1、DRAFT FOR DEVELOPMENT DD CEN/TS 15279:2006 Workplace exposure Measurement of dermal exposure Principles and methods ICS 13.100 DD CEN/TS 15279:2006 published under the authority of the Standards Policy and Strategy Committee on 28 April 2006 BSI 2006 National foreword This Draft for Development is t
2、he official English language version of CEN/TS 15279:2006. This publication is not to be regarded as a British Standard. It is being issued in the Draft for Development series of publications and is of a provisional nature. It should be applied on this provisional basis, so that information and expe
3、rience of its practical application may be obtained. Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the European organization responsible for its conversion to a European standard. A review of this publication will be initiated 2 ye
4、ars after its publication by the European organization so that a decision can be taken on its status at the end of its 3-year life. Notification of the start of the review period will be made in an announcement in the appropriate issue of Update Standards. According to the replies received by the en
5、d of the review period, the responsible BSI Committee will decide whether to support the conversion into a European Standard, to extend the life of the Technical Specification or to withdraw it. Comments should be sent in writing to the Secretary of BSI Subcommittee EH/2/2, Workplace atmospheres, at
6、 British Standards House, 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text. request to its secretary. WARNING The responsible BSI committee, EH/2/2, Air quality Workplace atmospheres, wishes to b
7、ring to the attention of users that this DD CEN/TS is not applicable to assess risk from dermal absorption of vapours. Typically, of inhalation exposure at any given concentration. However, it can reach levels humidity/high temperature (30 C) environments with chemicals that are readily absorbed by
8、the skin. Risk from dermal exposure to vapours can be particularly significant for workers operating in confined spaces using respiratory apparatus. This risk can be further exacerbated by heavy protective clothing, such as overalls, which can increase the temperature and humidity near the skin. Sum
9、mary of pages This document comprises a front cover, an inside front cover, page i, a blank page, the EN title page, pages 2 to 41 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comm
10、ents This Draft for Development was A list of organizations represented on this subcommittee can be obtained on equivalent to 40 % of inhalation exposure for workers operating in high exposure due to dermal absorption of vapours can be assumed to equate to 10 % ISBN 0 580 48102 6DD CEN/TS 15279:2006
11、 i Where the rate of chemical uptake into the skin is high, biological monitoring (if available) can be used to check on all routes of exposure including dermal exposure to vapours. Its use should also be considered if the toxicity of the chemical is high, even if the rate of chemical uptake into th
12、e skin is expected to be low. Available biological monitoring methods include blood, urine and breath Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International
13、 Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. testing. Further information is available in HSE publication “Biological Monitoring in the Workplace”, HSE www.hse.gov.uk.blankTECHNICALSPECIFICATION SPCIFICATIONTECHNI
14、QUE TECHNISCHESPEZIFIKATION CEN/TS15279 March2006 ICS13.100 EnglishVersion WorkplaceexposureMeasurementofdermalexposure Principlesandmethods ExpositionsurleslieuxdetravailMesuragedelexposition cutanePrincipesetmthodes ExpositionamArbeitsplatzMessungderHautbelastung GrundstzeundVerfahren ThisTechnica
15、lSpecification(CEN/TS)wasapprovedbyCENon22November2005forprovisionalapplication. TheperiodofvalidityofthisCEN/TSislimitedinitiallytothreeyears.AftertwoyearsthemembersofCENwillberequested tosubmittheir comments,particularlyonthequestionwhethertheCEN/TScanbeconvertedintoaEuropeanStandard. CENmembersar
16、erequiredtoannouncetheexistenceofthisCEN/TSinthesamewayasforanENandtomaketheCEN/TSavailable promptlyatnationallevelinanappropriateform.Itispermissibletokeepconflictingnationalstandardsinforce(inparall eltotheCEN/TS) untilthefinaldecisionaboutthepossibleconversionoftheCEN/TSintoanENisreached. CENmemb
17、ersarethenationalstandardsbodiesofAustria,Belgium,Cyprus,CzechRepublic,Denmark,Estonia,Finland,France, Germany,Greece,Hungary,Iceland,Ireland,Italy,Latvia,Lithuania,Luxembourg,Malta,Netherlands,Norway,Poland,Portugal, Romania, Slovakia,Slovenia,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMI
18、TTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2006CEN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.CEN/TS15279:2006:ECEN/TS 15279:2006 2 Contents Page Foreword3 Introductio
19、n .4 1 Scope 5 2 Terms and definitions .6 3 Principles and methods 9 4 Quality issues.10 5 Report .11 Annex A (informative) Interception methods13 Annex B (informative) Hand wash methods .18 Annex C (informative) Wipe methods22 Annex D (informative) Tape-stripping method .26 Annex E (informative) In
20、-situ methods31 Bibliography 38 CEN/TS 15279:2006 3 Foreword This Technical Specification (CEN/TS 15279:2006) has been prepared by Technical Committee CEN/TC 137 “Assessment of workplace exposure to chemical and biological agents”, the secretariat of which is held by DIN. Attention is drawn to the p
21、ossibility 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. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to
22、announce this Technical Specification: 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
23、and the United Kingdom. 4 Introduction Dermal exposure assessment explores the dynamic interaction between environmental contaminants and the skin. In contrast to inhalation exposure assessment, the assessment of dermal exposure remained a nascent field of scientific research and applied occupationa
24、l hygiene for most of the twentieth century, although multiple fatalities and occupational skin diseases due to dermal exposure have been described in literature. During the last decade, dermal exposure has received more attention, and one of the important results was the development of a conceptual
25、 model for dermal exposure (see 1). The model systematically describes the transport of contaminant mass from exposure sources to the surface of the skin. The model provides a structure for evaluating dermal exposure both qualitatively and quantitatively. The purpose of evaluating dermal exposure ca
26、n differ substantially, as exposure analysis (to give guidance to control), risk assessment, and evaluation of exposure control can all be objectives to undertake assessments. In order to give guidance and to harmonise measurements, requirements and test methods for measurement of dermal exposure ar
27、e proposed. CEN/TS 15279:20065 1 Scope This Technical Specification establishes principles and describes methods for the measurement of dermal exposure in workplaces. It gives guidance on the commonly used approaches to the measurement of dermal exposure, their advantages and limitations and how the
28、se might be assessed in specific circumstances for specific compounds. This Technical Specification should enable users of dermal sampling methods to adopt a consistent approach to method validation and provide a framework for the assessment of method performance. This Technical Specification descri
29、bes the requirements against which sampling methods need to be assessed. It will then indicate methods for agreement with these requirements. Requirements include specification of the following: NOTE Not all requirements are applicable to all methods. sampling efficiency; recovery efficiency; sample
30、 stability; maximum capacity; bias, precision, overall uncertainty; core information; contextual information. CEN/TS 15279:20066 2 Terms and definitions For the purposes of this Technical Specification, the following terms and definitions apply. NOTE The definitions are based on CEN/TR 15278. 2.1 ag
31、ent any chemical or biological entity on its own or admixed as it occurs in the natural state or as produced by any work activity, whether or not produced intentionally and whether or not placed on the market NOTE Adapted from EN 1540. 2.2 bias consistent deviation of the measured value from the val
32、ue of the air quality characteristic itself or the accepted reference value ISO 6879:1995, 5.2.3.1 2.3 dermal contact volume volume containing the mass of the agent that contacts the exposure surface NOTE 1 The dermal contact volume is given in litres (l). NOTE 2 The dermal contact volume is equival
33、ent to the volume of the skin contaminant layer, and for practical reasons it is defined by the mass in kilograms (kg) of all substances contained in this compartment. 2.4 dermal exposure process of contact between an agent and human skin at an exposure surface over an exposure period 2.5 dermal exp
34、osure concentration exposure mass divided by the dermal contact volume or the exposure mass divided by the mass contained in the skin contaminant layer NOTE The dermal exposure concentration is expressed in grams per litre (g/l) or grams per kilogram (g/kg) respectively. 2.6 dermal exposure loading
35、exposure mass divided by the exposure surface NOTE For practical reasons it can be expressed as the time-averaged mass divided by area-averaged skin contaminant layer surface area in grams per square centimetre (g/cm 2 ). 2.7 dermal exposure mass mass of agent present in the dermal contact volume NO
36、TE 1 For practical reasons it is defined by the amount of agent in grams (g) present in the skin contaminant layer. NOTE 2 The outcome of the process of dermal exposure, i.e. the contact, can be expressed by different parameters of exposure. CEN/TS 15279:20067 2.8 dermal exposure surface skin surfac
37、e area where an agent is present NOTE For practical reasons this is represented by a two dimensional representation of the skin contaminant layer in square centimetres (cm 2 ). 2.9 exposure period time the agent is present in the skin contaminant layer, i.e. contact time NOTE 1 The process by which
38、an agent crosses an outer exposure surface of a target is called intake. In case of the concentration driven transport from the skin contaminant layer into the skin, i.e. crossing the (exposure surface) interface between SCL and the stratum corneum as an absorption barrier, the process is called upt
39、ake. Therefore, relevant for uptake would be the time- exposure concentration profile for an identified area of the skin contaminant layer over a defined period of time. NOTE 2 Other relevant types of time intervals, e.g. sampling time (B-C), immission or loading time (A-D), and post emission time (
40、D-E), are illustrated in Figure 1. Key X time Y exposure loading A-E exposure/contact time A-D immission/loading time D-E post immission time B-C sampling time Figure 1 Different types of time intervals relevant in view of dermal exposure 2.10 immission transport of an agent from a defined source to
41、 the skin or outer clothing contaminant layer compartment 2.11 limit of detection LOD background level plus three times estimated standard deviation of measured blank substrate mass NOTE Adapted from ISO 15767. CEN/TS 15279:20068 2.12 limit of quantitation LOQ background level plus ten times estimat
42、ed standard deviation of measured blank substrate mass NOTE Adapted from ISO 15767. 2.13 overall method efficiency 2.13.1 overall method efficiency sampling efficiency multiplied by recovery efficiency 2.13.2 overall method efficiency mass of agent detected divided by mass of agent in analysed conta
43、ct volume NOTE Mass of agent detected either directly or indirectly by use of a tracer. 2.14 overall uncertainty quantity used to characterise as a whole the uncertainty of the result given by an apparatus or measuring procedure NOTE It is expressed, as a percentage, by a combination of bias and pre
44、cision usually according to the formula: ref ref 2 x s x x + where x is the mean value of results of a number (n) of repeated measurements; x ref is the true or accepted reference value of concentration; s is the standard deviation of the measurements. EN 1540:1998, 3.17 2.15 potential dermal exposu
45、re mass mass retrieved from (outer and inner clothing contaminant layer and exposure mass, i.e. mass retrieved from the covered and uncovered by clothing) parts of the skin contaminant layer compartment NOTE For practical reasons related to sampling methodology and strategy the term potential exposu
46、re mass has been introduced. It refers to the agent mass that has the potential the reach the skin (contaminant layer) since it has landed on the clothing and the agent mass that has actually reached the skin. The conceptual model distinguishes between outer and inner clothing contaminant layer comp
47、artment, respectively, and characterises the clothing itself as a buffer layer. 2.16 precision the closeness of agreement between independent test results obtained under stipulated conditions ISO 6879:1995, 5.2.16 CEN/TS 15279:20069 2.17 quality control sample blank substrate that undergoes the same
48、 handling as the sampling substrate and can either be fortified with the agent or not 2.18 recovery efficiency mass of agent recovered from collection substrate divided by mass of agent present on the substrate immediately after collection NOTE For in situ methods recovery efficiency is not applicable. 2.19 sampling efficiency NOTE For in situ methods sampling efficiency is not applicable. 2.19.1 sampling efficiency mass of agent on collection substrate at end of sampling divided by immission of agent to sampled ar
