GB 9706.15-2008 Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems
This part applies to the safety of MEDICAL ELECTRICAL SYSTEMS, as defined in 2.201. It describes the safety requirements necessary to provide protection for the PATIENT, the OPERATOR and surroundings.
2 Terms and definitions
In this COLLATERAL STANDARD, terms printed in small capitals are used in accordance with their definitions in GB 9706.1.
Where the terms "voltage" and "current" are used, they mean the r.m.s. values of an alternating, direct or composite voltage or current.
For the purpose of this part the following additional definitions apply:
2.201
MEDICAL ELECTRICAL SYSTEM (hereinafter referred to as SYSTEM)
combination of items of equipment, at least one of which must be MEDICAL ELECTRICAL EQUIPMENT and inter-connected by FUNCTIONAL CONNECTION or use of a MULTIPLE PORTABLE SOCKET-OUTLET
Note: Equipment, when mentioned in connection with a SYSTEM, shall be taken to include EQUIPMENT. (See also examples given in Annexes BBB and FFF.)
2.202*
PATIENT ENVIRONMENT
any volume in which intentional or unintentional contact can occur between PATIENT and parts of the SYSTEM or between PATIENT and other persons touching parts of the SYSTEM (see Figure 201)
2.203*
SEPARATION DEVICE
a component or arrangement of components with input parts and output parts that, for safety reasons, prevent a transfer of unwanted voltage or current between parts of a SYSTEM
2.204*
MULTIPLE PORTABLE SOCKET-OUTLET
a combination of two or more socket-outlets intended to be connected to, or integral with, flexible cables or cords, and which can easily be moved from one place to another while connected to the supply
Note: A MULTIPLE PORTABLE SOCKET-OUTLET may be a separate item or an integral part of medical or non-medical equipment.
2.205*
FUNCTIONAL CONNECTION
connection, electrical or otherwise, including those intended to transfer signals and/or power and/or substances
3 General requirements
3.201* General requirements for the SYSTEM
After installation or subsequent modification, a SYSTEM shall not cause a SAFETY HAZARD.
A SYSTEM shall provide:
——within the PATIENT ENVIRONMENT, a level of safety comparable to that provided by MEDICAL ELECTRICAL EQUIPMENT complying with GB 9706.1, and
——outside the PATIENT ENVIRONMENT, the level of safety appropriate for non-medical electrical equipment complying with other IEC or ISO safety standards.
Compliance is considered to exist if the requirements of 3.201.1, 3.201.2, 3.201.3 and 3.201.4 are met. A SYSTEM incorporating equipment or parts, which use materials or have forms of construction different from those detailed in relevant standards as mentioned in 3.201.1 and 3.201.2, shall be accepted if it can be demonstrated that an equivalent degree of safety is obtained.
3.201.1 Medical electrical equipment
MEDICAL ELECTRICAL EQUIPMENT shall comply with the requirements of GB 9706.1 and its relevant particular standards.
Compliance is checked by inspection of appropriate documents or certificates.
3.201.2 Non-medical electrical equipment
Non-medical electrical equipment shall comply with IEC and ISO safety standards that are relevant to that equipment. See also Annex DDD.
