YY/T 0708-2009Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems (English PDF)

Foreword

This Collateral Standard is identical to IEC 60601-1-4:2000 "Medical electrical equipment - Part 1-4.General requirements for safety - Collateral Standard. Programmable electrical medical systems".

This Collateral Standard is a Collateral Standard of the General Standard GB 9706.1-2007 "Medical electrical equipment - Part 1: General requirements for safety" (IEC 60601-1:1988, IDT).

Annex AAA of this Collateral Standard is a normative annex. Annex BBB, annex CCC, annex DDD, annex EEE, annex FFF are all informative annexes.

1 Scope of application, object and relationship to other standards

A requirement in a Particular Standard takes priority over the corresponding requirement in this Collateral Standard.

6 Identification, marking and documents

Information pertaining to any specific EQUIPMENT that software is intended to be used in conjunction with, and a means by which the MANUFACTURER can be contacted, can be located on the package or in the INSTRUCTIONS FOR USE so that it is available to the USER independently of the software operation.

52 Abnormal operation and fault conditions

The leader of the team carrying out the VALIDATION shall be independent of the design team. Compliance is checked by inspection of the RISK MANAGEMENT FILE. Annex AAA (Normative)

Terminology - Index of defined terms With current technology there is no definitive way to determine what processes are appropriate for any particular case. Users of the standard should use their best judgement, based on what is reasonably practicable and taking account of the ALARP principle. […]