BS EN ISO 19001-2013 In vitro diagnostic medical devices Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology《体外诊断医疗设备 生物着色用实验室诊断试剂生产厂.pdf

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 It supersedes BS EN 12376:1999 which is withdrawn.The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs.A list of organizations represented on this committee can be obtained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 NORM EN ISO 19001 March 2013 ICS 11.100.10; 11.040.55 English Version In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)

6、Dispositifs 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 biolog

7、ische 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 European Standard the status of a national standard without any alteration. Up-to-date

8、 lists 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 u

9、nder 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, Forme

10、r Yugoslav 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 E

11、UROPEN 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 Foreword

12、This 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/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held by DIN. This European S

13、tandard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2013, and conflicting national standards shall be withdrawn at the latest by March 2016. 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 notice The text of ISO 19001:2013 has been approved by CEN as EN ISO 19001:2013 without any modification. BS EN ISO 19001:2013ISO 19001:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 1

17、2 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 supplied by the manufacturer with reagents commonly u

18、sed in biological staining procedures . 7Bibliography .13BS EN ISO 19001:2013EN ISO 19001:2013 (E) 3 Foreword This 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 Commi

19、ttee CEN/TC 140 “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 by endorsement, at the latest by September 2013, and conflicting national standards sha

20、ll be withdrawn at the latest by March 2016. 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 Reg

21、ulations, 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,

22、Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 19001:2013 has been approved by CEN as EN ISO 19001:2013 without any modification. EN ISO 190

23、01:2013 (E) 3 Foreword This 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/TC 140 “In vitro diagnostic medical devices” the secretariat of which is held

24、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 September 2013, and conflicting national standards shall be withdrawn at the latest by March 2016. Attention is drawn to the possibility tha

25、t 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 12376:1999. According to the CEN-CENELEC Internal Regulations, the national standards organizations

26、 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, Italy, Latvia, Lithuania, Luxembourg, Malta, N

27、etherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 19001:2013 has been approved by CEN as EN ISO 19001:2013 without any modification. BS EN ISO 19001:2013ISO 19001:2013(E) ISO 2013 All right

28、s reserved 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 in

29、formation supplied by the manufacturer with reagents commonly used in biological staining procedures . 7Bibliography .13BS EN ISO 19001:2013EN ISO 19001:2013 (E) 3 Foreword This document (EN ISO 19001:2013) has been prepared by Technical Committee ISO/TC 212 “Clinical laboratory testing and in vitro

30、 diagnostic test systems“ in collaboration with Technical Committee CEN/TC 140 “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 by endorsement, at the

31、latest by September 2013, and conflicting national standards shall be withdrawn at the latest by March 2016. 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 a

32、ll such 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

33、 Macedonia, 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 notice The text of ISO 19001:2013 has been approved

34、by CEN as EN ISO 19001:2013 without 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 ou

35、t 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 on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO co

36、llaborates closely 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 St

37、andards. Draft 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 o

38、f 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 Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems.This second edition cancels and replaces the

39、 first edition (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 i

40、n 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 consensus; they constitute the scientific justification for the requirements listed in Clause 4. This information is intended to assist ma

41、nufacturers, 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 Standardiz

42、ation) 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 to be

43、 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 Standard

44、s 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 Internat

45、ional 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 19001 was pr

46、epared by Technical 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)IntroductionT

47、his 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 well as the specific examples of information supplied by the manufacturer for two staining procedures as provided in Annex A are based o

48、n a European 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 requir

49、ed specific product 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, haema