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1.1 General This Technical Report provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. This...

IEC 60601-1:1988, Clause 1 applies, except as follows. Amendment (add at the end of the Subclause 1.1): This part of ISO 17510 specifies requirements for equipment intended for sleep apnoea breathing therapy for domiciliary...

This part of ISO 17510 applies to masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any...

1.1 This part of ISO 10524 applies to pressure regulators integrated with cylinder valves (as defined in 3.16) intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of...

This part of ISO 9360 is based on ISO 9360-1:2000 and specifies certain requirements and test methods for heat and moisture exchangers (HMEs) without machine connector ports, including those incorporating breathing system...

This part of ISO 9360 specifies certain requirements for heat and moisture exchangers (HMEs), including those incorporating breathing system filters, intended for the humidification of respired gases for use primarily with...

This part of ISO 10651 specifies the basic safety and essential performance requirements for gas-powered emergency resuscitators (3.10) intended for use with humans by first responders. This equipment is intended for...

This technical report describes the electromagnetic disturbance phenomena of voltage dips and short interruptions in terms of their sources, effects, remedial measures, methods of measurement, and measurement results (in so...

This part of IEC 61347 specifies particular safety requirements for electronic ballasts for use on a.c. supplies up to 1 000 V at 50 Hz or 60 Hz with operating frequencies deviating from the supply frequency, associated with...

This Technical Report (TR) provides: - a description of the ISO/IEC 8802-2 LLC addressing conventions, and - the consideration for the manner in which new LLC address uses are assigned a value. It is outside the scope of this...

This technical report recommends the procedures to assess the disturbance levels produced by the emission of the devices, equipment and systems installed in non-public networks in industrial environment as far as the low...

This part of ISO/IEC 23008-3 specifies technology which supports the efficient transmission of 3D audio signals and flexible rendering for the playback of 3D audio in a wide variety of listening scenarios. These include 3D...