YY/T 0316-2016Medical devices-Application of risk management to medical devices (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY/T 0316-2008, Medical devices - Application of risk management to medical devices. Compared with YY/T 0316-2008, apart from editorial changes, the main technical changes are as follows:

- for consistency with GB/T 20000.4-2003, Guidelines for standardization - Part 4: Safety aspects - Guidelines for their inclusion in standards, the following terms and definitions have been revised: the terms for harm, hazard and hazardous situation and their definitions, and the definitions of residual risk, risk, risk analysis, risk assessment and safety;

- Figure 1, A schematic representation of the risk management process, has been amended in accordance with ISO 14971:2007 (corrected version of 2007-10-01).

This standard uses the translation method to adopt the corrected version of ISO 14971:2007, Medical devices - Application of risk management to medical devices, identically.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing authority shall not be held responsible for identifying any or all such patent rights.

This standard was proposed by the China Food and Drug Administration and is under the jurisdiction of the National Technical Committee on Quality Management and General Requirements for Medical Devices of Standardization Administration of China (SAC/TC 221).

Drafting organization: Beijing Huaguang Certification Co., Ltd. for Medical Devices.

Main drafters: Wang Huifang, Zheng Yihan, Mi Lanying, Chen Zhigang.

The previous editions replaced by this standard are: YY/T 0316-2000, YY/T 0316-2003 and YY/T 0316-2008.

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.

2 Terms and definitions

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

2.2 harm: physical injury or damage to the health of people, or damage to property or the environment.

5 Risk evaluation

For each identified hazardous situation, the manufacturer shall decide, using the criteria defined in the risk management plan, if risk reduction is required. If risk reduction is not required, the requirements given in 6.2 to 6.6 do not apply for this hazardous situation (i.e., proceed to 6.7).

7 Evaluation of overall residual risk acceptability

After all risk control measures have been implemented and verified, the manufacturer shall decide if the overall residual risk posed by the medical device is acceptable using the criteria defined in the risk management plan.

8 Risk management report

Prior to release for commercial distribution of the medical device, the manufacturer shall carry out a review of the risk management process.

9 Production and post-production information

The manufacturer shall establish, document and maintain a system to collect and review information about the medical device or similar devices in the production and the post-production phases.