1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 80369-1:2010Small bore connectors forliquids and gases in healthcareapplicationsPart 1: General requirements (ISO80369-1:2010)BS EN ISO 80369-1:2010 BRITISH STANDARDNat
2、ional forewordThis British Standard is the UK implementation of EN ISO80369-1:2010. It supersedes BS EN 15546-1:2008 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/210/5, Small Bore Connectors for Medical Devices.A list of organizations represented
3、on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 60941 1ICS 11.040.10; 11.040.20Compliance with a British Standard cannot confe
4、r immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 80369-1 December 2010 ICS 11.040.10; 11
5、.040.20 Supersedes EN 15546-1:2008 English version Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010)Raccords de petite taille pour liquides et gaz utiliss dans le domaine de la sant - Partie 1: Exigences gnrales (ISO 80369-1:2010
6、) Verbindungsstcke mit kleinem Durchmesser fr Flssigkeiten und Gase in medizinischen Anwendungen - Teil 1: Allgemeine Anforderungen (ISO 80369-1:2010) This European Standard was approved by CEN on 14 December 2010. CEN and CENELEC members are bound to comply with the CEN/CENELEC Internal Regulations
7、 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 standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN and CENELEC
8、 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 and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the off
9、icial versions. CEN and CENELEC members are the national standards bodies and national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malt
10、a, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. CEN Management Centre: CENELEC Central Secretariat:Avenue Marnix 17, B-1000 Brussels Avenue Marnix 17, B-1000 Brussels 2010 CEN/CENELEC All rights of exploitation in any form and by
11、any means reserved worldwide for CEN national Members and for CENELEC Members. Ref. No. EN ISO 80369-1:2010 EBS EN ISO 80369-1:2010EN ISO 80369-1:2010 (E) 3 Foreword This document (EN ISO 80369-1:2010) has been prepared by Technical Committee ISO/TC 210 “Quality management and corresponding general
12、aspects for medical devices“ in collaboration with Technical Committee CEN/CLC/TC 3 “Quality management and corresponding general aspects for medical devices” the secretariat of which is held by NEN. This European Standard shall be given the status of a national standard, either by publication of an
13、 identical text or by endorsement, at the latest by June 2011, and conflicting national standards shall be withdrawn at the latest by June 2011. 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
14、responsible for identifying any or all such patent rights. This document supersedes EN 15546-1:2008. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship
15、with EU Directive, see informative Annex ZA, which is an integral part of this document. Compared to EN 15546-1:2008 the following changes were implemented: a) Clause 3 “Terms and definitions“ has been editorially revised and amended by the terms “accessory“, “breathing system“, “non-interconnectabl
16、e“, “patient“ and “responsible organization“. The terms “risk“ and “safety“ have been cancelled and replaced by a general reference to the appropriate terms given in EN ISO 14971 and IEC 62366; b) Clause 4 on materials has been amended by a reference to two ASTM standards for tests on conformity; c)
17、 Clause 5 on the requirements has been completely revised and amended by a sub-section on incompatibility; d) A new Clause 6 on additional applications has been added; e) Clause 7 (respectively Clause 6 in EN 15546-1) on the assessment of new designs (validation) has been completely revised, more de
18、tailed in the structure and amended. Especially the sections on the proposal initiation (7.2) and on the procedure to assess acceptability and non-interconnectable characteristics (7.3) have been stated more detailed; f) Annex A “Rationale“ has been completely revised by providing the reasons for th
19、is standard by clauses. In addition the Table A.1 on risk analysis of possible misconnections has been cancelled; g) A new Annex B “Mechanical tests for verifying non-interconnectable characteristics“ has been added; h) Annex C “Applications“ (respectively Clause B in EN 15546-1) has been editoriall
20、y revised; i) Annex C “Small bore connectors for vascular systems applications“ of EN 15546-1 has been cancelled; j) A new Annex D “Reference to the Essential Principles“ according ISO/TR 16142 has been added; k) Annex ZA on the relationship to the Medical Device Directive (93/42/EWG) has been align
21、ed; l) The Bibliography has been updated and amended; BS EN ISO 80369-1:2010EN ISO 80369-1:2010 (E) 4 m) A new clause Terminology has been added at the end of the standard; n) Editorial revision in alignment with the overtaking of the original European Standard into an International Standard. Accord
22、ing 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, France, Germany, Greece, Hungary, Iceland, Ireland, Ital
23、y, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 80369-1:2010 has been approved by CEN as a EN ISO 80369-1:2010 without any modification. BS EN ISO 80369-
24、1:2010EN ISO 80369-1:2010 (E) 5 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Union and the European Free Trade Association to provide a
25、 means to conforming to Essential Requirements of the New 576 Approach Directive 93/42/EEC, Council Directive of 14 June 1993 on the approximation of the laws of the Member States concerning medical devices” (Medical Device Directive). Once this document is cited in the Official Journal of the Europ
26、ean Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this document given in Table ZA.1, within the limits of the scope of this document, a presumption of conformity with the corresponding Essential Requirements of
27、 that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC Clause/subclause of this Document Corresponding Essential Requirement of Directive 93/42/EEC Qualifying remarks/notes all 1, 2 4, 5 7.5, 7.6, 9.1, 12.7.4 6 6 a, 7.5, 7.6,
28、 9.1, 12.7.4 WARNING: Other requirements and other EU Directives may be applicable to the products falling within the 585 scope of this International Standard. BS EN ISO 80369-1:2010ISO 80369-1:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1 2 Normative refe
29、rences2 3 Terms and definitions .2 4 Materials used for SMALL-BORE CONNECTORS3 5 Requirements for SMALL-BORE CONNECTORS for specific APPLICATIONS4 5.1 SMALL-BORE CONNECTOR incompatibility.4 5.2 BREATHING SYSTEMS and driving gases APPLICATIONS 4 5.3 Enteral and gastric APPLICATIONS4 5.4 Urethral and
30、urinary APPLICATIONS4 5.5 Limb cuff inflation APPLICATIONS.4 5.6 Neuraxial APPLICATIONS 5 5.7 Intravascular or hypodermic APPLICATIONS .5 5.8 Alternative SMALL-BORE CONNECTORS 5 6 Additional SMALL-BORE CONNECTOR APPLICATIONS.5 7 PROCEDURE to assess a proposed new design of SMALL-BORE CONNECTOR for i
31、nclusion in this series of standards 6 7.1 General .6 7.2 Proposal initiation .6 7.3 PROCEDURE to assess acceptability and NON-INTERCONNECTABLE characteristics6 7.3.1 Design.6 7.3.2 Design realization6 7.3.3 Design VERIFICATION .7 7.3.4 Design validation.7 7.4 Design review 7 7.5 Subsequent parts of
32、 this series of standards 7 Annex A (informative) Rationale8 Annex B (normative) Mechanical tests for verifying NON-INTERCONNECTABLE characteristics.11 Annex C (informative) APPLICATIONS of SMALL-BORE CONNECTORS .12 Annex D (informative) Reference to the Essential Principles 14 Bibliography16 Termin
33、ology Alphabetized index of defined terms17 BS EN ISO 80369-1:2010ISO 80369-1:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Stand
34、ards 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 on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also ta
35、ke part in the work. ISO collaborates 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 i
36、s to prepare International Standards. 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 possibili
37、ty 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 80369-1 was prepared by a Joint Working Group of Technical Committee ISO/TC 210, Quality management and corresponding general aspect
38、s for medical devices, IEC/TC 62, Electrical equipment, Subcommittee SC D, Electrical equipment in medical practice and CEN/CENELEC TC 3/WG 2, Small-bore connectors. ISO 80369 consists of the following parts, under the general title, Small-bore connectors for liquids and gases in healthcare applicat
39、ions: Part 1: General requirements The following parts are under preparation: Part 2: Connectors for breathing systems and driving gases applications Part 3: Connectors for enteral applications Part 4: Connectors for urethral and urinary applications Part 5: Connectors for limb cuff inflation applic
40、ations Part 6: Connectors for neuraxial applications Part 7: Connectors for intravascular or hypodermic applications BS EN ISO 80369-1:2010ISO 80369-1:2010(E) ISO 2010 All rights reserved vIntroduction In the 1990s concern grew regarding the proliferation of MEDICAL DEVICES fitted with Luer CONNECTO
41、RS and the reports of PATIENT death or injury arising from misconnections that resulted in the inappropriate delivery of enteral solutions, intrathecal medication or compressed gases. Concerns regarding the use of Luer CONNECTORS with enteral feeding tubes and gas sampling and gas delivery systems w
42、ere raised with CEN/BT and the European Commission. In November 1997 the newly created CHeF steering group set up a Forum Task Group (FTG) to consider the problem. The FTG produced CEN Report CR 13825, in which they concluded that there is a problem arising from the use of a single CONNECTOR design
43、to a number of incompatible APPLICATIONS. In a coronary care unit there are as many as 40 Luer CONNECTORS on the MEDICAL DEVICES used with a single PATIENT. Therefore it is not surprising that misconnections are made. MEDICAL DEVICES have for many years followed the established principle of “safety
44、under single fault conditions”. Simply stated this means that a single fault should not result in an unacceptable RISK. This principle is embodied in the requirements of numerous MEDICAL DEVICE standards. Extending this principle to the application of Luer CONNECTORS, i.e. that misconnection should
45、not result in an unacceptable RISK to a PATIENT, the FTG recommended that the Luer CONNECTOR should be restricted to MEDICAL DEVICES intended to be connected to the vascular system or a hypodermic syringe. In addition, new designs of SMALL-BORE CONNECTORS should be developed for other APPLICATIONS,
46、and these should be NON-INTERCONNECTABLE with Luer CONNECTORS and each other. ISO/TR 16142:2006 addresses this type of problem in Essential Principle A.1.2: The solutions adopted by the manufacturer for the design and construction of the devices should conform to safety principles, taking into accou
47、nt the generally acknowledged state of the art. In selecting the most appropriate solutions, the manufacturer should apply the following principles in the following order: identify hazards and the associated risks arising from the intended use and foreseeable misuse; eliminate or reduce risks as far
48、 as possible (inherently safe design and construction); It is understood that SMALL-BORE CONNECTOR systems cannot be designed to overcome all chances of misconnection or to eliminate deliberate misuse. However, a number of steps that would improve the current situation and lead to greater PATIENT sa
49、fety can be taken. This will only be achieved through a long-term commitment involving industry, healthcare professionals, MEDICAL DEVICE purchasers and MEDICAL DEVICE regulatory authorities. This is the first edition of ISO 80369-1 and it cancels and replaces EN 15546-1:2008 which has been editorially revised. Part 1 of this International Standard and its parts are intended to be the reference documents in which the necessary measures and PROCEDURES to prevent misconnection between SMALL-BORE CONNECTORS used in different APPLICATIONS and des
