YY 0709-2009Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems (English PDF)

Foreword

All technical contents of this collateral standard are mandatory.

The serial standards on the safety of Medical Electrical Equipment consist of the following two Parts.

--- Part 1: General Requirements for Safety;

--- Part 2: Particular Requirements for Safety.

Thereof, the Part 1 also includes other standards besides this collateral standard.

--- GB 9706.1 Medical Electrical Equipment--Part 1: General Requirements for Safety;

--- YY 0505 Medical Electrical Equipment-Part 1-2.General Requirements for Safety-Collateral Standards. Electromagnetic Compatibility-Requirements and Tests;

--- GB 9706.12 Medical Electrical Equipment - Part 1: General Requirements for Safety 3.Collateral Standard. General Requirements for Radiation Protection in Diagnostic X-Ray Equipment;

--- GB 9706.15 Medical Electrical Equipment - Part 1: General Requirements for Safety - 1.Collateral Standard. Safety Requirements for Medical Electrical Systems.

This collateral standard belongs to Part 1-8 of Medical Electrical Equipment.

This collateral standard replaced the following standards. YY 0574.1-2005 Anaesthesia and Respiratory Care Alarm Signals - Part 1: Visual Alarm Signals, YY 0574.2-2005 Anaesthesia and Respiratory Care Alarm Signals- Part 2: Auditory Alarm Signal, YY 0574.3-2005 Anaesthesia and Respiratory Care Alarm Signals - Part 3. Guidance on Application of Alarm.

This Standard equivalently adopts IEC 60601-1-8:2003 Medical Electrical Equipment - Part 1-8.General Requirements for Safety - Collateral Standard. General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems.

The major differences between this collateral standard and IEC 60601-1-8 are as follows.

--- For other international standards referenced in this Standard, if they have been converted into Chinese Standard, this collateral standard shall replace the referenced international standards number with the corresponding national standard number;

--- Delete the index of the term definitions;

--- Terms are indicated in bold in the text.

This collateral standard's Annexes, D and EEE are normative; while the Annexes AAA, BBB, CCC, DDD are informative.

1 Scope and Object

The object of this collateral standard is to specify basic safety and essential performance requirements and tests for ALARM SYSTEMS in MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS and to provide guidance for their application. This is accomplished by defining alarm categories (priorities) by degree of urgency, consistent ALARM SIGNALS and consistent control states and their marking for all ALARM SYSTEMS.

2 Terminology and Definitions

For the purposes of this collateral standard, the following definitions apply. 4)

NOTE: This collateral standard uses the term "equipment" to mean MEDICAL ELECTRICAL EQUIPMENT or non-MEDICAL ELECTRICAL EQUIPMENT in the context of a MEDICAL ELECTRICAL SYSTEM.

6 Identification, Marking and Documents

Additional requirements for the marking on controls and instruments are specified in this collateral standard, together with the technical requirements, giving rise to requirements on markings. These requirements are also listed in BBB.1.

201 Alarm Systems Each ALARM CONDITION shall cause the generation of visual ALARM SIGNALS as specified in this collateral standard. If deemed necessary by risk assessment regarding the environment in which the ALARM SYSTEM is intended to be used, additional ALARM SIGNALS shall be generated. […]