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YY/T 0316-2016 PDF English

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YY/T 0316-2016: Medical devices - Application of risk management to medical devices
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YY/T 0316: Historical versions

Standard IDUSDBUY PDFDeliveryStandard Title (Description)Status
YY/T 0316-2016405 Add to Cart Auto, 9 seconds. Medical devices - Application of risk management to medical devices Valid
YY/T 0316-2008RFQ ASK 7 days Medical devices. Application of risk management to medical devices Obsolete
YY/T 0316-2003RFQ ASK 4 days Medical devices-Application of risk management to medical devices Obsolete
YY/T 0316-2000679 Add to Cart 3 days Medical devices. Risk management. Part 1: Application of risk analysis Obsolete

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YY/T 0316-2016: Medical devices - Application of risk management to medical devices

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YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.01 C 30 YY/T 0316-2016 / ISO 14971.2007 corrected version Replacing YY/T 0316-2008 Medical devices - Application of risk management to medical devices (ISO 14971.2007 corrected version, IDT) Issued on. JANUARY 26, 2016 Implemented on. JANUARY 01, 2017 Issued by. China Food and Drug Administration

Table of Contents

Foreword... 4 Introduction... 6 1 Scope... 8 2 Terms and definitions... 8 3 General requirements for risk management... 15 3.1 Risk management process... 15 3.2 Management responsibilities... 16 3.3 Qualification of personnel... 17 3.4 Risk management plan... 17 3.5 Risk management file... 18 4 Risk analysis... 19 4.1 Risk analysis process... 19 4.2 Intended use and identification of characteristics related to the safety of the medical device... 20 4.3 Identification of hazards (sources)... 20 4.4 Estimation of the risk(s) for each hazardous situation... 20 5 Risk evaluation... 21 6 Risk control... 22 6.1 Risk reduction... 22 6.2 Risk control option analysis... 22 6.3 Implementation of risk control measure(s)... 23 6.4 Residual risk evaluation... 23 6.5 Risk/benefit analysis... 23 6.6 Risks arising from risk control measures... 24 6.7 Completeness of risk control... 24 7 Evaluation of overall residual risk acceptability... 24 8 Risk management report... 25 9 Production and post-production information... 25 Annex A (informative) Rationale for requirements... 27 Annex B (informative) Overview of the risk management process for medical devices... 39 Annex C (informative) Questions that can be used to identify medical device characteristics that could impact on safety... 41 Annex D (informative) Risk concepts applied to medical devices... 49 Annex E (informative) Examples of hazards (sources), foreseeable sequences of events and hazardous situations... 71 Annex F (informative) Risk management plan... 77 Annex G (informative) Information on risk management techniques... 79 Annex H (informative) Guidance on risk management for in vitro diagnostic medical devices... 84 Annex I (informative) Guidance on risk analysis process for biological hazards (sources)... 104 Annex J (informative) Information for safety and information about residual risk ... 106 Bibliography... 108

Foreword

This Standard is drafted in accordance with the rules given GB/T 1.1-2009. This Standard replaces YY/T0 316-2008 “Medical devices - Application of risk management to medical devices”. Compared with YY/T 0316-2008, in addition to editorial modifications, the main technical changes are as follows. - In order to be consistent with the terms in GB/T 20000.4-2003 “Guide for standardization - Part 4.Safety aspects for their inclusion in standards”, revise the following terms and definitions. - REVISE “damage” to “harm”, and REVISE the definition; - REVISE “danger” to “hazard”, and REVISE the definition; - REVISE “dangerous situation” to “hazardous situation”, and REVISE the definition; - REVISE the definition of “residual risk"; - REVISE the definition of “risk”; - REVISE the definition of “risk analysis”; - REVISE the definition of “risk assessment”; - REVISE “safety” to “safety", and REVISE the definition. - According to ISO 14971.2007 (2007-10-01 corrected version), amend Figure 1 “A schematic representation of the risk management process”. This Standard is identical to ISO 14971.2007 “Medical devices - Application of risk management to medical devices” corrected version by translation method. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing organization of this document shall not be held responsible for identifying any or all such patent rights. This Standard is proposed by China Food and Drug Administration. This Standard is under the jurisdiction of National Technical Committee on Quality Management and Corresponding General Aspects for Medical Devices of Standardization Administration of China (SAC/TC 221). Drafting organization of this Standard. Beijing Hua Guang Certification of Medical Devices Co., Ltd. Main drafters of this Standard. Wang Huifang, Zheng Yihan, Mi Lanying, Chen Zhigang. The historical editions of the standard replaced by this Standard are as follows. - YY/T 0316-2000, YY/T 0316-2003, YY/T 0316-2008.

1 Scope

This Standard specifies a process for a manufacturer to identify the hazards (sources) 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. Physical injury or damage to the health of people, or damage to property or the environment.

3 General requirements for risk management

Persons performing risk management tasks shall have the knowledge and experience appropriate to the tasks assigned to them. These shall include, where appropriate, knowledge and experience of the particular medical device (or similar medical devices) and its use, the technologies involved or risk management techniques. Appropriate qualification records shall be maintained.

4 Risk analysis

In addition to the records required in 4.2 to 4.4, the documentation of the conduct and results of the risk analysis shall include at least the following. The manufacturer shall compile documentation on known and foreseeable hazards (sources) associated with the medical device in both normal and fault conditions.

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).

6 Risk control

The manufacturer shall identify risk control measure(s) that are appropriate for reducing the risk(s) to an acceptable level. The manufacturer shall use one or more of the following risk control options in the priority order listed. After the risk control measures are applied, any residual risk shall be evaluated using the criteria defined in the risk management plan.

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. This review shall at least ensure that.

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. When establishing a system to collect and review information about the medical device, the manufacturer should consider among other things. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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