1、February 2016 English price group 19No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.20!%LSL“2414841www.din.d
2、eDIN EN ISO 26722Water treatment equipment for haemodialysis applications and related therapies (ISO 26722:2014);English version EN ISO 26722:2015,English translation of DIN EN ISO 26722:2016-02Ausstattung zur Wasseraufbereitung zur Verwendung in der Hmodialyse und in verwandten Therapien (ISO 26722
3、:2014);Englische Fassung EN ISO 26722:2015,Englische bersetzung von DIN EN ISO 26722:2016-02quipement de traitement de leau pour des applications en hmodialyse et aux thrapies apparentes (ISO 26722:2014);Version anglaise EN ISO 26722:2015,Traduction anglaise de DIN EN ISO 26722:2016-02www.beuth.deDo
4、cument comprises 43 pagesDTranslation by DIN-Sprachendienst.In case of doubt, the German-language original shall be considered authoritative.03.16 DIN EN ISO 26722:2016-02 2 A comma is used as the decimal marker. National foreword The text of ISO 26722:2014 has been prepared by Technical Committee I
5、SO/TC 150 “Implants for surgery” and has been taken over as EN ISO 26722:2015 by Technical Committee CEN/TC 205 “Non-active medical devices” (Secretariat: DIN, Germany). The responsible German body involved in its preparation was DIN-Normenausschuss Medizin (DIN Standards Committee Medicine), Workin
6、g Committee NA 063-01-03 AA Extrakorporaler Kreislauf, Apparate und Einmalartikel. The DIN Standards corresponding to the International Standards referred to in this document are as follows: ISO 13959 DIN EN ISO 13959 ISO 14971 DIN EN ISO 14971 IEC 60601-1-8 DIN EN 60601-1-8 National Annex NA (infor
7、mative) Bibliography DIN EN ISO 13959, Water for haemodialysis and related therapies DIN EN ISO 14971, Medical devices Application of risk management to medical devices DIN EN 60601-1-8, Medical electrical equipment Part 1-8: General requirements for basic safety and essential performance Collateral
8、 standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 26722 December 2015 ICS 11.040.40 English Version Water treatment equipment for haemodialysis applications and
9、 related therapies (ISO 26722:2014) quipement de traitement de leau pour des applications en hmodialyse et aux thrapies apparentes (ISO 26722:2014) Ausstattung zur Wasseraufbereitung zur Verwendung in der Hmodialyse und in verwandten Therapien(ISO 26722:2014) This European Standard was approved by C
10、EN on 23 November 2015. 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 standa
11、rds 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 responsibility of a CEN member into its own language and not
12、ified 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 Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, I
13、celand, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey andUnited Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Man
14、agement Centre: Avenue Marnix 17, B-1000 Brussels 2015 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 26722:2015 EContents PageEuropean foreword .3Introduction .61 Scope 71.1 General 71.2 Inclusions 71.3 Exclusions . 72 Normat
15、ive references . 73 Terms and definitions 84 Requirements 134.1 Dialysis water quality requirements 134.2 Water treatment equipment requirements 145 Tests .195.1 Compliance with dialysis water quality requirements .195.2 Compliance with water treatment equipment requirements 216 Labelling 236.1 Gene
16、ral . 236.2 Device markings 236.3 Product literature . 24Annex A (informative) Rationale for the development and provisions of this International Standard 26Annex B (informative) Reference tables from ISO 13959 .36Bibliography 40Annex ZA (informative) Relationship between this European Standard and
17、the Essential Requirements of EU Directive 93/42/EEC on medical devices 39 DIN EN ISO 26722:2016-02 EN ISO 26722:2015 (E) 2Foreword .5.European foreword The text of ISO 26722:2014 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of the International Organization for Standar
18、dization (ISO) and has been taken over as EN ISO 26722:2015 by Technical Committee CEN/TC 205 “Non-active 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, a
19、t the latest by June 2016, and conflicting national standards shall be withdrawn at the latest by June 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
20、ll such patent rights. 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 with EU Directive, see informative Annex ZA, which is an integral part of this
21、 document. The following referenced documents are indispensable for the application of this document. For undated references, the latest edition of the referenced document (including any amendments) applies. For dated references, only the edition cited applies. However, for any use of this standard
22、within the meaning of Annex ZA, the user should always check that any referenced document has not been superseded and that its relevant contents can still be considered the generally acknowledged state-of-art. When an IEC or ISO standard is referred to in the ISO standard text, this shall be underst
23、ood as a normative reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC standard, as listed below. NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they
24、apply. DIN EN ISO 26722:2016-02 EN ISO 26722:2015 (E) 3 Table 1 Correlation between normative references and dated EN and ISO standards Normative references as listed in Clause 2 of the ISO standard Equivalent dated standard EN ISO or IEC ISO 13959:2014 EN ISO 13959:20151)ISO 13959:2014 ISO 14971:20
25、07 EN ISO 14971:2012 ISO 14971:2007 IEC 60601-1-8 EN 60601-1-8:2007+Cor.:2010+A1:2013 IEC 60601-1-8:2006+A1:2012 According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgari
26、a, 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, Slovenia, Spain, Sweden, Switzerland, Turke
27、y and the United Kingdom. Endorsement notice The text of ISO 26722:2014 has been approved by CEN as EN ISO 26722:2015 without any modification. 1) To be published. DIN EN ISO 26722:2016-02 EN ISO 26722:2015 (E) 4 ForewordISO (the International Organization for Standardization) is a worldwide federat
28、ion 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 on that committe
29、e. 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.The procedures used to develop this document and th
30、ose intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2
31、(see www.iso.org/directives).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. Details of any patent rights identified during the development of the do
32、cument will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms an
33、d expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 150, Implants for surgery, Subco
34、mmittee SC 2, Cardiovascular implants and extracorporeal systems.This second edition cancels and replaces the first edition (ISO 26722:2009), which has been technically revised.DIN EN ISO 26722:2016-02 EN ISO 26722:2015 (E) 5 IntroductionThis International Standard reflects the conscientious efforts
35、 of concerned physicians, clinical engineers, nurses, dialysis technicians, and dialysis patients, in consultation with device manufacturers and government representatives, to develop an International Standard for performance levels that could be reasonably achieved at the time of publication. The t
36、erm “consensus,” as applied to the development of voluntary medical device International Standards, does not imply unanimity of opinion, but rather reflects the compromise necessary in some instances when a variety of interests should be merged.The provisions of this International Standard apply to
37、individual water treatment devices and to water treatment systems assembled from one or more of these devices. In the first instance, this International Standard is directed at the individual or company that specifies the complete water treatment system and, second, at the supplier who assembles and
38、 installs the system. Since systems can be assembled from a number of individual water treatment devices, the provisions of this International Standard are also directed at the manufacturers of these devices, provided that the manufacturer indicates that the device is intended for use in haemodialys
39、is applications. This International Standard is written principally to address water treatment systems for dialysis facilities treating multiple patients. However, many of its provisions equally apply to water treatment systems used in applications where a single patient is treated, such as in a hom
40、e dialysis or acute hospital dialysis setting. Specifically, requirements for the chemical and microbiological quality of water are considered to apply in all settings, regardless of whether a single patient or many patients are being treated.The verbal forms used in this International Standard conf
41、orm to usage described in Annex H of the ISO/IEC Directives, Part 2. For the purposes of this International Standard, the auxiliary verb “shall” means that compliance with a requirement or a test is mandatory for compliance with this International Standard, “should” means that compliance with a requ
42、irement or a test is recommended but is not mandatory for compliance with this International Standard, and “may” is used to describe a permissible way to achieve compliance with a requirement or test.The requirements established by this International Standard should help protect haemodialysis patien
43、ts from adverse effects arising from known chemical and microbial contaminants found in water supplies. However, proper dialysis and patient safety is ultimately dependent on the quality of the dialysis fluid. Since the manufacturer or supplier of water treatment equipment does not have control over
44、 the dialysis fluid, any reference to dialysis fluid in this International Standard is for clarification only and not a requirement of the manufacturer. The responsibility for assuring that the dialysis fluid is not contaminated, mismatched, or otherwise damaging to the patient rests with the clinic
45、al professionals caring for the patient under the supervision of the medical director. Recommendations on the preparation and handling of water and dialysis fluid in a dialysis facility are provided in ISO 23500.DIN EN ISO 26722:2016-02 EN ISO 26722:2015 (E) 6 1 Scope1.1 GeneralThis International St
46、andard is addressed to the manufacturer and/or supplier of water treatment systems and/or devices used for the express purpose of providing water for haemodialysis or related therapies.1.2 InclusionsThis International Standard covers devices used to treat water intended for use in the delivery of ha
47、emodialysis and related therapies, including water used for: (1) the preparation of concentrates from powder or other highly concentrated media at a dialysis facility; (2) the preparation of dialysis fluid, including dialysis fluid that can be used for the preparation of substitution fluid; (3) the
48、reprocessing of dialysers for multiple uses.Included within the scope of this International Standard are all devices, piping and fittings between the point at which potable water is delivered to the water treatment system, and the point of use of the dialysis water. Examples of devices included within the scope of this International Standard are water purification devices, online water quality monitors (such as conductivity monitors), and piping systems for t
