ISO 8536-1-2011 pdf free.Infusion equipment for medical use -Part 1: Infusion glass bottles.
This part of ISO 8536 specifies the dimensions, performance and requirements of infusion glass bottles necessary to ensure functional interchangeability. It is applicable only to infusion bottles for single use.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 719:1985, Glass — Hydrolytic resistance of glass grains at 98 °C — Method of test and classification ISO 720:1985, Glass — Hydrolytic resistance of glass grains at 121 °C — Method of test and classification
ISO 4802-1 :2010, Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification
ISO 4802-2:2010, Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification
ISO 7458, Glass containers — Internal pressure resistance — Test methods
ISO 7459, Glass containers — Thermal shock resistance and thermal shock endurance — Test methods
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4802-1 and ISO 4802-2 apply.
4 Dimensions
The dimensions of the infusion glass bottle shall meet the requirements of Figure 1 and Tables 1, 2 and 3.
5 Designation
5.1 General
An infusion glass bottle for medical use compiying witfl me requirements laid aown in tnis part of ISO 8536 is designated using the descriptor infusion bottle followed by, in the order given, a reference to this part of Iso 8536, the model of the infusion bottle, the nominal capacity, the colour and the hydrolytic resistance container dass (see 8.1).
EXAMPLE 1 An infusion bottle (model A) with a nominal capacity of 500 ml. made of colourless glass (Cl) of hydrolytic resistance container class HC 2 complying with the requirements laid down in this part of ISO 8536 is designated as follows:
Infusion bottle ISO 8536-1 — A — 500 — cI — HC 2
EXAMPLE 2 An infusion bottle (model C) with a nominal capadty of 500 ml, made of colourless glass (ci) of hydrolytic resistance container class HC 2 complying with the requirements laid down in this part of ISO 8536 is designated as follows:
Infusion bottle ISO 8536-1 — C — 500 — cI — HC 2
5.2 Location of designation marks
The designation marks on the bottom, as specified in Figure 1 a). may also be fixed at the body of the bottle but not at the cylindrical part. The manufacturer’s code can also be placed at the shoulder of the bottle. If marked at the lower bottom radius, r2, or at the shoulder. r3, the diameter at these places should not exceed the diameter. d1. of the bottle. The designation of hydrolytic resistance container class is abbreviated as given in 9.1.
6 Material
Infusion bottles shall be constructed from
a) colourless (cl)or amber (br) borosilicate glass (see ISO 4802-1:2010, 3.6, and ISO 4802-2:2010, 3.6). or
b) soda-lime-silica glass (see ISO 4802-1:2010, 3.7, and ISO 4802-2:2010, 3.7) of the following hydrolytic resistance grain class:
– ISO 720 — HGA 1;
– IS0 719—HGB3orISO72O—HGA2.
A change in the composition of the glass material or of the colouring oxides shall be notified to the user at least nine months in advance.ISO 8536-1 pdf download.
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