The requirements of this Standard are applicable to all stages of the life-cycle of a medical device.

This Standard does not apply to clinical decision making.

This Standard does not specify acceptable risk levels.

This Standard does not require that the manufacturer have a quality management system in place.

However, risk management can be an integral part of a quality management system.

NOTE: The International Standard corresponding to this Standard and the symbol of degree of correspondence are as follows.

ISO 14971: 2007 Medical devices-Application of risk management to medical devices (IDT)

In addition, symbols which denote the degree of correspondence in the contents between the relevant International Standard and JIS are IDT (identical), MOD (modified), and NEQ (not equivalent) according to ISO/IEC Guide 21-1.

Furthermore, JIS T 14971: 2003 is applicable until 28 February 2015.

This Standard does not cover multiple taps and cord connector bodies, and hospital grade outlet-sockets and plugs for special service such as floor mount type, waterproof type and explosion proof type.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so.

If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this Standard are not covered by specific requirements in this Standard except in 7.2.13 and 8.4.1.

NOTE 1 See also 4.2.

This Standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability.

In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series.

This Standard does not apply to the implantable parts of active implantable medical devices covered by the ISO 14708-1 series.

NOTE 2 The International Standards corresponding to this Standard and the symbol of degree of correspondence are as follows.

NOTE: The International Standard corresponding to this Standard and the symbol of degree of correspondence are as follows.

IEC 60601-1-2: 2001 Medical electrical equipment-Part 1-2: General requirements for safety-Collateral standard: Electromagnetic compatibility- Requirements and tests and Amendment 1: 2004 (lDT)

In addition, symbols which denote the degree of correspondence in the contents between the relevant International Standard and JIS are IDT (identical), MOD (modified), and NEQ (not equivalent) according to ISO/IEC Guide 21-1.