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YY/T 1473-2023Guide for standardization for medical devices - Inclusion of safety aspects in standards (English PDF)

医疗器械标准化工作指南涉及安全内容的标准制定

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Issued by

NMPA

Level / Type

Industry · Recommended

Issue date

January 13, 2023

Implementation date

January 15, 2024

Scope

YY/T 1473-2023 is the English-translated version of 医疗器械标准化工作指南涉及安全内容的标准制定.

YY/T 1473-2023 is the Chinese standard "Guide for standardization for medical devices - Inclusion of safety aspects in standards". Its scope clause reads: This document provides standards writers with requirements and recommendations for including safety-related content in medical device standards.

These requirements and The recommendations are based on established risk management concepts and approaches. This document applies to the safety-related content of personnel, property, environment or a combination of these factors involved in medical device standards.

In this document, the term "product" includes a single medical device or a combination of one or more medical devices (may also be used in combination with non-medical devices) composed system. Its clauses include terms and definitions.

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Document preview — YY/T 1473-2023

National Standard of the People's Republic of China

ICS: 11.040.01; 01.120
Classification: C30

Issued by: National Medical Products Administration

Preface
Introduction
1 Scope
2 Normative references
3 Terms and Definitions
4 Use of the terms "safe", "safe", "effective" and "effectiveness"
4.1 Security
4.2 Safe
4.3 Effective
4.4 Effectiveness
5 Principles for Safety Content in Medical Device Standards
5.1 Scope of medical device standards involving safety content
5.2 Purpose of medical device standards involving safety content
5.3 Standard type
5.4 Looking at security issues from a practical perspective
5.5 Harmonization of medical device standards
5.6 Meaning of standards used by laws or regulations
6 The nature of the risk
6.1 Elements of Risk
6.2 Systematic or random risks
7 Risk-based process for developing medical device standards involving safety content
7.1 General
7.2 Preparation
7.3 Drafting
7.4 Validation of standards
7.5 Conclusion
8 Overview of the application of medical device standards with safety aspects within a risk management framework

1 Scope

This document provides standards writers with requirements and recommendations for including safety-related content in medical device standards. These requirements and

The recommendations are based on established risk management concepts and approaches.

This document applies to the safety-related content of personnel, property, environment or a combination of these factors involved in medical device standards.

In this document, the term "product" includes a single medical device or a combination of one or more medical devices (may also be used in combination with non-medical devices) composed system.

2 Normative references

This document has no normative references.

3 Terms and Definitions

The following terms and definitions apply to this document.

3.1 hurt harm

Injury or damage to human health, or damage to property or the environment.

[Source. GB/T.20002.4-2015, 3.1, with modifications]

3.2 danger hazard

potential source of harm (3.1).

[Source. GB/T.20002.4-2015, 3.2]

3.3 hazardous situation

Situation in which people, property or the environment are exposed to one or more hazards (3.2).

[Source. GB/T.20002.4-2015, 3.4]

3.4 intended use

intended use of a product, process or service in accordance with the specifications, instructions and information provided by the manufacturer (3.6)

NOTE. The intended medical indication, patient population, body part or tissue type with which the medical device interacts, user characteristics, environment of use, and principle of operation are

Typical elements of use.

3.5 life cycle

All stages in the life of a medical device, from initial concept to eventual decommissioning and disposal.

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

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YY/T 1465.6|YY/T 1465.4|YY/T 1465.5|YY/T 1465.7

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