1、BSI Standards PublicationBS EN ISO 19001:2013In vitro diagnostic medicaldevices Information suppliedby the manufacturer with invitro diagnostic reagents forstaining in biologyBS EN ISO 19001:2013Incorporating corrigendum August 2013BS EN ISO 19001:2013 BRITISH STANDARDNational forewordThis British S
2、tandard is the UK implementation of EN ISO 19001:2013. It supersedes BS EN 12376:1999 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained on request to its secretary.This pu
3、blication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards Limited 2013ISBN 978 0 580 83125 6ICS 11.040.55; 11.100.10Compliance with a British Standard cannot
4、confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 March 2013.Amendments/corrigenda issued since publicationDate Text affected31 August 2013 Implementation of CENELEC correction notice 24 April 2013: Sup
5、ersession information correctedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORMEN ISO 19001 March 2013 ICS 11.100.10; 11.040.55English Version In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013) Di
6、spositifs mdicaux de diagnostic in vitro - Informations fournies par le fabricant avec les ractifs de coloration de diagnostic in vitro utiliss en biologie (ISO 19001:2013) In-vitro-Diagnostika - Bereitstellung von Informationen durch den Hersteller von in-vitro-diagnostischen Reagenzien fr biologis
7、che Frbungen (ISO 19001:2013) This European Standard was approved by CEN on 14 March 2013. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date li
8、sts and bibliographical 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 unde
9、r the responsibility 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, Former Yu
10、goslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROP
11、EN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 19001:2013: EBS EN ISO 19001:2013EN ISO 19001:2013(E)3 ForewordThis do
12、cument (EN ISO 19001:2013) has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems“ in collaboration with Technical Committee CEN/TC140“In vitro diagnostic medical devices” the secretariat of which is held by DIN. This European Standard s
13、hall be given the status of a national standard, either by publication of an identical text or b y e ndorsement, at t he l atest b y September 201 3, a nd c onflicting national s tandards s hall b e withdrawn at the latest by March2016. Attention is drawn to the possibility that some of the elements
14、 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 implement this Europea
15、n Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Sloven
16、ia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO19001:2013has been approved by CEN as EN ISO 19001:2013without any modification.BS EN ISO 19001:2013ISO 19001:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Norm
17、ative references 13 Terms and definitions . 14 Requirements for information supplied by the manufacturer 34.1 General requirements . 34.2 Additional requirements for specific kinds of reagent . 4Annex A (informative) Examples of information supplied by the manufacturer with reagents commonly used in
18、 biological staining procedures . 7Bibliography .13BS EN ISO 19001:2013EN ISO 19001:2013(E)3 ForewordThis document (EN ISO 19001:2013) has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems“ in collaboration with Technical Committee CEN/
19、TC140“In vitro diagnostic 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 ext or b y e ndorsement, at t he l atest b y September 201 3, a nd c onflicting national s tandards s hal
20、l b e withdrawn at the latest by March2016. 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.According to the CEN-CENELEC Internal Regul
21、ations, 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, It
22、aly, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO19001:2013has been approved by CEN as EN ISO 19001:2013without any modification.EN ISO 19001:2013(
23、E)3 ForewordThis document (EN ISO 19001:2013) has been prepared by Technical Committee ISO/TC 212 “ Clinical laboratory testing and in vitro diagnostic test systems“ in collaboration with Technical Committee CEN/TC140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN.This
24、 European Standard shall be given the status of a national standard, either by publication of an identical text or b y e ndorsement, at t he l atest b y September 201 3, a nd c onflicting national standards s hall b e withdrawn at the latest by March2016. Attention is drawn to the possibility that s
25、ome 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 EN12376:1999. According to the CEN-CENELEC Internal Regulations, the national standards organizations of t
26、he following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Nether
27、lands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO19001:2013has been approved by CEN as EN ISO 19001:2013without any modification.BS EN ISO 19001:2013ISO 19001:2013(E) ISO 2013 All rights reserved
28、iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Requirements for information supplied by the manufacturer 34.1 General requirements . 34.2 Additional requirements for specific kinds of reagent . 4Annex A (informative) Examples of information s
29、upplied by the manufacturer with reagents commonly used in biological staining procedures . 7Bibliography .13BS EN ISO 19001:2013EN ISO 19001:2013(E)3 ForewordThis document (EN ISO 19001:2013) has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic te
30、st systems“ in collaboration with Technical Committee CEN/TC140“In vitro diagnostic 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 b y e ndorsement, at t he l atest b y S
31、eptember 201 3, a nd c onflicting national s tandards s hall b e withdrawn at the latest by March2016. 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 suc
32、h patent rights.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, Former Yugoslav Republic of Macedo
33、nia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.Endorsement noticeThe text of ISO19001:2013has been approved by CEN as E
34、N ISO 19001:2013without any modification.BS EN ISO 19001:2013ISO 19001:2013(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO
35、 technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates cl
36、osely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards 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. Draf
37、t International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International 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 docume
38、nt may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 19001 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.This second edition cancels and replaces the first editio
39、n (ISO 19001:2002), which has been technically revised.iv ISO 2013 All rights reservedBS EN ISO 19001:2013ISO 19001:2013(E)IntroductionThis International Standard relates to ISO 18113-1 and ISO 18113-2, which can be used in conjunction with it.The use of reagents required for staining in biology as
40、well as the specific examples of information supplied by the manufacturer for two staining procedures as provided in Annex A are based on a European consensus; they constitute the scientific justification for the requirements listed in Clause 4. This information is intended to assist manufacturers,
41、suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in biology in complying with the required specific product data. ISO 2013 All rights reserved vBS EN ISO 19001:2013ISO 19001:2013(E)ForewordISO (the International Organization for Standardization) is a w
42、orldwide 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 to be represented
43、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 Standards are drafted
44、 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 International Standar
45、d 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 19001 was prepared by Tec
46、hnical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.This second edition cancels and replaces the first edition (ISO 19001:2002), which has been technically revised.iv ISO 2013 All rights reservedBS EN ISO 19001:2013ISO 19001:2013(E)IntroductionThis Internati
47、onal Standard relates to ISO 18113-1 and ISO 18113-2, which can be used in conjunction with it.The use of reagents required for staining in biology as well as the specific examples of information supplied by the manufacturer for two staining procedures as provided in Annex A are based on a European
48、consensus; they constitute the scientific justification for the requirements listed in Clause 4. This information is intended to assist manufacturers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in biology in complying with the required specific p
49、roduct data. ISO 2013 All rights reserved vBS EN ISO 19001:2013 BS EN ISO 19001:2013In vitro diagnostic medical devices Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology1 ScopeThis International Standard specifies requirements for information supplied by the manufacturer with reagents used in staining in biology. It applies to producers, suppliers and vendors of dyes, stains, chromogenic reagents and other reagents used for staining in histology and cytology including bacteriology, haematology, histo
