YY/T 0567.7-2016Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (English PDF)

Foreword

YY/T 0567 "Sterile processing of health care products" is divided into the following sections.

- Part 1. General requirements; Part 2. Filtering;

- Part 3. freeze - drying method;

- Part 4. Online cleaning technology;

- Part 5. Online sterilization;

- Part 6. Isolator systems;

- Part 7. Alternative processing of medical devices and combined products. This part is part 7 of YY/T 0567.

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

This part is equivalent to ISO 13408-7.:2012 "Sterile processing of health care products Part 7. Medical devices and their combination products Alternative Processing ".

Introduction

YY/T 0567 is an industry standard for aseptic processing of health care products. Historically, sterile medical products are usually liquid, Powder or suspension, usually not finally sterilized. Recently, medical devices and medical products have evolved into combination with drug-containing products, including organisms Active cells, these products can not be finally sterilized.

YY/T 0567.1-2013 requirements for the production of simulated medical equipment and combination of products to provide. And this part of the content to

YY/T 0567.1-2013, based on the development of alternative methods to simulate the sterile processing of medical devices and combinations of products and make it meet The quality standards set out the requirements and provide guidance.

YY/T 0567.1-2013 10.1.2 Medical devices or combinations that can not be evaluated using conventional liquid culture filling methods Type products, should be used to simulate alternative production methods.

Generally require sterile processing of medical devices and their combination products may include the following, for example.

a) Medical devices that can not be used in accordance with YY/T 0567.1-2013 using simulated production methods and for final sterilization.

--- biological prostheses (such as heart valves, vascular stents, etc.); Biodegradable implanted material (eg hernia patch);

- artificial and/or non-bioactive substrates;

- in vitro treatment equipment (eg immunosorbette);

--- Implantable osmotic pump;

--- Fully enclosed electromechanical facilities and partially enclosed electronic facilities (eg invasive and non-invasive diagnostic equipment).

b) Combination products (including active cell matrix products).

- implants covered with drugs and/or biologically derived substances (eg drug scaffolds, carrier-carrying substances, Long factor bone graft material, biodegradable drug scaffold);

- wound dressings (eg dressings containing hemostatic agents, tissue sealants or biological agents);

- percutaneous or injectable release systems (eg drug patch containing drug coating or biologics);

A kit consisting of a biological agent or a pharmaceutical ingredient (e.g., a decalcified bone matrix).

The entire product life/production cycle, the use of risk management strategies and methods to identify the risk of pollution, assessment and quantification, and the use of the environment Monitoring and microbiology research to evaluate the effectiveness of pollution control and risk control. Design simulation production based on risk analysis results, such as simulation Production results are acceptable, indicating that the aseptic processing in the pollution control state (that is, in the aseptic processing process did not introduce foreign micro Substance/microbial contaminants). This part can be used in conjunction with YY/T 0567.1-2013. Sterile processing of health care products - Part 7. Alternative processing of medical devices and combined products

1 Scope

This standard specifies a medical device that can not be final sterilized and is not suitable for YY/T 0567.1-2013 simulated production methods Equipment and combinations of products, aseptic processing performance confirmation of the simulation production alternative requirements, and provide guidance.

This standard is applicable to the development of aseptic processing during the development of sterile processing, when the processing is not allowed to use the media directly substitute products, or the media can not replace On the basis of practical aseptic processing, the use of risk assessment to design medical equipment and combinatorial products simulation production research.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

YY/T 0567.1-2013 Sterile processing of health care products - Part 1. General requirements (ISO 13408-1.:2008, IDT)

3 Terms and definitions YY/T 0567.1-2013 and the following

terms and definitions apply to this document.

4 Quality system elements

YY/T 0567.1-2013 Chapter 4 applies.

5 Definition of aseptic processing