Full Description

Withdrawn, with Replacement ISO 10079.1, ISO 10079.2, ISO 10079.3

1.1 This specification describes minimum safety and performance requirements for medical and surgical suction and drainage apparatus.

1.2 This specification covers apparatus to be used for:

1.2.1 Oral, nasal, tracheal (ONT) suction,

1.2.2 Gastrointestinal drainage,

1.2.3 Pleural space and mediastinal drainage,

1.2.4 Closed wound drainage, and

1.2.5 Surgical suction (including uterine aspiration).

1.2.6 This specification also covers devices powered by centrally piped vacuum systems, compressed gases, electricity, and manual operation.

1.3 This specification does not cover the following:

1.3.1 Central vacuum pumps and piping systems of vehicles and buildings,

1.3.2 Catheters, tubes, drains, curettes, and suction tips inserted into the patient,

1.3.3 Syringes,

1.3.4 Breast pumps,

1.3.5 General dentistry suction equipment,

1.3.6 Waste gas scavenging systems,

1.3.7 Laboratory suction,

1.3.8 Fetal vacuum extractor or vacuum forceps with self- contained suction,

1.3.9 Autotransfusion,

1.3.10 Cardiopulmonary bypass pumps, and

1.3.11 Urinary drainage.

1.4 The following precautionary caveat pertains only to the test method portion, Section 5, of this specification: This standard does not purport to address all of the safety problems, if any, associated with its use. It is the responsibility of the user of this standard to consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use. See 5.3.3.