GB/T 42062-2022Medical devices - Application of risk management to medical devices (English PDF)

Foreword

This Document was drafted as per the rules specified in GB/T 1.1-2020 Directives for

Standardization - Part 1.Rules for the Structure and Drafting of Standardizing Documents.

This Document equivalently adopts ISO 14971.2019 Medical Devices - Application of Risk

Management to Medical Devices.

Please note some contents of this Document may involve patents. The issuing agency of this

Document shall not assume the responsibility to identify these patents.

This Document was proposed by National Medical Products Administration.

This Document shall be under the jurisdiction of National Technical Committee on Quality

Management and General Requirements for Medical Device of Standardization Administration

of China (SAC/TC 221).

Drafting organizations of this Document. Beijing Hua Guang Certification of Medical Devices

Co., Ltd.; National Institutes for Food and Drug Control; Neusoft Medical Systems Co., Ltd.;

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.; Shanghai MicroPort Medical (Group)

Co., Ltd.; Shanghai United Imaging Healthcare Co., Ltd.; Shandong Weigao Group Medical

Polymer Co., Ltd.; Contec Medical Systems Co., Ltd.; GE Hangwei Medical Systems Co., Ltd.;

Shanghai Siemens Medical Equipment Ltd.; and Lepu Medical Technology (Beijing) Co., Ltd.

Chief drafting staffs of this Document. Wang Huifang, Sun Ye, Zheng Jia, Wang Zhiqiang,

Wang Hongman, Li Yong, Wang Shumei, Liu Lina, Li Xueyong, Han Qiang, Lu Zhi, Jiang Bo,

Li Haohui, Wang Meiying, Lou Xiaodong, Li Xin, Chang Jia, Liu Rongming, Shao Yubo, Wang

Tingting, and Ai Yingying.

1 Scope

This document specifies terminology, principles and a process for risk management of medical

devices, including software as a medical device and in vitro diagnostic medical devices. The

process described in this document intends to assist manufacturers of medical devices to

identify the hazards associated with the medical device, to estimate and evaluate the associated

risks, to control these risks, and to monitor the effectiveness of the controls.

2 Normative References

There are no normative references in this Document.

3 Terms and Definitions

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

ISO and IEC maintain terminological databases for use in standardization at the following

addresses.

4 General Requirements for Risk Management System

Top management shall provide evidence of its commitment to the risk management process by

ensuring.

Risk management activities shall be planned. For the particular medical device being

considered, the manufacturer shall establish and document a risk management plan in

accordance with the risk management process. The risk management plan shall be part of the

risk management file.

5 Risk Analysis

The manufacturer shall document the intended use of the particular medical device being

considered.

For the particular medical device being considered, the manufacturer shall identify and

document those qualitative and quantitative characteristics that could affect the safety of the

medical device. Where appropriate, the manufacturer shall define limits of those characteristics.

6 Risk Evaluation

For each identified hazardous situation, the manufacturer shall evaluate the estimated risks and

determine if the risk is acceptable or not, using the criteria for risk acceptability defined in the

risk management plan.

7 Risk Control

The manufacturer shall implement the risk control measures selected in 7.1.

Implementation of each risk control measure shall be verified. This verification shall be

recorded in the risk management file.

8 Evaluation of Overall Residual Risk

After all risk control measures have been implemented and verified, the manufacturer shall

evaluate the overall residual risk posed by the medical device, taking into account the

contributions of all residual risks, in relation to the benefits of the intended use, using the

method and the criteria for acceptability of the overall residual risk defined in the risk

management plan [see 4.4 e)].

9 Risk Management Review

Prior to release for commercial distribution of the medical device, the manufacturer shall review

the execution of the risk management plan. This review shall at least ensure that.

10 Production and Post-Production Activities

The manufacturer shall review the information collected for possible relevance to safety,

especially whether.

Annex A

(Informative)

Rationale for Requirements

The ISO/TC 210 - IEC/SC 62A Joint Working Group 1 (JWG 1), Application of risk

management to medical devices, developed this rationale to document its reasoning for

establishing the various requirements contained in this document.

The second edition of ISO 14971 was developed and published in 2007 to address the need for

additional guidance on its application and on the relationship between hazards and hazardous

situations.

Annex B

(Informative)

Risk Management Process for Medical Devices

The numbering of clauses and subclauses has changed with this third edition of this Document.

Table B.1 provides the correspondence between clauses and subclauses in the YY/T 0316-2016

[9] and those in this Document.

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