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National Health Act, 2003 (Act No. 61 of 2003)


Regulations Norms and Standards Regulations Applicable to Different Categories of Health Establishments, 2017

Definitions, Purpose and Application

1. Definitions


"building regulations"

means the building regulations issued in terms of any of the following legislation or regulations—

(a) National Building Regulations and Buildings Standards Act, 1977 (Act No. 103 of 1977); or
(b) Regulation Governing Private Hospitals and Unattached Operating Theatre Units, published in Government Gazette, Notice No. R. 158 of 1 February 1980; or
(c) Regulation Governing Private Health Establishments, Western Cape, published in Provincial Gazette Extraordinary 5728, Provincial Notice No. 187 of 22 June 2001;



means any health establishment that provides mainly outpatient services to the community;


"clinical risk"

means the likelihood that an adverse incident will cause injury or harm to users;


"Community Health Centre (CHC)"

means any health establishment that provides mainly outpatient services and short stay to the community;



means any source of potential damage, harm, adverse health effects on users or health care personnel, or any threat to their safety;


"health record"

means any record made by a health care provider, at the time of or shortly after seeing the user, upon examination or treatment, that contains information about the health of the user and includes any results of diagnostic investigations performed on the user and is recorded by a health care provider, either personally or under his or her direction;



means the executive management and all heads of departments, including clinical and non -clinical service areas of a health establishment;


"medical equipment"

means any instrument, apparatus or machine, intended for use in the clinical diagnosis, treatment, monitoring and direct care of users that needs to be calibrated, maintained, repaired and decommissioned;


"medical supplies"

means products and devices other than medicines that are used for therapeutic purposes;


"national department"

means the national department responsible for health;


"Pharmacy Act"

means the Pharmacy Act, 1974 (Act No. 53 of 1974);


"responsible authority"

means a sub-district, district or management of a private health care establishment that provides supervisory support to the health establishment;


"security threats and risks"

means any criminal activity or threat of a potential criminal activity on the property, health care personnel or users in the health establishment including theft, assault, abuse and injury; and



means a designated team, committee or forum.