ISO 15010 pdf download

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...