YY/T 0467-2016Medical devices-Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices (English PDF)

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY/T 0467-2003 "Medical equipment to protect the safety and performance of medical devices recognized the basic principles of the standard selection refers to south". Compared with YY/T 0467-2003, the main changes are as follows.

--- modified the "preface";

- the addition of the "basic standard" (see 4.1);

--- Added "standard accreditation" (see 4.2);

--- Appendix A name changed to "basic principle and standard correspondence table";

Added an example of the reference to "basic criteria" in Appendix B;

- a list of additional URLs for Appendix C "suitable for medical device industry and assessment purposes";

--- modified the reference.

This standard uses the translation method equivalent to ISO /T R16142..2006 "Medical equipment to ensure the safety and performance of medical equipment recognized basic Guidelines for the Selection of Principles of Principles "(English version).

And the normative reference in this standard international documents are consistent with the relationship between China's documents are as follows.

--- GB/T 1962 (All Parts) Syringes, Needles and Other Medical Devices 6% (Ruhr) Cone Joints [ISO 594 section)]

--- GB 4793 (all parts) Safety requirements for electrical equipment for measurement, control and laboratory use [IEC 61010 (all parts)]

GB/T 5465.2-1996 Graphical symbols for electrical equipment (IEC 60417.:1994, IDT) A technical committee or subcommittee within the scope of a specific or a family of products, processes or services of all necessary Safety and basic performance requirements (as far as possible references to basic standards and class standards).

--- GB 9706 (all parts) Medical electrical equipment [IEC 60601 (all parts)]

GB/T 16237.1-1996 Symbols for graphic symbols for equipment (ISO 7000. 1989, IDT)

--- GB/T 16886 (all parts) Biological evaluation of medical devices [ISO 10993 (all parts)]

--- GB 18279 (all parts) Health care products Sterilized ethylene oxide [ISO 11135 (all parts)]

--- GB 18280 (all parts) Health care products Sterilization radiation [ISO 11137 (all parts)]

--- GB 19633 (all parts) Packaging of the final sterilized medical device [ISO 11607 (all parts)]

--- GB/T 19973 (all parts) Sterilization of medical devices Microbiological methods [ISO 11737 (all parts)]

GB/T 19974-2005 Characteristics of sterilization factor for medical care products and setting of sterilization process for medical devices And general requirements for routine control (ISO 14937.:2000, IDT)

GB/T 20000.4-2003 Guidelines for the standardization of work Part 4. Safety content in the standard (ISO /IEC Guide 51..1999, MOD)

--- YY/T 0287-2003 Medical device quality management system for regulatory requirements (ISO 13485.:2003, IDT)

--- YY/T 0297 (all parts) Clinical investigation of medical devices [ISO 14155 (all parts)]

- YY/T 0316-2008 Medical Device Risk Management for Medical Devices (ISO 14971.:2007, IDT)

--- YY/T 0466 (all parts) Medical devices Symbols for labeling, labeling and providing information on medical devices [ISO 15223 (All parts)]

- YY/T 0567 (all parts) Sterile processing of medical products [ISO 13408 (all parts)]

YY/T 0595-2006 Medical Device Quality Management System YY/T 0287-2003 Application Note (ISO /TR 14969.:2004, IDT)

- YY/T 0771.1-2009 Animal source medical device - Part 1. Risk management applications (ISO 22442-1.:2007, IDT)

- YY/T 0771.2-2009 Animal sources Medical devices - Part 2. Control of sources, collection and disposal (ISO 22442-2.:2007, IDT)

- YY/T 0771.3-2009 Animal source medical device - Part 3. Virus and transmissible spongiform encephalopathy (TSE) factor In addition to confirmation of inactivation (ISO 22442-3.:2007, IDT)

Introduction

The standard and standardization process can be made more effective by better understanding the needs and requirements of standard users or standard affected persons. standard Will help to promote global coordination at all levels.

Continuous innovation is the key to improving medical device technology and promoting more effective health care. Regulatory requirements or supportive standards The use of standards and the use of the product should ensure that the safety and effectiveness of the product at the same time, allowing the industry to product innovation.

The timely and regular revision of medical device standards makes it an effective and efficient way to support regulatory systems and promote global compliance laws and regulations tool.

Recommended standards and guidelines can help manufacturers comply with statutory requirements, and if the criteria are recognized for inclusion in a given regulatory system, The standard can be considered to meet the statutory requirements. This kind of regulatory acceptance does not in itself mean that these standards are mandatory.

The medical device standard sets out the consensus requirements for promoting public health while promoting innovation.

The harmonization of regulations is a key factor in the timely introduction of advanced technology into the market, and the appropriate use of relevant medical device standards can promote regulation The coherence. These should be based on the following prerequisites.

--- standards should be based on experience, in other words, is retrospective;

--- Innovation may indicate an unpredictable challenge to experience;

--- The rigid, mandatory application of the standard may hinder innovation;

The operation of the assessed quality management system has been widely recognized as a basic and effective tool for the protection of public health;

--- quality management system provides a description of innovation and experience;

- The quality management system provides on-site experience, risk analysis and management, phase review, document and record keeping, and product Standard use of the standard.

1 Scope

This standard considers and identifies certain important criteria and guidelines that are useful for the assessment of compliance with the basic principles of medical device safety and performance.

This standard is intended for use by manufacturers, standardization bodies and regulatory agencies for compliance assessment.

2 Terms and definitions

The following terms and definitions apply to this document.

3 Medical equipment safety and performance of the basic principles

Safety and performance (hereinafter referred to as "the basic principles") provides for the general requirements for the design and manufacture of medical devices to ensure that Safety and performance. This concept is used to promote medicine The integration of equipment regulatory system development.

To ensure that the relevant basic principles are met, the manufacturer may use a consensus standard that sets out the basic principles. These standards provide a more basic than the original You can express the more detailed content. Likewise, the legislator may consider the basic principles and their associated standards in the medical device regulatory system is useful.

4 to ensure the application of standards and guidelines for regulatory requirements

4 Application of standards and guidelines for regulatory requirements