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YY/T 0869.1-2016Medical devices - Hierarchical coding structure for adverse events - Part 1: Event type codes (English PDF)

医疗器械不良事件分级编码结构第1部分：事件类型编码

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 26, 2016

Implementation date

January 1, 2017

Scope

YY/T 0869.1-2016 is the English-translated version of 医疗器械不良事件分级编码结构第1部分：事件类型编码.

YY/T 0869.1-2016 is the Chinese standard "Medical devices - Hierarchical coding structure for adverse events - Part 1: Event type codes". Its scope clause reads: 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. Its clauses include terms and definitions; adverse event type encoding requirements.

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Document preview — YY/T 0869.1-2016

National Standard of the People's Republic of China

ICS: 03.120.10; 11.040.01
Classification: C30
Replacing: YY/T 0869-2013

Issued by: National Medical Products Administration

Preface
Introduction
1 Scope
2 terms and definitions
3 Adverse Event Type Encoding Requirements
4 Adverse Event Type Code
Appendix A (informative) Encoding system structure
Appendix B (informative) Event Type Code Selection Example

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

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.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 27 pages — is available in the English PDF.

Editions of YY/T 0869.1

Edition	Title	Revision	Status
YY/T 0869.1-2016	Medical devices - Hierarchical coding structure for adverse events - Part 1: Event type codes	current edition	Current
YY/T 0869-2013	Medical devices - Hierarchical coding structure for adverse events - Part 1: Event type codes	previous edition	In force until 2017-01-01

This page sells the current edition, YY/T 0869.1-2016. Earlier editions are listed for reference only.

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