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YY/T 0869.1-2016: Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
Status: Valid YY/T 0869.1: Evolution and historical versions
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| YY/T 0869.1-2016 | English | 304 |
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Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
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YY/T 0869.1-2016
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| YY/T 0869-2013 | English | 559 |
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Medical devices. Coding structure for adverse event type and cause
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YY/T 0869-2013
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Basic data | Standard ID | YY/T 0869.1-2016 (YY/T0869.1-2016) | | Description (Translated English) | Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C30 | | Classification of International Standard | 03.120.10; 11.040.01 | | Word Count Estimation | 16,136 | | Date of Issue | 2016-01-26 | | Date of Implementation | 2017-01-01 | | Older Standard (superseded by this standard) | YY/T 0869-2013 | | Adopted Standard | ISO/TS 19218-1-2011, IDT | | Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the requirements for describing the hierarchical coding structure of adverse events associated with medical devices. This code is intended for use by medical device users, manufacturers, regulators, medical establishments, and other organizations. Coding may be used to encode events that are not related to death or serious injury, or to code that could cause death or serious injury. This standard is not intended to determine whether an incident needs to be reported. | YY/T 0869.1-2016: Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
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Medical devices.Hierarchical coding structure for adverse events.Part 1. Event-type codes
ICS 03.120.10; 11.040.01
C30
People's Republic of China Pharmaceutical Industry Standard
Part of the replacement YY/T 0869-2013
Classification of Medical Device Adverse Event
Part 1. Event Type Encoding
Medicaldevices-Hierarchicalcoding structures foradverseevents-
Part 1. Event-typecodes
(ISO /T S19218-1..2011, IDT)
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Directory
Preface III
Introduction IV
1 Scope 1
2 terms and definitions
3 Adverse Event Type Encoding Requirements 1
4 Adverse Event Type Code 2
Appendix A (informative) Encoding system structure 10
Appendix B (informative) Event Type Code Selection Example 11
Reference 12
Foreword
YY/T 0869 "Medical device adverse event classification coding structure", by the following components.
Part 1. Event type encoding;
Part 2. Evaluation code.
This part is part 1 of YY/T 0869.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part together with YY/T 0869.2-2016 instead of YY/T 0869-2013 "medical device adverse event type and cause of the series
Code structure ", this part and YY/T 0869-2013 compared to the main changes are as follows.
--- modified the "preface";
--- modified "Introduction";
- the terms "permanent damage" and "permanent damage" are removed;
- the term "intended use" has been added;
--- modified the "bad event type code" content;
--- delete the "bad event cause code" content;
--- modified "Table 1 bad event type encoding" content;
--- "Appendix A" is modified to "Coding system structure";
--- "Appendix B" is modified to "Event Type Code Selection Example";
--- modified the "reference".
This part uses the translation method equivalent to ISO /T S19218-1..2011 "Medical device adverse event classification coding structure Part 1
Points. event type encoding "(English version).
Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents.
This section is proposed by the State Food and Drug Administration.
This part of the National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC221) centralized.
This part of the drafting unit. Beijing Guoya Huaguang Certification Co., Ltd.
This part of the main drafters. Milan British, Zheng Yi Han, Chen Zhigang.
This part of the previous version of the standard to replace the release of the situation.
--- YY/T 0869-2013.
Introduction
YY/T 0869 In this section, the adverse event coding system envisages a medical device adverse event report originating from one of two sources.
Related equipment users or manufacturers. In this section, the user may be a medical service person, but may also be the general public. by
YY/T 0869 provides the structure of this part, the type of adverse events can be used in the post-marketing stage to collect medical equipment supervision information. use
The common code also makes it easy for the information to be exchanged internationally.
This part of YY/T 0869 may be used by the user, manufacturer and regulatory authority in the following manner.
- users can report to manufacturers or regulators, using a code to describe the general understanding of the adverse events;
--- Manufacturers and regulators are easy to identify generally accepted types of adverse events that can be obtained globally by regulators
Recognition;
- Users and manufacturers can also apply these codes as part of a medical device monitoring or reporting system.
Classification of Medical Device Adverse Event
Part 1. Event Type Encoding
1 Scope
This part of YY/T 0869 specifies the requirements for describing the hierarchical coding structure of adverse events related to medical devices. This code prepares
Period is used by medical device users, manufacturers, regulators, medical institutions and other organizations. Coding may be used to fight with death or serious
Injury-related events, or to faults that may cause death or serious injury.
This section is not intended to determine whether an incident needs to be reported.
2 terms and definitions
The following terms and definitions apply to this document.
2.1
Adverse event
With a medical device that causes the patient, the user or other person to die or cause serious injury, or if the reproduction may result in the patient,
Or other person's death or serious injury.
Note 1. This definition is consistent with the guidelines in GHTF/SG2/N54/R8..2006 [7].
NOTE 2 This definition includes equipment failure or performance degradation that has not caused death or serious injury but may lead to death or serious injury.
2.2
Serious injury seriousinjury
Including life-threatening illness or injury, or permanent damage to human body function or permanent damage to human structure, or medical or external
Branch dry to prevent the permanent damage to the human body function or the permanent deterioration of the permanent damage to the human body structure.
Note 1. The term "permanent" means an unrecoverable injury or damage to a human body structure or function, with the exception of minor damage or damage.
Note 2. This definition is consistent with the guidelines in GHTF/SG2/N21/R8..1999 [5].
2.3
Intended use
Expected purpose
An objective description of the manufacturer's use of the product is embodied in the manufacturer's specifications, instructions or information.
Note. This definition is consistent with GHTF/SG1/N41/R9..2005 [4].
3 Adverse event type encoding requirements
The adverse event type encoding describes the use/failure/failure characteristics of the medical device observed at the time of the event. The code should be selected from
Table 4 of the four-digit code.
Note 1. A single code that is closest to the depicted adverse event can be used. However, sometimes in order to fully represent an adverse event may need to use multiple coding.
Note 2. Adverse event type coding is useful for describing the dangers of an adverse event. It may also be useful in the User Reporting System.
When combined with adverse event evaluation codes (from YY/T 0869.2), the characteristics of adverse events can be better expressed.
Note 3. Selection of adverse event type codes to describe adverse events at the time of the incident, reflecting the latest assessment of adverse events and taking into account the occurrence of the incident and
The report submits any additional information obtained during this time.
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