This European Standard was approved by CEN on 22 April 2010.
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 CEN Management Centre 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 CEN Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, 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:
Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 421:2010: ESIST EN 421:2010



EN 421:2010 (E) 2 Contents Page Foreword .41 Scope .52 Normative references .53 Terms and definitions .54 Requirements .64.1 General .64.2 Design principles .74.2.1 General principles.74.2.2 Glove sizing and dimensions .74.3 Attenuation efficiency and uniformity of distribution of protective material .74.4 Glove integrity .84.5 Mechanical requirements .84.6 Chemical requirements .84.7 Specific requirements for gloves for containment enclosures .84.7.1 General requirement for gloves for containment enclosures .84.7.2 Design for gloves for containment enclosures .94.7.3 Specific integrity test for gloves for containment enclosures .94.7.4 Resistance to ozone cracking (static strain) .95 Test methods . 105.1 Determination of lead equivalent thickness and uniformity of distribution . 105.1.1 Introduction . 105.1.2 Sampling . 105.1.3 Test conditions . 105.1.4 Expression of results . 115.1.5 Detection with an X-ray film . 115.1.6 Detection with numeric films . 125.1.7 Detection with an ionising chamber . 125.2 Determination of glove integrity, air leak test . 135.2.1 Principle . 135.2.2 Sampling . 135.2.3 Test apparatus . 135.2.4 Test procedure . 145.2.5 Test report . 145.3 Determination of resistance to ozone cracking (Static Strain Method) . 145.3.1 Procedure . 145.3.2 Test conditions . 155.3.3 Sampling . 155.3.4 Reporting of results . 155.4 Pull test for assemblages (sleeve and glove) . 156 Marking . 157 Information supplied by the manufacturer . 16Annex A (informative)
Determination of water vapour permeability . 17A.1 Requirement for water vapour permeability . 17A.2 Test method . 17A.2.1 Principle . 17A.2.2 Apparatus and materials . 17A.2.3 Sampling . 19A.2.4 Procedure . 19A.2.5 Report, calculation and result . 20SIST EN 421:2010



EN 421:2010 (E) 3 Annex B (informative)
Warning . 21B.1 General . 21B.2 Special tests: Chemical resistance . 21B.3 Special tests: Radiation resistance . 21Annex C (informative)
Uncertainty of measurement and results interpretation . 23Annex D (informative)
Significant technical changes between this European Standard and the previous edition . 25Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 89/686/EEC . 26Bibliography . 27 Figures Figure 1 — Examples of glove integrity test apparatus for the air leak test . 14Figure 2 — Pictogram ISO 7000 – 2484
Protection against particulate radioactive contamination . 15Figure 3 — Pictogram ISO 7000 – 2809
Protection against ionizing radiation . 16Figure A.1 — Diagram of dishes and templates (water vapour permeability test) . 18Figure C.1 — Result pass . 23Figure C.2 — Result fail . 23Figure C.3 — Result fail . 24 SIST EN 421:2010



EN 421:2010 (E) 4 Foreword This document (EN 421:2010) has been prepared by Technical Committee CEN/TC 162 “Protective clothing including hand and arm protection and lifejackets”, 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 November 2010, and conflicting national standards shall be withdrawn at the latest by November 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights. This document supersedes EN 421:1994. 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(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. Annex D provides details of significant technical changes between this European Standard and the previous edition EN 421:1994. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, 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 the United Kingdom. SIST EN 421:2010



EN 421:2010 (E) 5 1 Scope This European Standard specifies requirements and test methods for gloves to protect against ionizing radiation and radioactive contamination. The standard is applicable to gloves offering protection to the hand and various parts of the arm and shoulder. It applies also to gloves to be mounted in permanent containment enclosures. This European Standard also applies to intermediary sleeves used between a glove and a permanent containment enclosure (report to 4.7.2.3). The requirements of this European Standard do not apply to protective gloves against X-ray radiation. 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 374-1:2003, Protective gloves against chemicals and micro-organisms — Part 1: Terminology and performance requirements EN 374-3, Protective gloves against chemicals and micro-organisms — Part 3: Determination of resistance to permeation by chemicals EN 388:2003, Protective gloves against mechanical risks EN 420:2003+A1:2009, Protective gloves — General requirements and test methods EN 61331-1:2002, Protective devices against diagnostic medical X-radiation — Part 1: Determination of attenuation properties of materials (IEC 61331-1:1994) ISO 1431-1, Rubber, vulcanised or thermoplastic — Resistance to ozone cracking — Part 1: Static and dynamic strain testing ISO 7000:2004, Graphical symbols for use on equipment — Index and synopsis ISO 11933-1, Components for containment enclosures — Part 1: Glove/bag ports, bungs for glove/bag ports, enclosure rings and interchangeable units ISO 11933-2, Components for containment enclosures — Part 2: Gloves, welded bags, gaiters for remote - handling tongs and for manipulators CEN ISO/TR 11610:2004, Protective clothing — Vocabulary (ISO/TR 11610:2004) 3 Terms and definitions For the purposes of this document, the terms and definitions given in CEN ISO/TR 11610:2004 and the following apply. 3.1 radioactive contamination presence of radioactive substances in or on a material or in a place where they are undesirable or could be harmful SIST EN 421:2010



EN 421:2010 (E) 6 3.2 ionizing radiation radiation constituted by particles directly or indirectly ionizing (photons included) or by a mixture of both 3.3 irradiation exposure of a living being or matter to ionizing radiation by external sources (X, Alpha, Beta, Gamma or Neutron radiations) 3.4 water vapour permeability weight of water vapour in grams transmitted through a material per square metre per 24 h time, under specified conditions of temperature and humidity (gm-2d-1) 3.5 containment enclosure enclosure that prevent from the spreading of products contained in the inside medium towards the outside medium, or the penetration of outside atmosphere towards the inside medium or both 3.6 glove box containment enclosure in which material or products can be manipulated being isolated from the operator, which is realized thanks to gloves fixed in a tightness way to openings that are designed in walls of the enclosure (glove port or cell ring) 3.7 glove for glove box or for containment enclosure glove with a long cuff constituted in flexible elastomeric material, intended to enable a tight clamping on the circumference or the extremity of a glove port or on any other component and enabling at the same time a good mechanical resistance 3.8 glove port cylindrical collar fitted with a bead or a groove, fixed on the wall of a glove box or a containment enclosure in order to receive a glove or any other flexible accessory finished with a bead of same diameter 3.9 cell ring sectional ring in plastic or metal fixed on the enclosure, that receive interchangeable tightness accessories by pushing and which can be replaced without breaking the containment 3.10 support ring interchangeable tightness ring, in metallic alloy or plastic, fitted with grooves, fixed on a cell ring and equipped with a glove or other plastic component, finished by a bead, a toric joint or a lip joint of same diameter 3.11 protective glove material material or combination of materials used in a glove for the purpose of preventing the user from direct contact with radioactive contamination or of minimizing the radiation dose to the user from external radiation sources 4 Requirements 4.1 General Table 1 gives the requirements for gloves and gloves for containment enclosures for protection against radioactive contamination and protection against ionizing radiation. SIST EN 421:2010



EN 421:2010 (E) 7 Table 1 — Requirements for gloves and gloves for containment enclosures
Gloves Gloves for containment enclosures Protection against radioactive contamination Protection against radioactive contamination and protection against ionizing radiation Protection against radioactive contamination Protection against radioactive contamination and protection against ionizing radiation Requirements 4.2.1 X X X X 4.2.2 X X
4.3
X
X 4.4 X X
4.5 X X X X 4.6 ‘ ‘ ‘ ‘ 4.7.2
X X 4.7.3
X X 4.7.4
 
‘‘‘‘ : optional requirement  : mandatory if the gloves are used in an atmosphere containing ozone
4.2 Design principles 4.2.1 General principles The glove shall comply with the relevant requirements defined in EN 420, with the following specific additions. The glove may be constructed from a single or multiple material layers. The choice of material is defined by the end use requirements. In the case of protection against external ionizing radiation the glove may contain lead (PbO, Pb3O4) or other heavy metallic elements to act as attenuation medium in one or more of the layers. Metallic element distribution may be uniform or designed. 4.2.2 Glove sizing and dimensions Gloves shall be sized following prescriptions of EN 420:2003+A1:2009, 5.1. NOTE In case where specific use identified, special tests can be identified according to Annex B. 4.3 Attenuation efficiency and uniformity of distribution of protective material The lead equivalent thickness shall be measured by one of the methods described in 5.1. The test methods give equivalent results. The efficiency of the glove material to absorb radiation is quoted as lead equivalent thickness. The gloves shall have at least a lead equivalence thickness of 0,05 mm. SIST EN 421:2010



EN 421:2010 (E) 8 Except for special design (see 4.7.2) the uniformity shall be such that no single measurement shall be below the specified value of the stated lead equivalent thickness. A minimum of four measurements shall be taken for each test condition (see 5.1.3) and the minimum value obtained is taken as the lead equivalence in millimetres. The lead equivalent thickness shall always be linked with the nature and energy of the radiation used during tests (see Clauses 6 and 7). 4.4 Glove integrity The purpose of the glove to protect against ionizing radiation or radioactive contamination is to isolate the user from the potential hazard. This is only possible if the integrity of the glove is proven. Gloves shall pass an integrity test: the integrity shall comply with the requirements of EN 374-1:2003, 5.2. 4.5 Mechanical requirements For each protective glove against radioactive contamination and/or ionizing radiation, the obtained performance level shall be indicated in the information supplied by the manufacturer for the following mechanical tests:  abrasion resistance;  blade cut resistance;  tearing resistance;  puncture resistance. According to the test methods described in EN 388:2003, at least level 1 shall be reached for one of the four mechanical properties. For special purposes, dexterity is the most important parameter, in this case no level of protection of EN 388 has to be reached, but the following sentence shall be written in the user notice of the gloves: “This gloves does not protect against mechanical risks." 4.6 Chemical requirements If required, the chemicals properties of the gloves shall be determined following the requirements defined in EN 374-1:2003, 5.3.1. The test method for permeation is described in EN 374-3. Two possibilities are acceptable:  The glove fulfills EN 374-1:2003, 5.3.2; In this case the pictogram of EN 374-1:2003, Figure 1 shall be used.  The chemicals to be tested are defined taking into account the use of the glove at the work place. In this case the pictogram of EN 374-1:2003, Figure 2 shall be used. 4.7 Specific requirements for gloves for containment enclosures 4.7.1 General requirement for gloves for containment enclosures Gloves for containment enclosures shall comply with 4.1, 4.2, 4.3 and 4.4. NOTE Annex A provides an optional test method for water vapour permeability. SIST EN 421:2010



EN 421:2010 (E) 9 4.7.2 Design for gloves for containment enclosures 4.7.2.1 General The glove shall comply with the relevant requirements defined in ISO 11933-2. When the metallic element distribution is not uniform over the glove, the manufacturer shall mark the equipment and provide the information accordingly (see Clauses 6 and 7). 4.7.2.2 Glove sizing and dimensions In the case of gloves to be mounted in containment enclosures, prescriptions of ISO 11933-1 and
ISO 11933-2 shall be followed. Gloves used in containment enclosures are often used with under gloves. The user will have to take into account this parameter for the choice of an adapted size of equipment. NOTE ISO 11933-1 and ISO 11933-2 detail a list of characteristics of standardized gloves, glove ports, support rings, cell rings, etc. 4.7.2.3 Accessories used with gloves 4.7.2.3.1 Gloves equipped with a support ring In a few permanent containment enclosures, gloves can be equipped with a support ring. The support ring is considered as an integral part of the glove, and the whole equipment shall be tested according to the air leak test using a test bench equipped with a cell ring (see 4.7.3). 4.7.2.3.2 Sleeve Gloves mounted in permanent containment enclosures can be used with an intermediary sleeve, fixed between the glove and the containment enclosure. This sleeve is not considered as an integral part of the glove. It shall fulfill all requirements of this European Standard and shall be compatible with the glove used. The way of fixation between the glove and the sleeve and between the sleeve and the containment enclosure shall be detailed in the information supplied by the manufacturers. The sleeve shall be tested with one compatible glove as regards the integrity using the air leak test (see 4.7.3) Such an assemblage shall resist to a tensile strength test of 100 N according to 5.4. 4.7.3 Specific integrity test for gloves for containment enclosures The integrity of gloves used in containment enclosures shall be tested by the air leak test described in 5.2. The pressure shall not decrease by more than half the initial pressure. The initial pressure shall be mentioned in the instructions supplied by the manufacturer if it is different from 3 000 Pa. 4.7.4 Resistance to ozone cracking (static strain) When gloves can be exposed to ozone, the resistance to ozone cracking shall be determined. NOTE Powders emitting alpha particles can generate ozone containment enclosures. The performance level shall be determined by the method described in 5.3; at least level 1 of Table 2 shall be achieved. SIST EN 421:2010



EN 421:2010 (E) 10 Table 2 — Performance level: Resistance to ozone cracking Performance level State of the material 1 cracks apparent at 10 % elongation 2 no cracks apparent at 10 % elongation 3 no cracks apparent at 20 % elongation 4 no cracks apparent at 100 % elongation 5 Test methods 5.1 Determination of lead equivalent thickness and uniformity of distribution 5.1.1 Introduction This European Standard specifies several methods by which lead equivalent thickness may be measured. Either method may be used for determination. The determination of lead equivalent thickness does not lead to an absolute answer but will depend upon the source and energy spectrum of the radiation and hence should always be used as a relative measure. In addition, due to its toxicity, Lead is today more and more substituted by other materials and therefore the lead equivalent thickness shall be checked at different conditions (see 5.1.3). These conditions have been selected because they give a good correlation with the behaviour of the material of the gloves exposed to commonly used radionuclides such as Americium and Plutonium. NOTE The user should be warned that if other radionuclides are used, the behaviour of the gloves could be different. Several detectors can be used for the detection of the X-rays. The corresponding test methods are developed hereafter. Either of them can be used for the determination of the lead equivalence thickness. 5.1.2 Sampling The sampling does not depend on the test method used. A minimum of two samples shall be tested. On each sample, a minimum of four measurements shall be done. The definition of the surface of a measurement point is developed in each specific test method. These points are placed:  on the centre line of the palm side of the glove, at the centre of the palm;  on the centre line of the palm side of the glove, at a distance of 10 cm from the cuff;  on the centre line of the back side of the glove, at the centre of the back;  when possible, on one finger (the thumb for example);  when the measurement on the finger is impossible (due for example to the shape of the equipment or to the test method used), and for long dimensions gloves, another measurement point is placed on the centre line of the palm side of the glove, at the mid point between the palm and the cuff. 5.1.3 Test conditions The test method used for determination of lead equivalent thickness and uniformity of distribution (see 5.1.5, 5.1.6 and 5.1.7) shall be performed with a test bench of EN 61331-1, at the following X-ray beam qualities:  X-ray tube voltage of 70 kV with a copper filtration of 0,10 mm; SIST EN 421:2010



EN 421:2010 (E) 11  X-ray tube voltage of 100 kV with a copper filtration of 0,25 mm;  X-ray tube voltage of 120 kV with a copper filtration of 0,40 mm;  X-ray tube voltage of 150 kV with a copper filtration of 0,70 mm. 5.1.4 Expression of results The minimum value obtained for the measurement points and for the different test conditions is taken as the lead equivalence in millimetres. 5.1.5 Detection with an X-ray film 5.1.5.1 Principle Lead equivalence thickness shall be determined by a standard X-ray tube source. The gloves shall be compared with calibrated lead step wedges. The method consists of placing an X-ray film under different parts of the glove placed next to calibrated lead step wedges. The whole system is then exposed using an x-ray tube with the specified x-ray tube voltage and filtration. The X-ray film is then developed and read on a densitometer. The test bench of EN 61331-1:2002, Figure 1 shall be used (large beam geometry test bench). 5.1.5.2 Apparatus and consumable 5.1.5.2.1 Generator delivering a continuous X-ray beam at 70 kV, 100 kV, 120 kV and 150 kV. 5.1.5.2.2 Appropriate Copper filter (respectively 0,10 mm Cu, 0,25 mm Cu, 0,40 mm Cu and 0,70 mm Cu). 5.1.5.2.3 Calibrated step wedges in lead. 5.1.5.2.4 Elements of the test bench: collimation of the generator, supports of the test bench. 5.1.5.2.5 Appropriate X-ray films. 5.1.5.2.6 Densitometer. 5.1.5.2.7 Necessary laboratory apparatus for the developing of X-ray films. 5.1.5.3 Procedure 5.1.5.3.1 General The measurement points are identified on the samples. Each measurement point can be considered as a circular surface of approximately 5 cm² (diameter of approximately 2,5 cm). Then, the glove is cut in sections perpendicular to the longitudinal axis of the glove, around the measurement points. The section of material to test is placed on an X-ray film placed in an appropriate test bench. Calibrated lead step wedges of adapted thicknesses are placed beside the section of the glove, on the X-ray film. The system is then exposed to the radiation of a continuous X-ray generator at one specified test condition (see 5.1.3). Exposure times will be dependant on both the intensity of the X-ray source and the attenuation efficiency of the glove. Exposure times and current are c
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