YY/T 0595-2006Medical devices-Quality management systems-Guidance on the application of YY/T0287-2003 (English PDF)

1 Foreword

YY/T 0595-2006 was issued by National Medical Products Administration of the People's Republic of China on 19 June 2006 and has been in force since 1 May 2007.

This standard is identical to ISO/TR 14969:2004 "Medical Devices — Quality Management Systems — Guidance on the Application of ISO 13485:2003". ISO 13485:2003 already translated into YY/T 0287-2003 "Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes".

The word "should" used in this standard just for directing or assigning role, which is different from the word "shall" used in YY/T 0287-2003 (idt ISO 13485:2003).

This standard can be used together with YY/T 0287 "Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes".

Appendix A and Appendix B of this standard are informative.

Throughout this standard, when the text of YY/T 0287-2003 is directly quoted, it appears enclosed in boxes prefaced by: “YY/T 0287-2003, Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes”.

2 Introduction

0.1.1 This standard provides guidance to assist in the development, implementation and maintenance of quality management systems that aim to meet the requirements of YY/T 0287 for organizations that design and develop, produce, install and service medical devices, or that design, develop and provide related services. It provides guidance related to quality management systems for a wide variety of medical devices and related services. Such medical devices include active, non-active, implantable and non-implantable medical devices and in vitro diagnostic medical devices.

YY/T 0287 specifies the quality management system requirements for medical devices for regulatory purposes (see Appendix A). YY/T 0287 accommodates the previous YY/T 0288 by permissible exclusion as specified in YY/T 0287-2003, 1.2.

When judging the applicability of the guidance in this standard, one should consider the nature of the medical device(s) to which it will apply, the risk associated with the use of these medical devices, and the applicable regulatory requirements.

As used in this standard, the term “regulatory requirement” includes any part of a law, ordinance, decree or national and/or regional regulation applicable to quality management systems for medical devices and related services.

This standard provides some approaches that an organization can use to implement and maintain a quality management system which conforms with YY/T 0287. Alternative approaches can be used if they also satisfy the requirements of YY/T 0287.

0.1.2 The guidance given in this standard is applicable to the design, development, production, installation and servicing of medical devices of all kinds. It describes concepts and methods that can be considered by organizations which are establishing and maintaining quality management systems.

3 Scope Preview

YY/T 0595-2006 carries no ICS number and no Chinese Standard Classification code.

This catalogue holds 2,111 other YY/T standards.

Of the 977 YY/T standards that do carry an ICS number, 960 (98%) fall under ICS 11, in the field of health care technology.

4 About this standard

Issued by: National Medical Products Administration of the People's Republic of China

English translation: about 56 pages

5 Related standards

Other editions:

YY/T 0595-2020 (later edition)

6 Classification and status

Chinese Standard Classification (CCS): C 37

Prefix YY/T: recommended standard.