ImageVerifierCode 换一换
格式:PDF , 页数:38 ,大小:1.22MB ,
资源ID:581868      下载积分:10000 积分
快捷下载
登录下载
邮箱/手机:
温馨提示:
如需开发票,请勿充值!快捷下载时,用户名和密码都是您填写的邮箱或者手机号,方便查询和重复下载(系统自动生成)。
如填写123,账号就是123,密码也是123。
特别说明:
请自助下载,系统不会自动发送文件的哦; 如果您已付费,想二次下载,请登录后访问:我的下载记录
支付方式: 支付宝扫码支付 微信扫码支付   
注意:如需开发票,请勿充值!
验证码:   换一换

加入VIP,免费下载
 

温馨提示:由于个人手机设置不同,如果发现不能下载,请复制以下地址【http://www.mydoc123.com/d-581868.html】到电脑端继续下载(重复下载不扣费)。

已注册用户请登录:
账号:
密码:
验证码:   换一换
  忘记密码?
三方登录: 微信登录  

下载须知

1: 本站所有资源如无特殊说明,都需要本地电脑安装OFFICE2007和PDF阅读器。
2: 试题试卷类文档,如果标题没有明确说明有答案则都视为没有答案,请知晓。
3: 文件的所有权益归上传用户所有。
4. 未经权益所有人同意不得将文件中的内容挪作商业或盈利用途。
5. 本站仅提供交流平台,并不能对任何下载内容负责。
6. 下载文件中如有侵权或不适当内容,请与我们联系,我们立即纠正。
7. 本站不保证下载资源的准确性、安全性和完整性, 同时也不承担用户因使用这些下载资源对自己和他人造成任何形式的伤害或损失。

版权提示 | 免责声明

本文(BS EN ISO 24442-2011 Cosmetics Sun protection test methods In vivo determination of sunscreen UVA protection《化妆品 防晒试验方法 遮光剂长波紫外线防护的体内测定》.pdf)为本站会员(terrorscript155)主动上传,麦多课文库仅提供信息存储空间,仅对用户上传内容的表现方式做保护处理,对上载内容本身不做任何修改或编辑。 若此文所含内容侵犯了您的版权或隐私,请立即通知麦多课文库(发送邮件至master@mydoc123.com或直接QQ联系客服),我们立即给予删除!

BS EN ISO 24442-2011 Cosmetics Sun protection test methods In vivo determination of sunscreen UVA protection《化妆品 防晒试验方法 遮光剂长波紫外线防护的体内测定》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 24442:2011Cosmetics Sun protectiontest methods In vivodetermination of sunscreenUVA protection(ISO 24442:2011)Copyright European Committee for Standardization Provided

2、by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 24442:2011 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO 24442:2011.The UK participation in its preparation was entrusted to Technical

3、 Committee CW/217, Cosmetics.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution

4、 2012 ISBN 978 0 580 61109 4 ICS 71.100.70 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 29 February 2012.Amendments issued since publicationDate Text affected

5、Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 24442 December 2011 ICS 71.100.70 English Version Cosmetics - Sun protect

6、ion test methods - In vivo determination of sunscreen UVA protection (ISO 24442:2011) Cosmtique - Mthodes dvaluation de la protection solaire - Dtermination in vivo de la protection UVA (ISO 24442:2011) Kosmetik - Prfverfahren fr Sonnenschutzmittel - In-vivo-Bestimmung des UVA-Sonnenschutzes (ISO 24

7、442:2011)This European Standard was approved by CEN on 14 December 2011. 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 bibliogra

8、phical references concerning such national standards may be obtained on application to the CEN-CENELEC 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 responsibil

9、ity of a CEN member into its own language and notified to the CEN-CENELEC 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,

10、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 COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management C

11、entre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 24442:2011: ECopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or

12、networking permitted without license from IHS-,-,-BS EN ISO 24442:2011EN ISO 24442:2011 (E) 3 Foreword This document (EN ISO 24442:2011) has been prepared by Technical Committee ISO/TC 217 “Cosmetics“ in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held b

13、y AFNOR. 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 2012, and conflicting national standards shall be withdrawn at the latest by June 2012. Attention is drawn to the possibility that som

14、e 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. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to impl

15、ement 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, Sw

16、itzerland and the United Kingdom. Endorsement notice The text of ISO 24442:2011 has been approved by CEN as a EN ISO 24442:2011 without any modification. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted witho

17、ut license from IHS-,-,-BS EN ISO 24442:2011ISO 24442:2011(E) ISO 2011 All rights reserved iiiContents PageForeword . ivIntroduction . v1 Scope 12 Terms and definitions .13 Principle .24 Test subjects .24.1 Selection of test subjects 24.2 Number of subjects .35 Reference sunscreen formulae .36 UVA s

18、ource 36.1 Spectral characteristics .36.2 Maintenance and monitoring the UV solar simulator output 46.3 Beam size and uniformity .46.4 Total irradiance (UV, visible and near-infrared rays) .47 Product application quantity and procedure .57.1 General .57.2 Position of the subject .57.3 Defining test

19、sites .57.4 Application procedure .68 Determination of minimal persistent pigment darkening doses (MPPDD) 68.1 UV exposure timing and subject position 68.2 Determination of the minimal pigmenting dose on the unprotected test sites (MPPDDu) using a multiple-beam solar simulator .68.3 Determination of

20、 the MPPDDu using a single-beam output solar simulator 78.4 Determination of the MPPDDp using a multiple-beam solar simulator 78.5 Determination of the MPPDDp on the protected test site with a single-beam solar simulator .89 Product removal 810 MPPDD assessment procedure .910.1 Observation time for

21、responses of MPPDDs .910.2 Position of subjects for MPPDD observations 910.3 MPPDD evaluation .911 Calculations of the UVAPF and statistics .1011.1 Calculation of the individual UVAPF (UVAPFi) for each test product for each subject .1011.2 Calculation of the mean UVAPF 1011.3 Statistical test .1011.

22、4 Test rejection for failure of meeting the statistical test for the reference sunscreen .1012 Test report .10Annex A (normative) Selection criteria for the test subjects 11Annex B (normative) Definition of the source of UVA radiation 13Annex C (normative) UVAPF reference sunscreen S1 .15Annex D (no

23、rmative) Statistics and calculations .23Bibliography .26Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 24442:2011ForewordISO (the International Organization for Standa

24、rdization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right t

25、o be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Stan

26、dards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an Inte

27、rnational Standard requires approval by at least 75 % of the member bodies casting a vote.Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 24442 wa

28、s prepared by Technical Committee ISO/TC 217, Cosmetics.ISO 24442:2011(E)iv ISO 2011 All rights reservedCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 24442:2011Introd

29、uctionThis International Standard specifies the procedure to determine the Ultraviolet A Protection Factor (UVAPF) of a sunscreen product using the persistent pigment darkening method according to the principles recommended by the Japan Cosmetic Industry Association (JCIA) in 19951. The outcome of t

30、his test method can be used to determine the UVA classification of topical sunscreen products according to local regulatory requirements.Topical sunscreen products are primarily rated and labelled according to their ability to protect against sunburn, using a test method to determine the in vivo Sun

31、 Protection Factor (see ISO/FDIS 24444). This rating evaluates filtration of sunburn generating radiation across the electromagnetic UV spectrum (290 nm to 400 nm). However, knowledge of the Sun Protection Factor (SPF) rating does not provide explicit information on the magnitude of the protection p

32、rovided specifically in the UVA range of the spectrum (320 nm to 400 nm), as it is possible to have high SPF products with very modest UVA protection (e.g. SPF 50 with a UVAPF of only 3 to 4). There is demand among medical professionals, as well as knowledgeable consumers, to have fuller information

33、 on the UVA protection provided by their sunscreen product, in addition to the SPF, in order to make a more informed choice of product, providing a more balanced and broader-spectrum protection. The UVAPF value of a product provides information on the magnitude of the protection provided explicitly

34、in the UVA portion of the spectrum, independent of the SPF values.The test method outlined in this International Standard is derived primarily from the UVAPF test methods as developed by the JCIA. Modifications have been made to attempt to harmonize with other methodologies without changing the inte

35、grity of the fundamental underlying principles of the test method.ISO 24442:2011(E) ISO 2011 All rights reserved vCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 24442:

36、2011Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 24442:2011INTERNATIONAL STANDARD ISO 24442:2011(E)Cosmetics Sun protection test methods In vivo determination of sun

37、screen UVA protection1 ScopeThis International Standard specifies an in vivo method for assessment of the UVA protection factor (UVAPF) of topical sunscreen products. This International Standard is applicable to cosmetics, drugs and other products intended to be topically applied to human skin, incl

38、uding any component able to absorb, reflect or scatter UV rays.It provides a basis for the evaluation of sunscreen products for the protection of human skin against UVA radiation from solar or other light sources.2 Terms and definitionsFor the purposes of this document, the following terms and defin

39、itions apply.2.1ultraviolet radiationelectromagnetic radiation in the range of 290 nm to 400 nmNOTE UVB null 290 nm to 320 nm; UVA null 320 nm to 400 nm (UVA II null 320 nm to 340 nm; UVA I null 340 nm to 400 nm).2.2erythemareddening of the skin caused by UV radiation2.3persistent pigment darkeningP

40、PDskin darkening that persists more than 2 h after the end of UVA exposure2.4minimal persistent pigment darkening doseMPPDDlowest Ultraviolet A (UVA) dose that produces the first perceptible unambiguous persistent pigment darkening response with defined borders appearing over most of the field of UV

41、A exposure, observed between 2 h and 24 h after the end of the UVA exposureNOTE The MPPDD on unprotected skin is referenced as “MPPDDu”, and the MPPDD on sunscreen-protected skin is referenced as “MPPDDp”.2.5individual Ultraviolet A protection factorUVAPFiratio of the minimal persistent pigment dark

42、ening dose on product-protected skin (MPPDDp) to the minimal persistent pigment darkening dose on unprotected skin (MPPDDu) of the same subject:UVAPFiMPPDDpMPPDDunull2.6UVA protection factor of a productUVAPFarithmetic mean of all valid individual UVAPFi values obtained from all subjects in the test

43、 ISO 2011 All rights reserved 1Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BS EN ISO 24442:20112.7test areaback between the scapula line and the waist2.8test sitearea of skin

44、 to which a test product or reference sunscreen is applied within the test areaNOTE The area used to determine the MPPDDu is also a test site.2.9test subsiteskin areas within a test site exposed to UVA radiation3 PrincipleThe UVAPF test method is analogous to the test method used to determine the SP

45、F of a sunscreen product. However, it utilizes only the UVA portion of the xenon arc lamp solar simulator of defined and known output to determine the protection provided by sunscreen products on human skin in the UVA portion of the spectrum.The UVAPF test method uses persistent pigment darkening (P

46、PD) responses of the skin as the end point for evaluating transmitted UVA radiation. The test is restricted to the area of the back of selected human subjects. An area of each subjects skin is exposed to UVA light without any protection and another (different) area is exposed after application of th

47、e sunscreen product under test. One further area is exposed after application of a reference UVA sunscreen formulation, which is used to validate the procedure.To determine the UVAPF, incremental series of UVA exposures are delivered to five or six small subsites on the skin to induce darkening resp

48、onses. These responses are visually assessed for pigment darkness 2 h to 24 h after UVA exposure, by the judgement of a trained evaluator. The minimal persistent pigment darkening dose (MPPDD) for unprotected skin (MPPDDu) and the MPPDD obtained after application of a sunscreen product (i.e. the MPPDD for product-protected skin, MPPDDp) are determined on the same subject on the same day. An individual sun protection factor (UVAPFi) for each subject tested is calculated as the ratio of MPPDDp/MPPDDu.4 Test subjects4.1 Selection of test subjects4.1.1 GeneralFor subject inclusion

copyright@ 2008-2019 麦多课文库(www.mydoc123.com)网站版权所有
备案/许可证编号:苏ICP备17064731号-1