draft amendment to mexican official standard nom-015-ssa1-1993 establishing sanitary specifications for needleless transfusion equipment with filter 37 pages in spanish . 6. this draft mexican official standard establishes the minimum operating and safety standards for needleless transfusion equipment with filter used by the medical services in mexico for administering blood or blood components as well as the test methods for checking the equipment. the purpose of this draft mexican official standard is to minimize during the administration of blood or blood component the risks of -contamination -gaseous embolism -interaction between the administering equipment and the fluids passing through it -the potential release of harmful substances from the materials used to manufacture the equipment and their transfer into the bloodstream. this draft mexican official standard must be observed in all of the industries laboratories and establishments engaged in the manufacturing of this product in mexico and shall apply in respect of the product to the purchase inclusion reception inspection complaints sampling and supply processes without undermining such other activities as may be carried out by the health authorities. description of content contd the tests provided for in this draft relating to systematic and intracutaneous injections the identification of materials used to manufacture the transporting tube the haemolytic index heavy metals and acidity and alkalinity limits do not necessarily have to be carried out as a matter of routine provided that the manufacturers do not make significant changes to the manufacturing process or to the raw materials used when the product was approved in accordance with the product records and validation studies so that the manufacturers suppliers or distributors must provide the corresponding quality certificates issued by accredited laboratories. pursuant to this draft purchasers shall be entitled to carry out all of the tests on a particular batch as they deem necessary or to conduct the mentioned tests as and when they decide. this standard is partially equivalent to international standard iso 1135-4 transfusion equipment for medical use part 4 transfusion sets for single use