ISO 12772:1997 download.Laboratory glassware-Disposable microhaematocrit capillary tubes.
ISO 12772 provides details for two types of disposable glass capillary tubes, suitable for the microhaematocrit test and other analytical tests which include a separation of plasma and cells. The details specified are in conformity with ISO 8417, to the greatest possible extent.
WARNING — Capillary tubes can break during the analytical test procedure, resulting in broken sharp glass, blood spillage and aerosols. Appropriate precautions shall be taken to avoid dangerous infections.
Normative references
The following standards contain provisions which, through references in this text, constitute provisions of ISO 12772. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on ISO 12772 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 719:1985, Glass – Hydrolytic resistance of glass grains at 98°C – Method of test and classification.
ISO 8417:—i, Laboratory volumetric instruments – Principles of design and construction of disposable volumetric articles.
S Construction
5.1 Matatiat
When tested art accordance with the procedure and classification given in ISO 719. th• glass used for the capillary tubes shall at least comply with the requirements of disc HGB 3.
Th. glass shall be free from visible defects and shall be free from internal stresses which would wnpair the performance of the capillary tube,
52 DesIgn
The tubes shall be straight and open it both ends without bp or constriction. The tubes may be slightly fire- polished on one ot both ends.
5.3 DImensions
The dimensions of the tubes shall be as follows:
Length: (75 ± 0.5) mm
Internal diameter. (1,15j 0,081 mm
Wall thickness: (0,2 0.025) mm
Th. bore of the tubes shall be uniform and shall not vary by more than 4% of the total over a distance 0175 mm.
NOTE — Ai the bore van.tion is critical foe the analytical result, smaller bore variations than 4 % may be marked on the packaging of th, capillary tubes.
5.4 RIng math
The tubes may be provided with a ring mark to ease filling. Such a ring mark shall be at a distance of 60 mm max. from one end of the tub.. The line thickness shall be between 0,5mm and 1 mm.
In the case of colour-coded tubes (see 6.2). th, colour of the ring mark should preferably be that of the colour code, or may be black.
5.5 Realetanc, to c.ntr*ugal foics
When th• tubes are tested as specified in annex A, not more than 0,5% shall break.
5.6 CapiIIae*y
The tube shall be capable of drawing plasma, serum or human whole blood to a level wIthin 20mm from the far end of the tube when tested as specified iii annex B.
NOTE — In view of the possible infection riaki, human blood should not be used.
5.7 AntI-coagulant flypel only)
The inner surface of Type I tubes shall be evenly coated with an anti-coagulant (see claus. 41. In the case of heparin, the coating shill show an activity of 2,13 Hi to 7.45 It) (international Units) per capillary when tested as described in annex E. An airtight container should be used In order to prevent deterioration of the anticoagulant caused by air moisture.
5.8 EHicacy of heparin coating (Type I onlyl
Coagulation of the sheep plasma shall not be evident when viewed under nomial room lighting This can be
tested as described in annex 0.
8 MarkIngs
6.1 LelIIng
The outer st,ippng carton shall be clearly marted with the loIlow*ng information:
al manufacturers or vendor’s name and/or mark.
bi product description (e.g. disposable mlcrohaeniatocflt cap.llary tubesi and the glass material (e.g. borosilicate glass 3.3 ci soda-lime glassi:
ci number of tubes a, the package:
dl batch number or date of manufacture;
ci the number of this International Standard, I… ISO 12712:
and. If applicable (Type I onlyl:
I) type of anti-coagulant (e.g. lithium heparin):
g) anticoagulant activity and date of expiration.
— As the expay date may strongly depend on storage cvnthticns. that Infoimation should prelerably be given In conn.ct ion with storage requirements.
The smaNest packaging unit shall be marked at least with the information stated in a), b). d and I).
62 Colow cod.
62.1 Each Type I tube shall be colour coded to identity the type of anti-coagulant. The colour code for tubes coated with the following anti-coagulents shall be:
orange for lithium haparin
-red for sodium heperwi
-green for ammonium heparin
-yeUow for sodium or potassium fluoride
-purple for sodium or potassium EDTA
At the manufacturers discretion. th, tubes may be colour coded at the extreme tip of the tube (see also 5.41. Antl-co.gulants containing lithium should not be used if the sample is to be tested for lithium; the same constraints apply to sodium, potassium and arnrnonlum compounds.
622 Type II tubes may be colour coded to identity that they are uncoated. It colour coded, the colour shall be blue.