YY/T 0316-2008Medical devices - Application of risk management to medical devices (English PDF)

Foreword

This document was issued on 25 April 2008 by the State Food and Drug Administration, and applied from 1 December 2009.

It has been superseded by YY/T 0316-2016, Medical devices - Application of risk management to medical devices.

It is a YY/T standard: a recommended industry standard of China's pharmaceutical and medical device sector.

1 Scope

This standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

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.

2 Terms and definitions

For the purposes of this standard, the following terms and definitions apply.

2.1 accompanying document: document accompanying a medical device and containing information for those accountable for the installation, use and maintenance of the medical device, the operator or the user, particularly regarding safety (adapted from IEC 60601-1:2005, definition 3.4)

2.2 harm: physical injury or damage to the health of people, or damage to property or the environment [ISO/IEC Guide 51:1999, definition 3.3]

2.3 hazard: potential source of harm [ISO/IEC Guide 51:1999, definition 3.5]

2.4 hazardous situation: circumstance in which people, property or the environment are exposed to one or more hazards [ISO/IEC Guide 51:1999, definition 3.6]

Note: See Annex E for an explanation of the relationship between hazard and hazardous situation.

2.5 intended use; intended purpose: use for which a product, process or service is intended according to the specifications, instructions and information provided by the manufacturer

2.6 in vitro diagnostic medical device; IVD medical device: medical device intended by the manufacturer for the examination of specimens derived from the human body to provide information for diagnostic, monitoring or compatibility purposes, for example reagents, calibrators, specimen collection and storage devices, control materials and related instruments, apparatus or articles

2.7 life cycle: all phases in the life of a medical device, from the initial conception to final decommissioning and disposal

2.8 manufacturer: natural or legal person with responsibility for the design, manufacture, packaging or labelling of a medical device, assembling a system, or adapting a medical device before it is placed on the market or put into service, regardless of whether these operations are carried out by that person or on that person's behalf by a third party

Note: Attention is drawn to the fact that the provisions of national or regional regulations can apply to the definition of manufacturer. For a definition of labelling, see ISO 13485:2003, definition 3.6.

2.9 medical device: any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury; investigation, replacement, modification or support of the anatomy or of a physiological process; supporting or sustaining life; control of conception; disinfection of medical devices; providing information for medical purposes by means of in vitro examination of specimens derived from the human body; and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means