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1、BRITISH STANDARD BS ISO 6710:1995 Implementation of ISO 6710:1995 Single-use containers for venous blood specimen collection ICS 11.040.20 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 6710:1995 This British Standard, having been pr
2、epared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 July 1996 BSI 12-1999 The following BSI references relate to the work on this standard: Committee reference CH/29 Draft for comment 92/58306 DC
3、ISBN 0 580 26128 X Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/29, Medical sample containers and anticoagulants, upon which the following bodies were represented: Association of Clinical Biochemists Association of
4、Clinical Pathologists BLWA Limited (The Association of the Laboratory Supply Industry) British Glass Manufacturers Confederation British Society for Haematology Department of Health European Laboratory Plastics Association Institute of Materials Medical Sterile Products Association Ministry of Agric
5、ulture, Fisheries and Food Public Health Laboratory Service Royal College of Pathologists Trades Union Congress Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 6710:1995 BSI 12-
6、1999i Contents Page Committees responsibleInside front cover National forewordii Forewordiii Text of ISO 67101 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 6710:1995 ii BSI 12-1999 National foreword This British Standard reproduces
7、 verbatim ISO 6710:1995 and implements it as the UK national standard. This British Standard is published under the direction of the Health and Environment Sector Board whose Technical Committee CH/29 has the responsibility to: aid enquirers to understand the text; present to the responsible interna
8、tional committee any enquiries on interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK. NOTEInternational and European Standards, as well as overseas standards, are available from Customer Servi
9、ces, BSI, 389 Chiswick High Road, London W4 4AL. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal oblig
10、ations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the ISO title page, pages ii to iv, pages 1 to 8 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendm
11、ent table on the inside front cover. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 6710:1995 ii BSI 12-1999 Contents Page For
12、ewordiii 1Scope1 2Normative references1 3Definitions1 4Materials2 5Capacity2 6Design2 7Construction2 8Sterility3 9Additives3 10Marking and labelling3 11Container identification3 Annex A (normative) Nominal capacity and minimum free space tests for non-evacuated containers5 Annex B (normative) Tests
13、for draw volume and minimum free space for evacuated containers5 Annex C (normative) Test for leakage of container6 Annex D (normative) Test for robustness of container7 Annex E (normative) Concentrations of additives and volume of liquid additive7 Annex F (informative) Bibliography8 Table 1 Minimum
14、 free space to enable adequate mixing2 Table 2 Letter codes and recommended colour codes for identifying additives4 Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 6710:1995 BSI 12-1999iii Foreword ISO (the International Organization
15、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 committee has been established has t
16、he 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 electrotechnical standardization. Draft I
17、nternational 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. International Standard ISO 6710 was prepared by Technical Committee ISO/TC 76, T
18、ransfusion, infusion and injection equipment for medical use. Annex A, Annex B, Annex C, Annex D and Annex E form an integral part of this International Standard. Annex F is for information only. Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:39 GMT+00:00 2006, Uncontrolled Copy, (c) B
19、SI iv blank Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 6710:1995 BSI 12-19991 1 Scope This International Standard specifies requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers
20、. It does not specify requirements for blood collection needles or needle holders. NOTE 1This International Standard replaces the requirements for non-evacuated containers previously specified in ISO 4822, Single use blood specimen containers up to 25 ml capacity, which has been withdrawn. 2 Normati
21、ve references The following standards contain provisions which, through reference in this text, constitute provisions 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 Internat
22、ional Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and
23、 certain other medical equipment Part 1: General requirements. ISO 3696:1987, Water for analytical laboratory use Specification and test methods. ISO 7000:1989, Graphical symbols for use on equipment Index and synopsis. 3 Definitions For the purposes of this International Standard, the following def
24、initions apply. 3.1 container vessel to contain a blood specimen, with closure in place 3.2 evacuated container container intended for blood collection by means of evacuation either already induced by the manufacturer (i.e., pre-evacuated containers) or induced by the user before blood is taken 3.3
25、tube that part of the container, without the closure, that contains the specimen 3.4 closure component by which the container is closed 3.5 primary pack smallest package of containers 3.6 container interior inside surface of the container 3.7 additive any substance (other than inside surface treatme
26、nts designed to be irremovable) that is placed in the container in order to allow the intended analysis to be performed 3.8 nominal capacity volume of whole blood with which the container is intended to be filled 3.9 free space extra capacity, or head space, which is provided to allow adequate mixin
27、g of the contents of a container, as determined by the minimum free space tests laid down in Annex A and Annex B 3.10 fill line line marked on a tube or its label to indicate the nominal capacity of a container 3.11 draw volume nominal capacity of an evacuated container 3.12 expiry date date after w
28、hich the manufacturer does not claim that a container complies with the requirements of this International Standard 3.13 closing torque twisting force, specified by the manufacturer, that is required to tighten a closure sufficiently by means of a torque wrench to effect the sealing of a container 3
29、.14 visual inspection inspection by an observer with normal or corrected-to-normal vision without magnification under a uniform illuminance between 300 lx and 750 lx Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 6710:1995 2 BSI 12-1
30、999 4 Materials 4.1 The tube shall be made of material which allows a clear view of the contents when subjected to visual inspection. It is recommended that the inner surfaces of glass tubes intended to receive specimens for blood coagulation studies should not allow contact activation (see 1). 4.2
31、If a container is intended specifically for the determination of a certain substance, the maximum level of container interior contamination with that substance and the analytical method employed shall be stated by the manufacturer in accompanying literature or on the label or packaging (see also 10.
32、4). For the determination of specified metals and other specified substances, the formulation of the closure material should be such as not to interfere with the determination thereby affecting the results. NOTE 2For highly sensitive determinations (for example those using fluorimetry) or little-use
33、d tests, limits of interference may not have been agreed on. In such cases the user is recommended to consult the manufacturer. 4.3 Containers with microbe-supporting additives such as trisodium citrate or citrate phosphate dextrose adenine solution shall have been subjected to a validated process t
34、o eliminate microbial contamination from the additive and the container interior. NOTE 3Validation of the process is the responsibility of the manufacturer. This International Standard does not specify a validation procedure but International Standards on this subject are being prepared. 4.4 The con
35、tainer shall be free from foreign matter when subjected to visual inspection. 5 Capacity 5.1 When tested in accordance with the methods specified in Annex A and Annex B, the volume of water added from or drawn from the burette shall be within 10 % of the nominal capacity. 5.2 For containers with an
36、additive, there shall be sufficient free space, when tested in accordance with the methods specified in Annex A and Annex B, to allow adequate mixing by mechanical or manual means. The minimum free space shall be as specified in Table 1. Allowance shall be made for the fact that the available free s
37、pace for mixing the contents of a container is bounded by the underside of the closure and the liquid meniscus. Table 1 Minimum free space to enable adequate mixing 6 Design 6.1 The closure shall not become loose during mixing when tested for leakage in accordance with the methods specified in Annex
38、 C. 6.2 Where a closure is intended to be removed to gain access to the contents of the container, it shall be designed so that it can be removed by gripping with the fingers and/or by mechanical means without that part of the closure which may be contaminated by contact with the specimen being touc
39、hed by the fingers. NOTE 4Some instrumentation, e.g. blood cell counters, is designed to enable aspiration of the contents of a blood specimen container without the need to remove the closure. 6.3 When the container is tested for leakage in accordance with the method specified in Annex C, no fluores
40、cence shall be detectable in the water in which the container has been immersed. 7 Construction 7.1 The container holding the specimen, when centrifuged, shall withstand an acceleration of 3 000 g in a longitudinal axis when tested in accordance with the method specified in Annex D. NOTE 5gn= 9,806
41、65 m/s2 7.2 When subjected to visual inspection, the container shall not have a sharp edge, projection or surface roughness capable of accidentally cutting, puncturing or abrading the skin of the user. Nominal capacity of container Minimum free space requirement W 0,5 ml and 5 ml+ 25 % of nominal ca
42、pacity W 5 ml+ 15 % of nominal capacity Licensed Copy: sheffieldun sheffieldun, na, Sun Nov 26 01:53:39 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS ISO 6710:1995 BSI 12-19993 8 Sterility 8.1 If a manufacturer claims that a product is sterile, the container interior and any contents shall have been
43、 subjected to a validated process designed to ensure that the unopened and unused container interior and any contents of the container are sterile. NOTE 6Validation of the efficacy of the process is the responsibility of the manufacturer. This International Standard does not specify a validation pro
44、cedure but International Standards on methods of controlling and validating sterilization processes are being prepared. In the absence of International Standards, it is recommended that reference should be made to any national requirements that exist. Where no national requirements exist, reference
45、should be made to the current European Pharmacopoeia, the current United States Pharmacopoeia or the current British Pharmacopoeia. 8.2 Sterility is mandatory when during blood collection there is any possibility of direct contact between the container interior and the patients blood flow. 9 Additiv
46、es 9.1 The stated nominal amount of additive shall be within the range specified in Annex E. NOTE 7With one exception (see 9.2), assay methods are not specified. Flame photometric assays are recommended where additives contain sodium, potassium or lithium. It is important that assays are carried out
47、 with an accuracy commensurate with the limit of error implied in Annex E. If the assay method used is non-specific, e.g. flame photometry for sodium and potassium salts of EDTA, it is recommended that an identification test be carried out. 9.2 The volume of a liquid additive in a container shall be
48、 determined gravimetrically with a correction being made for the specific gravity of the liquid. 10 Marking and labelling 10.1 Labels shall not completely encircle the tubes. 10.2 The marking and labelling on the container shall remain adherent after exposure in air at (4 1) C for not less than 48 h
49、. NOTE 8This subclause specifies the requirement for products under normal conditions. However, when products are stored or used under extreme conditions (e.g. extreme temperature or humidity, or abnormal transportation or storage for long periods) the requirement may be inadequate. A manufacturer is responsible for a claim that a product is suitable for storage or use under extreme or abnormal conditions. 10.3 Each primary pack shall be marked on the outside with the following information: a) the manufacturers or suppliers name or trademark; b) the