BS ISO 15010-1998 Disposable hanging devices for transfusion and infusion bottles - Requirements and test methods《输液瓶和输注瓶用一次性悬吊装置 要求和试验方法》.pdf

1、BRITISH STANDARD BS ISO 15010:1998 Disposable hanging devices for transfusion and infusion bottles Requirements and test methods ICS11.040.20BSISO15010:1998 This British Standard, having been prepared under the directionof the Health and Environment Sector Board, waspublished under the authorityof t

2、he Standards Boardand comes into effect on 15 August 1998 BSI 04-1999 ISBN 0 580 30315 2 National foreword This British Standard reproduces verbatim ISO15010:1998 and implements it as the UK national standard. The UK participation in its preparation was entrusted to Technical Committee CH/11, Transf

3、usion equipment for medical use, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and Euro

4、pean developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Stand

5、ards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible f

6、or their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pagesi andii, theISO title page, page ii, pages1 and 2 and a back cover. This standard has been u

7、pdated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No. Date CommentsBSISO15010:1998 BSI 04-1999 i Contents Page National foreword Inside front cover Foreword iii Intro

8、duction 1 1 Scope 1 2 Normative references 1 3 Designation code and test weights 1 4 Material 1 5 Requirements 1 6 Testing 2 7 Packaging and storage 2 8 Marking 2 Figure 1 Test hook2 Table 1 Designation code and test weight for permanent loading test 1ii blankBSISO15010:1998 ii BSI 04-1999 Foreword

9、ISO (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 technical committees. Each member body interested in a subject for which a technical

10、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 closely with the International Electrotechnical Commission (IEC) on all matters of elect

11、rotechnical standardization. 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 least75% of the member bodies casting a vote. International Standard ISO15010 was prepared b

12、y Technical Committee ISO/TC76, Transfusion, infusion and injection equipment for medical use. Descriptors: Medical equipment, blood transfusion equipment, parenteral infusion equipment, bottles, disposable equipment, suspension devices, specifications, performance, tests, mechanical tests, marking,

13、 designation, packaging.BSISO15010:1998 BSI 04-1999 1 Introduction This International Standard deals with hanging devices for transfusion bottles in accordance with ISO1135-1 and infusion bottles in accordance with ISO8536-1. The intended purpose of hanging devices is to avoid drop-downs of transfus

14、ion and infusion bottles during administering of blood or pharmaceutical solutions. 1 Scope This International Standard specifies requirements for hanging devices for transfusion bottles in accordance with ISO1135-1 and infusion bottles in accordance with ISO8536-1. The hanging devices are intended

15、for single use only. The purpose of this International Standard is to establish a safe hanging device for transfusion and infusion bottles during administering of their contents. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provi

16、sions of this International Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standar

17、ds indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO1135-1:1987, Transfusion equipment for medical use Part1: Glass transfusion bottles, closures and caps. ISO2768-1:1989, General tolerances Part1:Tolerances for linear and angular dimensions w

18、ithout individual tolerance indications. ISO8536-1:1991, Infusion equipment for medical use Part1: Infusion glass bottles. 3 Designation code and test weights Disposable hanging devices in accordance with the requirements of this International Standard are designated by the description block, follow

19、ed by a reference to this International Standard, followed by the designation code as specified in Table 1. For example, a hanging device for an infusion bottle in accordance with ISO8536-1 of nominal capacity50ml is designated as follows: Hanging device ISO15010A50 Test weights used for the permane

20、nt loading test (see6.2) are also a function of the nominal capacity of the hanging device and are specified in Table 1. Table 1 Designation code and test weight for permanent loading test 4 Material Materials selected for the hanging device shall ensure that all requirements given in clause5 can be

21、 met. The materials shall retain their characteristics when exposed to ultraviolet light or disinfection procedures. 5 Requirements 5.1 Assembly resistance The disposable hanging device shall not be damaged by a single dismantling and renewed installation. After such manipulation it shall still pass

22、 the tests specified in6.1 and6.2. 5.2 Gravitational loading When tested in accordance with6.1, the disposable hanging device shall not detach from the infusion bottle. It shall not be damaged by the test. 5.3 Permanent loading When tested in accordance with6.2, the disposable hanging device shall p

23、revent the transfusion or infusion bottle from falling. 5.4 Surface quality The surface shall be clean and shall not possess sharp edges or burrs. 5.5 Design The disposable hanging device shall be designed to ensure that the transfusion or infusion bottle hangs upside down. Designation code for disp

24、osable hanging device Nominal capacity ml Test weight kg Transfusion bottle in accordance with ISO1135-1 Infusion bottle in accordance with ISO8536-1 A50 50 3 A100 120 100 A250 250 A300 300 5 A500 500 500 A1000 1000BSISO15010:1998 2 BSI 04-1999 6 Testing 6.1 Gravitational test Attach the disposable

25、hanging device, fitted with a filled infusion bottle in accordance with ISO8536-1, to the curve of the test hook (see Figure 1). Attach one end of a cord to the upper part of the hook, and the other end to a separate fixed point. Hold the hanging device and hook level with the fixed point and drop t

26、he assemblage such that the cord breaks the fall with the hanging device at a vertical distance of30cm from the fixed point. The test is regarded as passed if the hanging device has met the requirements specified in5.2. 6.2 Permanent loading test Using a hook of diameter4mm, e.g.in accordance with F

27、igure 1, load the disposable hanging device for24h at(23 2) C and(50 3)% relative humidity with a test weight in accordance with Table 1. The test is regarded as passed if, after this exposure, the hanging device has met the requirements specified in5.3. 7 Packaging and storage The packaging and sto

28、rage conditions shall be selected to ensure that all requirements will continue to be met during the lifetime of the hanging device. 8 Marking Disposable hanging devices complying with the requirements of this International Standard shall be marked on the packaging with the year of manufacture and t

29、he designation in accordance with clause3, e.g.: 1997 Hanging device ISO15010A250 Figure 1 Test hook3 blankBS ISO 15010:1998 BSI 389 Chiswick High Road London W4 4AL BSIBritishStandardsInstitution BSI is the independent national body responsible for preparing BritishStandards. It presents the UK vie

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