ISO 15010 pdf download.Disposable hanging devices for transfusion and infusion bottles — Requirements and test methods
1 Scope
This International Standard specifies requirements for hanging devices for transfusion bottles in accordance with ISO 1135-1 and infusion bottles in accordance with ISO 8536-1 . The hanging devices are intended for single use only. The purpose of this International Standard is to establish a safe hanging device for transfusion and infusion bottles during administering of their contents.
2 Normative 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 International 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 1 1 35-1 :1 987, Transfusion equipment for medical use — Part 1 : Glass transfusion bottles, closures and caps. ISO 2768-1 :1 989, General tolerances — Part 1 : Tolerances for linear and angular dimensions without individual tolerance indications. ISO 8536-1 :1 991 , Infusion equipment for medical use — Part 1 : Infusion glass bottles.
3 Designation code and test weights
Disposable hanging devices in accordance with the requirements of this International Standard are designated by the description block, followed by a reference to this International Standard, followed by the designation code as specified in table 1. For example, a hanging device for an infusion bottle in accordance with ISO 8536-1 of nominal capacity 50 ml is designated as follows:
4 Material
Materials selected for the hanging device shall ensure that all requirements given in clause 5 can be met. The materials shall retain their characteristics when exposed to ultraviolet light or disinfection procedures.
5 Requirements
5.1 Assembly resistance The disposable hanging device shall not be damaged by a single dismantling and renewed installation. After such manipulation it shall still pass the tests specified in 6.1 and 6.2. 5.2 Gravitational loading When tested in accordance with 6.1, the disposable hanging device shall not detach from the infusion bottle. It shall not be damaged by the test. 5.3 Permanent loading When tested in accordance with 6.2, the disposable hanging device shall prevent the transfusion or infusion bottle from falling. 5.4 Surface quality The surface shall be clean and shall not possess sharp edges or burrs. 5.5 Design The disposable hanging device shall be designed to ensure that the transfusion or infusion bottle hangs upside down.
6 Testing
6.1 Gravitational test Attach the disposable hanging device, fitted with a filled infusion bottle in accordance with ISO 8536-1, to the curve of the test hook (see figure 1). Attach one end of a cord to the upper part of the hook, and the other end to a separate fixed point. Hold the hanging device and hook level with the fixed point and drop the assemblage such that the cord breaks the fall with the hanging device at a vertical distance of 30 cm from the fixed point. The test is regarded as passed if the hanging device has met the requirements specified in 5.2. 6.2 Permanent loading test Using a hook of diameter 4 mm, e. g. in accordance with figure 1, load the disposable hanging device for 24 h at (23 ± 2) °C and (50 ± 3) % relative humidity with a test weight in accordance with table 1. The test is regarded as passed if, after this exposure, the hanging device has met the requirements specified in 5.3.