YY 0332-2011Implantable drug delivery devices (English PDF)

Foreword

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

This standard replaces YY 0332-2002 "implantable drug delivery device", compared with YY 0332-2002, the main technical changes are as follows.

--- Modified puncture crumbs falling demands, and only limited use of special needles;

--- Given product classification of single and multi-cavity;

--- Canceled suture pinhole requirements;

--- Connect securely requirements change into dynamic fracture strength requirements;

--- Modify the X-ray detectability test methods;

--- For intravenous drug delivery device, the injection units are recommended transparent material;

--- Modify the flexural properties;

--- Cancel the inspection rules.

1 Scope

This standard specifies the implanted drug delivery system (hereinafter. the delivery device, see 3.1) requirements.

This standard does not specify the drug delivery device supporting the supply of auxiliary equipment requirements.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 14233.2 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods

GB 15810 single-use sterile syringes

GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation of the risk management process and Test

YY/T 0313-1998 Medical Polymer Co., packaging, labeling, transportation and storage

YY 0334 silicone rubber surgical implants - General requirements

YY/T 0586-2005 Medical Polymer Co. X-ray opaque Test Method

YY 0881 disposable needle implantable drug delivery system dedicated

ISO 5832 (all parts) 1) metallic materials for surgical implants

3 Terms and Definitions

The following terms and definitions apply to this document.