YY/T 0316-2016 PDF English
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| YY/T 0316-2016 | English | 405 |
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Medical devices - Application of risk management to medical devices
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| YY/T 0316-2008 | English | RFQ |
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Medical devices. Application of risk management to medical devices
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| YY/T 0316-2003 | English | RFQ |
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Medical devices-Application of risk management to medical devices
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| YY/T 0316-2000 | English | 679 |
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Medical devices. Risk management. Part 1: Application of risk analysis
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YY/T 0316-2016: Medical devices - Application of risk management to medical devices---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0316-2016
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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