YY 0333-2010Soft-tissue expander device (English PDF)

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. This standard and ASTM F1441-03 "soft tissue expander standards," the non-equivalent.

This standard replaces YY 0333-2002 "soft tissue expander." The main technical differences between this standard and YY 0333-2002 that.

--- Increased soft tissue expander classification;

--- Seam into critical and non-critical seams seams, increased non-critical joint connection strength requirements;

--- Increasing the injection seat specifications;

--- Increasing the pipeline to extend the joint strength test;

--- Increased volume requirements, size, fixed position, targeting methods;

--- Removes the requirement housing physical and mechanical properties of elongation;

--- Cancel the inspection rules.

This standard by the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center.

This standard drafting units. Shandong Medical Devices Product Quality Inspection Center.

Introduction

Soft tissue expander surgery is expected to be placed in the muscles or soft tissues of the instrument.

Soft tissue expander is expected at the implantation site filling, so that the pressure is sufficient to expand the implant site soft tissue. This expansion may also occur in the soft tissue Weaving the stent envelope or housing, because the expansion may be filling in normal use exceeds its nominal volume, which is also considered to be reasonable of. To make use of leak or collapse of the possible minimum, this standard includes structural materials, adhesive bonding or physical area and the connecting member Energy requirements.

When using a hypodermic needle through the soft tissue expander injection seat expansion is completed, in order to achieve proper expansion, generally need to occasionally Its multiple injections. Accordingly, the standard include multiple injections of anti-needle injection seat leakage requirements.

Soft tissue expander covered by this standard in order to achieve its intended purpose, which is expected to have many shapes and sizes, types and design of its junction Materials of construction will be a lot. Thus, the standard includes requirements for the label, including the expansion given the features and functionality of the appropriate use and other information.

Methodology and indicators for tear test without making the appropriate consideration, so the standard is not the final product made tear requirements.

The performance requirements for the preparation of a gap measurements on the sample, the instrument due to cracks caused by narrow and severely damaged. Recommended by the GB/T 529 constituting the soft tissue expander raw materials used tear tests, test results and evaluate whether the supplier material specification Consistent.

This standard includes technology infrastructure based on the requirements of the present stage of science. These requirements have been proven to ensure a soft tissue expander assembly Have appropriate safety and efficacy is crucial.

This standard does not apply to equipment production expectations related science and technology has brought restrictions. If there are new information, or based on previous scientific Where relevant scientific and technical equipment level changes, we need to consider the revision of this standard. Soft tissue expander

1 Scope

This standard applies to single-use can be filled with brine, used in surgery or post-implant soft tissue expander removed within 6 months.

This standard applies only to soft tissue expander housing is made of an elastic, do not include any other standard production of customized soft tissue expansion Zhang is. For the "expander/breast" combination instrument, this standard applies (see 4.3).

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 528-1998 Determination of vulcanized rubber or thermoplastic rubber tensile stress-strain properties

GB 15811-time use of sterile needles

YY 0334 silicone rubber surgical implants - General requirements

YY 0647 requirements for active surgical implants breast implants

3 Terms and Definitions

The following terms and definitions apply to this document.