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UDC 615.473
IS0
I NT ERN AT1 O NA L O RG A N IZAT I ON FOR STAND AR D IZ AT1 O N
IS0 RECOMMENDATION
R 595
SYRINGES FOR MEDICAL USE
1st EDITION
July 1967
COPYRIGHT RESERVED
The copyright of IS0 Recommendations and IS0 Standards
belongs to IS0 Member Bodies. Reproduction of these
documents, in any country, may be authorized therefore only
by the national standards organization of that country, being
a member of ISO.
For each individual country the only valid standard is the national standard of that country.
Printed in Switzerland
Also issued in French and Russian. Copies to be obtained through the national standards organizations
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BRIEF HISTORY
The 1SO Recommendation R 595, Syringes for Medical Use, was drawn up by
Technical Committee ISO/TC 84, Syringes ,for Medical Use and Needles for Injections,
the Secretariat of which is held by the Association Française de Nornialisation (AFNOR).
Work on this question by the Technical Committee began in 1957 and led, in 1963,
to the adoption of a Draft IS0 Recommendation.
In September 1964, this Draft IS0 Recommendation (No. 740) was circulated to all
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the IS0 Member Bodies for enquiry. It was approved, subject to a few modifications of
an editorial nature, by the following Member Bodies:
Argentina Greece Republic of
Bulgaria Hungary South Africa
Canada Ireland Spain
Chile Israel Sweden
Czechoslovakia Korea, Rep. of Switzerland
Denmark Netherlands Turkey
France New Zealand U.A.R.
Germ an y Poland Yugoslavia
One Member Body opposed the approval of the Draft:
United Kingdom.
The Draft IS0 Recommendation was then submitted by correspondence to the IS0
Council, which decided, in July 1967, to accept it as an IS0 RECOMMENDATION.
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IS0 / R 595 - 1967 (E)
IS0 Recommendation R 595 July 1967
SYRINGES FOR MEDICAL USE
INTRODUCTION
This IS0 Recommendation relates to syringes for general use in medicine and specifies essential
requirements for capacity, graduation and basic dimensions.
Requirements for certain performance characteristics, notably for a test for leakage past the
piston, have been deferred in order to effect early issue of this IS0 Recommendation.
1. SCOPE
This 1SO Recommendation specifies requirements for all-glass and metal-and-glass syringes of
graduated capacity from 1 ml up to 100 ml for general use.
It does not cover insulin syringes and syringes made of plastics materials although certain require-
ments will apply equally to syringes of these types.
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1. The term all-glass syringe relates to syringes with a barrel and piston made entirely of glass,
with the nozzle either of glass or of metal, or of any other material. The term metal-and-glass
syringe relates to syringes with a glass barrel, a metal nozzle, and a piston which may be
either metal or partially metal.
2. IS0 Recommendation R 596, Hypodermic Needles, deals with hypodermic needles suitable
for use with syringes complying with the requirements of this IS0 Recommendation.
2. DETERMINATION OF CAF'ACXY
The capacity corresponding to any scale interval is determined by the volume of water at 20 "C
expelled from the syringe when the fiducial line of the piston traverses that interval.
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IS0 / R 595 - 1967 (E)
3. TOLERANCES ON THE GRADUATED CAPACITY
The admissible tolerances on the graduated capacity are given in Table 1, page 8.
4. RANGE OF SIZES
Syringes should be designated by their graduated capacity. The range of sizes of syringes should
be as given in Table 1, page 8.
5. DIMENSIONS
The dimensions of all-glass syringes are given in Table 2, page 9. The dimensions of metal-
and-glass syringes are given in Table 3, page 9.
The dimensional characteristics of all-glass and metal-and-glass syringes are given in Figure 1,
page 11.
6. GRADUATION
6.1 Length of scale
The length of the scale should be as given in Table 1.
6.2 Position of scale
When the piston is fully inserted into the syringe, the centre of the zero graduation line of the
f 0.2 mm of the fiducial line on the piston.
scale should be within
6.3 Graduation lines
The scale should be graduated in accordance with Table 1, page 8, and Figure 2, page 12.
The graduation lines should be clearly defined, legible, durable and of uniform thickness,
and should lie in planes essentially at right angles to the axis of the barrel.
There should be no evident irregularity in the spacing of the graduation lines and they
should be evenly spaced between the zero line and the line for the graduated capacity.
When the syringe is held vertically with the conical tip uppermost and with the scale to the
front, the ends of all the graduation lines to the left of the scale should lie vertically beneath
each other.
The lengths of the long graduation lines should be greater than or equal to the values given
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in Table 1, and the short graduation lines should be approximately equal to half the length
of the long lines.
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IS0 / R 595 - 1967 (E)
6.4 Numbering of graduation lines
The graduation lines should be numbered in accordance with Figure 2. The figures should
be clearly defined, durable and easily legible.
When the syringe is held vertically with the conical tip uppermost and with the scale to the
front, the figures should appear on the right of the scale and in a position such that they
would be bisected by a prolongation of the graduation line to which they relate.
The figures should be close to, but should not touch, the ends of the graduation lines to
which they relate.
7. FIDUCIAL LINE OF PISTON
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The end of the piston which enters the barrel of the syringe should have a clearly defined line
to serve as a fiducial line for
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