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YY/T 0869.2-2016Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes (English PDF)

医疗器械不良事件分级编码结构第2部分：评价编码

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 26, 2016

Implementation date

January 1, 2017

Scope

YY/T 0869.2-2016 is the English-translated version of 医疗器械不良事件分级编码结构第2部分：评价编码.

YY/T 0869.2-2016 is the Chinese standard "Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes". Its scope clause reads: This part of YY/T 0869 specifies the classification of the relevant medical device adverse events in the analysis or evaluation results.

Requirements. These codes are expected to be used primarily by medical device manufacturers and regulators. Encoding is not only used to cause death or serious injury And can also be used to analyze or evaluate the results of events other than 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 evaluation code requirements.

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Document preview — YY/T 0869.2-2016

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 Evaluation Code Requirements
4 Adverse Event Evaluation Code
Appendix A (informative) Encoding system structure

1 Scope

This part of YY/T 0869 specifies the classification of the relevant medical device adverse events in the analysis or evaluation results.

Requirements. These codes are expected to be used primarily by medical device manufacturers and regulators. Encoding is not only used to cause death or serious injury

And can also be used to analyze or evaluate the results of events other than 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 [5].

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.

Note 3. This definition is not intended to determine whether an event is reported to a regulatory authority.

2.2 Serious injury

Serious deterioration of health conditions includes any of the following.

A life-threatening illness or injury, or

- permanent damage to human body function or permanent damage to human structure, or

- require medical or surgical intervention to prevent permanent damage to human body function or permanent damage to human structure.

Note 1. "permanent" here means irreversible damage or damage, except for minor damage or damage.

Note 2. This definition is consistent with the guidelines in GHTF/SG2/N54/R8..2006 [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 [6].

3 Adverse Event Evaluation Code Requirements

Adverse event evaluation codes describe the characteristics of adverse event analysis or investigation of the latest conclusions. The code shall be a five-digit number selected from Table 1 code.

Note 1. Multiple coding is necessary to fully evaluate the adverse events.

Note 2. Adverse event evaluation codes are useful for manufacturers and regulators to track reported adverse events. When combined with bad event type encoding,

The characteristics of the adverse events can be conveyed concisely.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 25 pages — is available in the English PDF.

Editions of YY/T 0869.2

Edition	Title	Revision	Status
YY/T 0869.2-2016	Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes	current edition	Current
YY/T 0869-2013	Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes	previous edition	In force until 2017-01-01

This page sells the current edition, YY/T 0869.2-2016. Earlier editions are listed for reference only.

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