BS 6674-1985 Specification for disposable micropipettes《一次性使用的微量吸移管规范》.pdf

1、BRITISH STANDARD BS 6674:1985 ISO 7550:1985 Specification for Disposable micropipettes ISO title: Laboratory glassware Disposable micropipettes UDC 542.3:531.732 + 666.172.7181.48BS6674:1985 This British Standard, having been prepared under the directionof the Laboratory Apparatus Standards Committe

2、e,was published underthe authority of the BoardofBSI and comes into effect on 31 December 1985 BSI 10-1999 The following BSI references relate to the work on this standard: Committee reference LBC/27 Draft for comment 82/52909 DC ISBN 0 580 14881 5 Committees responsible for this British Standard Th

3、e preparation of this British Standard was entrusted by the Laboratory Apparatus Standards Committee (LBC/-) to Technical Committee LBC/27 upon which the following bodies were represented: Association of Clinical Biochemists British Laboratory Ware Association British Lampblown Scientific Glassware

4、Manufacturers Association Ltd. Department of Health and Social Security Department of Trade and Industry (Laboratory of the Government Chemist) Department of Trade and Industry (National Weights and Measures Laboratory) Glass Manufacturers Federation Institute of Medical Laboratory Sciences Medical

5、Sterile Products Association Ministry of Defence Society of Chemical Industry Amendments issued since publication Amd. No. Date of issue CommentsBS6674:1985 BSI 10-1999 i Contents Page Committees responsible Inside front cover National foreword ii 1 Scope and field of application 1 2 References 1 3

6、Definitions 1 4 Basis of adjustment 1 5 Dimensions, types, series of capacities 1 6 Construction 1 7 Volumetric performance 2 8 Definition of capacity 2 9 Determination of accuracy and repeatability 2 10 Inscriptions and markings 3 Figure 1 Type I pipettes 4 Figure 2 Type II pipettes 5 Table 1 Requi

7、rements for type I pipettes 4 Table 2 Requirements for type II pipettes 5 Publications referred to Inside back coverBS6674:1985 ii BSI 10-1999 National foreword This British Standard has been prepared under the direction of the Laboratory Apparatus Standards Committee and is identical withISO7550:19

8、85 “Laboratory glassware Disposable micropipettes”, published by the International Organization for Standardization (ISO). Terminology and conventions. The text of the International Standard has been approved as suitable for publication as a British Standard without deviation. Some terminology and c

9、ertain conventions are not identical with those used in British Standards; attention is drawn especially to the following. The comma has been used as a decimal marker. In British Standards it is current practice to use a full point on the baseline as the decimal marker. Except in10.1 h), wherever th

10、e words “International Standard” appear, referring to this standard, they should be read as “British Standard”. In British Standards it is current practice to use the symbol “L” for litre (and its submultiples) rather than “l”. The Technical Committee has reviewed the provisions ofISO1769, to which

11、reference is made in the text, and has decided that they are acceptable for use in conjunction with this standard. A related British Standard toISO1769 isBS3996:1978 “Specification for colour coding for one-mark and graduated pipettes (including requirements for the service performance of the colour

12、 coding enamels)”. The reference toISO8417 1)in the text is for information only and does not affect the validity of this standard. Additional information. (1) Purchasers ordering to this standard are advised to specify in their purchasing contract that the supplier operate a quality system in compl

13、iance withBS5750-1 to ensure to their satisfaction that products claimed to comply withBS6674 consistently achieve the required level of quality. (2) Attention is drawn to the option of marking with the BS number 2)given in10.1 h). NOTETypographical error. In 9.2 b) V ishould read V i . Cross-refere

14、nces International Standards Corresponding British Standards ISO 719:1981 BS 3473 Chemical resistance of glass used in the production of laboratory glassware Part 2:1982 Method for determination of hydrolytic resistance of glass grains at98 C (Identical) ISO 3534:1977 BS 5532:1978 Statistics Vocabul

15、ary and symbols (Identical) 1) In preparation. 2) MarkingBS6674 on or in relation to a product is a claim by the manufacturer that the product has been manufactured to the requirements of the standard. The accuracy of such a claim is therefore solely the manufacturers responsibility. Enquiries as to

16、 the availability of third party certification to support such claims should be addressed to the Director, Quality Assurance Division, BSI, PO Box 375, Milton Keynes MK14 6LO for certification marks administered by BSI or to the appropriate authority for other certification marks.BS6674:1985 BSI 10-

17、1999 iii 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 obligations. Summary of pages This document c

18、omprises a front cover, an inside front cover, pages i to iv, pages1to 6, an inside back cover and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.iv blankBS6674:1985 B

19、SI 10-1999 1 1 Scope and field of application This International Standard specifies requirements for disposable glass micropipettes adjusted to contain, suitable for general laboratory purposes. The details specified are in conformity withISO8417. 2 References ISO 719, Glass Hydrolytic resistance of

20、 glass grains at98 C Method of test and classification. ISO 1769, Laboratory glassware Pipettes Colour coding. ISO 3534, Statistics Vocabulary and symbols. ISO 8417, Laboratory volumetric instruments Disposable volumetric articles Principles of design and construction 3) . 3 Definitions For the purp

21、ose of this International Standard, the following definitions apply. 3.1 disposable micropipette a micropipette intended to be used once only and then discarded NOTESuch pipettes will only be expected to provide their specified performance during the original operation. 3.2 accuracy (of a micropipet

22、te) the closeness of agreement between the nominal volume and the mean volume, obtained by applying the test procedure specified in clause9. It is quantified by the inaccuracy of the mean 3.3 repeatability (of a micropipette) the closeness of agreement between the individual volumes obtained by appl

23、ying the test procedure specified in clause9. It is quantified by the imprecision NOTEThe definitions for “accuracy” and “reliability” apply only in the cases where the distributions are Gaussian. 4 Basis of adjustment 4.1 Unit of volume The unit of volume is the cubic millimetre (mm 3 ), for which

24、the name microlitre (4l) may be used. NOTEThe term microlitre (4l) is commonly used as a special name for the cubic millimetre (mm 3 ), in accordance with the International System of Units (SI). 4.2 Reference temperature The reference temperature, i.e. the temperature at which the pipette is intende

25、d to contain its nominal volume (nominal capacity), is20 C. NOTEIf the pipette is required for use in a country which has adopted a reference temperature of27 C (the alternative specified in ISO8417 for tropical use), this value shall be substituted for20 C. 5 Dimensions, types, series of capacities

26、 5.1 Dimensions The dimensions shall be as shown inTable 1 andTable 2. 5.2 Types This International Standard specifies two types of pipettes. Type I: Disposable glass micropipettes with graduation line and colour code (seeFigure 1) which contain their volume when filled to the graduation line from t

27、he end away from the colour code. Type II: Disposable glass micropipettes without markings (seeFigure 2) which contain their volume when filled completely. 5.3 Series of capacities 5.3.1 The series of capacities of type I disposable pipettes is as follows: 5 10 20 25 50 100 200 4l If pipettes of oth

28、er capacities (e.g.44,74l) are required, they shall comply with the essential provisions of this International Standard. 5.3.2 The series of capacities of type II disposable pipettes is as follows: 1 2 3 4 5 10 20 25 50 100 4l 6 Construction 6.1 Material The pipettes shall be made of glass. When tes

29、ted in accordance with the procedure and using the classification laid down inISO719, the glass shall comply with the requirements of class HGB3or better. The glass shall be free from visible defects and from internal stress which would impair the performance of the pipettes. 3) At present at the st

30、age of draftBS6674:1985 2 BSI 10-1999 6.2 Graduation line Pipettes type I shall be provided with a black graduation line having a maximum thickness of0,5mm, which shall encircle the pipette completely in a plane perpendicular to its axis and shall be durable at least until the pipette has been used.

31、 6.3 Workmanship 6.3.1 Pipettes shall be of one-piece construction in accordance withFigure 1 andFigure 2 for shape, dimensions and permissible variations. Any cross-section of the pipette, taken in a plane perpendicular to the longitudinal axis, shall essentially be circular. 6.3.2 The pipettes sha

32、ll be free from foreign matter, loose or embedded lint, from chips that affect the bore and from stains when viewed under normal room lighting. 6.3.3 “Toe-nails” and “chips” shall not exceed the dimensions shown inFigure 1 andFigure 2. NOTEActual manufacturing techniques normally result in toe-nails

33、 and chips considerably smaller than those shown inFigure 1 and Figure 2. 6.3.4 The graduation line and colour code on type I pipettes shall be applied to the glass pipettes at the locations specified inFigure 1. The graduation line shall be clear and durable to enable the setting of the meniscus an

34、d the colour band shall be clear and durable to identify the pipette as to its nominal volume. 7 Volumetric performance When tested in accordance with clause9, the accuracy and repeatability shall be within the limits stated by the manufacturer. 8 Definition of capacity 8.1 Setting of the meniscus 8

35、1.1 Set the meniscus so that the plane of the upper edge of the graduation line is horizontally tangential to the lowest point of the meniscus, the line of sight being in the same plane. 8.1.2 In order that the lowest point of the meniscus may be observed, place a shade of some dark material immedi

36、ately below and behind the meniscus. This renders the profile of the meniscus dark and clearly visible against a light background. 8.2 Type I Allow a dry pipette and a vessel of distilled water to stand at an ambient temperature of20 C for2h. Weigh the pipette and record the mass. Fill the same pipe

37、tte with water, taking particular care to remove all water from the exterior of the pipette with a dry cloth or gauze. Adjust it to the graduation line according to the method outlined in 8.1.1. Reweigh the pipette, with water content, and record the mass. Subtract the recorded mass for the dry pipe

38、tte from the recorded mass for the pipette filled with distilled water. The difference represents the mass of the contained water. 8.3 Type II Allow a dry pipette and a vessel of distilled water to stand at an ambient temperature of20 C for2h. Weigh the pipette and record the mass. Fill the same pip

39、ette completely with water by capillary action, taking particular care to remove all water from the exterior of the pipette with a dry cloth or gauze. Reweigh the pipette, with water content, and record the mass. Subtract the recorded mass for the dry pipette from the recorded mass for the pipette f

40、illed with distilled water. The difference represents the mass of the contained water. NOTE 1The difference obtained in this way represents the mass, uncorrected for air buoyancy and water density. This correction is not necessary in this particular case. NOTE 2In order to carry out accurately the t

41、est methods outlined in8.2 and8.3, the reliability of the balance used should be confirmed against a known standard and the balance should have the following discrimination: NOTE 3Where, exceptionally, the reference temperature is27 C, this value shall be substituted for20 C. 9 Determination of accu

42、racy and repeatability Volumetric accuracy and repeatability shall be determined for a single pipette or a minimum of30pipettes as follows. 9.1 Volumetric capacity deviation (single pipette) Capacity deviation for a single pipette shall be calculated as follows: where Nominal capacity Discrimination

43、 1 to 10 4l 0,001 mg or better 10 to 200 4l 0,01mg or better V 0 is the nominal capacity of the pipette; V 1 is the capacity at the reference temperature.BS6674:1985 BSI 10-1999 3 9.2 Volumetric capacity deviation (number of pipettes) Volumetric deviation for a minimum of30pipettes shall be calculat

44、ed as follows: a) where b) Coefficient of variation: CV % = whereis the mean of the sample measurements; V 1is the individual sample measurement at the reference temperature; n is the number of pipettes measured. 10 Inscriptions and markings 10.1 Inscriptions Each package of pipettes shall be clearl

45、y marked with the following information: a) the inscription “20 C” to indicate the reference temperature; NOTEWhere, exceptionally, the reference temperature is27 C, this value shall be substituted for20 C. b) the letters “In” to indicate that the pipettes have been adjusted to contain their indicat

46、ed capacity; NOTEOn manufacturers option, these inscriptions may also be marked on type I pipettes themselves. c) the manufacturers name and/or mark; d) the product description, e.g. disposable micropipettes,1004l; e) the volumetric performance in terms of accuracy and repeatability; f) the number o

47、f pipettes in the package; g) the batch number or date of manufacture; h) the number of this International Standard, i.e.ISO7550, or the number of the corresponding national standard. 10.2 Colour coding 10.2.1 Pipettes of type I shall be colour coded in accordance with ISO1769. The dimensions of the

48、 colour code bands, however, shall be as shown inFigure 1. 10.2.2 The packages of type II pipettes shall be colour coded in accordance withISO1769. is the mean of the sample measurements at the reference temperature; V 0 is the nominal capacity of the pipette. V 100 s V - VBS6674:1985 4 BSI 10-1999

49、Table 1 Requirements for type I pipettes * Pipettes packed shall not vary by more than 1 mm length, irrespective of their nominal length. Figure 1 Type I pipettes Nominal capacity 4l Colour code Minimum diameter, D mm Minimum wall thickness, S mm 5 White 1,0 0,35 10 Orange 1,0 0,25 20 Black 1,1 0,25 25 2 White 1,1 0,25 50 Green 1,3 0,20 100 Blue 1,6 0,20 200 Red 2,2 0,20BS6674:1985 BSI 10-1999 5 Table 2 Requirements for type II pipettes Figure 2 Type II pipettes Nomi