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This part of EN ISO 1135 specifies requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only.
The materials and the components of the sets are validated by various test methods.
The manufacturer shall select appropriate test methods to comply with the requirements laid down in this part of EN ISO 1135.
Secondary aims of this part of EN ISO 1135 are to provide
a) specifications relating to the quality and performance of materials used in transfusion equipment;
b) a unified presentation of terms and designations for such equipment.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of EN ISO 1135.
Reģistrācijas numurs (WIID)
59082
Darbības sfēra
This part of EN ISO 1135 specifies requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only.
The materials and the components of the sets are validated by various test methods.
The manufacturer shall select appropriate test methods to comply with the requirements laid down in this part of EN ISO 1135.
Secondary aims of this part of EN ISO 1135 are to provide
a) specifications relating to the quality and performance of materials used in transfusion equipment;
b) a unified presentation of terms and designations for such equipment.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of EN ISO 1135.
