Codes et normes - Achat
CAN/CSA-Z9919-94 (R2004)
Pulse Oximeters for Medical Use - Requirements (Adopted ISO 9919:1992)
SKU: 2409891
Publié par CSA Group
Année de publication 1994
Confirmé(e) en 2004
16 pages
Withdrawn
détails du produit
Preface
ISO 9919 is one of a series of International Standards based on IEC 601-1; in IEC 601-1 (the General Standard), this type of International Standard is referred to as a Particular Standard. As stated in 1.3 of IEC 601-1:1988, the requirements of this International Standard take precedence over those of IEC 601-1.
The scope and object given in clause 1 of IEC 601-1:1988 apply except that 1.1 shall be replaced by the following:
This International Standard specifies requirements for the safety of pulse oximeters, as defined in 1.3.12, intended for use in the approximate measurement of the saturation of human arterial haemoglobin, non-invasively.
The field of application includes, but is not limited to
(a) perioperative use;
(b) adult critical care application;
(c) paediatric and neonatal applications;
(d) general determination of saturation on hospitalized and non- hospitalized patients.
Pulse oximeters intended for use in laboratory research applications and bench-type oximeters that require a blood sample from the patient are outside the scope of this International Standard.
ISO 9919 is one of a series of International Standards based on IEC 601-1; in IEC 601-1 (the General Standard), this type of International Standard is referred to as a Particular Standard. As stated in 1.3 of IEC 601-1:1988, the requirements of this International Standard take precedence over those of IEC 601-1.
The scope and object given in clause 1 of IEC 601-1:1988 apply except that 1.1 shall be replaced by the following:
This International Standard specifies requirements for the safety of pulse oximeters, as defined in 1.3.12, intended for use in the approximate measurement of the saturation of human arterial haemoglobin, non-invasively.
The field of application includes, but is not limited to
(a) perioperative use;
(b) adult critical care application;
(c) paediatric and neonatal applications;
(d) general determination of saturation on hospitalized and non- hospitalized patients.
Pulse oximeters intended for use in laboratory research applications and bench-type oximeters that require a blood sample from the patient are outside the scope of this International Standard.