ISO 16201:2006 PDF

Scope: This International Standard specifies functional and technical requirements and test methods for environmental control systems intended for use to alleviate or compensate for a disability. The aim of this International Standard is to provide safety requirements and recommendations for manufacturers of such environmental control systems. Target devices are not covered by this International Standard. Technical requirements for items of equipment connected within the system are to be covered by their own specific standards, e.g. adjustable beds.

ISO 16201:2006 Referenced Document

EN 55011 Industrial, scientific and medical equipment - Radio-frequency disturbance characteristics - limits and methods of measurement
IEC 60529 Degrees of Protection Provided by Enclosures (IP Code) (Edition 2.1 ***Applies to French text only***)*， 2024-04-18 Update
IEC 60601-1 Medical electrical equipment - ALL PARTS*， 2015-01-20 Update
IEC 60601-1-1 Medical electrical equipment - Part 1-1: General requirements for safety; Collateral standard: Safety requirements for medical electrical systems
ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update

2006 ISO 16201:2006 Technical aids for persons with disability - Environmental control systems for daily living