【BS英国标准】BS EN 455-3-2006 Medical gloves for single use Part 3 Requirements and testing for biological evaluation.doc
《【BS英国标准】BS EN 455-3-2006 Medical gloves for single use Part 3 Requirements and testing for biological evaluation.doc》由会员分享,可在线阅读,更多相关《【BS英国标准】BS EN 455-3-2006 Medical gloves for single use Part 3 Requirements and testing for biological evaluation.doc(42页珍藏版)》请在三一文库上搜索。
1、国内外标准大全豆丁网国内外标准下载地址 http:/ STANDARDBS EN455-3:2006Medical gloves for single use Part 3: Requirements and testing for biological evaluationThe European Standard EN 455-3:2006 has the status of aBritish StandardICS 11.140 BS EN 455-3:2006National forewordThis British Standard was published by BSI. It
2、is the UK implementation ofEN 455-3:2006. It supersedes BS EN 455-3:2000 which is withdrawn.The UK participation in its preparation was entrusted by Technical Committee CH/205, Non-active medical devices, to Subcommittee CH/205/3, Medical gloves.A list of organizations represented on CH/205/3 can be
3、 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.Compliance with a British Standard cannot confer immunity from legal obligations.Amd. No.DateCommentsThis British Standard
4、was published under the authority of the Standards Policy and Strategy Committeeon 31 January 2007 BSI 2007ISBN 978 0 580 49995 1Amendments issued since publicationEUROPEAN STANDARD NORME EUROPENNEEUROPISCHE NORMEN 455-3December 2006ICS 11.140Supersedes EN 455-3:1999English VersionMedical gloves for
5、 single use - Part 3: Requirements and testing for biological evaluationGants mdicaux non rutilisables - Partie 3: Exigences et essais pour valuation biologiqueMedizinische Handschuhe zum einmaligen Gebrauch - Teil3: Anforderungen und Prfung fr die biologischeBewertungThis European Standard was appr
6、oved 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
7、 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 notifie
8、d 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
9、, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONC OM I T EUR OP EN DE NOR M AL I S ATI ON EUR OP I S C HES KOM I TEE F R NOR M UNG Management Centre: rue de Stassart, 36 B-1050 Brussels 2006 CENAll rights of
10、 exploitation in any form and by any means reserved worldwide for CEN national Members.Ref. No. EN 455-3:2006: EEN 455-3:2006 (E)ContentsPageForeword.3Introduction .41Scope .52Normative references .53Terms and definitions .64Requirements .65Test methods.86Test report .9Annex A (normative) Method for
11、 the determination of aqueous extractable proteins in naturalrubber gloves using the modified Lowry assay .10Annex B (informative) Immunological methods for the measurement of natural rubber latexallergens .20Annex C (informative) Amino acid analysis (AAA) by high pressure liquid chromatography(HPLC
12、) .27Annex ZA (informative) Relationship between this European Standard and the EssentialRequirements of EU Directive 93/42/EEC Medical Devices.3635ForewordThis document (EN 455-3:2006) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held
13、 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 docu
14、ment has been prepared under a mandate given to CEN by the European Commission and theEuropean 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 consis
15、ts 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 evaluationAccording to the CEN/CENELEC Internal Regulation
16、s, 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,
17、 Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.IntroductionAdverse 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
18、 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
19、 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 contrib
20、ute 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 o
- 配套讲稿:
如PPT文件的首页显示word图标,表示该PPT已包含配套word讲稿。双击word图标可打开word文档。
- 特殊限制:
部分文档作品中含有的国旗、国徽等图片,仅作为作品整体效果示例展示,禁止商用。设计者仅对作品中独创性部分享有著作权。
- 关 键 词:
- BS英国标准 【BS英国标准】BS EN 455-3-2006 Medical gloves for single use Part Requirements and testing biological BS
链接地址:https://www.31doc.com/p-3620129.html